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Nix Oxaliplatin, Up Radiation in Locally Advanced Rectal Cancer
MIAMI BEACH – For patients with locally advanced rectal cancer, hold the oxaliplatin, but up the preoperative radiation dose from 45 to 50 Gy, French investigators advised oncologists at a meeting here.
Chemoradiation with a less-toxic capecitabine (Xeloda)–containing regimen and 50 Gy radiation should become the standard of therapy for preoperative chemoradiation in patients with locally advanced rectal cancer, according to Dr. Jean-Pierre Gerard and his colleagues.
The assertion is based on evidence from a large phase III trial presented by Dr. Gerard and from earlier American and Italian studies suggesting better local control with higher radiation doses, but added toxicity from oxaliplatin (Eloxatin) without additional therapeutic benefit.
The evidence also suggests that capecitabine, which is given orally, can replace intravenous 5-fluourouracil (5-FU) infusions in this clinical setting, said Dr. Gerard, a radiation oncologist at the Centre Antoine-Lacassagne in Nice, France.
"When we take all the trials together, we propose the regimen we call ‘CAP50,’ where we give 5 weeks of treatment with 50 Gy, not 45 Gy. You sterilize more tumor, have only 4% local recurrence, replace 5-FU infusion with capecitabine by mouth – it’s very easy – and you delete oxaliplatin," Dr. Gerard said in a briefing at annual meeting of the American Society for Radiation Oncology, where he gave 3-year results from the ACCORD 12 trial.
Not everyone was convinced. Dr. Karyn A. Goodman, the invited discussant of Dr. Gerard’s featured talk in the meeting’s plenary session, said it’s difficult to tease out this conclusion from the data presented because the ACCORD 12 investigators, in an attempt to conduct a "pragmatic trial," moved the goalposts by changing the treatment parameters three times.
"The investigators took several leaps in the design of the study which make interpretation of their results more difficult," said Dr. Goodman from Memorial Sloan-Kettering Cancer Center in New York.
"First, they simultaneously increased the radiation dose to 50 Gy in 2-Gy fractions and added oxaliplatin in the experimental arm," she explained.
"Second, they changed the baseline chemotherapy from 5-FU to capecitabine, which is at a slightly lower dose than has been given in other preoperative chemoradiotherapy trials.
"Third, the primary end point was pathologic complete response, a marker for response that has not been validated as a surrogate for overall survival, and has even been shown ... to have not yet fulfilled the criteria to be a surrogate for overall survival or local control."
In addition, the study was powered to detect a large difference in pathological complete response rate, thus allowing for a smaller sample than would ordinarily be required to evaluate the effect of adjuvant therapy on colorectal cancer, Dr. Goodman added.
The rationale for ACCORD 12 came from large studies showing that even with total mesorectal excision, preoperative radiotherapy decreased local recurrence rates and that chemoradiotherapy – particularly preoperatively – was better than radiotherapy alone.
The trial designers emulated the design of the Italian STAR 01 trial (which was ongoing at the time the ACCORD 12 was started) by including oxaliplatin and with 50 Gy radiation prior to surgery in 747 patients. That trial, results of which were reported at the 2009 ASCO annual meeting, showed that oxaliplatin added nothing but toxicity to the therapeutic regimen
Dr. Gerard presented 3-year results from the study on 598 patients in an intention-to-treat population. The patients were randomized to receive either preoperative capecitabine 1600 mg/m2 for 5 days plus 45 Gy radiation in 1.8-Gy fractions or capecitabine at the same dose plus oxaliplatin 50 mg/m2 weekly plus 50 Gy divided into 2-Gy fractions. All patients then underwent total mesorectal excision, with adjuvant therapy at the treating center\'s discretion.
Early results, published in 2010 (J. Clin. Oncol. 2010;28:1638-44) showed no significant differences between capecitabine and 45 Gy (Cap45) and capecitabine plus oxaliplatin and 50 Gy (Capox50) for the primary end point of pathological complete response rates according to the Dworak criteria: 13.9% for 287 patients treated with Cap45 vs. 19.2% for 287 patients treated with Capox50 (P = .09). Grade 3 or 4 toxicities, however, were twice as high in the Capox50 patients, at 25%, compared with 11% of patients treated with Cap45 (P less than .001). This analysis was for the as-treated population.
At 3 years (intention-to-treat population, 299 patients in each arm), Dr. Gerard reported no significant differences between Cap45 and Capox50 in local recurrence (6.1% vs. 4.4%), distant metastases (25% vs. 21%), disease-free survival (71% vs. 73%), overall survival (85% vs. 88%), or grade 3 or great toxicities (2.7%, 4 patients, vs. 1.3%, 2 patients).
In exploratory analyses, significant predictors for 3-year disease-free survival were pathological stage (T0-1 vs. T2 or T3; P less than .00001), nodal status (N0 vs. N1-2; P less than .0001), and close margins (1 mm or less vs. greater than 1 mm; P less than .0001).
The investigations concluded that oxaliplatin increases toxicity (primarily diarrhea) without affecting pathological response, that 50 Gy over 5 weeks is compatible with surgery and may help to sterilize the surgical sample, and that capecitabine has activity equivalent to that of 5-FU, without the need for intravenous infusion.
The ACCORD 12 trial was supported in part by Roche and Sanofi-Aventis together with a grant of the French National Program of Research Programmes Hospitaliers de Recherche Clinique. It was conducted under the auspices of Institut National du Cancer. Dr. Gerard and Dr. Goodman reported that they had no relevant financial disclosures.
MIAMI BEACH – For patients with locally advanced rectal cancer, hold the oxaliplatin, but up the preoperative radiation dose from 45 to 50 Gy, French investigators advised oncologists at a meeting here.
Chemoradiation with a less-toxic capecitabine (Xeloda)–containing regimen and 50 Gy radiation should become the standard of therapy for preoperative chemoradiation in patients with locally advanced rectal cancer, according to Dr. Jean-Pierre Gerard and his colleagues.
The assertion is based on evidence from a large phase III trial presented by Dr. Gerard and from earlier American and Italian studies suggesting better local control with higher radiation doses, but added toxicity from oxaliplatin (Eloxatin) without additional therapeutic benefit.
The evidence also suggests that capecitabine, which is given orally, can replace intravenous 5-fluourouracil (5-FU) infusions in this clinical setting, said Dr. Gerard, a radiation oncologist at the Centre Antoine-Lacassagne in Nice, France.
"When we take all the trials together, we propose the regimen we call ‘CAP50,’ where we give 5 weeks of treatment with 50 Gy, not 45 Gy. You sterilize more tumor, have only 4% local recurrence, replace 5-FU infusion with capecitabine by mouth – it’s very easy – and you delete oxaliplatin," Dr. Gerard said in a briefing at annual meeting of the American Society for Radiation Oncology, where he gave 3-year results from the ACCORD 12 trial.
Not everyone was convinced. Dr. Karyn A. Goodman, the invited discussant of Dr. Gerard’s featured talk in the meeting’s plenary session, said it’s difficult to tease out this conclusion from the data presented because the ACCORD 12 investigators, in an attempt to conduct a "pragmatic trial," moved the goalposts by changing the treatment parameters three times.
"The investigators took several leaps in the design of the study which make interpretation of their results more difficult," said Dr. Goodman from Memorial Sloan-Kettering Cancer Center in New York.
"First, they simultaneously increased the radiation dose to 50 Gy in 2-Gy fractions and added oxaliplatin in the experimental arm," she explained.
"Second, they changed the baseline chemotherapy from 5-FU to capecitabine, which is at a slightly lower dose than has been given in other preoperative chemoradiotherapy trials.
"Third, the primary end point was pathologic complete response, a marker for response that has not been validated as a surrogate for overall survival, and has even been shown ... to have not yet fulfilled the criteria to be a surrogate for overall survival or local control."
In addition, the study was powered to detect a large difference in pathological complete response rate, thus allowing for a smaller sample than would ordinarily be required to evaluate the effect of adjuvant therapy on colorectal cancer, Dr. Goodman added.
The rationale for ACCORD 12 came from large studies showing that even with total mesorectal excision, preoperative radiotherapy decreased local recurrence rates and that chemoradiotherapy – particularly preoperatively – was better than radiotherapy alone.
The trial designers emulated the design of the Italian STAR 01 trial (which was ongoing at the time the ACCORD 12 was started) by including oxaliplatin and with 50 Gy radiation prior to surgery in 747 patients. That trial, results of which were reported at the 2009 ASCO annual meeting, showed that oxaliplatin added nothing but toxicity to the therapeutic regimen
Dr. Gerard presented 3-year results from the study on 598 patients in an intention-to-treat population. The patients were randomized to receive either preoperative capecitabine 1600 mg/m2 for 5 days plus 45 Gy radiation in 1.8-Gy fractions or capecitabine at the same dose plus oxaliplatin 50 mg/m2 weekly plus 50 Gy divided into 2-Gy fractions. All patients then underwent total mesorectal excision, with adjuvant therapy at the treating center\'s discretion.
Early results, published in 2010 (J. Clin. Oncol. 2010;28:1638-44) showed no significant differences between capecitabine and 45 Gy (Cap45) and capecitabine plus oxaliplatin and 50 Gy (Capox50) for the primary end point of pathological complete response rates according to the Dworak criteria: 13.9% for 287 patients treated with Cap45 vs. 19.2% for 287 patients treated with Capox50 (P = .09). Grade 3 or 4 toxicities, however, were twice as high in the Capox50 patients, at 25%, compared with 11% of patients treated with Cap45 (P less than .001). This analysis was for the as-treated population.
At 3 years (intention-to-treat population, 299 patients in each arm), Dr. Gerard reported no significant differences between Cap45 and Capox50 in local recurrence (6.1% vs. 4.4%), distant metastases (25% vs. 21%), disease-free survival (71% vs. 73%), overall survival (85% vs. 88%), or grade 3 or great toxicities (2.7%, 4 patients, vs. 1.3%, 2 patients).
In exploratory analyses, significant predictors for 3-year disease-free survival were pathological stage (T0-1 vs. T2 or T3; P less than .00001), nodal status (N0 vs. N1-2; P less than .0001), and close margins (1 mm or less vs. greater than 1 mm; P less than .0001).
The investigations concluded that oxaliplatin increases toxicity (primarily diarrhea) without affecting pathological response, that 50 Gy over 5 weeks is compatible with surgery and may help to sterilize the surgical sample, and that capecitabine has activity equivalent to that of 5-FU, without the need for intravenous infusion.
The ACCORD 12 trial was supported in part by Roche and Sanofi-Aventis together with a grant of the French National Program of Research Programmes Hospitaliers de Recherche Clinique. It was conducted under the auspices of Institut National du Cancer. Dr. Gerard and Dr. Goodman reported that they had no relevant financial disclosures.
MIAMI BEACH – For patients with locally advanced rectal cancer, hold the oxaliplatin, but up the preoperative radiation dose from 45 to 50 Gy, French investigators advised oncologists at a meeting here.
Chemoradiation with a less-toxic capecitabine (Xeloda)–containing regimen and 50 Gy radiation should become the standard of therapy for preoperative chemoradiation in patients with locally advanced rectal cancer, according to Dr. Jean-Pierre Gerard and his colleagues.
The assertion is based on evidence from a large phase III trial presented by Dr. Gerard and from earlier American and Italian studies suggesting better local control with higher radiation doses, but added toxicity from oxaliplatin (Eloxatin) without additional therapeutic benefit.
The evidence also suggests that capecitabine, which is given orally, can replace intravenous 5-fluourouracil (5-FU) infusions in this clinical setting, said Dr. Gerard, a radiation oncologist at the Centre Antoine-Lacassagne in Nice, France.
"When we take all the trials together, we propose the regimen we call ‘CAP50,’ where we give 5 weeks of treatment with 50 Gy, not 45 Gy. You sterilize more tumor, have only 4% local recurrence, replace 5-FU infusion with capecitabine by mouth – it’s very easy – and you delete oxaliplatin," Dr. Gerard said in a briefing at annual meeting of the American Society for Radiation Oncology, where he gave 3-year results from the ACCORD 12 trial.
Not everyone was convinced. Dr. Karyn A. Goodman, the invited discussant of Dr. Gerard’s featured talk in the meeting’s plenary session, said it’s difficult to tease out this conclusion from the data presented because the ACCORD 12 investigators, in an attempt to conduct a "pragmatic trial," moved the goalposts by changing the treatment parameters three times.
"The investigators took several leaps in the design of the study which make interpretation of their results more difficult," said Dr. Goodman from Memorial Sloan-Kettering Cancer Center in New York.
"First, they simultaneously increased the radiation dose to 50 Gy in 2-Gy fractions and added oxaliplatin in the experimental arm," she explained.
"Second, they changed the baseline chemotherapy from 5-FU to capecitabine, which is at a slightly lower dose than has been given in other preoperative chemoradiotherapy trials.
"Third, the primary end point was pathologic complete response, a marker for response that has not been validated as a surrogate for overall survival, and has even been shown ... to have not yet fulfilled the criteria to be a surrogate for overall survival or local control."
In addition, the study was powered to detect a large difference in pathological complete response rate, thus allowing for a smaller sample than would ordinarily be required to evaluate the effect of adjuvant therapy on colorectal cancer, Dr. Goodman added.
The rationale for ACCORD 12 came from large studies showing that even with total mesorectal excision, preoperative radiotherapy decreased local recurrence rates and that chemoradiotherapy – particularly preoperatively – was better than radiotherapy alone.
The trial designers emulated the design of the Italian STAR 01 trial (which was ongoing at the time the ACCORD 12 was started) by including oxaliplatin and with 50 Gy radiation prior to surgery in 747 patients. That trial, results of which were reported at the 2009 ASCO annual meeting, showed that oxaliplatin added nothing but toxicity to the therapeutic regimen
Dr. Gerard presented 3-year results from the study on 598 patients in an intention-to-treat population. The patients were randomized to receive either preoperative capecitabine 1600 mg/m2 for 5 days plus 45 Gy radiation in 1.8-Gy fractions or capecitabine at the same dose plus oxaliplatin 50 mg/m2 weekly plus 50 Gy divided into 2-Gy fractions. All patients then underwent total mesorectal excision, with adjuvant therapy at the treating center\'s discretion.
Early results, published in 2010 (J. Clin. Oncol. 2010;28:1638-44) showed no significant differences between capecitabine and 45 Gy (Cap45) and capecitabine plus oxaliplatin and 50 Gy (Capox50) for the primary end point of pathological complete response rates according to the Dworak criteria: 13.9% for 287 patients treated with Cap45 vs. 19.2% for 287 patients treated with Capox50 (P = .09). Grade 3 or 4 toxicities, however, were twice as high in the Capox50 patients, at 25%, compared with 11% of patients treated with Cap45 (P less than .001). This analysis was for the as-treated population.
At 3 years (intention-to-treat population, 299 patients in each arm), Dr. Gerard reported no significant differences between Cap45 and Capox50 in local recurrence (6.1% vs. 4.4%), distant metastases (25% vs. 21%), disease-free survival (71% vs. 73%), overall survival (85% vs. 88%), or grade 3 or great toxicities (2.7%, 4 patients, vs. 1.3%, 2 patients).
In exploratory analyses, significant predictors for 3-year disease-free survival were pathological stage (T0-1 vs. T2 or T3; P less than .00001), nodal status (N0 vs. N1-2; P less than .0001), and close margins (1 mm or less vs. greater than 1 mm; P less than .0001).
The investigations concluded that oxaliplatin increases toxicity (primarily diarrhea) without affecting pathological response, that 50 Gy over 5 weeks is compatible with surgery and may help to sterilize the surgical sample, and that capecitabine has activity equivalent to that of 5-FU, without the need for intravenous infusion.
The ACCORD 12 trial was supported in part by Roche and Sanofi-Aventis together with a grant of the French National Program of Research Programmes Hospitaliers de Recherche Clinique. It was conducted under the auspices of Institut National du Cancer. Dr. Gerard and Dr. Goodman reported that they had no relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR RADIATION ONCOLOGY
Major Finding: At 3 years, there were no significant differences between Cap45 and Capox50 in local recurrence (6.1% vs. 4.4%), distant metastases (25% vs. 21%), disease-free survival (71% vs. 73%), overall survival (85% vs. 88%), or grade 3 or great toxicities (2.7% vs. 1.3%).
Data Source: 598 patients with advanced rectal cancer in the phase III, randomized ACCORD 12 trial.
Disclosures: The trial was supported in part by Roche and Sanofi- Aventis together with a grant of the French National Program of Research Programmes. It was conducted under the auspices of Institut National du Cancer. Dr. Gerard and Dr. Goodman reported that they had no relevant financial disclosures.
Less Toxic IMRT Controls Cervical Cancer After Hysterectomy
MIAMI BEACH – For women with cervical cancer, intensity-modulated radiation therapy to the pelvis after surgery provides disease control similar to that seen with standard external beam radiation therapy, but with lower acute bowel toxicity, investigators reported here.
Two-year results from the phase II Radiation Therapy Oncology Group (RTOG) 0418 trial showed that the combination of the newer radiation technique and weekly cisplatin chemotherapy was associated with an estimated disease-free survival rate of 86.9%. This compares with historic data, Dr. Lorraine Portelance told attendees at the annual meeting of the American Society for Radiation Oncology (ASTRO).
The RTOG investigators had previously reported that pelvic intensity-modulated radiation therapy (IMRT) to 50.4 Gy delivered over 28 fractions plus weekly cisplatin 40 mg/m2 with or without vaginal brachytherapy was associated with a significant reduction in grade 2 or greater short-term bowel toxicity compared with historical controls.
"One very important question remained, though: were we able to achieve decreased toxicity and good chemotherapy compliance at a cost of disease control loss? We have now reached the point where we could analyze the secondary end point of disease control, which is of prime importance to determine if this disease approach is viable," said Dr. Portelance from the University of Miami’s Sylvester Comprehensive Cancer Center.
A total of 40 patients from 25 institutions were eligible for analysis of the secondary end point. All had hysterectomies (3 total abdominal, 3 vaginal, 28 radical, and 6 laparoscopic assisted).
Two patients (5%) had International Federation of Gynecologists and Obstetricians (FIGO) stage IA disease; 31 (77.5%) had stage IB; 4 (10%) had stage IIA; and 3 (7.5) had stage IIB disease. In 25 patients there was no nodal involvement; 15 had 1 involved node.
At a median 2.68 years’ follow-up, there were 5 local-regional relapses (estimated 2-year rate, 10.6%); 3 para-aortic nodes involved (5.3%); and 4 distant metastases (excluding the para-aortic nodes; 10.3%).
Dr. Portelance noted that this translated into an estimated 2-year disease-free survival rate of 86.9%, which is comparable to that shown in an intergroup trial, published in 2000, that compared concurrent chemotherapy and pelvic radiation therapy with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cervical cancer (J. Clin. Oncol. 2000;18:1606-13).
In the RTOG 0418 trial, the estimated 2-year overall survival rate is 94.6%, again comparable with previously published data, Dr. Portelance said.
"This ROTG 0418 study provides level II evidence that, when done under clear guidelines, postoperative pelvic intensity-modulated radiation could lead to decreased toxicity and excellent chemotherapy without any cost in disease control," she concluded.
The study was supported by grants from the National Cancer Institute. Dr. Portelance said she had no conflicts of interest.
MIAMI BEACH – For women with cervical cancer, intensity-modulated radiation therapy to the pelvis after surgery provides disease control similar to that seen with standard external beam radiation therapy, but with lower acute bowel toxicity, investigators reported here.
Two-year results from the phase II Radiation Therapy Oncology Group (RTOG) 0418 trial showed that the combination of the newer radiation technique and weekly cisplatin chemotherapy was associated with an estimated disease-free survival rate of 86.9%. This compares with historic data, Dr. Lorraine Portelance told attendees at the annual meeting of the American Society for Radiation Oncology (ASTRO).
The RTOG investigators had previously reported that pelvic intensity-modulated radiation therapy (IMRT) to 50.4 Gy delivered over 28 fractions plus weekly cisplatin 40 mg/m2 with or without vaginal brachytherapy was associated with a significant reduction in grade 2 or greater short-term bowel toxicity compared with historical controls.
"One very important question remained, though: were we able to achieve decreased toxicity and good chemotherapy compliance at a cost of disease control loss? We have now reached the point where we could analyze the secondary end point of disease control, which is of prime importance to determine if this disease approach is viable," said Dr. Portelance from the University of Miami’s Sylvester Comprehensive Cancer Center.
A total of 40 patients from 25 institutions were eligible for analysis of the secondary end point. All had hysterectomies (3 total abdominal, 3 vaginal, 28 radical, and 6 laparoscopic assisted).
Two patients (5%) had International Federation of Gynecologists and Obstetricians (FIGO) stage IA disease; 31 (77.5%) had stage IB; 4 (10%) had stage IIA; and 3 (7.5) had stage IIB disease. In 25 patients there was no nodal involvement; 15 had 1 involved node.
At a median 2.68 years’ follow-up, there were 5 local-regional relapses (estimated 2-year rate, 10.6%); 3 para-aortic nodes involved (5.3%); and 4 distant metastases (excluding the para-aortic nodes; 10.3%).
Dr. Portelance noted that this translated into an estimated 2-year disease-free survival rate of 86.9%, which is comparable to that shown in an intergroup trial, published in 2000, that compared concurrent chemotherapy and pelvic radiation therapy with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cervical cancer (J. Clin. Oncol. 2000;18:1606-13).
In the RTOG 0418 trial, the estimated 2-year overall survival rate is 94.6%, again comparable with previously published data, Dr. Portelance said.
"This ROTG 0418 study provides level II evidence that, when done under clear guidelines, postoperative pelvic intensity-modulated radiation could lead to decreased toxicity and excellent chemotherapy without any cost in disease control," she concluded.
The study was supported by grants from the National Cancer Institute. Dr. Portelance said she had no conflicts of interest.
MIAMI BEACH – For women with cervical cancer, intensity-modulated radiation therapy to the pelvis after surgery provides disease control similar to that seen with standard external beam radiation therapy, but with lower acute bowel toxicity, investigators reported here.
Two-year results from the phase II Radiation Therapy Oncology Group (RTOG) 0418 trial showed that the combination of the newer radiation technique and weekly cisplatin chemotherapy was associated with an estimated disease-free survival rate of 86.9%. This compares with historic data, Dr. Lorraine Portelance told attendees at the annual meeting of the American Society for Radiation Oncology (ASTRO).
The RTOG investigators had previously reported that pelvic intensity-modulated radiation therapy (IMRT) to 50.4 Gy delivered over 28 fractions plus weekly cisplatin 40 mg/m2 with or without vaginal brachytherapy was associated with a significant reduction in grade 2 or greater short-term bowel toxicity compared with historical controls.
"One very important question remained, though: were we able to achieve decreased toxicity and good chemotherapy compliance at a cost of disease control loss? We have now reached the point where we could analyze the secondary end point of disease control, which is of prime importance to determine if this disease approach is viable," said Dr. Portelance from the University of Miami’s Sylvester Comprehensive Cancer Center.
A total of 40 patients from 25 institutions were eligible for analysis of the secondary end point. All had hysterectomies (3 total abdominal, 3 vaginal, 28 radical, and 6 laparoscopic assisted).
Two patients (5%) had International Federation of Gynecologists and Obstetricians (FIGO) stage IA disease; 31 (77.5%) had stage IB; 4 (10%) had stage IIA; and 3 (7.5) had stage IIB disease. In 25 patients there was no nodal involvement; 15 had 1 involved node.
At a median 2.68 years’ follow-up, there were 5 local-regional relapses (estimated 2-year rate, 10.6%); 3 para-aortic nodes involved (5.3%); and 4 distant metastases (excluding the para-aortic nodes; 10.3%).
Dr. Portelance noted that this translated into an estimated 2-year disease-free survival rate of 86.9%, which is comparable to that shown in an intergroup trial, published in 2000, that compared concurrent chemotherapy and pelvic radiation therapy with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cervical cancer (J. Clin. Oncol. 2000;18:1606-13).
In the RTOG 0418 trial, the estimated 2-year overall survival rate is 94.6%, again comparable with previously published data, Dr. Portelance said.
"This ROTG 0418 study provides level II evidence that, when done under clear guidelines, postoperative pelvic intensity-modulated radiation could lead to decreased toxicity and excellent chemotherapy without any cost in disease control," she concluded.
The study was supported by grants from the National Cancer Institute. Dr. Portelance said she had no conflicts of interest.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR RADIATION ONCOLOGY
Major Finding: Intensity-modulated radiation therapy following surgery was associated with an estimated 2-year disease-free survival rate of 86.9%, and overall survival rate of 94.6%, in patients with cervical cancer.
Data Source: Follow-up of the prospective multi-institutional RTOG 0418 trial.
Disclosures: The study was supported by grants from the National Cancer Institute. Dr. Portelance had no conflict of interest disclosures.
Multimodal DCIS Therapy, Tamoxifen Cuts Breast Cancer Deaths
MIAMI BEACH – Adding radiotherapy and tamoxifen to breast-conserving surgery significantly reduces the local recurrence rate and the breast cancer–specific death rate in women with ductal carcinoma in situ, according to a systematic review and meta-analysis.
The review of 22 studies with a minimum of 10-year follow-up data showed that surgery plus radiation therapy nearly halved the rate of ipsilateral local recurrence from 23.5% with surgery alone to 13.5%, and the addition of tamoxifen cut the rate even further, to 9.2%.
The addition of tamoxifen to surgery and radiation also reduced breast cancer death rates from 3.1% without the drug to 1.5% with it, reported Dr. Kirsty Stuart of the Westmead Breast Cancer Institute at Westmead Hospital in Sydney, Australia.
"DCIS [ductal carcinoma in situ] treatment, however, will ultimately depend on the individual patient, their general condition, their tumor, and their fears," she told attendees at the annual meeting of the American Society for Radiation Oncology.
Dr. Stuart and colleagues conducted a meta-analysis of published randomized or nonrandomized trials of long-term outcomes in DCIS to determine the benefits of adjuvant radiotherapy and tamoxifen, a selective estrogen receptor modulator. The subjects all had pure DCIS with a minimum of 10-years’ follow-up, with data on treatment type and local recurrence. All studies were peer reviewed.
The investigators defined local recurrence as subsequent ipsilateral breast or chest wall disease (DCIS or invasive), and calculated the breast cancer death rate as the number of deaths from breast cancer divided by the total number of DCIS cases.
They identified a total of 22 qualifying studies dating from 1974 through 2011 with 6,167 patients. In all, 4.9% of patients had mastectomies, 51.8% had conservative surgery plus radiation, 41.2% had conservative surgery alone, and 2.1% had biopsy alone.
Among all cases, ipsilateral local recurrence was seen in 3.3% of mastectomy patients, 13.5% of patients who had surgery and radiation, 23.5% of surgery only patients, and 35.1% of biopsy only patients. Between-treatment comparisons showed that mastectomy was significantly better than each of the forms of therapy, both at preventing all cases of ipsilateral local recurrences and all cases of invasive local recurrence.
Looking at the addition of tamoxifen to surgery with or without radiation, the authors found that the drug significantly reduced the rate of local recurrence, from 24.1% with surgery alone to 19.8% with surgery and tamoxifen, and from 14.9% for the surgery/radiation combination to 9.2% for the two modalities plus tamoxifen.
Between-treatment comparisons showed that adding tamoxifen to radiation and surgery significantly improved recurrence rates over surgery plus radiation (P = .037), surgery plus tamoxifen (P = .0086), or surgery alone (P less than .000001). Compared with surgery only, the relative risk for invasive local recurrence was 0.71 for surgery plus tamoxifen, 0.63 for surgery plus radiotherapy, and 0.35 for all three treatments.
Invasive breast cancer death rates were also significantly lower when tamoxifen was added to surgery and radiation, decreasing from 8.4% without the drug to 4.3% with it.
"From the pooled data, conservative surgery alone for DCIS has a high recurrence rate that is partly reduced with tamoxifen," Dr. Stuart said.
"DCIS treatment will ultimately depend on the individual patient, their general condition, their tumor, and their fears."
"Conservative surgery plus radiation therapy almost halves the ipsilateral recurrence rate, and has a breast cancer death rate that is equivalent to that of the mastectomy population.
"Conservative surgery and radiation therapy plus tamoxifen halves the invasive local recurrence rate, from 8% to 4%, and halves the breast cancer death rate, from 3% to 1.5%."
In a separate study Dr. Julia Wong of the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, both in Boston, presented 8-year follow-up data on wide-area excision alone in 132 patients treated for DCIS. The investigators found that 19 patients had a local recurrence. The cumulative 8-year local recurrence rate was 14.4%. A total of 13 of the recurrences were DCIS, and 6 were invasive disease. All but one of the recurrences was detectable by mammogram, and one was palpable.
A total of 14 of the recurrences were in the same quadrant as the original tumor, and 5 were elsewhere in the same breast. Of the six patients with invasive disease, none had axillary involvement, and no patients developed distant metastases.
Other events seen in the study included 13 contralateral breast cancers (4 DCIS, 9 invasive), 1 other cancer, and 3 deaths from other causes.
"Even in this highly selected group of patients with small grade 1 or 2 DCIS treated with wide excision alone and margins 1 cm or greater, there is a substantial local recurrence rate, especially in the same quadrant," Dr. Wong said.
The meta-analysis was internally funded. Dr. Stuart reported having no relevant financial disclosures. Dr. Wong’s study was funded by participating institutions. Dr. Wong reported no other relevant financial disclosures.
MIAMI BEACH – Adding radiotherapy and tamoxifen to breast-conserving surgery significantly reduces the local recurrence rate and the breast cancer–specific death rate in women with ductal carcinoma in situ, according to a systematic review and meta-analysis.
The review of 22 studies with a minimum of 10-year follow-up data showed that surgery plus radiation therapy nearly halved the rate of ipsilateral local recurrence from 23.5% with surgery alone to 13.5%, and the addition of tamoxifen cut the rate even further, to 9.2%.
The addition of tamoxifen to surgery and radiation also reduced breast cancer death rates from 3.1% without the drug to 1.5% with it, reported Dr. Kirsty Stuart of the Westmead Breast Cancer Institute at Westmead Hospital in Sydney, Australia.
"DCIS [ductal carcinoma in situ] treatment, however, will ultimately depend on the individual patient, their general condition, their tumor, and their fears," she told attendees at the annual meeting of the American Society for Radiation Oncology.
Dr. Stuart and colleagues conducted a meta-analysis of published randomized or nonrandomized trials of long-term outcomes in DCIS to determine the benefits of adjuvant radiotherapy and tamoxifen, a selective estrogen receptor modulator. The subjects all had pure DCIS with a minimum of 10-years’ follow-up, with data on treatment type and local recurrence. All studies were peer reviewed.
The investigators defined local recurrence as subsequent ipsilateral breast or chest wall disease (DCIS or invasive), and calculated the breast cancer death rate as the number of deaths from breast cancer divided by the total number of DCIS cases.
They identified a total of 22 qualifying studies dating from 1974 through 2011 with 6,167 patients. In all, 4.9% of patients had mastectomies, 51.8% had conservative surgery plus radiation, 41.2% had conservative surgery alone, and 2.1% had biopsy alone.
Among all cases, ipsilateral local recurrence was seen in 3.3% of mastectomy patients, 13.5% of patients who had surgery and radiation, 23.5% of surgery only patients, and 35.1% of biopsy only patients. Between-treatment comparisons showed that mastectomy was significantly better than each of the forms of therapy, both at preventing all cases of ipsilateral local recurrences and all cases of invasive local recurrence.
Looking at the addition of tamoxifen to surgery with or without radiation, the authors found that the drug significantly reduced the rate of local recurrence, from 24.1% with surgery alone to 19.8% with surgery and tamoxifen, and from 14.9% for the surgery/radiation combination to 9.2% for the two modalities plus tamoxifen.
Between-treatment comparisons showed that adding tamoxifen to radiation and surgery significantly improved recurrence rates over surgery plus radiation (P = .037), surgery plus tamoxifen (P = .0086), or surgery alone (P less than .000001). Compared with surgery only, the relative risk for invasive local recurrence was 0.71 for surgery plus tamoxifen, 0.63 for surgery plus radiotherapy, and 0.35 for all three treatments.
Invasive breast cancer death rates were also significantly lower when tamoxifen was added to surgery and radiation, decreasing from 8.4% without the drug to 4.3% with it.
"From the pooled data, conservative surgery alone for DCIS has a high recurrence rate that is partly reduced with tamoxifen," Dr. Stuart said.
"DCIS treatment will ultimately depend on the individual patient, their general condition, their tumor, and their fears."
"Conservative surgery plus radiation therapy almost halves the ipsilateral recurrence rate, and has a breast cancer death rate that is equivalent to that of the mastectomy population.
"Conservative surgery and radiation therapy plus tamoxifen halves the invasive local recurrence rate, from 8% to 4%, and halves the breast cancer death rate, from 3% to 1.5%."
In a separate study Dr. Julia Wong of the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, both in Boston, presented 8-year follow-up data on wide-area excision alone in 132 patients treated for DCIS. The investigators found that 19 patients had a local recurrence. The cumulative 8-year local recurrence rate was 14.4%. A total of 13 of the recurrences were DCIS, and 6 were invasive disease. All but one of the recurrences was detectable by mammogram, and one was palpable.
A total of 14 of the recurrences were in the same quadrant as the original tumor, and 5 were elsewhere in the same breast. Of the six patients with invasive disease, none had axillary involvement, and no patients developed distant metastases.
Other events seen in the study included 13 contralateral breast cancers (4 DCIS, 9 invasive), 1 other cancer, and 3 deaths from other causes.
"Even in this highly selected group of patients with small grade 1 or 2 DCIS treated with wide excision alone and margins 1 cm or greater, there is a substantial local recurrence rate, especially in the same quadrant," Dr. Wong said.
The meta-analysis was internally funded. Dr. Stuart reported having no relevant financial disclosures. Dr. Wong’s study was funded by participating institutions. Dr. Wong reported no other relevant financial disclosures.
MIAMI BEACH – Adding radiotherapy and tamoxifen to breast-conserving surgery significantly reduces the local recurrence rate and the breast cancer–specific death rate in women with ductal carcinoma in situ, according to a systematic review and meta-analysis.
The review of 22 studies with a minimum of 10-year follow-up data showed that surgery plus radiation therapy nearly halved the rate of ipsilateral local recurrence from 23.5% with surgery alone to 13.5%, and the addition of tamoxifen cut the rate even further, to 9.2%.
The addition of tamoxifen to surgery and radiation also reduced breast cancer death rates from 3.1% without the drug to 1.5% with it, reported Dr. Kirsty Stuart of the Westmead Breast Cancer Institute at Westmead Hospital in Sydney, Australia.
"DCIS [ductal carcinoma in situ] treatment, however, will ultimately depend on the individual patient, their general condition, their tumor, and their fears," she told attendees at the annual meeting of the American Society for Radiation Oncology.
Dr. Stuart and colleagues conducted a meta-analysis of published randomized or nonrandomized trials of long-term outcomes in DCIS to determine the benefits of adjuvant radiotherapy and tamoxifen, a selective estrogen receptor modulator. The subjects all had pure DCIS with a minimum of 10-years’ follow-up, with data on treatment type and local recurrence. All studies were peer reviewed.
The investigators defined local recurrence as subsequent ipsilateral breast or chest wall disease (DCIS or invasive), and calculated the breast cancer death rate as the number of deaths from breast cancer divided by the total number of DCIS cases.
They identified a total of 22 qualifying studies dating from 1974 through 2011 with 6,167 patients. In all, 4.9% of patients had mastectomies, 51.8% had conservative surgery plus radiation, 41.2% had conservative surgery alone, and 2.1% had biopsy alone.
Among all cases, ipsilateral local recurrence was seen in 3.3% of mastectomy patients, 13.5% of patients who had surgery and radiation, 23.5% of surgery only patients, and 35.1% of biopsy only patients. Between-treatment comparisons showed that mastectomy was significantly better than each of the forms of therapy, both at preventing all cases of ipsilateral local recurrences and all cases of invasive local recurrence.
Looking at the addition of tamoxifen to surgery with or without radiation, the authors found that the drug significantly reduced the rate of local recurrence, from 24.1% with surgery alone to 19.8% with surgery and tamoxifen, and from 14.9% for the surgery/radiation combination to 9.2% for the two modalities plus tamoxifen.
Between-treatment comparisons showed that adding tamoxifen to radiation and surgery significantly improved recurrence rates over surgery plus radiation (P = .037), surgery plus tamoxifen (P = .0086), or surgery alone (P less than .000001). Compared with surgery only, the relative risk for invasive local recurrence was 0.71 for surgery plus tamoxifen, 0.63 for surgery plus radiotherapy, and 0.35 for all three treatments.
Invasive breast cancer death rates were also significantly lower when tamoxifen was added to surgery and radiation, decreasing from 8.4% without the drug to 4.3% with it.
"From the pooled data, conservative surgery alone for DCIS has a high recurrence rate that is partly reduced with tamoxifen," Dr. Stuart said.
"DCIS treatment will ultimately depend on the individual patient, their general condition, their tumor, and their fears."
"Conservative surgery plus radiation therapy almost halves the ipsilateral recurrence rate, and has a breast cancer death rate that is equivalent to that of the mastectomy population.
"Conservative surgery and radiation therapy plus tamoxifen halves the invasive local recurrence rate, from 8% to 4%, and halves the breast cancer death rate, from 3% to 1.5%."
In a separate study Dr. Julia Wong of the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, both in Boston, presented 8-year follow-up data on wide-area excision alone in 132 patients treated for DCIS. The investigators found that 19 patients had a local recurrence. The cumulative 8-year local recurrence rate was 14.4%. A total of 13 of the recurrences were DCIS, and 6 were invasive disease. All but one of the recurrences was detectable by mammogram, and one was palpable.
A total of 14 of the recurrences were in the same quadrant as the original tumor, and 5 were elsewhere in the same breast. Of the six patients with invasive disease, none had axillary involvement, and no patients developed distant metastases.
Other events seen in the study included 13 contralateral breast cancers (4 DCIS, 9 invasive), 1 other cancer, and 3 deaths from other causes.
"Even in this highly selected group of patients with small grade 1 or 2 DCIS treated with wide excision alone and margins 1 cm or greater, there is a substantial local recurrence rate, especially in the same quadrant," Dr. Wong said.
The meta-analysis was internally funded. Dr. Stuart reported having no relevant financial disclosures. Dr. Wong’s study was funded by participating institutions. Dr. Wong reported no other relevant financial disclosures.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR RADIATION ONCOLOGY
Major Finding: The addition of tamoxifen to surgery and radiation reduced breast cancer death rates from 3.1% without the drug to 1.5% with it.
Data Source: Systematic review and meta-analysis of 22 studies with long-term follow-up of women treated for ductal carcinoma in situ.
Disclosures: The meta-analysis was internally funded. Dr. Stuart reported having no relevant financial disclosures. Dr. Wong's study was funded by the participating institutions. Dr. Wong reported having no other relevant financial disclosures.
Lower Radiation Dose Improves Lung Cancer Survival
MIAMI BEACH – Less turned out to be better in a large clinical trial comparing radiation doses in patients treated with radiation and chemotherapy for stage III non–small cell lung cancer, investigators reported here.
The median overall survival rate at 1 year was 81% for patients treated with standard-dose (60 Gy) radiation, compared with 70.4% for those who received the high dose (74 Gy), according to preliminary findings from the radiation-dose arm of the ongoing phase III Radiation Therapy Oncology Group (RTOG) 0617 trial. The respective median survival rates were 21.7 months and 20.7 months (P = .02).
A planned interim analysis from the trial showed that the radiation comparison had crossed the prespecified boundary for futility, and the high-dose arm was stopped in June 2011, reported Dr. Jeffrey Bradley from Washington University in St. Louis.
"I think this changes practice: If [cancer centers] weren’t using 60 Gray before, perhaps they should go back to using 60 Gray, because it does not appear that a higher dose is better," Dr. Bradley commented at the annual meeting of the American Society of Radiation Oncology (ASTRO).
Dr. Tim R. Williams, from the Lynn Cancer Institute at Boca Raton (Fla.) Regional Hospital, the immediate-past chairman of ASTRO, noted that his center has used high-dose radiation in stage III non–small cell lung cancer (NSCLC) patients for about 5 years. Although practice patterns vary, it’s likely that many treatment centers currently use the higher dose, he said.
In RTOG 0617, a total of 500 patients with stage IIIA/IIIB NSCLC were scheduled for randomization to one of four arms in a 2 x 2 factorial design with patients assigned to receive either 74 Gy or 60 Gy radiation with or without cetuximab (Erbitux), on a background chemotherapy regimen of weekly paclitaxel (45 mg/m2) and carboplatin (titrated to an area-under-the-curve of 2).
The radiation was delivered in 2 Gy fractions over 30 to 37 fractions.
The analysis was performed on 426 patients who had been enrolled in the study before June 17, 2011.
Seeking to understand why the higher radiation dose was not better – the investigators had originally hypothesized that 74 Gy would result in a 7-month improvement in overall survival vs. 64 Gy.– they performed univariate analyses, and found that significant predictors for better outcomes included continuous therapy, nonsquamous histology, and, female gender. In multivariate analysis, radiation dose (60 Gy vs. 74 Gy) was associated with a hazard ratio for overall survival of 1.48 (P = .038),
nonsquamous histology versus squamous was associated with an HR of 1.52 (P = .025), and gross or internal tumor volume had a small but significant HR of 1.002 (P = .011).
Dr. Benjamin Movsas, chair of radiation oncology at the Henry Ford Health System in Detroit, the invited discussant, said that "as of 2011, level I evidence demonstrates no role for dose escalation in stage III non–small cell lung cancer."
He noted that although there were small differences between the radiation dose groups in terms of tumor histology, gross tumor volume, and other factors, they were not large enough to explain the differences in outcomes.
Citing the advice of his late father, also a physician, Dr. Movsas reminded the audience that "More is not always better."
The trial is continuing with patients assigned to 60 Gy radiation only, with the goal of evaluating the secondary study end point of overall survival of patients with or without cetuximab added to concurrent chemoradiotherapy.
The RTOG 0617 trial is supported by grants from the U.S. National Cancer Institute, with additional support from Bristol-Myers Squibb and ImClone.
Dr. Bradley and Dr. Williams had no disclosures. Dr. Movsas disclosed departmental research support from Varian and Philips. He also has served as a chair of an RTOG committee, but was not involved in the 0617 study.
MIAMI BEACH – Less turned out to be better in a large clinical trial comparing radiation doses in patients treated with radiation and chemotherapy for stage III non–small cell lung cancer, investigators reported here.
The median overall survival rate at 1 year was 81% for patients treated with standard-dose (60 Gy) radiation, compared with 70.4% for those who received the high dose (74 Gy), according to preliminary findings from the radiation-dose arm of the ongoing phase III Radiation Therapy Oncology Group (RTOG) 0617 trial. The respective median survival rates were 21.7 months and 20.7 months (P = .02).
A planned interim analysis from the trial showed that the radiation comparison had crossed the prespecified boundary for futility, and the high-dose arm was stopped in June 2011, reported Dr. Jeffrey Bradley from Washington University in St. Louis.
"I think this changes practice: If [cancer centers] weren’t using 60 Gray before, perhaps they should go back to using 60 Gray, because it does not appear that a higher dose is better," Dr. Bradley commented at the annual meeting of the American Society of Radiation Oncology (ASTRO).
Dr. Tim R. Williams, from the Lynn Cancer Institute at Boca Raton (Fla.) Regional Hospital, the immediate-past chairman of ASTRO, noted that his center has used high-dose radiation in stage III non–small cell lung cancer (NSCLC) patients for about 5 years. Although practice patterns vary, it’s likely that many treatment centers currently use the higher dose, he said.
In RTOG 0617, a total of 500 patients with stage IIIA/IIIB NSCLC were scheduled for randomization to one of four arms in a 2 x 2 factorial design with patients assigned to receive either 74 Gy or 60 Gy radiation with or without cetuximab (Erbitux), on a background chemotherapy regimen of weekly paclitaxel (45 mg/m2) and carboplatin (titrated to an area-under-the-curve of 2).
The radiation was delivered in 2 Gy fractions over 30 to 37 fractions.
The analysis was performed on 426 patients who had been enrolled in the study before June 17, 2011.
Seeking to understand why the higher radiation dose was not better – the investigators had originally hypothesized that 74 Gy would result in a 7-month improvement in overall survival vs. 64 Gy.– they performed univariate analyses, and found that significant predictors for better outcomes included continuous therapy, nonsquamous histology, and, female gender. In multivariate analysis, radiation dose (60 Gy vs. 74 Gy) was associated with a hazard ratio for overall survival of 1.48 (P = .038),
nonsquamous histology versus squamous was associated with an HR of 1.52 (P = .025), and gross or internal tumor volume had a small but significant HR of 1.002 (P = .011).
Dr. Benjamin Movsas, chair of radiation oncology at the Henry Ford Health System in Detroit, the invited discussant, said that "as of 2011, level I evidence demonstrates no role for dose escalation in stage III non–small cell lung cancer."
He noted that although there were small differences between the radiation dose groups in terms of tumor histology, gross tumor volume, and other factors, they were not large enough to explain the differences in outcomes.
Citing the advice of his late father, also a physician, Dr. Movsas reminded the audience that "More is not always better."
The trial is continuing with patients assigned to 60 Gy radiation only, with the goal of evaluating the secondary study end point of overall survival of patients with or without cetuximab added to concurrent chemoradiotherapy.
The RTOG 0617 trial is supported by grants from the U.S. National Cancer Institute, with additional support from Bristol-Myers Squibb and ImClone.
Dr. Bradley and Dr. Williams had no disclosures. Dr. Movsas disclosed departmental research support from Varian and Philips. He also has served as a chair of an RTOG committee, but was not involved in the 0617 study.
MIAMI BEACH – Less turned out to be better in a large clinical trial comparing radiation doses in patients treated with radiation and chemotherapy for stage III non–small cell lung cancer, investigators reported here.
The median overall survival rate at 1 year was 81% for patients treated with standard-dose (60 Gy) radiation, compared with 70.4% for those who received the high dose (74 Gy), according to preliminary findings from the radiation-dose arm of the ongoing phase III Radiation Therapy Oncology Group (RTOG) 0617 trial. The respective median survival rates were 21.7 months and 20.7 months (P = .02).
A planned interim analysis from the trial showed that the radiation comparison had crossed the prespecified boundary for futility, and the high-dose arm was stopped in June 2011, reported Dr. Jeffrey Bradley from Washington University in St. Louis.
"I think this changes practice: If [cancer centers] weren’t using 60 Gray before, perhaps they should go back to using 60 Gray, because it does not appear that a higher dose is better," Dr. Bradley commented at the annual meeting of the American Society of Radiation Oncology (ASTRO).
Dr. Tim R. Williams, from the Lynn Cancer Institute at Boca Raton (Fla.) Regional Hospital, the immediate-past chairman of ASTRO, noted that his center has used high-dose radiation in stage III non–small cell lung cancer (NSCLC) patients for about 5 years. Although practice patterns vary, it’s likely that many treatment centers currently use the higher dose, he said.
In RTOG 0617, a total of 500 patients with stage IIIA/IIIB NSCLC were scheduled for randomization to one of four arms in a 2 x 2 factorial design with patients assigned to receive either 74 Gy or 60 Gy radiation with or without cetuximab (Erbitux), on a background chemotherapy regimen of weekly paclitaxel (45 mg/m2) and carboplatin (titrated to an area-under-the-curve of 2).
The radiation was delivered in 2 Gy fractions over 30 to 37 fractions.
The analysis was performed on 426 patients who had been enrolled in the study before June 17, 2011.
Seeking to understand why the higher radiation dose was not better – the investigators had originally hypothesized that 74 Gy would result in a 7-month improvement in overall survival vs. 64 Gy.– they performed univariate analyses, and found that significant predictors for better outcomes included continuous therapy, nonsquamous histology, and, female gender. In multivariate analysis, radiation dose (60 Gy vs. 74 Gy) was associated with a hazard ratio for overall survival of 1.48 (P = .038),
nonsquamous histology versus squamous was associated with an HR of 1.52 (P = .025), and gross or internal tumor volume had a small but significant HR of 1.002 (P = .011).
Dr. Benjamin Movsas, chair of radiation oncology at the Henry Ford Health System in Detroit, the invited discussant, said that "as of 2011, level I evidence demonstrates no role for dose escalation in stage III non–small cell lung cancer."
He noted that although there were small differences between the radiation dose groups in terms of tumor histology, gross tumor volume, and other factors, they were not large enough to explain the differences in outcomes.
Citing the advice of his late father, also a physician, Dr. Movsas reminded the audience that "More is not always better."
The trial is continuing with patients assigned to 60 Gy radiation only, with the goal of evaluating the secondary study end point of overall survival of patients with or without cetuximab added to concurrent chemoradiotherapy.
The RTOG 0617 trial is supported by grants from the U.S. National Cancer Institute, with additional support from Bristol-Myers Squibb and ImClone.
Dr. Bradley and Dr. Williams had no disclosures. Dr. Movsas disclosed departmental research support from Varian and Philips. He also has served as a chair of an RTOG committee, but was not involved in the 0617 study.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR RADIATION ONCOLOGY
Major Finding: Median overall survival among patients with stage III NSCLC treated with chemotherapy was 20.7 months with high-dose radiation (74 Gy), vs. 21.7 months with standard-dose radiation (60 Gy; P =.02).
Data Source: 426 patients enrolled in the randomized controlled RTOG 0617 trial.
Disclosures: Dr. Bradley and Dr. Williams had no disclosures. Dr. Movsas disclosed departmental research support from Varian and Philips. He also has served as a chair of an RTOG committee, but was not involved in the 0617 study.
PET Scans Key to Less Radiation for Hodgkin's Lymphoma
MIAMI BEACH – Patients with Hodgkin’s lymphoma may be spared additional radiotherapy following chemotherapy if they have a negative positron-emission tomography result, investigators from the German Hodgkin Study Group reported.
The negative predictive value for FDG (18fluorodeoxyglucose)–PET at 1 year was 94%, said Dr. Rolf P. Mueller of the University of Cologne (Germany). Among patients who had residual tumors measuring 2.5 cm or greater in diameter following chemotherapy, only 4% of those who were negative for residual disease on FDG-PET scans relapsed or required additional radiotherapy, compared with 11% of FDG-PET–positive patients.
"Thus, only those advanced-stage Hodgkin lymphoma patients with residual disease who are PET-positive patients might need additional radiotherapy," Dr. Mueller said at the annual meeting of the American Society of Radiation Oncology (ASTRO).
The investigators also found a significant difference in time-to-progression favoring PET-negative patients (P =.008) with Hodgkin’s lymphoma, also known as Hodgkin’s disease.
The percentage of patients who received radiation in this clinical trial, designated GHSG (German Hodgkin Study Group) HD-15, was 11%, compared with 70% of patients in the group’s GHSG-9 trial, Mueller noted. GHSG-15 studied the role of FDG-PET for evaluating residual disease and relapse risk among patients with advanced-stage Hodgkin’s lymphoma who had undergone six to eight cycles of chemotherapy with the BEACOPP regimen (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) (J. Clin. Oncol. 2003;21:1734-9).
Early results were published in 2008 (Blood 2008;112: 3989-94). In the current report, Mueller presented data on a larger cohort.
All patients with a partial response or better and a residual mass measuring 2.5 cm or greater received FDG-PET scans. Of the 728 patients with residual disease following BEACOPP, 540 (74.2%) were PET negative, and 188 were PET positive. Mueller presented data on 701 patients who had at least 1 year of follow-up.
At 1 year, 96% (522) of PET-negative patients had neither progression nor relapse, compared with 11% of those who were PET positive. Of the PET-negative patients, 23 experienced disease progression (eight in the residual mass, six with new disease outside of the mass, and nine with progression/relapse in both areas). An additional eight PET-negative patients required additional radiotherapy.
The study was funded by the member centers of the GSHG. Dr. Mueller had no conflict of interest disclosures.
MIAMI BEACH – Patients with Hodgkin’s lymphoma may be spared additional radiotherapy following chemotherapy if they have a negative positron-emission tomography result, investigators from the German Hodgkin Study Group reported.
The negative predictive value for FDG (18fluorodeoxyglucose)–PET at 1 year was 94%, said Dr. Rolf P. Mueller of the University of Cologne (Germany). Among patients who had residual tumors measuring 2.5 cm or greater in diameter following chemotherapy, only 4% of those who were negative for residual disease on FDG-PET scans relapsed or required additional radiotherapy, compared with 11% of FDG-PET–positive patients.
"Thus, only those advanced-stage Hodgkin lymphoma patients with residual disease who are PET-positive patients might need additional radiotherapy," Dr. Mueller said at the annual meeting of the American Society of Radiation Oncology (ASTRO).
The investigators also found a significant difference in time-to-progression favoring PET-negative patients (P =.008) with Hodgkin’s lymphoma, also known as Hodgkin’s disease.
The percentage of patients who received radiation in this clinical trial, designated GHSG (German Hodgkin Study Group) HD-15, was 11%, compared with 70% of patients in the group’s GHSG-9 trial, Mueller noted. GHSG-15 studied the role of FDG-PET for evaluating residual disease and relapse risk among patients with advanced-stage Hodgkin’s lymphoma who had undergone six to eight cycles of chemotherapy with the BEACOPP regimen (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) (J. Clin. Oncol. 2003;21:1734-9).
Early results were published in 2008 (Blood 2008;112: 3989-94). In the current report, Mueller presented data on a larger cohort.
All patients with a partial response or better and a residual mass measuring 2.5 cm or greater received FDG-PET scans. Of the 728 patients with residual disease following BEACOPP, 540 (74.2%) were PET negative, and 188 were PET positive. Mueller presented data on 701 patients who had at least 1 year of follow-up.
At 1 year, 96% (522) of PET-negative patients had neither progression nor relapse, compared with 11% of those who were PET positive. Of the PET-negative patients, 23 experienced disease progression (eight in the residual mass, six with new disease outside of the mass, and nine with progression/relapse in both areas). An additional eight PET-negative patients required additional radiotherapy.
The study was funded by the member centers of the GSHG. Dr. Mueller had no conflict of interest disclosures.
MIAMI BEACH – Patients with Hodgkin’s lymphoma may be spared additional radiotherapy following chemotherapy if they have a negative positron-emission tomography result, investigators from the German Hodgkin Study Group reported.
The negative predictive value for FDG (18fluorodeoxyglucose)–PET at 1 year was 94%, said Dr. Rolf P. Mueller of the University of Cologne (Germany). Among patients who had residual tumors measuring 2.5 cm or greater in diameter following chemotherapy, only 4% of those who were negative for residual disease on FDG-PET scans relapsed or required additional radiotherapy, compared with 11% of FDG-PET–positive patients.
"Thus, only those advanced-stage Hodgkin lymphoma patients with residual disease who are PET-positive patients might need additional radiotherapy," Dr. Mueller said at the annual meeting of the American Society of Radiation Oncology (ASTRO).
The investigators also found a significant difference in time-to-progression favoring PET-negative patients (P =.008) with Hodgkin’s lymphoma, also known as Hodgkin’s disease.
The percentage of patients who received radiation in this clinical trial, designated GHSG (German Hodgkin Study Group) HD-15, was 11%, compared with 70% of patients in the group’s GHSG-9 trial, Mueller noted. GHSG-15 studied the role of FDG-PET for evaluating residual disease and relapse risk among patients with advanced-stage Hodgkin’s lymphoma who had undergone six to eight cycles of chemotherapy with the BEACOPP regimen (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) (J. Clin. Oncol. 2003;21:1734-9).
Early results were published in 2008 (Blood 2008;112: 3989-94). In the current report, Mueller presented data on a larger cohort.
All patients with a partial response or better and a residual mass measuring 2.5 cm or greater received FDG-PET scans. Of the 728 patients with residual disease following BEACOPP, 540 (74.2%) were PET negative, and 188 were PET positive. Mueller presented data on 701 patients who had at least 1 year of follow-up.
At 1 year, 96% (522) of PET-negative patients had neither progression nor relapse, compared with 11% of those who were PET positive. Of the PET-negative patients, 23 experienced disease progression (eight in the residual mass, six with new disease outside of the mass, and nine with progression/relapse in both areas). An additional eight PET-negative patients required additional radiotherapy.
The study was funded by the member centers of the GSHG. Dr. Mueller had no conflict of interest disclosures.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR RADIATION ONCOLOGY
Major Finding: FDG-PET scans following chemotherapy in patients with advanced-stage Hodgkin’s lymphoma have a negative predictive value of 94%.
Data Source: The prospective GHSG HD-15 trial involving 701 patients.
Disclosures: The study was funded by the GSHG. Dr. Mueller had no conflict of interest disclosures.
Prone Position During Breast Irradiation Lessens Lung Cancer Risk
MIAMI BEACH – Placing breast cancer patients in a prone rather than supine position during whole breast irradiation may significantly reduce their risk for secondary lung cancers, investigators reported at the annual meeting of the American Society for Radiation Oncology.
The total radiation dose that would be delivered to the corresponding (ipsilateral) lung of patients treated while they were lying face down was less than one-tenth of the dose delivered to that of patients treated while lying on their backs, said Dr. John Ng, senior radiation oncology resident at Columbia University Medical Center in New York.
The mean expected lifetime risk for radiation-associated secondary lung cancer is 1.99% in patients given whole breast irradiation with a prone technique, compared with 4.86% for patients treated with a supine technique, he reported. It was 3.87% for patients treated with a 3-D conformal partial breast irradiation technique, and 2.92% for patients treated with balloon brachytherapy (P less than .001 for all comparisons).
By way of comparison, the estimated expected background risk for lung cancer is about 1.5%, Dr. Ng and his colleagues wrote in a poster presentation.
"It’s documented that there is some excess relative risk of lung cancers after breast radiation treatment – I think everybody agrees with that. What people will disagree on is how significant this risk is, and that\'s what motivates us to do this study," Dr. Ng said in an interview.
The prone technique is, however, considerably more time consuming in terms of treatment planning and positioning of the patient, resulting in treatment sessions that are about twice as long as those for patients treated supinely (about 45 vs. 20 minutes, Dr. Ng said).
The investigators used a mathematical model to estimate the risk of both spontaneous and radiation-induced lung cancer risk in 25 women with early-stage breast cancer undergoing treatment planning with CT simulation for post-lumpectomy radiation therapy. Patients scheduled for whole breast irradiation were simulated in both the prone and the supine positions; those scheduled for partial breast irradiation were simulated in the supine position only.
The model encompassed standard dosing (50 Gy, delivered in 25 fractions), hypofractionation (42 Gy in 16 fractions), or standard external-beam accelerated partial breast irradiation (38.5 Gy in 10 fractions).
For each of the 15 patients treated in the prone technique, there would be significantly less radiation (54.2 cGy, on average) delivered to the lung than with the supine technique (646.5 cGy), balloon brachytherapy (291.0 cGy), or partial-breast irradiation (275.2 cGy; P less than .001 for all comparisons).
The relative risks for each technique and dosing schedule, compared with background risk, were 4.04 for supine standard fractionation, 3.98 for supine hypofractionation, 2.54 for balloon brachytherapy, 2.36 for 3D conformal accelerated partial-breast irradiation, and 1.56 for standard fractionation.
"The take-home point is that there is substantial risk of secondary lung malignancy from our standard technique. You can improve it with partial breast irradiation, but our study shows that the best results come from the prone technique," Dr. Ng said.
Dr. Phillip M. Devlin, chief of the division of brachytherapy at Dana-Farber Cancer Institute, Boston, commented that the study was interesting but complex, with the issue of prone vs. supine muddied by the inclusion of brachytherapy into the mix.
"In this small study, the hypothesis is generated that there would be less cancer caused by prone technique than by supine technique, and therefore a prospective analysis of this may be warranted. However, with these findings one might even ask whether it would be ethical to do the prospective study," said Dr. Devlin, who was not involved in the study.
He noted that the prone technique was originally developed to help women with more pendulous breasts tolerate whole breast irradiation better, with fewer side effects and improved cosmesis.
"Given the fact that we chose this technique for other end points, isn’t it interesting that if we also look at reasonable modeling done on a reasonably small data set, in the model the risk is lower with the prone technique, further endorsing what we’ve already found for a bigger and different reason. The cost to achieve this in terms of patient throughput is in play, but it is counterbalanced against the potential extra cost of treating either a local recurrence or a second malignant neoplasm," Dr. Devlin said.
The study was internally funded. Neither Dr. Ng nor Dr. Devlin had conflicts of interest to disclose.
MIAMI BEACH – Placing breast cancer patients in a prone rather than supine position during whole breast irradiation may significantly reduce their risk for secondary lung cancers, investigators reported at the annual meeting of the American Society for Radiation Oncology.
The total radiation dose that would be delivered to the corresponding (ipsilateral) lung of patients treated while they were lying face down was less than one-tenth of the dose delivered to that of patients treated while lying on their backs, said Dr. John Ng, senior radiation oncology resident at Columbia University Medical Center in New York.
The mean expected lifetime risk for radiation-associated secondary lung cancer is 1.99% in patients given whole breast irradiation with a prone technique, compared with 4.86% for patients treated with a supine technique, he reported. It was 3.87% for patients treated with a 3-D conformal partial breast irradiation technique, and 2.92% for patients treated with balloon brachytherapy (P less than .001 for all comparisons).
By way of comparison, the estimated expected background risk for lung cancer is about 1.5%, Dr. Ng and his colleagues wrote in a poster presentation.
"It’s documented that there is some excess relative risk of lung cancers after breast radiation treatment – I think everybody agrees with that. What people will disagree on is how significant this risk is, and that\'s what motivates us to do this study," Dr. Ng said in an interview.
The prone technique is, however, considerably more time consuming in terms of treatment planning and positioning of the patient, resulting in treatment sessions that are about twice as long as those for patients treated supinely (about 45 vs. 20 minutes, Dr. Ng said).
The investigators used a mathematical model to estimate the risk of both spontaneous and radiation-induced lung cancer risk in 25 women with early-stage breast cancer undergoing treatment planning with CT simulation for post-lumpectomy radiation therapy. Patients scheduled for whole breast irradiation were simulated in both the prone and the supine positions; those scheduled for partial breast irradiation were simulated in the supine position only.
The model encompassed standard dosing (50 Gy, delivered in 25 fractions), hypofractionation (42 Gy in 16 fractions), or standard external-beam accelerated partial breast irradiation (38.5 Gy in 10 fractions).
For each of the 15 patients treated in the prone technique, there would be significantly less radiation (54.2 cGy, on average) delivered to the lung than with the supine technique (646.5 cGy), balloon brachytherapy (291.0 cGy), or partial-breast irradiation (275.2 cGy; P less than .001 for all comparisons).
The relative risks for each technique and dosing schedule, compared with background risk, were 4.04 for supine standard fractionation, 3.98 for supine hypofractionation, 2.54 for balloon brachytherapy, 2.36 for 3D conformal accelerated partial-breast irradiation, and 1.56 for standard fractionation.
"The take-home point is that there is substantial risk of secondary lung malignancy from our standard technique. You can improve it with partial breast irradiation, but our study shows that the best results come from the prone technique," Dr. Ng said.
Dr. Phillip M. Devlin, chief of the division of brachytherapy at Dana-Farber Cancer Institute, Boston, commented that the study was interesting but complex, with the issue of prone vs. supine muddied by the inclusion of brachytherapy into the mix.
"In this small study, the hypothesis is generated that there would be less cancer caused by prone technique than by supine technique, and therefore a prospective analysis of this may be warranted. However, with these findings one might even ask whether it would be ethical to do the prospective study," said Dr. Devlin, who was not involved in the study.
He noted that the prone technique was originally developed to help women with more pendulous breasts tolerate whole breast irradiation better, with fewer side effects and improved cosmesis.
"Given the fact that we chose this technique for other end points, isn’t it interesting that if we also look at reasonable modeling done on a reasonably small data set, in the model the risk is lower with the prone technique, further endorsing what we’ve already found for a bigger and different reason. The cost to achieve this in terms of patient throughput is in play, but it is counterbalanced against the potential extra cost of treating either a local recurrence or a second malignant neoplasm," Dr. Devlin said.
The study was internally funded. Neither Dr. Ng nor Dr. Devlin had conflicts of interest to disclose.
MIAMI BEACH – Placing breast cancer patients in a prone rather than supine position during whole breast irradiation may significantly reduce their risk for secondary lung cancers, investigators reported at the annual meeting of the American Society for Radiation Oncology.
The total radiation dose that would be delivered to the corresponding (ipsilateral) lung of patients treated while they were lying face down was less than one-tenth of the dose delivered to that of patients treated while lying on their backs, said Dr. John Ng, senior radiation oncology resident at Columbia University Medical Center in New York.
The mean expected lifetime risk for radiation-associated secondary lung cancer is 1.99% in patients given whole breast irradiation with a prone technique, compared with 4.86% for patients treated with a supine technique, he reported. It was 3.87% for patients treated with a 3-D conformal partial breast irradiation technique, and 2.92% for patients treated with balloon brachytherapy (P less than .001 for all comparisons).
By way of comparison, the estimated expected background risk for lung cancer is about 1.5%, Dr. Ng and his colleagues wrote in a poster presentation.
"It’s documented that there is some excess relative risk of lung cancers after breast radiation treatment – I think everybody agrees with that. What people will disagree on is how significant this risk is, and that\'s what motivates us to do this study," Dr. Ng said in an interview.
The prone technique is, however, considerably more time consuming in terms of treatment planning and positioning of the patient, resulting in treatment sessions that are about twice as long as those for patients treated supinely (about 45 vs. 20 minutes, Dr. Ng said).
The investigators used a mathematical model to estimate the risk of both spontaneous and radiation-induced lung cancer risk in 25 women with early-stage breast cancer undergoing treatment planning with CT simulation for post-lumpectomy radiation therapy. Patients scheduled for whole breast irradiation were simulated in both the prone and the supine positions; those scheduled for partial breast irradiation were simulated in the supine position only.
The model encompassed standard dosing (50 Gy, delivered in 25 fractions), hypofractionation (42 Gy in 16 fractions), or standard external-beam accelerated partial breast irradiation (38.5 Gy in 10 fractions).
For each of the 15 patients treated in the prone technique, there would be significantly less radiation (54.2 cGy, on average) delivered to the lung than with the supine technique (646.5 cGy), balloon brachytherapy (291.0 cGy), or partial-breast irradiation (275.2 cGy; P less than .001 for all comparisons).
The relative risks for each technique and dosing schedule, compared with background risk, were 4.04 for supine standard fractionation, 3.98 for supine hypofractionation, 2.54 for balloon brachytherapy, 2.36 for 3D conformal accelerated partial-breast irradiation, and 1.56 for standard fractionation.
"The take-home point is that there is substantial risk of secondary lung malignancy from our standard technique. You can improve it with partial breast irradiation, but our study shows that the best results come from the prone technique," Dr. Ng said.
Dr. Phillip M. Devlin, chief of the division of brachytherapy at Dana-Farber Cancer Institute, Boston, commented that the study was interesting but complex, with the issue of prone vs. supine muddied by the inclusion of brachytherapy into the mix.
"In this small study, the hypothesis is generated that there would be less cancer caused by prone technique than by supine technique, and therefore a prospective analysis of this may be warranted. However, with these findings one might even ask whether it would be ethical to do the prospective study," said Dr. Devlin, who was not involved in the study.
He noted that the prone technique was originally developed to help women with more pendulous breasts tolerate whole breast irradiation better, with fewer side effects and improved cosmesis.
"Given the fact that we chose this technique for other end points, isn’t it interesting that if we also look at reasonable modeling done on a reasonably small data set, in the model the risk is lower with the prone technique, further endorsing what we’ve already found for a bigger and different reason. The cost to achieve this in terms of patient throughput is in play, but it is counterbalanced against the potential extra cost of treating either a local recurrence or a second malignant neoplasm," Dr. Devlin said.
The study was internally funded. Neither Dr. Ng nor Dr. Devlin had conflicts of interest to disclose.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR RADIATION ONCOLOGY
Major Finding: A prone position for whole breast irradiation was associated with an estimated 1.99% lifetime risk for radiation-associated secondary lung cancer, compared with a 4.86% lifetime risk with a supine position.
Data Source: Computer modeling study of 25 patients treated with radiation therapy after lumpectomy for early-stage breast cancer
Disclosures: The study was internally funded. Neither Dr. Ng nor Dr. Devlin had conflicts of interest to disclose.
Children of Deployed Soldiers Fight Battles at Home
BOSTON – In addition to the day-to-day stresses faced by most families, the children of active-duty service members must cope with the uncertainties of multiple deployments and the possibility that the parent will sustain life-altering injuries, develop mental illness, or die, according to a psychiatrist who studies and treats military families.
Of the more than 2.2 million U.S. service members on active duty, 44% have children, and two-thirds of those children are under age 11, noted Dr. Stephen J. Cozza, professor of psychiatry and associate director of the center for the study of traumatic stress at the Uniformed Services University of the Health Sciences in Bethesda, Md.
"Military kids are our nation’s kids: They serve as their parents serve, and also they’re our future, in the fact that more than any other youth group in the United States, military kids select military careers," he said at a conference on the complexities and challenges of PTSD and TBI.
Military families are protected from some common stressors because they receive steady incomes, housing, and free medical care, and have access to many personal and community services. At the same time, however, they are buffeted by the stresses of deployments, relocations, separation from extended family, and in the case of National Guard and Reserve members, fewer community support systems, Dr. Cozza noted.
He cited a 2008 Department of Defense survey of 13,000 spouses of active-duty service members; it showed that while 53% said they felt their children coped well or very well with the absence of one parent, 23% felt that their children coped poorly or very poorly. The spouses also reported that 60% of the children had increased fear or anxiety, 57% had increased behavior problems at home, 38% had decreases in academic performance, and 36% had increased problems at school.
Uncovering Emotional Issues in Military Children
Other studies have shown that children of deployed parents have higher degrees of emotional difficulties than national samples and more problems with school, family, and peers (J. Adolesc. Health 2010;46:218-23), and that parental stress and cumulative length of deployment predict depression and behavioral symptoms in children (J. Am. Acad. Child Adolesc. Psychiatry 2010;49:310-20).
Lengthy deployments create what are essentially single-parent families, with the at-home spouse left to cope with running a household as well as dealing with anxiety and personal stress. In some families, the stresses of long and/or frequent deployments can lead to child maltreatment, often in the form of neglect, Dr. Cozza said (Child Abuse Rev. 2008;17:108-18).
Potential risk factors for maltreatment include preexisting psychiatric problems of the child or stay-at-home parent; poorly functioning or highly stressed nondeployed spouses; multiple, lengthy, or dual-parent deployments; lack of social connections or resources; and parental factors such as anger, disconnection, or marital conflict.
Another factor that can have a profound effect on children is a combat or deployment-related injury to a parent. Such an incident might involve a fear of loss of that parent, family separations, hospital visits, a change in the injured parent’s personality, and a potential move away from the community after a discharge from service.
"Over 95% of the severely injured are male; they’re typically young men with a strong sense of themselves as parents and as fathers in a physical fashion, and depending upon the nature of the injury, the loss of a limb or a change in the capacity to engage, all of that really changes the way they relate to their children," Dr. Cozza said.
The rehabilitation process for such patients involves helping them to learn new strategies for relating to their children and families in the presence of the injury.
For parents, especially those who have sustained a traumatic brain injury or develop posttraumatic stress disorder, their self-image as the ideal parent might be challenged, and they must find a way to integrate their new sense of self into their relationships with their children, Dr. Cozza said.
The center for traumatic stress is currently recruiting for a national military family bereavement study. It is looking at preexisting personal and contextual factors; the influence of death and the circumstances surrounding it; early bereavement response and context; and outcomes such as grief reactions, psychiatric illness, traumatic response, complicated or prolonged grief, and functioning among individuals and families as a whole.
Dr. Cozza presented his findings at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. He said he had no relevant financial disclosures.
BOSTON – In addition to the day-to-day stresses faced by most families, the children of active-duty service members must cope with the uncertainties of multiple deployments and the possibility that the parent will sustain life-altering injuries, develop mental illness, or die, according to a psychiatrist who studies and treats military families.
Of the more than 2.2 million U.S. service members on active duty, 44% have children, and two-thirds of those children are under age 11, noted Dr. Stephen J. Cozza, professor of psychiatry and associate director of the center for the study of traumatic stress at the Uniformed Services University of the Health Sciences in Bethesda, Md.
"Military kids are our nation’s kids: They serve as their parents serve, and also they’re our future, in the fact that more than any other youth group in the United States, military kids select military careers," he said at a conference on the complexities and challenges of PTSD and TBI.
Military families are protected from some common stressors because they receive steady incomes, housing, and free medical care, and have access to many personal and community services. At the same time, however, they are buffeted by the stresses of deployments, relocations, separation from extended family, and in the case of National Guard and Reserve members, fewer community support systems, Dr. Cozza noted.
He cited a 2008 Department of Defense survey of 13,000 spouses of active-duty service members; it showed that while 53% said they felt their children coped well or very well with the absence of one parent, 23% felt that their children coped poorly or very poorly. The spouses also reported that 60% of the children had increased fear or anxiety, 57% had increased behavior problems at home, 38% had decreases in academic performance, and 36% had increased problems at school.
Uncovering Emotional Issues in Military Children
Other studies have shown that children of deployed parents have higher degrees of emotional difficulties than national samples and more problems with school, family, and peers (J. Adolesc. Health 2010;46:218-23), and that parental stress and cumulative length of deployment predict depression and behavioral symptoms in children (J. Am. Acad. Child Adolesc. Psychiatry 2010;49:310-20).
Lengthy deployments create what are essentially single-parent families, with the at-home spouse left to cope with running a household as well as dealing with anxiety and personal stress. In some families, the stresses of long and/or frequent deployments can lead to child maltreatment, often in the form of neglect, Dr. Cozza said (Child Abuse Rev. 2008;17:108-18).
Potential risk factors for maltreatment include preexisting psychiatric problems of the child or stay-at-home parent; poorly functioning or highly stressed nondeployed spouses; multiple, lengthy, or dual-parent deployments; lack of social connections or resources; and parental factors such as anger, disconnection, or marital conflict.
Another factor that can have a profound effect on children is a combat or deployment-related injury to a parent. Such an incident might involve a fear of loss of that parent, family separations, hospital visits, a change in the injured parent’s personality, and a potential move away from the community after a discharge from service.
"Over 95% of the severely injured are male; they’re typically young men with a strong sense of themselves as parents and as fathers in a physical fashion, and depending upon the nature of the injury, the loss of a limb or a change in the capacity to engage, all of that really changes the way they relate to their children," Dr. Cozza said.
The rehabilitation process for such patients involves helping them to learn new strategies for relating to their children and families in the presence of the injury.
For parents, especially those who have sustained a traumatic brain injury or develop posttraumatic stress disorder, their self-image as the ideal parent might be challenged, and they must find a way to integrate their new sense of self into their relationships with their children, Dr. Cozza said.
The center for traumatic stress is currently recruiting for a national military family bereavement study. It is looking at preexisting personal and contextual factors; the influence of death and the circumstances surrounding it; early bereavement response and context; and outcomes such as grief reactions, psychiatric illness, traumatic response, complicated or prolonged grief, and functioning among individuals and families as a whole.
Dr. Cozza presented his findings at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. He said he had no relevant financial disclosures.
BOSTON – In addition to the day-to-day stresses faced by most families, the children of active-duty service members must cope with the uncertainties of multiple deployments and the possibility that the parent will sustain life-altering injuries, develop mental illness, or die, according to a psychiatrist who studies and treats military families.
Of the more than 2.2 million U.S. service members on active duty, 44% have children, and two-thirds of those children are under age 11, noted Dr. Stephen J. Cozza, professor of psychiatry and associate director of the center for the study of traumatic stress at the Uniformed Services University of the Health Sciences in Bethesda, Md.
"Military kids are our nation’s kids: They serve as their parents serve, and also they’re our future, in the fact that more than any other youth group in the United States, military kids select military careers," he said at a conference on the complexities and challenges of PTSD and TBI.
Military families are protected from some common stressors because they receive steady incomes, housing, and free medical care, and have access to many personal and community services. At the same time, however, they are buffeted by the stresses of deployments, relocations, separation from extended family, and in the case of National Guard and Reserve members, fewer community support systems, Dr. Cozza noted.
He cited a 2008 Department of Defense survey of 13,000 spouses of active-duty service members; it showed that while 53% said they felt their children coped well or very well with the absence of one parent, 23% felt that their children coped poorly or very poorly. The spouses also reported that 60% of the children had increased fear or anxiety, 57% had increased behavior problems at home, 38% had decreases in academic performance, and 36% had increased problems at school.
Uncovering Emotional Issues in Military Children
Other studies have shown that children of deployed parents have higher degrees of emotional difficulties than national samples and more problems with school, family, and peers (J. Adolesc. Health 2010;46:218-23), and that parental stress and cumulative length of deployment predict depression and behavioral symptoms in children (J. Am. Acad. Child Adolesc. Psychiatry 2010;49:310-20).
Lengthy deployments create what are essentially single-parent families, with the at-home spouse left to cope with running a household as well as dealing with anxiety and personal stress. In some families, the stresses of long and/or frequent deployments can lead to child maltreatment, often in the form of neglect, Dr. Cozza said (Child Abuse Rev. 2008;17:108-18).
Potential risk factors for maltreatment include preexisting psychiatric problems of the child or stay-at-home parent; poorly functioning or highly stressed nondeployed spouses; multiple, lengthy, or dual-parent deployments; lack of social connections or resources; and parental factors such as anger, disconnection, or marital conflict.
Another factor that can have a profound effect on children is a combat or deployment-related injury to a parent. Such an incident might involve a fear of loss of that parent, family separations, hospital visits, a change in the injured parent’s personality, and a potential move away from the community after a discharge from service.
"Over 95% of the severely injured are male; they’re typically young men with a strong sense of themselves as parents and as fathers in a physical fashion, and depending upon the nature of the injury, the loss of a limb or a change in the capacity to engage, all of that really changes the way they relate to their children," Dr. Cozza said.
The rehabilitation process for such patients involves helping them to learn new strategies for relating to their children and families in the presence of the injury.
For parents, especially those who have sustained a traumatic brain injury or develop posttraumatic stress disorder, their self-image as the ideal parent might be challenged, and they must find a way to integrate their new sense of self into their relationships with their children, Dr. Cozza said.
The center for traumatic stress is currently recruiting for a national military family bereavement study. It is looking at preexisting personal and contextual factors; the influence of death and the circumstances surrounding it; early bereavement response and context; and outcomes such as grief reactions, psychiatric illness, traumatic response, complicated or prolonged grief, and functioning among individuals and families as a whole.
Dr. Cozza presented his findings at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. He said he had no relevant financial disclosures.
FROM A CONFERENCE ON THE COMPLEXITIES AND CHALLENGES OF PTSD AND TBI
Major Finding: Among 13,000 spouses of active-duty armed services members surveyed, 23% said their children were not coping well with the deployment of the other parent.
Data Source: Overview of data on the psychological stresses on children in military families.
Disclosures: Presented at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. Dr. Cozza said he had no relevant financial disclosures.
Suicides, Homicides Among Military Share Common Features
BOSTON – A volatile mixture of individual, environmental, and social factors may cause a soldier to explode with anger and aggression toward himself or his fellows in arms, said a psychiatrist who studies suicidal behaviors and homicidal acts among U.S. service members.
"I don’t want to say that every vet is a walking time bomb, but I think you need to be thinking about it all the time," said Dr. Elspeth Cameron Ritchie at a conference on the complexities and challenges of PTSD and TBI, sponsored by Massachusetts General Hospital.
Reviews of mass shootings at bases in the United States and abroad, as well as homicides among soldiers at Fort Carson, Colo., show that many of the factors that are known to heighten risk for violence in the general population are present in the military, with the addition of a key significant factor: ready access to lethal weapons.
"I don’t think it’s a great message when we sell weapons in PXs [post exchanges]. We have had some episodes where people have bought weapons and then shot themselves or another member, sometimes in the PX itself," said Dr. Ritchie, chief clinical officer for the District of Columbia Department of Mental Health and a retired colonel in the U.S. Army.
Army Suicide Rates Rising
Risk factors for suicide and violence toward others in the military population are similar to those seen in civilian life: acute psychosis, insult-evoked reactions, drug and alcohol use/abuse, recent stressors, unstable mood and affect, mania, and severe depression.
Mood and adjustment disorders and substance abuse are relatively common among Army personnel who commit suicide, but more serious psychiatric disorders and personality disorders are less frequent, Dr. Ritchie said. Suicides are often linked to relationship problems, legal or occupational difficulties, and chronic pain and/or disability. Recently, there has been an uptick in suicides among older service members, higher ranks, and women.
Historically, the rates of suicides among active-duty Army members had been lower than that of the general population. But data from the Centers for Disease Control and Prevention’s National Center for Health Statistics shows that while suicide rates among the general population remained flat from 2001 through 2006, the rate among active Army members doubled, and is expected to be about 23/100,000, higher than that of the age- and gender-adjusted rate in the United States of about 18/100,000 when the most recent data (for 2008 and 2009) become available.
A review by the Army’s Epidemiology Consultant Service (EPICON) of suicides and homicides among active-duty soldiers in the United States reveals common themes involving individual and system-related risk factors, including:
• Deployment length, frequency, unpredictability.
• Combat intensity.
• Family separation, relationship stress, lack of support.
• Increased violence against others, including spouse/family.
• Increased drug/alcohol use and related offenses.
• Previous gestures/attempts and/or behavioral health contact.
• Manipulation, malingering.
• Legal/financial troubles.
• History of misconduct.
System-related issues include:
• Stigma: personal, peer, leadership, career.
• Poor service delivery for dependents.
• Transition, reintegration issues.
• Problems with behavioral health services.
• Lack of standardized screening, tracking, intervention or data collection.
• Leadership management/climate.
Cases of Violence at Army Bases
Dr. Ritchie reviewed several well-known and less well-publicized examples of violence at U.S. Army bases over the last decade.
For example, at Fort Bragg, N.C., there were two cases of husbands murdering wives and two husband and wife murder-suicides in 2002. A 12-member Army team reviewed the cases and determined that rapid return from the theater of battle, infidelity, access to weapons ("a gun in the nightstand"), lack of access to care, and perceived stigma were common factors.
Suicides and other acts of violence at Fort Hood, Tex., in 2005 and Fort Campbell, Ky., in 2007 had several key features in common, including high operational tempo, transition in leadership, fragmentation of care, and access to weapons.
And in the most notorious event, an Army psychiatrist at Fort Hood killed 13 people in a deployment clinic on base in 2009. Dr. Ritchie said that in retrospect, many of the previously mentioned red flags were present in that case. Although it led to multiple efforts to screen soldiers for violence, most are unlikely to confess on questionnaires to having violent thoughts, she added.
Heed Warning Signs in Soldiers
Clinicians treating soldiers at risk for violence should look for warning signs that might include an angry appearance, agitated or loud behavior, obtaining or carrying a weapon when not authorized to do so, suicidal acts, discussions of violence, obsession with death, or preoccupation with religion, which may be a symptom of a psychosis or delusional disorder, Dr. Ritchie said.
Other risk factors clinicians should look for are emotional withdrawal, substance abuse, hopelessness and despair, lingering resentment, humiliation by a coworker or superior, feelings of persecution, and recent break-up of a romantic relationship.
She recommended that clinicians ask about history of head trauma and screen for impulsivity, brain trauma, alcohol and drug use, weapons access, marital/relationship issues, financial concerns, and recent humiliating events.
She also advised creation of a safety plan, use of a panic button to call for specialized help, and training of clinic personnel in safety procedures.
Dr. Ritchie presented her findings at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General. She had no relevant conflict of interest disclosures.
BOSTON – A volatile mixture of individual, environmental, and social factors may cause a soldier to explode with anger and aggression toward himself or his fellows in arms, said a psychiatrist who studies suicidal behaviors and homicidal acts among U.S. service members.
"I don’t want to say that every vet is a walking time bomb, but I think you need to be thinking about it all the time," said Dr. Elspeth Cameron Ritchie at a conference on the complexities and challenges of PTSD and TBI, sponsored by Massachusetts General Hospital.
Reviews of mass shootings at bases in the United States and abroad, as well as homicides among soldiers at Fort Carson, Colo., show that many of the factors that are known to heighten risk for violence in the general population are present in the military, with the addition of a key significant factor: ready access to lethal weapons.
"I don’t think it’s a great message when we sell weapons in PXs [post exchanges]. We have had some episodes where people have bought weapons and then shot themselves or another member, sometimes in the PX itself," said Dr. Ritchie, chief clinical officer for the District of Columbia Department of Mental Health and a retired colonel in the U.S. Army.
Army Suicide Rates Rising
Risk factors for suicide and violence toward others in the military population are similar to those seen in civilian life: acute psychosis, insult-evoked reactions, drug and alcohol use/abuse, recent stressors, unstable mood and affect, mania, and severe depression.
Mood and adjustment disorders and substance abuse are relatively common among Army personnel who commit suicide, but more serious psychiatric disorders and personality disorders are less frequent, Dr. Ritchie said. Suicides are often linked to relationship problems, legal or occupational difficulties, and chronic pain and/or disability. Recently, there has been an uptick in suicides among older service members, higher ranks, and women.
Historically, the rates of suicides among active-duty Army members had been lower than that of the general population. But data from the Centers for Disease Control and Prevention’s National Center for Health Statistics shows that while suicide rates among the general population remained flat from 2001 through 2006, the rate among active Army members doubled, and is expected to be about 23/100,000, higher than that of the age- and gender-adjusted rate in the United States of about 18/100,000 when the most recent data (for 2008 and 2009) become available.
A review by the Army’s Epidemiology Consultant Service (EPICON) of suicides and homicides among active-duty soldiers in the United States reveals common themes involving individual and system-related risk factors, including:
• Deployment length, frequency, unpredictability.
• Combat intensity.
• Family separation, relationship stress, lack of support.
• Increased violence against others, including spouse/family.
• Increased drug/alcohol use and related offenses.
• Previous gestures/attempts and/or behavioral health contact.
• Manipulation, malingering.
• Legal/financial troubles.
• History of misconduct.
System-related issues include:
• Stigma: personal, peer, leadership, career.
• Poor service delivery for dependents.
• Transition, reintegration issues.
• Problems with behavioral health services.
• Lack of standardized screening, tracking, intervention or data collection.
• Leadership management/climate.
Cases of Violence at Army Bases
Dr. Ritchie reviewed several well-known and less well-publicized examples of violence at U.S. Army bases over the last decade.
For example, at Fort Bragg, N.C., there were two cases of husbands murdering wives and two husband and wife murder-suicides in 2002. A 12-member Army team reviewed the cases and determined that rapid return from the theater of battle, infidelity, access to weapons ("a gun in the nightstand"), lack of access to care, and perceived stigma were common factors.
Suicides and other acts of violence at Fort Hood, Tex., in 2005 and Fort Campbell, Ky., in 2007 had several key features in common, including high operational tempo, transition in leadership, fragmentation of care, and access to weapons.
And in the most notorious event, an Army psychiatrist at Fort Hood killed 13 people in a deployment clinic on base in 2009. Dr. Ritchie said that in retrospect, many of the previously mentioned red flags were present in that case. Although it led to multiple efforts to screen soldiers for violence, most are unlikely to confess on questionnaires to having violent thoughts, she added.
Heed Warning Signs in Soldiers
Clinicians treating soldiers at risk for violence should look for warning signs that might include an angry appearance, agitated or loud behavior, obtaining or carrying a weapon when not authorized to do so, suicidal acts, discussions of violence, obsession with death, or preoccupation with religion, which may be a symptom of a psychosis or delusional disorder, Dr. Ritchie said.
Other risk factors clinicians should look for are emotional withdrawal, substance abuse, hopelessness and despair, lingering resentment, humiliation by a coworker or superior, feelings of persecution, and recent break-up of a romantic relationship.
She recommended that clinicians ask about history of head trauma and screen for impulsivity, brain trauma, alcohol and drug use, weapons access, marital/relationship issues, financial concerns, and recent humiliating events.
She also advised creation of a safety plan, use of a panic button to call for specialized help, and training of clinic personnel in safety procedures.
Dr. Ritchie presented her findings at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General. She had no relevant conflict of interest disclosures.
BOSTON – A volatile mixture of individual, environmental, and social factors may cause a soldier to explode with anger and aggression toward himself or his fellows in arms, said a psychiatrist who studies suicidal behaviors and homicidal acts among U.S. service members.
"I don’t want to say that every vet is a walking time bomb, but I think you need to be thinking about it all the time," said Dr. Elspeth Cameron Ritchie at a conference on the complexities and challenges of PTSD and TBI, sponsored by Massachusetts General Hospital.
Reviews of mass shootings at bases in the United States and abroad, as well as homicides among soldiers at Fort Carson, Colo., show that many of the factors that are known to heighten risk for violence in the general population are present in the military, with the addition of a key significant factor: ready access to lethal weapons.
"I don’t think it’s a great message when we sell weapons in PXs [post exchanges]. We have had some episodes where people have bought weapons and then shot themselves or another member, sometimes in the PX itself," said Dr. Ritchie, chief clinical officer for the District of Columbia Department of Mental Health and a retired colonel in the U.S. Army.
Army Suicide Rates Rising
Risk factors for suicide and violence toward others in the military population are similar to those seen in civilian life: acute psychosis, insult-evoked reactions, drug and alcohol use/abuse, recent stressors, unstable mood and affect, mania, and severe depression.
Mood and adjustment disorders and substance abuse are relatively common among Army personnel who commit suicide, but more serious psychiatric disorders and personality disorders are less frequent, Dr. Ritchie said. Suicides are often linked to relationship problems, legal or occupational difficulties, and chronic pain and/or disability. Recently, there has been an uptick in suicides among older service members, higher ranks, and women.
Historically, the rates of suicides among active-duty Army members had been lower than that of the general population. But data from the Centers for Disease Control and Prevention’s National Center for Health Statistics shows that while suicide rates among the general population remained flat from 2001 through 2006, the rate among active Army members doubled, and is expected to be about 23/100,000, higher than that of the age- and gender-adjusted rate in the United States of about 18/100,000 when the most recent data (for 2008 and 2009) become available.
A review by the Army’s Epidemiology Consultant Service (EPICON) of suicides and homicides among active-duty soldiers in the United States reveals common themes involving individual and system-related risk factors, including:
• Deployment length, frequency, unpredictability.
• Combat intensity.
• Family separation, relationship stress, lack of support.
• Increased violence against others, including spouse/family.
• Increased drug/alcohol use and related offenses.
• Previous gestures/attempts and/or behavioral health contact.
• Manipulation, malingering.
• Legal/financial troubles.
• History of misconduct.
System-related issues include:
• Stigma: personal, peer, leadership, career.
• Poor service delivery for dependents.
• Transition, reintegration issues.
• Problems with behavioral health services.
• Lack of standardized screening, tracking, intervention or data collection.
• Leadership management/climate.
Cases of Violence at Army Bases
Dr. Ritchie reviewed several well-known and less well-publicized examples of violence at U.S. Army bases over the last decade.
For example, at Fort Bragg, N.C., there were two cases of husbands murdering wives and two husband and wife murder-suicides in 2002. A 12-member Army team reviewed the cases and determined that rapid return from the theater of battle, infidelity, access to weapons ("a gun in the nightstand"), lack of access to care, and perceived stigma were common factors.
Suicides and other acts of violence at Fort Hood, Tex., in 2005 and Fort Campbell, Ky., in 2007 had several key features in common, including high operational tempo, transition in leadership, fragmentation of care, and access to weapons.
And in the most notorious event, an Army psychiatrist at Fort Hood killed 13 people in a deployment clinic on base in 2009. Dr. Ritchie said that in retrospect, many of the previously mentioned red flags were present in that case. Although it led to multiple efforts to screen soldiers for violence, most are unlikely to confess on questionnaires to having violent thoughts, she added.
Heed Warning Signs in Soldiers
Clinicians treating soldiers at risk for violence should look for warning signs that might include an angry appearance, agitated or loud behavior, obtaining or carrying a weapon when not authorized to do so, suicidal acts, discussions of violence, obsession with death, or preoccupation with religion, which may be a symptom of a psychosis or delusional disorder, Dr. Ritchie said.
Other risk factors clinicians should look for are emotional withdrawal, substance abuse, hopelessness and despair, lingering resentment, humiliation by a coworker or superior, feelings of persecution, and recent break-up of a romantic relationship.
She recommended that clinicians ask about history of head trauma and screen for impulsivity, brain trauma, alcohol and drug use, weapons access, marital/relationship issues, financial concerns, and recent humiliating events.
She also advised creation of a safety plan, use of a panic button to call for specialized help, and training of clinic personnel in safety procedures.
Dr. Ritchie presented her findings at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General. She had no relevant conflict of interest disclosures.
FROM A CONFERENCE ON THE COMPLEXITIES AND CHALLENGES OF PTSD AND TBI
Major Finding: Suicide rates among active-duty U.S. Army soldiers are expected to be about 22/100,000, exceeding that of the age- and gender-adjusted U.S. population when the most recent data (for 2008-2009) become available.
Data Source: Overview of data on suicide and violence among active duty U.S. service members.
Disclosures: Dr. Ritchie presented her findings at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. She had no relevant conflict of interest disclosures.
Diagnosing TBI and PTSD in Returning Soldiers
BOSTON – For clinicians evaluating returning soldiers for posttraumatic stress disorder and traumatic brain injury, one of the greatest obstacles may be the soldiers’ inability to admit they may have a problem, said a specialist at a conference on the complexities and challenges of PTSD and TBI.
The DSM-IV diagnostic criteria for PTSD include experiencing or witnessing an event involving actual or threatened death or serious injury, and a response involving "intense fear, helplessness, or horror," noted Dr. Lisa Brenner, associate professor of psychiatry, neurology, and physical medicine and rehabilitation at the University of Colorado, Aurora.
"When I have a 25- or 26-year-old soldier or a veteran in my office, and I say, ‘Were you afraid?’ What do you think they say to me? ‘No. I wasn’t afraid. I am trained to not be afraid.’ How do you engage in a conversation about whether or not this event really did have the impact on them that we think it did, in language that makes sense to our returning soldiers?" she asked.
Combat-associated trauma differs significantly from trauma experienced by, say, an auto-accident victim, Dr. Brenner added. PTSD in military service members develops following long-term exposure to multiple traumatic events, possibly during multiple deployments.
In addition, at least two of the key symptom clusters of PTSD – numbness/detachment from others and hyperarousal – may be protective or even lifesaving on the battlefield, but don’t work well when soldiers return home, she noted. Soldiers may need help finding alternative ways of coping in their off-duty lives, without losing the advantage that the aforementioned coping mechanisms could give them should they return to the front lines.
Equally challenging for the clinician is differentiating symptoms of mild TBI from those of PTSD, especially when they co-occur, Dr. Brenner said.
Screening for PTSD and TBI
Screening instruments can help to identify those who need further assessment for PTSD, but screening alone is not sufficient for a diagnosis, Dr. Brenner cautioned.
In the military, service members are commonly screened with the PTSD checklist, a 17-item self-report measure of the 17 DSM-IV–designated symptoms of PTSD. The checklist appears to be a clinically useful screening instrument, but a critical review published in 2010 showed that it performs differently across civilian, military, and other specific populations. The authors concluded that it should be used with a second-tier diagnostic test such as a standardized interview (Clin. Psychol. Rev. 2010;30:976-87).
Traumatic brain injury (TBI) involves an alteration in consciousness, ranging from brief changes (mild TBI) to an extended period of unconsciousness or amnesia (severe TBI).
"Most of the people in Iraq and Afghanistan who sustain TBIs sustain mild brain injuries, and we expect recovery," Dr. Brenner said.
Nearly everyone who sustains a mild TBI or concussion reports immediate postinjury symptoms that may include headache, poor concentration, memory loss, irritability, fatigue, depression, anxiety, dizziness, or light and sound sensitivity. These symptoms are not specific, however, and should not be the basis for a diagnosis of TBI.
Returning service members are screened with a questionnaire that asks whether they had an injury event and, if so, whether they lost consciousness, felt dazed or confused, didn’t recall experiencing the event, or had a diagnosed concussion or head injury. They are also asked about acute and persistent problems with memory, balance, ringing in the ears, photosensitivity, headache, and sleep problems.
"I think this is a perfectly good screen; we just need to be really, really clear about what we’re screening for. We’re not screening for a history of TBI; we’re screening for a history of TBI with persistent symptoms," Dr. Brenner said.
TBI screening of soldiers returning from Iraq and Afghanistan has been routine since 2007 in the Veterans Affairs health system and since 2008 in the Department of Defense medical system. As a result, many veterans deployed earlier may have had TBIs that went undetected. In addition, returning soldiers, anxious to get home, may falsely report having no exposure, in the fear that a positive response would further delay their return, Dr. Brenner said.
Co-Occurring PTSD and TBI
PTSD and mild TBI can co-occur and have many overlapping symptoms, including problems with sleep, memory, cognition, and mood. The gold standard for diagnosing the conditions is a validated, structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS) or the Ohio State University Traumatic Brain Injury Identification Method.
Dr. Brenner and her colleagues found in a recent study that "in soldiers with histories of physical injury, mild TBI and PTSD were independently associated with postconcussive symptom reporting. Those with both conditions were at greater risk for postconcussive symptoms than those with either PTSD, mild TBI, or neither" (J. Head Trauma Rehabil. 2010;25:307-12).
Regarding treatment, "there’s no reason not to provide somebody with the best PTSD treatment if they have a mild TBI," Dr. Brenner said. A 2008 VA consensus conference on treatment of veterans with comorbid mild TBI, pain, and PTSD recommended that "veterans who experience mild TBI and/or pain, along with PTSD, should have the opportunity to receive the two best evidence-based treatments in the VA/DoD practice guidelines for PTSD: prolonged exposure therapy or cognitive processing therapy."
The conference was sponsored by Massachusetts General Hospital, Boston. Dr. Brenner presented her research at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. She reported no relevant conflicts of interest.
post traumatic stress disorder in soldiers, PTSD treatment for soldiers, mental health of soldiers, TBI screening
BOSTON – For clinicians evaluating returning soldiers for posttraumatic stress disorder and traumatic brain injury, one of the greatest obstacles may be the soldiers’ inability to admit they may have a problem, said a specialist at a conference on the complexities and challenges of PTSD and TBI.
The DSM-IV diagnostic criteria for PTSD include experiencing or witnessing an event involving actual or threatened death or serious injury, and a response involving "intense fear, helplessness, or horror," noted Dr. Lisa Brenner, associate professor of psychiatry, neurology, and physical medicine and rehabilitation at the University of Colorado, Aurora.
"When I have a 25- or 26-year-old soldier or a veteran in my office, and I say, ‘Were you afraid?’ What do you think they say to me? ‘No. I wasn’t afraid. I am trained to not be afraid.’ How do you engage in a conversation about whether or not this event really did have the impact on them that we think it did, in language that makes sense to our returning soldiers?" she asked.
Combat-associated trauma differs significantly from trauma experienced by, say, an auto-accident victim, Dr. Brenner added. PTSD in military service members develops following long-term exposure to multiple traumatic events, possibly during multiple deployments.
In addition, at least two of the key symptom clusters of PTSD – numbness/detachment from others and hyperarousal – may be protective or even lifesaving on the battlefield, but don’t work well when soldiers return home, she noted. Soldiers may need help finding alternative ways of coping in their off-duty lives, without losing the advantage that the aforementioned coping mechanisms could give them should they return to the front lines.
Equally challenging for the clinician is differentiating symptoms of mild TBI from those of PTSD, especially when they co-occur, Dr. Brenner said.
Screening for PTSD and TBI
Screening instruments can help to identify those who need further assessment for PTSD, but screening alone is not sufficient for a diagnosis, Dr. Brenner cautioned.
In the military, service members are commonly screened with the PTSD checklist, a 17-item self-report measure of the 17 DSM-IV–designated symptoms of PTSD. The checklist appears to be a clinically useful screening instrument, but a critical review published in 2010 showed that it performs differently across civilian, military, and other specific populations. The authors concluded that it should be used with a second-tier diagnostic test such as a standardized interview (Clin. Psychol. Rev. 2010;30:976-87).
Traumatic brain injury (TBI) involves an alteration in consciousness, ranging from brief changes (mild TBI) to an extended period of unconsciousness or amnesia (severe TBI).
"Most of the people in Iraq and Afghanistan who sustain TBIs sustain mild brain injuries, and we expect recovery," Dr. Brenner said.
Nearly everyone who sustains a mild TBI or concussion reports immediate postinjury symptoms that may include headache, poor concentration, memory loss, irritability, fatigue, depression, anxiety, dizziness, or light and sound sensitivity. These symptoms are not specific, however, and should not be the basis for a diagnosis of TBI.
Returning service members are screened with a questionnaire that asks whether they had an injury event and, if so, whether they lost consciousness, felt dazed or confused, didn’t recall experiencing the event, or had a diagnosed concussion or head injury. They are also asked about acute and persistent problems with memory, balance, ringing in the ears, photosensitivity, headache, and sleep problems.
"I think this is a perfectly good screen; we just need to be really, really clear about what we’re screening for. We’re not screening for a history of TBI; we’re screening for a history of TBI with persistent symptoms," Dr. Brenner said.
TBI screening of soldiers returning from Iraq and Afghanistan has been routine since 2007 in the Veterans Affairs health system and since 2008 in the Department of Defense medical system. As a result, many veterans deployed earlier may have had TBIs that went undetected. In addition, returning soldiers, anxious to get home, may falsely report having no exposure, in the fear that a positive response would further delay their return, Dr. Brenner said.
Co-Occurring PTSD and TBI
PTSD and mild TBI can co-occur and have many overlapping symptoms, including problems with sleep, memory, cognition, and mood. The gold standard for diagnosing the conditions is a validated, structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS) or the Ohio State University Traumatic Brain Injury Identification Method.
Dr. Brenner and her colleagues found in a recent study that "in soldiers with histories of physical injury, mild TBI and PTSD were independently associated with postconcussive symptom reporting. Those with both conditions were at greater risk for postconcussive symptoms than those with either PTSD, mild TBI, or neither" (J. Head Trauma Rehabil. 2010;25:307-12).
Regarding treatment, "there’s no reason not to provide somebody with the best PTSD treatment if they have a mild TBI," Dr. Brenner said. A 2008 VA consensus conference on treatment of veterans with comorbid mild TBI, pain, and PTSD recommended that "veterans who experience mild TBI and/or pain, along with PTSD, should have the opportunity to receive the two best evidence-based treatments in the VA/DoD practice guidelines for PTSD: prolonged exposure therapy or cognitive processing therapy."
The conference was sponsored by Massachusetts General Hospital, Boston. Dr. Brenner presented her research at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. She reported no relevant conflicts of interest.
BOSTON – For clinicians evaluating returning soldiers for posttraumatic stress disorder and traumatic brain injury, one of the greatest obstacles may be the soldiers’ inability to admit they may have a problem, said a specialist at a conference on the complexities and challenges of PTSD and TBI.
The DSM-IV diagnostic criteria for PTSD include experiencing or witnessing an event involving actual or threatened death or serious injury, and a response involving "intense fear, helplessness, or horror," noted Dr. Lisa Brenner, associate professor of psychiatry, neurology, and physical medicine and rehabilitation at the University of Colorado, Aurora.
"When I have a 25- or 26-year-old soldier or a veteran in my office, and I say, ‘Were you afraid?’ What do you think they say to me? ‘No. I wasn’t afraid. I am trained to not be afraid.’ How do you engage in a conversation about whether or not this event really did have the impact on them that we think it did, in language that makes sense to our returning soldiers?" she asked.
Combat-associated trauma differs significantly from trauma experienced by, say, an auto-accident victim, Dr. Brenner added. PTSD in military service members develops following long-term exposure to multiple traumatic events, possibly during multiple deployments.
In addition, at least two of the key symptom clusters of PTSD – numbness/detachment from others and hyperarousal – may be protective or even lifesaving on the battlefield, but don’t work well when soldiers return home, she noted. Soldiers may need help finding alternative ways of coping in their off-duty lives, without losing the advantage that the aforementioned coping mechanisms could give them should they return to the front lines.
Equally challenging for the clinician is differentiating symptoms of mild TBI from those of PTSD, especially when they co-occur, Dr. Brenner said.
Screening for PTSD and TBI
Screening instruments can help to identify those who need further assessment for PTSD, but screening alone is not sufficient for a diagnosis, Dr. Brenner cautioned.
In the military, service members are commonly screened with the PTSD checklist, a 17-item self-report measure of the 17 DSM-IV–designated symptoms of PTSD. The checklist appears to be a clinically useful screening instrument, but a critical review published in 2010 showed that it performs differently across civilian, military, and other specific populations. The authors concluded that it should be used with a second-tier diagnostic test such as a standardized interview (Clin. Psychol. Rev. 2010;30:976-87).
Traumatic brain injury (TBI) involves an alteration in consciousness, ranging from brief changes (mild TBI) to an extended period of unconsciousness or amnesia (severe TBI).
"Most of the people in Iraq and Afghanistan who sustain TBIs sustain mild brain injuries, and we expect recovery," Dr. Brenner said.
Nearly everyone who sustains a mild TBI or concussion reports immediate postinjury symptoms that may include headache, poor concentration, memory loss, irritability, fatigue, depression, anxiety, dizziness, or light and sound sensitivity. These symptoms are not specific, however, and should not be the basis for a diagnosis of TBI.
Returning service members are screened with a questionnaire that asks whether they had an injury event and, if so, whether they lost consciousness, felt dazed or confused, didn’t recall experiencing the event, or had a diagnosed concussion or head injury. They are also asked about acute and persistent problems with memory, balance, ringing in the ears, photosensitivity, headache, and sleep problems.
"I think this is a perfectly good screen; we just need to be really, really clear about what we’re screening for. We’re not screening for a history of TBI; we’re screening for a history of TBI with persistent symptoms," Dr. Brenner said.
TBI screening of soldiers returning from Iraq and Afghanistan has been routine since 2007 in the Veterans Affairs health system and since 2008 in the Department of Defense medical system. As a result, many veterans deployed earlier may have had TBIs that went undetected. In addition, returning soldiers, anxious to get home, may falsely report having no exposure, in the fear that a positive response would further delay their return, Dr. Brenner said.
Co-Occurring PTSD and TBI
PTSD and mild TBI can co-occur and have many overlapping symptoms, including problems with sleep, memory, cognition, and mood. The gold standard for diagnosing the conditions is a validated, structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS) or the Ohio State University Traumatic Brain Injury Identification Method.
Dr. Brenner and her colleagues found in a recent study that "in soldiers with histories of physical injury, mild TBI and PTSD were independently associated with postconcussive symptom reporting. Those with both conditions were at greater risk for postconcussive symptoms than those with either PTSD, mild TBI, or neither" (J. Head Trauma Rehabil. 2010;25:307-12).
Regarding treatment, "there’s no reason not to provide somebody with the best PTSD treatment if they have a mild TBI," Dr. Brenner said. A 2008 VA consensus conference on treatment of veterans with comorbid mild TBI, pain, and PTSD recommended that "veterans who experience mild TBI and/or pain, along with PTSD, should have the opportunity to receive the two best evidence-based treatments in the VA/DoD practice guidelines for PTSD: prolonged exposure therapy or cognitive processing therapy."
The conference was sponsored by Massachusetts General Hospital, Boston. Dr. Brenner presented her research at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. She reported no relevant conflicts of interest.
post traumatic stress disorder in soldiers, PTSD treatment for soldiers, mental health of soldiers, TBI screening
post traumatic stress disorder in soldiers, PTSD treatment for soldiers, mental health of soldiers, TBI screening
EXPERT ANALYSIS FROM A CONFERENCE ON THE COMPLEXITIES AND CHALLENGES OF PTSD AND TBI
Cognitive Interventions, Acupuncture May Help Pain, PTSD
BOSTON – Cognitive therapies and acupuncture can be as powerful as narcotics and analgesics for treating the chronic pain associated with posttraumatic stress disorder and traumatic brain injury, investigators reported at the annual conference on the complexities and challenges of PTSD and TBI.
An intensive, integrated approach that combines elements of evidence-based cognitive behavioral treatments for chronic pain and PTSD may help some patients find substantial relief with little or no additional medication, said John D. Otis, Ph.D., who is with the department of psychiatry at Boston University, and is a clinical psychologist at the VA Boston Healthcare System.
In addition, complementary and alternative medicine (CAM) techniques that are performed "in theater" can offer what one soldier calls "a moment of peace in a sea of pain," noted Capt. Robert Koffman, director of deployment health at the National Naval Medical Center in Bethesda, Md.
"Emotional pain" appears to have a solid grounding in biology, Dr. Otis said, pointing to a recent study in which people who recently experienced an unwanted breakup viewed photos of their former partners during a functional MRI scan. The scans showed that areas supporting the sensory components of pain, including the somatosensory cortex and dorsal posterior insula, became active (Proc. Natl. Acad. Sci. U. S. A. 2011;108:6270-5).
Chronic Pain Common Among Vets
About half of all veterans in the VA health care system report chronic pain. A 2006 study of 1,800 veterans of the wars in Afghanistan and Iraq showed that 46.5% of those seeking VA care reported some pain, and that 59% had a pain score of 4 or greater on a scale of 0-10, which exceeded the VA pain threshold (Pain Med. 2006;7:339-43).
"Pain is usually considered to be chronic when it lasts for 3 months or longer. That’s not a very long time. Most of the people I see at the VA have had pain for a lot longer than 3 months; they’ve had it for 3 years, 10 years, sometimes even 30 years," Dr. Otis said.
Pain is also a frequent comorbidity with PTSD and traumatic brain injury (TBI). A sample of 340 veterans of the conflicts in Iraq and Afghanistan showed that 42.1% had a confluence of PTSD, TBI, and chronic pain (J. Rehabil. Res. Dev. 2009;46:697-702).
CBT for Chronic Pain Relief
Although pain is an adaptive reaction to an injury and will gradually decrease over time for many people, for some it can be persistent, leading to negative mood (including depression) and disability. For such patients, cognitive behavioral therapy (CBT) can provide significant relief. CBT has been found to be effective in the treatment of headache, rheumatic disease, chronic pain syndrome, chronic low-back pain, and irritable bowel syndrome, Dr. Otis said.
Elements of CBT in chronic pain treatment include setting activity goals for patients, identifying and challenging their inaccurate beliefs about pain, teaching coping skills (such as activity pacing and restructuring of negative thoughts), practicing and consolidating the newly learned skills, and reinforcing their appropriate use.
In their integrated approach, Dr. Otis and his colleagues present CBT as part of a multidisciplinary pain management program incorporating anesthesiology, neurology, physical and occupational therapy, and psychology. The CBT component consists of 11 sessions that begin with a discussion of the rationale for therapy so that patients "buy in," followed by sessions focusing on theories of pain; breathing and relaxation techniques (such as yoga and tai chi); cognitive errors and restructuring; stress management; time-based activity pacing; scheduling of pleasant activities; anger management; sleep hygiene; and relapse prevention.
CBT for Comorbid Pain and PTSD
"In PTSD samples, the prevalence of chronic pain is approximately 66%-80%. In pain samples, the prevalence of PTSD is approximately 34%-50%," Dr. Otis said. He pointed to a significant overlap between the conditions, which suggests an opportunity for therapy to treat both conditions.
In a study of pain and PTSD comorbidity that he and his colleagues conducted with 149 veterans who participated in a VA pain management program, the researchers found that the presence of PTSD predicted experience of chronic pain, even after they controlled for the effects of depressed mood. They also found that "the largest portion of the association between PTSD and pain was accounted for by pain-relevant affective distress" such as anxiety, anger, and irritability (Psychol. Serv. 2010;7:126-35).
Given the similarity of CBT for both pain and PTSD, Dr. Otis and his colleagues are testing a treatment they developed for both conditions that is designed to be "transportable," so that clinicians can learn the technique with a minimum of training. The treatment was originally designed to be given in 12 sessions focusing on education and attitudes about chronic pain and PTSD, cognitive interventions, relaxation, avoidance issues, interoceptive exposure, and other elements focusing on anger control, safety, trust, and relapse prevention. In a pilot study with six patients, however, two dropped out before the third session because of the lengthy time commitment. The investigators have since modified the program to be more intensive, with six sessions given over 3 weeks.
In a pilot study with eight patients to test the feasibility of the program, there were significant reductions in the CAPS (Clinician Administered Assessment of PTSD) inventory from baseline to post treatment (P = .03) and in the Pain Catastrophizing Scale (P = .05). There were also nonsignificant reductions in the Numerical Rating Scale, Beck Depression Inventory, and Anxiety Sensitivity Index.
"We had great feedback from the patients. They all really enjoyed learning skills for pain and PTSD," Dr. Otis said. There were no dropouts.
The investigators are continuing to study the treatment, and if it proves to be successful in a larger treatment sample it could be a first step to help veterans of current wars to learn how to effectively cope with pain and PTSD in their daily lives, Dr. Otis concluded.
Acupuncture Near the Front Line
In a related presentation, Dr. Koffman discussed the use of acupuncture as a pain-relief and relaxation technique for active duty military.
"Acupuncture is now listed as one of the acceptable modalities" in the Department of Defense/VA clinical practice guideline, he said.
The guidelines note that research focusing on the efficacy of acupuncture "is still relatively limited. The few available studies are well done and demonstrate significant improvement in both PTSD and PTSD-associated symptomatology. A larger numbers of studies exist, concluding acupuncture’s efficacy in pain management, insomnia, depression, and substance abuse."
A recent, unpublished, Department of Defense/VA randomized controlled trial cited in the guidelines looked at 55 active-duty service members with PTSD who were randomized to treatment as usual with or without acupuncture sessions. The study showed that a 4-week course of twice-weekly 90-minute acupuncture sessions was associated with significantly greater improvement in PTSD symptoms and depression and pain scores.
The guidelines also state that "CAM approaches that facilitate a relaxation response [such as mindfulness, yoga, acupuncture, massage, and others] may be considered for adjunctive treatment of hyperarousal symptoms, although there is no evidence that these are more effective than standard stress inoculation techniques."
Dr. Otis and Dr. Koffman presented their research at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. Neither clinician reported relevant conflicts of interest.
BOSTON – Cognitive therapies and acupuncture can be as powerful as narcotics and analgesics for treating the chronic pain associated with posttraumatic stress disorder and traumatic brain injury, investigators reported at the annual conference on the complexities and challenges of PTSD and TBI.
An intensive, integrated approach that combines elements of evidence-based cognitive behavioral treatments for chronic pain and PTSD may help some patients find substantial relief with little or no additional medication, said John D. Otis, Ph.D., who is with the department of psychiatry at Boston University, and is a clinical psychologist at the VA Boston Healthcare System.
In addition, complementary and alternative medicine (CAM) techniques that are performed "in theater" can offer what one soldier calls "a moment of peace in a sea of pain," noted Capt. Robert Koffman, director of deployment health at the National Naval Medical Center in Bethesda, Md.
"Emotional pain" appears to have a solid grounding in biology, Dr. Otis said, pointing to a recent study in which people who recently experienced an unwanted breakup viewed photos of their former partners during a functional MRI scan. The scans showed that areas supporting the sensory components of pain, including the somatosensory cortex and dorsal posterior insula, became active (Proc. Natl. Acad. Sci. U. S. A. 2011;108:6270-5).
Chronic Pain Common Among Vets
About half of all veterans in the VA health care system report chronic pain. A 2006 study of 1,800 veterans of the wars in Afghanistan and Iraq showed that 46.5% of those seeking VA care reported some pain, and that 59% had a pain score of 4 or greater on a scale of 0-10, which exceeded the VA pain threshold (Pain Med. 2006;7:339-43).
"Pain is usually considered to be chronic when it lasts for 3 months or longer. That’s not a very long time. Most of the people I see at the VA have had pain for a lot longer than 3 months; they’ve had it for 3 years, 10 years, sometimes even 30 years," Dr. Otis said.
Pain is also a frequent comorbidity with PTSD and traumatic brain injury (TBI). A sample of 340 veterans of the conflicts in Iraq and Afghanistan showed that 42.1% had a confluence of PTSD, TBI, and chronic pain (J. Rehabil. Res. Dev. 2009;46:697-702).
CBT for Chronic Pain Relief
Although pain is an adaptive reaction to an injury and will gradually decrease over time for many people, for some it can be persistent, leading to negative mood (including depression) and disability. For such patients, cognitive behavioral therapy (CBT) can provide significant relief. CBT has been found to be effective in the treatment of headache, rheumatic disease, chronic pain syndrome, chronic low-back pain, and irritable bowel syndrome, Dr. Otis said.
Elements of CBT in chronic pain treatment include setting activity goals for patients, identifying and challenging their inaccurate beliefs about pain, teaching coping skills (such as activity pacing and restructuring of negative thoughts), practicing and consolidating the newly learned skills, and reinforcing their appropriate use.
In their integrated approach, Dr. Otis and his colleagues present CBT as part of a multidisciplinary pain management program incorporating anesthesiology, neurology, physical and occupational therapy, and psychology. The CBT component consists of 11 sessions that begin with a discussion of the rationale for therapy so that patients "buy in," followed by sessions focusing on theories of pain; breathing and relaxation techniques (such as yoga and tai chi); cognitive errors and restructuring; stress management; time-based activity pacing; scheduling of pleasant activities; anger management; sleep hygiene; and relapse prevention.
CBT for Comorbid Pain and PTSD
"In PTSD samples, the prevalence of chronic pain is approximately 66%-80%. In pain samples, the prevalence of PTSD is approximately 34%-50%," Dr. Otis said. He pointed to a significant overlap between the conditions, which suggests an opportunity for therapy to treat both conditions.
In a study of pain and PTSD comorbidity that he and his colleagues conducted with 149 veterans who participated in a VA pain management program, the researchers found that the presence of PTSD predicted experience of chronic pain, even after they controlled for the effects of depressed mood. They also found that "the largest portion of the association between PTSD and pain was accounted for by pain-relevant affective distress" such as anxiety, anger, and irritability (Psychol. Serv. 2010;7:126-35).
Given the similarity of CBT for both pain and PTSD, Dr. Otis and his colleagues are testing a treatment they developed for both conditions that is designed to be "transportable," so that clinicians can learn the technique with a minimum of training. The treatment was originally designed to be given in 12 sessions focusing on education and attitudes about chronic pain and PTSD, cognitive interventions, relaxation, avoidance issues, interoceptive exposure, and other elements focusing on anger control, safety, trust, and relapse prevention. In a pilot study with six patients, however, two dropped out before the third session because of the lengthy time commitment. The investigators have since modified the program to be more intensive, with six sessions given over 3 weeks.
In a pilot study with eight patients to test the feasibility of the program, there were significant reductions in the CAPS (Clinician Administered Assessment of PTSD) inventory from baseline to post treatment (P = .03) and in the Pain Catastrophizing Scale (P = .05). There were also nonsignificant reductions in the Numerical Rating Scale, Beck Depression Inventory, and Anxiety Sensitivity Index.
"We had great feedback from the patients. They all really enjoyed learning skills for pain and PTSD," Dr. Otis said. There were no dropouts.
The investigators are continuing to study the treatment, and if it proves to be successful in a larger treatment sample it could be a first step to help veterans of current wars to learn how to effectively cope with pain and PTSD in their daily lives, Dr. Otis concluded.
Acupuncture Near the Front Line
In a related presentation, Dr. Koffman discussed the use of acupuncture as a pain-relief and relaxation technique for active duty military.
"Acupuncture is now listed as one of the acceptable modalities" in the Department of Defense/VA clinical practice guideline, he said.
The guidelines note that research focusing on the efficacy of acupuncture "is still relatively limited. The few available studies are well done and demonstrate significant improvement in both PTSD and PTSD-associated symptomatology. A larger numbers of studies exist, concluding acupuncture’s efficacy in pain management, insomnia, depression, and substance abuse."
A recent, unpublished, Department of Defense/VA randomized controlled trial cited in the guidelines looked at 55 active-duty service members with PTSD who were randomized to treatment as usual with or without acupuncture sessions. The study showed that a 4-week course of twice-weekly 90-minute acupuncture sessions was associated with significantly greater improvement in PTSD symptoms and depression and pain scores.
The guidelines also state that "CAM approaches that facilitate a relaxation response [such as mindfulness, yoga, acupuncture, massage, and others] may be considered for adjunctive treatment of hyperarousal symptoms, although there is no evidence that these are more effective than standard stress inoculation techniques."
Dr. Otis and Dr. Koffman presented their research at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. Neither clinician reported relevant conflicts of interest.
BOSTON – Cognitive therapies and acupuncture can be as powerful as narcotics and analgesics for treating the chronic pain associated with posttraumatic stress disorder and traumatic brain injury, investigators reported at the annual conference on the complexities and challenges of PTSD and TBI.
An intensive, integrated approach that combines elements of evidence-based cognitive behavioral treatments for chronic pain and PTSD may help some patients find substantial relief with little or no additional medication, said John D. Otis, Ph.D., who is with the department of psychiatry at Boston University, and is a clinical psychologist at the VA Boston Healthcare System.
In addition, complementary and alternative medicine (CAM) techniques that are performed "in theater" can offer what one soldier calls "a moment of peace in a sea of pain," noted Capt. Robert Koffman, director of deployment health at the National Naval Medical Center in Bethesda, Md.
"Emotional pain" appears to have a solid grounding in biology, Dr. Otis said, pointing to a recent study in which people who recently experienced an unwanted breakup viewed photos of their former partners during a functional MRI scan. The scans showed that areas supporting the sensory components of pain, including the somatosensory cortex and dorsal posterior insula, became active (Proc. Natl. Acad. Sci. U. S. A. 2011;108:6270-5).
Chronic Pain Common Among Vets
About half of all veterans in the VA health care system report chronic pain. A 2006 study of 1,800 veterans of the wars in Afghanistan and Iraq showed that 46.5% of those seeking VA care reported some pain, and that 59% had a pain score of 4 or greater on a scale of 0-10, which exceeded the VA pain threshold (Pain Med. 2006;7:339-43).
"Pain is usually considered to be chronic when it lasts for 3 months or longer. That’s not a very long time. Most of the people I see at the VA have had pain for a lot longer than 3 months; they’ve had it for 3 years, 10 years, sometimes even 30 years," Dr. Otis said.
Pain is also a frequent comorbidity with PTSD and traumatic brain injury (TBI). A sample of 340 veterans of the conflicts in Iraq and Afghanistan showed that 42.1% had a confluence of PTSD, TBI, and chronic pain (J. Rehabil. Res. Dev. 2009;46:697-702).
CBT for Chronic Pain Relief
Although pain is an adaptive reaction to an injury and will gradually decrease over time for many people, for some it can be persistent, leading to negative mood (including depression) and disability. For such patients, cognitive behavioral therapy (CBT) can provide significant relief. CBT has been found to be effective in the treatment of headache, rheumatic disease, chronic pain syndrome, chronic low-back pain, and irritable bowel syndrome, Dr. Otis said.
Elements of CBT in chronic pain treatment include setting activity goals for patients, identifying and challenging their inaccurate beliefs about pain, teaching coping skills (such as activity pacing and restructuring of negative thoughts), practicing and consolidating the newly learned skills, and reinforcing their appropriate use.
In their integrated approach, Dr. Otis and his colleagues present CBT as part of a multidisciplinary pain management program incorporating anesthesiology, neurology, physical and occupational therapy, and psychology. The CBT component consists of 11 sessions that begin with a discussion of the rationale for therapy so that patients "buy in," followed by sessions focusing on theories of pain; breathing and relaxation techniques (such as yoga and tai chi); cognitive errors and restructuring; stress management; time-based activity pacing; scheduling of pleasant activities; anger management; sleep hygiene; and relapse prevention.
CBT for Comorbid Pain and PTSD
"In PTSD samples, the prevalence of chronic pain is approximately 66%-80%. In pain samples, the prevalence of PTSD is approximately 34%-50%," Dr. Otis said. He pointed to a significant overlap between the conditions, which suggests an opportunity for therapy to treat both conditions.
In a study of pain and PTSD comorbidity that he and his colleagues conducted with 149 veterans who participated in a VA pain management program, the researchers found that the presence of PTSD predicted experience of chronic pain, even after they controlled for the effects of depressed mood. They also found that "the largest portion of the association between PTSD and pain was accounted for by pain-relevant affective distress" such as anxiety, anger, and irritability (Psychol. Serv. 2010;7:126-35).
Given the similarity of CBT for both pain and PTSD, Dr. Otis and his colleagues are testing a treatment they developed for both conditions that is designed to be "transportable," so that clinicians can learn the technique with a minimum of training. The treatment was originally designed to be given in 12 sessions focusing on education and attitudes about chronic pain and PTSD, cognitive interventions, relaxation, avoidance issues, interoceptive exposure, and other elements focusing on anger control, safety, trust, and relapse prevention. In a pilot study with six patients, however, two dropped out before the third session because of the lengthy time commitment. The investigators have since modified the program to be more intensive, with six sessions given over 3 weeks.
In a pilot study with eight patients to test the feasibility of the program, there were significant reductions in the CAPS (Clinician Administered Assessment of PTSD) inventory from baseline to post treatment (P = .03) and in the Pain Catastrophizing Scale (P = .05). There were also nonsignificant reductions in the Numerical Rating Scale, Beck Depression Inventory, and Anxiety Sensitivity Index.
"We had great feedback from the patients. They all really enjoyed learning skills for pain and PTSD," Dr. Otis said. There were no dropouts.
The investigators are continuing to study the treatment, and if it proves to be successful in a larger treatment sample it could be a first step to help veterans of current wars to learn how to effectively cope with pain and PTSD in their daily lives, Dr. Otis concluded.
Acupuncture Near the Front Line
In a related presentation, Dr. Koffman discussed the use of acupuncture as a pain-relief and relaxation technique for active duty military.
"Acupuncture is now listed as one of the acceptable modalities" in the Department of Defense/VA clinical practice guideline, he said.
The guidelines note that research focusing on the efficacy of acupuncture "is still relatively limited. The few available studies are well done and demonstrate significant improvement in both PTSD and PTSD-associated symptomatology. A larger numbers of studies exist, concluding acupuncture’s efficacy in pain management, insomnia, depression, and substance abuse."
A recent, unpublished, Department of Defense/VA randomized controlled trial cited in the guidelines looked at 55 active-duty service members with PTSD who were randomized to treatment as usual with or without acupuncture sessions. The study showed that a 4-week course of twice-weekly 90-minute acupuncture sessions was associated with significantly greater improvement in PTSD symptoms and depression and pain scores.
The guidelines also state that "CAM approaches that facilitate a relaxation response [such as mindfulness, yoga, acupuncture, massage, and others] may be considered for adjunctive treatment of hyperarousal symptoms, although there is no evidence that these are more effective than standard stress inoculation techniques."
Dr. Otis and Dr. Koffman presented their research at a symposium supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. Neither clinician reported relevant conflicts of interest.
EXPERT ANALYSIS FROM THE ANNUAL CONFERENCE ON COMPLEXITIES AND CHALLENGES OF PTSD AND TBI
Major Finding: CBT and acupuncture are effective for the treatment of pain that is comorbid with PTSD.
Data Source: An overview of pain management among veterans and active duty U.S. service members.
Disclosures: The symposium was supported by the Home Base Program, a joint project of the Red Sox Foundation and Massachusetts General Hospital. Neither Dr. Otis nor Dr. Koffman reported relevant conflicts of interest.