Neil Osterweil

BOSTON – A concurrent combination of the targeted agent sorafenib and stereotactic body radiotherapy showed promising efficacy against advanced liver cancer in a phase I clinical trial, but investigators found toxicity was unacceptable for clinical use.

Only 3 of 16 patients completed the study evaluating the safety of concurrent sorafenib (Nexavar) and stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma (HCC), Dr. Anthony Brade reported at the annual meeting of the American Society for Radiation Oncology.

"We found delivery concurrently of sorafenib and radiotherapy was challenging and likely limited by the volume of tumor and liver that’s irradiated, as well as drug dose," Dr. Brade, a radiation oncologist at the University of Toronto, said at a news briefing.

"Despite the advanced tumor burden and toxicity, the response rates we observed were encouraging," he added. "Sorafenib alone has a response rate under 2%, so to see response rates in the 36%-50% range was very encouraging."

Two of four patients with small tumors involving less than 40% of the liver had a partial response to the combined therapy, and the other two had stable disease over 8-12 weeks of follow-up. Among 11 patients with tumors involving 40%-60% of the liver, four had a partial response and 7 had stable disease. One patient died of tumor rupture before receiving radiation.

The investigators reported a 50% response rate for the smaller-tumor group and 36% for the larger-tumor group.

Promise and Peril

Sorafenib, a tyrosine kinase inhibitor, is standard of care for locally advanced HCC. In a 2008 study it was shown to improve overall survival and time to radiologic progression in patients with advanced HCC who were ineligible for local therapies but had good liver function (Child-Pugh Class A), Dr. Brade noted (N. Engl. J. Med. 2008;359:378-90). Preclinical data also suggest that the combination of sorafenib and radiotherapy may improve outcomes, he said.

Similar in concept to stereotactic radiosurgery with a cyberknife, SBRT is a technique for precise high-dose targeting of tissues from multiple angles and planes, allowing delivery of much larger doses by fraction than conformal three-dimensional or intensity-modulated radiation therapy. With SBRT, radiation therapy sessions can often be compressed into as little as four to six fractions delivered over 2-2.5 weeks, compared with 8-9 weeks of daily fractions for other techniques.

The current phase I study enrolled patients with good performance status, good liver function (Child-Pugh Class A), more than 800 cc of liver without tumor involvement, adequate hematologic parameters and liver and kidney function, and minimal extrahepatic disease.

The participants had a median age of 61.5 years, and 10 patients each had the significant adverse prognostic features of tumor thrombus and multiple lesions, Dr. Brade noted.

Patients with smaller tumors (stratum 1) were assigned to receive low effective liver volume irradiation at less than 30% of volume, with doses ranges from 39-54 Gy in six fractions over 2 weeks.

Patients with larger tumors had high effective volume (30%-60%) irradiation, with doses ranging from 39-54 Gy, also in six fractions. The maximum permitted doses to the gastrointestinal lumen was 31-34 Gy.

Patients received sorafenib 1 week prior to, during, and 4 weeks post SBRT, at which point escalation to full-dose sorafenib was allowed. Although the protocol called for escalating from an initial dose of 200 mg b.i.d. (400 mg daily) to 600 mg daily delivered in a 400-mg morning and a 200-mg evening dose and finally to 800 mg (400 mg b.i.d.), the study was closed before the maximum was reached in stratum 1. In stratum 1 patients, the 200 mg b.i.d. dose appeared to be tolerable, Dr. Brade said.

Four patients discontinued the drug at less than 4 weeks either because of tumor progression (2) or toxicity (2). There were three dose-limiting toxicities in the larger tumor cohort: a grade-4 small bowel obstruction, a grade-3 lower gastrointestinal tract bleed, and a death from an upper gastrointestinal bleed and tumor rupture. These toxicities led to dose reductions to 200 mg sorafenib daily (compared with a standard oral dose of 400 mg b.i.d.).

"We do not recommend concurrent sorafenib and SBRT outside the context of clinical trials," Dr. Brade said.

Sequential Trial Being Planned

He noted that the outcomes of this trial have influenced the design of the Radiation Therapy Oncology Group (RTOG) 1112 phase III trial, which will compare sorafenib with sorafenib following stereotactic radiotherapy. The trial is still in its planning stages and the protocol has not been made public.

"The use of biologic targeting for radiosensitization in the context of SBRT is both a novel and promising approach," commented Dr. Catherine Park, a radiation oncologist at the University of California, San Francisco.

"The phase I study combining sorafenib with SBRT shown today highlights the exciting promise of greater efficacy, but with caution due to potential toxicity," she said. "It also reflects the challenging research necessary to optimize such novel approaches for clinical use."

Dr. Park was comoderator at a briefing where the data were presented but was not involved in the study.

Dr. Brade disclosed a research grant from Bayer. Dr. Park disclosed having an investment interest in Oncosynergy, a biotechnology company.

BOSTON – A concurrent combination of the targeted agent sorafenib and stereotactic body radiotherapy showed promising efficacy against advanced liver cancer in a phase I clinical trial, but investigators found toxicity was unacceptable for clinical use.

Only 3 of 16 patients completed the study evaluating the safety of concurrent sorafenib (Nexavar) and stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma (HCC), Dr. Anthony Brade reported at the annual meeting of the American Society for Radiation Oncology.

"We found delivery concurrently of sorafenib and radiotherapy was challenging and likely limited by the volume of tumor and liver that’s irradiated, as well as drug dose," Dr. Brade, a radiation oncologist at the University of Toronto, said at a news briefing.

"Despite the advanced tumor burden and toxicity, the response rates we observed were encouraging," he added. "Sorafenib alone has a response rate under 2%, so to see response rates in the 36%-50% range was very encouraging."

Two of four patients with small tumors involving less than 40% of the liver had a partial response to the combined therapy, and the other two had stable disease over 8-12 weeks of follow-up. Among 11 patients with tumors involving 40%-60% of the liver, four had a partial response and 7 had stable disease. One patient died of tumor rupture before receiving radiation.

The investigators reported a 50% response rate for the smaller-tumor group and 36% for the larger-tumor group.

Promise and Peril

Sorafenib, a tyrosine kinase inhibitor, is standard of care for locally advanced HCC. In a 2008 study it was shown to improve overall survival and time to radiologic progression in patients with advanced HCC who were ineligible for local therapies but had good liver function (Child-Pugh Class A), Dr. Brade noted (N. Engl. J. Med. 2008;359:378-90). Preclinical data also suggest that the combination of sorafenib and radiotherapy may improve outcomes, he said.

Similar in concept to stereotactic radiosurgery with a cyberknife, SBRT is a technique for precise high-dose targeting of tissues from multiple angles and planes, allowing delivery of much larger doses by fraction than conformal three-dimensional or intensity-modulated radiation therapy. With SBRT, radiation therapy sessions can often be compressed into as little as four to six fractions delivered over 2-2.5 weeks, compared with 8-9 weeks of daily fractions for other techniques.

The current phase I study enrolled patients with good performance status, good liver function (Child-Pugh Class A), more than 800 cc of liver without tumor involvement, adequate hematologic parameters and liver and kidney function, and minimal extrahepatic disease.

The participants had a median age of 61.5 years, and 10 patients each had the significant adverse prognostic features of tumor thrombus and multiple lesions, Dr. Brade noted.

Patients with smaller tumors (stratum 1) were assigned to receive low effective liver volume irradiation at less than 30% of volume, with doses ranges from 39-54 Gy in six fractions over 2 weeks.

Patients with larger tumors had high effective volume (30%-60%) irradiation, with doses ranging from 39-54 Gy, also in six fractions. The maximum permitted doses to the gastrointestinal lumen was 31-34 Gy.

Patients received sorafenib 1 week prior to, during, and 4 weeks post SBRT, at which point escalation to full-dose sorafenib was allowed. Although the protocol called for escalating from an initial dose of 200 mg b.i.d. (400 mg daily) to 600 mg daily delivered in a 400-mg morning and a 200-mg evening dose and finally to 800 mg (400 mg b.i.d.), the study was closed before the maximum was reached in stratum 1. In stratum 1 patients, the 200 mg b.i.d. dose appeared to be tolerable, Dr. Brade said.

Four patients discontinued the drug at less than 4 weeks either because of tumor progression (2) or toxicity (2). There were three dose-limiting toxicities in the larger tumor cohort: a grade-4 small bowel obstruction, a grade-3 lower gastrointestinal tract bleed, and a death from an upper gastrointestinal bleed and tumor rupture. These toxicities led to dose reductions to 200 mg sorafenib daily (compared with a standard oral dose of 400 mg b.i.d.).

"We do not recommend concurrent sorafenib and SBRT outside the context of clinical trials," Dr. Brade said.

Sequential Trial Being Planned

He noted that the outcomes of this trial have influenced the design of the Radiation Therapy Oncology Group (RTOG) 1112 phase III trial, which will compare sorafenib with sorafenib following stereotactic radiotherapy. The trial is still in its planning stages and the protocol has not been made public.

"The use of biologic targeting for radiosensitization in the context of SBRT is both a novel and promising approach," commented Dr. Catherine Park, a radiation oncologist at the University of California, San Francisco.

"The phase I study combining sorafenib with SBRT shown today highlights the exciting promise of greater efficacy, but with caution due to potential toxicity," she said. "It also reflects the challenging research necessary to optimize such novel approaches for clinical use."

Dr. Park was comoderator at a briefing where the data were presented but was not involved in the study.

Dr. Brade disclosed a research grant from Bayer. Dr. Park disclosed having an investment interest in Oncosynergy, a biotechnology company.

BOSTON – A concurrent combination of the targeted agent sorafenib and stereotactic body radiotherapy showed promising efficacy against advanced liver cancer in a phase I clinical trial, but investigators found toxicity was unacceptable for clinical use.

Only 3 of 16 patients completed the study evaluating the safety of concurrent sorafenib (Nexavar) and stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma (HCC), Dr. Anthony Brade reported at the annual meeting of the American Society for Radiation Oncology.

"We found delivery concurrently of sorafenib and radiotherapy was challenging and likely limited by the volume of tumor and liver that’s irradiated, as well as drug dose," Dr. Brade, a radiation oncologist at the University of Toronto, said at a news briefing.

"Despite the advanced tumor burden and toxicity, the response rates we observed were encouraging," he added. "Sorafenib alone has a response rate under 2%, so to see response rates in the 36%-50% range was very encouraging."

Two of four patients with small tumors involving less than 40% of the liver had a partial response to the combined therapy, and the other two had stable disease over 8-12 weeks of follow-up. Among 11 patients with tumors involving 40%-60% of the liver, four had a partial response and 7 had stable disease. One patient died of tumor rupture before receiving radiation.

The investigators reported a 50% response rate for the smaller-tumor group and 36% for the larger-tumor group.

Promise and Peril

Sorafenib, a tyrosine kinase inhibitor, is standard of care for locally advanced HCC. In a 2008 study it was shown to improve overall survival and time to radiologic progression in patients with advanced HCC who were ineligible for local therapies but had good liver function (Child-Pugh Class A), Dr. Brade noted (N. Engl. J. Med. 2008;359:378-90). Preclinical data also suggest that the combination of sorafenib and radiotherapy may improve outcomes, he said.

Similar in concept to stereotactic radiosurgery with a cyberknife, SBRT is a technique for precise high-dose targeting of tissues from multiple angles and planes, allowing delivery of much larger doses by fraction than conformal three-dimensional or intensity-modulated radiation therapy. With SBRT, radiation therapy sessions can often be compressed into as little as four to six fractions delivered over 2-2.5 weeks, compared with 8-9 weeks of daily fractions for other techniques.

The current phase I study enrolled patients with good performance status, good liver function (Child-Pugh Class A), more than 800 cc of liver without tumor involvement, adequate hematologic parameters and liver and kidney function, and minimal extrahepatic disease.

The participants had a median age of 61.5 years, and 10 patients each had the significant adverse prognostic features of tumor thrombus and multiple lesions, Dr. Brade noted.

Patients with smaller tumors (stratum 1) were assigned to receive low effective liver volume irradiation at less than 30% of volume, with doses ranges from 39-54 Gy in six fractions over 2 weeks.

Patients with larger tumors had high effective volume (30%-60%) irradiation, with doses ranging from 39-54 Gy, also in six fractions. The maximum permitted doses to the gastrointestinal lumen was 31-34 Gy.

Patients received sorafenib 1 week prior to, during, and 4 weeks post SBRT, at which point escalation to full-dose sorafenib was allowed. Although the protocol called for escalating from an initial dose of 200 mg b.i.d. (400 mg daily) to 600 mg daily delivered in a 400-mg morning and a 200-mg evening dose and finally to 800 mg (400 mg b.i.d.), the study was closed before the maximum was reached in stratum 1. In stratum 1 patients, the 200 mg b.i.d. dose appeared to be tolerable, Dr. Brade said.

Four patients discontinued the drug at less than 4 weeks either because of tumor progression (2) or toxicity (2). There were three dose-limiting toxicities in the larger tumor cohort: a grade-4 small bowel obstruction, a grade-3 lower gastrointestinal tract bleed, and a death from an upper gastrointestinal bleed and tumor rupture. These toxicities led to dose reductions to 200 mg sorafenib daily (compared with a standard oral dose of 400 mg b.i.d.).

"We do not recommend concurrent sorafenib and SBRT outside the context of clinical trials," Dr. Brade said.

Sequential Trial Being Planned

He noted that the outcomes of this trial have influenced the design of the Radiation Therapy Oncology Group (RTOG) 1112 phase III trial, which will compare sorafenib with sorafenib following stereotactic radiotherapy. The trial is still in its planning stages and the protocol has not been made public.

"The use of biologic targeting for radiosensitization in the context of SBRT is both a novel and promising approach," commented Dr. Catherine Park, a radiation oncologist at the University of California, San Francisco.

"The phase I study combining sorafenib with SBRT shown today highlights the exciting promise of greater efficacy, but with caution due to potential toxicity," she said. "It also reflects the challenging research necessary to optimize such novel approaches for clinical use."

Dr. Park was comoderator at a briefing where the data were presented but was not involved in the study.

Dr. Brade disclosed a research grant from Bayer. Dr. Park disclosed having an investment interest in Oncosynergy, a biotechnology company.

BOSTON – Delivering stereotactic body radiation for early-stage, inoperable non–small cell lung cancer doubled overall survival rates achieved in historical series with conventional radiation, investigators reported at the annual meeting of the American Society for Radiation Oncology.

The 3-year overall survival rate reached 59.9% for 100 patients whose stage IA non–small cell lung cancer (NSCLC) was treated with stereotactic body radiation therapy (SBRT), said Dr. Yasushi Nagata. He compared results of the nonrandomized phase II trial with 31%-39% in historical series with conventional radiation.

The 5-year overall survival rate was 40.8%, compared with 13%-22.2% historically, added Dr. Nagata from Hiroshima University, Japan.

He described SBRT as well tolerated with only mild toxicities, making it a suitable alternative to other therapies, particularly in older patients. "Patients with early inoperable lung cancer should consider this treatment," Dr. Nagata advised in a briefing.

The investigators concluded that the treatment should be the new standard, replacing conventional radiotherapy in this population.

Similar in concept to stereotactic radiosurgery with a cyberknife, SBRT is a technique for precise high-dose targeting of tissues from multiple angles and planes, allowing delivery of much larger doses by fraction than conformal 3-dimensional or intensity-modulated radiation therapy. With SBRT, radiation therapy sessions can often be compressed into as little as 4-6 fractions delivered over 2 to 2.5 weeks, compared with 8 to 9 weeks of daily fractions for other techniques.

The phase II Japanese Clinical Oncology Group trial, JCOG-0403, is said to be the first to evaluate SBRT in both operable and nonoperable NSCLC. At the 2010 ASTRO annual meeting, the investigators reported 3-year survival rates for 64 patients with surgically resectable NSCLC: overall survival was 76%; progression-free survival, 54.5%; local progression-free survival, 68.5%; and event-free survival, 51.4%.

In the current study, 77 men and 27 women with a median age of 78 years (range 59-90 years) were enrolled; four patients were later excluded from the study, three because they developed a second primary cancer within 5 years of registration, and one was "unexpectedly" treated with SBRT and chemotherapy.

The median tumor size was 21 mm (range 9-30 mm). Fifty patients had adenocarcinomas, 40 had squamous cell carcinomas, and 14 had other tumor histologies. All patients had histologically or cytologically proven NSCLC, clinical T1N0M0 disease, and were determined by thoracic surgeons to be inoperable.

All patients completed the treatment protocol, consisting of a dose of 48 Gy at the isocenter divided into 4 fractions over 4-8 days.

The progression-free survival rate at 3 years was 49.8%; the local progression-free survival rate was 52.8%, and event-free survival, 46.8%.

Grade 3 adverse events include dyspnea in 10 patients, hypoxia in 8, pneumonitis in 7, chest pain in 2 and cough in 1. There was one case each of grade 4 dyspnea and hypoxia, but no treatment-related deaths.

The study results indicate that "SBRT, a highly effective targeted approach for selected nonoperable cancers, is a modality with acceptable toxicity to consider for lung cancer patients," commented Dr. Eric Lin Chang, a professor of radiation oncology at the University of Southern California, Los Angeles. Dr. Chang was co-moderator of a briefing at which the data were presented, but was not involved in the study.

The study was supported by Japan’s Ministry of Health. Dr. Nagata and Dr. Chang disclosed no relevant conflicts of interest.

BOSTON – Delivering stereotactic body radiation for early-stage, inoperable non–small cell lung cancer doubled overall survival rates achieved in historical series with conventional radiation, investigators reported at the annual meeting of the American Society for Radiation Oncology.

The 3-year overall survival rate reached 59.9% for 100 patients whose stage IA non–small cell lung cancer (NSCLC) was treated with stereotactic body radiation therapy (SBRT), said Dr. Yasushi Nagata. He compared results of the nonrandomized phase II trial with 31%-39% in historical series with conventional radiation.

The 5-year overall survival rate was 40.8%, compared with 13%-22.2% historically, added Dr. Nagata from Hiroshima University, Japan.

He described SBRT as well tolerated with only mild toxicities, making it a suitable alternative to other therapies, particularly in older patients. "Patients with early inoperable lung cancer should consider this treatment," Dr. Nagata advised in a briefing.

The investigators concluded that the treatment should be the new standard, replacing conventional radiotherapy in this population.

Similar in concept to stereotactic radiosurgery with a cyberknife, SBRT is a technique for precise high-dose targeting of tissues from multiple angles and planes, allowing delivery of much larger doses by fraction than conformal 3-dimensional or intensity-modulated radiation therapy. With SBRT, radiation therapy sessions can often be compressed into as little as 4-6 fractions delivered over 2 to 2.5 weeks, compared with 8 to 9 weeks of daily fractions for other techniques.

The phase II Japanese Clinical Oncology Group trial, JCOG-0403, is said to be the first to evaluate SBRT in both operable and nonoperable NSCLC. At the 2010 ASTRO annual meeting, the investigators reported 3-year survival rates for 64 patients with surgically resectable NSCLC: overall survival was 76%; progression-free survival, 54.5%; local progression-free survival, 68.5%; and event-free survival, 51.4%.

In the current study, 77 men and 27 women with a median age of 78 years (range 59-90 years) were enrolled; four patients were later excluded from the study, three because they developed a second primary cancer within 5 years of registration, and one was "unexpectedly" treated with SBRT and chemotherapy.

The median tumor size was 21 mm (range 9-30 mm). Fifty patients had adenocarcinomas, 40 had squamous cell carcinomas, and 14 had other tumor histologies. All patients had histologically or cytologically proven NSCLC, clinical T1N0M0 disease, and were determined by thoracic surgeons to be inoperable.

All patients completed the treatment protocol, consisting of a dose of 48 Gy at the isocenter divided into 4 fractions over 4-8 days.

The progression-free survival rate at 3 years was 49.8%; the local progression-free survival rate was 52.8%, and event-free survival, 46.8%.

Grade 3 adverse events include dyspnea in 10 patients, hypoxia in 8, pneumonitis in 7, chest pain in 2 and cough in 1. There was one case each of grade 4 dyspnea and hypoxia, but no treatment-related deaths.

The study results indicate that "SBRT, a highly effective targeted approach for selected nonoperable cancers, is a modality with acceptable toxicity to consider for lung cancer patients," commented Dr. Eric Lin Chang, a professor of radiation oncology at the University of Southern California, Los Angeles. Dr. Chang was co-moderator of a briefing at which the data were presented, but was not involved in the study.

The study was supported by Japan’s Ministry of Health. Dr. Nagata and Dr. Chang disclosed no relevant conflicts of interest.

BOSTON – Delivering stereotactic body radiation for early-stage, inoperable non–small cell lung cancer doubled overall survival rates achieved in historical series with conventional radiation, investigators reported at the annual meeting of the American Society for Radiation Oncology.

The 3-year overall survival rate reached 59.9% for 100 patients whose stage IA non–small cell lung cancer (NSCLC) was treated with stereotactic body radiation therapy (SBRT), said Dr. Yasushi Nagata. He compared results of the nonrandomized phase II trial with 31%-39% in historical series with conventional radiation.

The 5-year overall survival rate was 40.8%, compared with 13%-22.2% historically, added Dr. Nagata from Hiroshima University, Japan.

He described SBRT as well tolerated with only mild toxicities, making it a suitable alternative to other therapies, particularly in older patients. "Patients with early inoperable lung cancer should consider this treatment," Dr. Nagata advised in a briefing.

The investigators concluded that the treatment should be the new standard, replacing conventional radiotherapy in this population.

Similar in concept to stereotactic radiosurgery with a cyberknife, SBRT is a technique for precise high-dose targeting of tissues from multiple angles and planes, allowing delivery of much larger doses by fraction than conformal 3-dimensional or intensity-modulated radiation therapy. With SBRT, radiation therapy sessions can often be compressed into as little as 4-6 fractions delivered over 2 to 2.5 weeks, compared with 8 to 9 weeks of daily fractions for other techniques.

The phase II Japanese Clinical Oncology Group trial, JCOG-0403, is said to be the first to evaluate SBRT in both operable and nonoperable NSCLC. At the 2010 ASTRO annual meeting, the investigators reported 3-year survival rates for 64 patients with surgically resectable NSCLC: overall survival was 76%; progression-free survival, 54.5%; local progression-free survival, 68.5%; and event-free survival, 51.4%.

In the current study, 77 men and 27 women with a median age of 78 years (range 59-90 years) were enrolled; four patients were later excluded from the study, three because they developed a second primary cancer within 5 years of registration, and one was "unexpectedly" treated with SBRT and chemotherapy.

The median tumor size was 21 mm (range 9-30 mm). Fifty patients had adenocarcinomas, 40 had squamous cell carcinomas, and 14 had other tumor histologies. All patients had histologically or cytologically proven NSCLC, clinical T1N0M0 disease, and were determined by thoracic surgeons to be inoperable.

All patients completed the treatment protocol, consisting of a dose of 48 Gy at the isocenter divided into 4 fractions over 4-8 days.

The progression-free survival rate at 3 years was 49.8%; the local progression-free survival rate was 52.8%, and event-free survival, 46.8%.

Grade 3 adverse events include dyspnea in 10 patients, hypoxia in 8, pneumonitis in 7, chest pain in 2 and cough in 1. There was one case each of grade 4 dyspnea and hypoxia, but no treatment-related deaths.

The study results indicate that "SBRT, a highly effective targeted approach for selected nonoperable cancers, is a modality with acceptable toxicity to consider for lung cancer patients," commented Dr. Eric Lin Chang, a professor of radiation oncology at the University of Southern California, Los Angeles. Dr. Chang was co-moderator of a briefing at which the data were presented, but was not involved in the study.

The study was supported by Japan’s Ministry of Health. Dr. Nagata and Dr. Chang disclosed no relevant conflicts of interest.

BOSTON – Here’s heartening news that physicians can convey to breast cancer survivors: Modern breast irradiation did not appear to cause late-term cardiac toxicity in a study that examined women a quarter of a century after they were treated.

Investigators found no significant differences in Framingham Heart Study risk scores, hemodynamic parameters, pericardial thickening, or heart failure among 50 women who had been randomized in the 1970s and 1980s to either mastectomy or breast-conserving surgery (BCS) and radiation, Dr. Charles B. Simone II reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

Although the survival rate was slightly lower among patients treated with breast-conserving therapy, the difference does not appear to be related to radiation dose to the heart, said Dr. Simone of the Hospital of the University of Pennsylvania in Philadelphia. There were no differences in survival among women treated with BCS and radiation to left- or right-sided tumors.

"Based on this study, in the era of 3D planning, patients with early-stage breast cancer treated with radiotherapy do not have a higher risk of long-term cardiac morbidity compared with patients having mastectomy," he said.

The patients studied included 50 of 102 survivors from an original cohort of 237 women who had participated in the National Cancer Institute’s Breast Conservation Trial (79-C-0111), with randomization from 1979 to 1986. In that trial, women with stage I or II breast cancer received modified radical mastectomy with axillary node dissection or they underwent lumpectomy plus node dissection and a radiation dose of 45-50.4 Gy to the whole breast; the latter came with or without treatment of regional nodes, followed by a boost of 15-20 Gy with either iridium 192 brachytherapy or electrons.

All node-positive patients underwent 6-11 cycles of chemotherapy with doxorubicin and cyclophosphamide, and beginning in 1985 postmenopausal women with positive nodes were given tamoxifen.

The trial was unique at the time in that it used CT simulations for treatment planning and dose inhomogeneity corrections, Dr. Simone noted.

Diverging Survival Curves

At a median of 25.7 years after randomization, 43.8% of mastectomy patients were still alive, compared with 37.9% of BCS patients. Although the difference was not significant, it appeared to represent a divergence of survival curves that had been virtually identical for the first 25 years.

The trend could not be accounted for by secondary malignancies, changes in distant metastasis, or any other breast cancer–related causes, leading the investigators to question whether it might be due to radiation toxicity to the heart, as some studies have suggested.

In all, 26 patients who had had BCS and 24 who underwent mastectomy agreed to come back for the cardiac toxicity study.

The investigators took a detailed cardiac history, and subjected the women to exams, cardiac labs, cardiac MRI with a 3 Tesla magnet to look for anatomic and functional abnormalities, and CT angiogram to look for stenotic coronary disease and determine coronary arterial calcium score (CAC) of atherosclerotic burden.

They also looked at radiation technique parameters such as central lung distance, field size, dose, and boost dose.

On cardiac MRI, they only saw two significant between-group differences. Time to peak filling rate was shorter for BCS patients (487 milliseconds vs. 647 ms for mastectomy patients; P = .02), but there was no difference in the peak filling rate itself. Left ventricular mass was smaller for BCS patients (mean 90.5 gm vs. 111 gm for mastectomy patients), but this difference was no longer significant after adjustment for systolic blood pressure, Dr. Simone noted.

"Interestingly, we didn’t see any evidence of myocardial fibrosis in any patient assessed, and only one patient in each arm had any degree of pericardial thickening," he said.

Reassuring Data

Additionally, investigators saw no significant differences on CT angiography in the presence of visible plaque or significant or severe vascular stenosis. There were also no differences in plaque or stenosis in the left anterior descending arteries of women treated with radiation for tumors on the left or the right side of the body.

"For each and every vessel we looked at, there was no difference in the degree of stenosis," Dr. Simone said.

Median CAC scores were low and in the normal range, but patients who had received chemotherapy had a trend toward increased atherosclerosis and plaque formation, Dr. Simone noted.

The study "gives some reassurance to our patients that, after 25 years of follow-up, using modern radiation techniques the delivery of radiation to the left does not cause cardiac toxicity," Dr. Bruce Haffty, chair of radiation oncology at the Cancer Institute of New Jersey, New Brunswick, said at a briefing.

The study was supported by the National Cancer Institute. Dr. Simone and Dr. Haffty reported no relevant disclosures.

BOSTON – Here’s heartening news that physicians can convey to breast cancer survivors: Modern breast irradiation did not appear to cause late-term cardiac toxicity in a study that examined women a quarter of a century after they were treated.

Investigators found no significant differences in Framingham Heart Study risk scores, hemodynamic parameters, pericardial thickening, or heart failure among 50 women who had been randomized in the 1970s and 1980s to either mastectomy or breast-conserving surgery (BCS) and radiation, Dr. Charles B. Simone II reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

Although the survival rate was slightly lower among patients treated with breast-conserving therapy, the difference does not appear to be related to radiation dose to the heart, said Dr. Simone of the Hospital of the University of Pennsylvania in Philadelphia. There were no differences in survival among women treated with BCS and radiation to left- or right-sided tumors.

"Based on this study, in the era of 3D planning, patients with early-stage breast cancer treated with radiotherapy do not have a higher risk of long-term cardiac morbidity compared with patients having mastectomy," he said.

The patients studied included 50 of 102 survivors from an original cohort of 237 women who had participated in the National Cancer Institute’s Breast Conservation Trial (79-C-0111), with randomization from 1979 to 1986. In that trial, women with stage I or II breast cancer received modified radical mastectomy with axillary node dissection or they underwent lumpectomy plus node dissection and a radiation dose of 45-50.4 Gy to the whole breast; the latter came with or without treatment of regional nodes, followed by a boost of 15-20 Gy with either iridium 192 brachytherapy or electrons.

All node-positive patients underwent 6-11 cycles of chemotherapy with doxorubicin and cyclophosphamide, and beginning in 1985 postmenopausal women with positive nodes were given tamoxifen.

The trial was unique at the time in that it used CT simulations for treatment planning and dose inhomogeneity corrections, Dr. Simone noted.

Diverging Survival Curves

At a median of 25.7 years after randomization, 43.8% of mastectomy patients were still alive, compared with 37.9% of BCS patients. Although the difference was not significant, it appeared to represent a divergence of survival curves that had been virtually identical for the first 25 years.

The trend could not be accounted for by secondary malignancies, changes in distant metastasis, or any other breast cancer–related causes, leading the investigators to question whether it might be due to radiation toxicity to the heart, as some studies have suggested.

In all, 26 patients who had had BCS and 24 who underwent mastectomy agreed to come back for the cardiac toxicity study.

The investigators took a detailed cardiac history, and subjected the women to exams, cardiac labs, cardiac MRI with a 3 Tesla magnet to look for anatomic and functional abnormalities, and CT angiogram to look for stenotic coronary disease and determine coronary arterial calcium score (CAC) of atherosclerotic burden.

They also looked at radiation technique parameters such as central lung distance, field size, dose, and boost dose.

On cardiac MRI, they only saw two significant between-group differences. Time to peak filling rate was shorter for BCS patients (487 milliseconds vs. 647 ms for mastectomy patients; P = .02), but there was no difference in the peak filling rate itself. Left ventricular mass was smaller for BCS patients (mean 90.5 gm vs. 111 gm for mastectomy patients), but this difference was no longer significant after adjustment for systolic blood pressure, Dr. Simone noted.

"Interestingly, we didn’t see any evidence of myocardial fibrosis in any patient assessed, and only one patient in each arm had any degree of pericardial thickening," he said.

Reassuring Data

Additionally, investigators saw no significant differences on CT angiography in the presence of visible plaque or significant or severe vascular stenosis. There were also no differences in plaque or stenosis in the left anterior descending arteries of women treated with radiation for tumors on the left or the right side of the body.

"For each and every vessel we looked at, there was no difference in the degree of stenosis," Dr. Simone said.

Median CAC scores were low and in the normal range, but patients who had received chemotherapy had a trend toward increased atherosclerosis and plaque formation, Dr. Simone noted.

The study "gives some reassurance to our patients that, after 25 years of follow-up, using modern radiation techniques the delivery of radiation to the left does not cause cardiac toxicity," Dr. Bruce Haffty, chair of radiation oncology at the Cancer Institute of New Jersey, New Brunswick, said at a briefing.

The study was supported by the National Cancer Institute. Dr. Simone and Dr. Haffty reported no relevant disclosures.

BOSTON – Here’s heartening news that physicians can convey to breast cancer survivors: Modern breast irradiation did not appear to cause late-term cardiac toxicity in a study that examined women a quarter of a century after they were treated.

Investigators found no significant differences in Framingham Heart Study risk scores, hemodynamic parameters, pericardial thickening, or heart failure among 50 women who had been randomized in the 1970s and 1980s to either mastectomy or breast-conserving surgery (BCS) and radiation, Dr. Charles B. Simone II reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

Although the survival rate was slightly lower among patients treated with breast-conserving therapy, the difference does not appear to be related to radiation dose to the heart, said Dr. Simone of the Hospital of the University of Pennsylvania in Philadelphia. There were no differences in survival among women treated with BCS and radiation to left- or right-sided tumors.

"Based on this study, in the era of 3D planning, patients with early-stage breast cancer treated with radiotherapy do not have a higher risk of long-term cardiac morbidity compared with patients having mastectomy," he said.

The patients studied included 50 of 102 survivors from an original cohort of 237 women who had participated in the National Cancer Institute’s Breast Conservation Trial (79-C-0111), with randomization from 1979 to 1986. In that trial, women with stage I or II breast cancer received modified radical mastectomy with axillary node dissection or they underwent lumpectomy plus node dissection and a radiation dose of 45-50.4 Gy to the whole breast; the latter came with or without treatment of regional nodes, followed by a boost of 15-20 Gy with either iridium 192 brachytherapy or electrons.

All node-positive patients underwent 6-11 cycles of chemotherapy with doxorubicin and cyclophosphamide, and beginning in 1985 postmenopausal women with positive nodes were given tamoxifen.

The trial was unique at the time in that it used CT simulations for treatment planning and dose inhomogeneity corrections, Dr. Simone noted.

Diverging Survival Curves

At a median of 25.7 years after randomization, 43.8% of mastectomy patients were still alive, compared with 37.9% of BCS patients. Although the difference was not significant, it appeared to represent a divergence of survival curves that had been virtually identical for the first 25 years.

The trend could not be accounted for by secondary malignancies, changes in distant metastasis, or any other breast cancer–related causes, leading the investigators to question whether it might be due to radiation toxicity to the heart, as some studies have suggested.

In all, 26 patients who had had BCS and 24 who underwent mastectomy agreed to come back for the cardiac toxicity study.

The investigators took a detailed cardiac history, and subjected the women to exams, cardiac labs, cardiac MRI with a 3 Tesla magnet to look for anatomic and functional abnormalities, and CT angiogram to look for stenotic coronary disease and determine coronary arterial calcium score (CAC) of atherosclerotic burden.

They also looked at radiation technique parameters such as central lung distance, field size, dose, and boost dose.

On cardiac MRI, they only saw two significant between-group differences. Time to peak filling rate was shorter for BCS patients (487 milliseconds vs. 647 ms for mastectomy patients; P = .02), but there was no difference in the peak filling rate itself. Left ventricular mass was smaller for BCS patients (mean 90.5 gm vs. 111 gm for mastectomy patients), but this difference was no longer significant after adjustment for systolic blood pressure, Dr. Simone noted.

"Interestingly, we didn’t see any evidence of myocardial fibrosis in any patient assessed, and only one patient in each arm had any degree of pericardial thickening," he said.

Reassuring Data

Additionally, investigators saw no significant differences on CT angiography in the presence of visible plaque or significant or severe vascular stenosis. There were also no differences in plaque or stenosis in the left anterior descending arteries of women treated with radiation for tumors on the left or the right side of the body.

"For each and every vessel we looked at, there was no difference in the degree of stenosis," Dr. Simone said.

Median CAC scores were low and in the normal range, but patients who had received chemotherapy had a trend toward increased atherosclerosis and plaque formation, Dr. Simone noted.

The study "gives some reassurance to our patients that, after 25 years of follow-up, using modern radiation techniques the delivery of radiation to the left does not cause cardiac toxicity," Dr. Bruce Haffty, chair of radiation oncology at the Cancer Institute of New Jersey, New Brunswick, said at a briefing.

The study was supported by the National Cancer Institute. Dr. Simone and Dr. Haffty reported no relevant disclosures.

BOSTON – A review of data on nearly 30,000 women suggests older age by itself should not be a barrier to radiotherapy after lumpectomy for early-stage breast cancer.

Older patients treated with both modalities had higher rates of overall and breast cancer–specific survival at 5 and 10 years compared with women who underwent lumpectomy alone, investigators reported at the annual meeting of the American Society for Radiation Oncology.

Courtesy American Society for Radiation Oncology

"The improvement in cause-specific survival with the addition or radiation suggests that in healthy, elderly women, adjuvant radiation should be strongly considered as part of their breast cancer treatment," said Dr. Randi J. Cohen, a radiation oncologist at the University of Maryland in Baltimore.

The review examined Surveillance, Epidemiology, and End Results (SEER) database records on 29,949 women, who were aged 70-84 years at diagnosis with clinical stage I, estrogen receptor–positive breast cancer and survived at least 1 year. About three-fourths underwent radiation after lumpectomy.

Women treated with lumpectomy and radiation had an overall survival rate of 88.6% at 5 years vs. 73.1% among those with no radiation (P less than .0001), Dr. Cohen reported. Overall survival rates at 10 years were 65.0% and 41.7%, respectively.

Cause-specific survival rates at 5 years were 98.3% for patients in the radiation plus surgery group and 97.4% for those with no radiation. At 10 years, the respective rates were 95.5% and 93.3% (P less than .0001 for both comparisons).

The median length of survival also was greater with the addition of radiotherapy – 13.1 years vs. 11.1 years with lumpectomy alone.

Radiation Was Independent Predictor

In multivariate analysis that controlled for age, tumor size, race, ductal histology, lymph nodes and marital status, hazard ratios also showed significantly worse outcomes without radiation – 1.56 in the overall survival analysis and 1.41 in the cause-specific survival analysis.

The results are similar to those in a meta-analysis from the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), said Dr. Cohen. That study showed an absolute benefit for adding radiation of 3% at 10 years, compared with 2.2% at 10 years in the current study.

Dr. Cohen said the review was prompted by questions raised in a 2004 study from the Cancer and Leukemia Group B (CALGB). In that trial, investigators looked at whether adding radiation to lumpectomy plus tamoxifen would have an effect on overall or breast cancer–specific survival in 630 women 70 years and older with early-stage disease. They found that at a median follow-up of 10.5 years, there was an absolute reduction of 6% in same-breast tumor recurrence with radiation, but no difference overall of disease-free survival.

In the much larger EBTCG study and the current study, however, the disease-specific survival advantages with the addition of radiation were likely related to greater locoregional control. Dr. Cohen said that the overall survival advantage in her study was probably due to selection of healthier patients with longer predicted life expectancy for radiotherapy.

She noted, however, that the study was limited by a lack of data on recurrence rates or hormonal therapy.

Strength of Benefit Questioned

"It’s highly unlikely that the magnitude of the benefits of cause-specific survival can be attributed to just radiation alone," said Dr. Meema Moran, the invited discussant. She noted that in EBCTCG study, there was only about a 3% benefit at 15 years in a seemingly low-risk population with shorter follow-up. The favorable survival in the meta-analysis may therefore be partly attributable to treatment selections bias, said Dr. Moran, a radiation oncologist at Yale University in New Haven, Conn.

She also noted that because local recurrence data are not collected in SEER, mastectomy-free survival is used as a surrogate for relapse, but mastectomy rates may vary due to differences in management of ipsilateral recurrence, such as mastectomy or repeat breast-conserving surgery.

The funding source for Dr. Cohen’s study was not disclosed. She reported no conflicts of interest. Dr. Moran reported serving on the Genomic Health Advisory Board.

BOSTON – A review of data on nearly 30,000 women suggests older age by itself should not be a barrier to radiotherapy after lumpectomy for early-stage breast cancer.

Older patients treated with both modalities had higher rates of overall and breast cancer–specific survival at 5 and 10 years compared with women who underwent lumpectomy alone, investigators reported at the annual meeting of the American Society for Radiation Oncology.

Courtesy American Society for Radiation Oncology

"The improvement in cause-specific survival with the addition or radiation suggests that in healthy, elderly women, adjuvant radiation should be strongly considered as part of their breast cancer treatment," said Dr. Randi J. Cohen, a radiation oncologist at the University of Maryland in Baltimore.

The review examined Surveillance, Epidemiology, and End Results (SEER) database records on 29,949 women, who were aged 70-84 years at diagnosis with clinical stage I, estrogen receptor–positive breast cancer and survived at least 1 year. About three-fourths underwent radiation after lumpectomy.

Women treated with lumpectomy and radiation had an overall survival rate of 88.6% at 5 years vs. 73.1% among those with no radiation (P less than .0001), Dr. Cohen reported. Overall survival rates at 10 years were 65.0% and 41.7%, respectively.

Cause-specific survival rates at 5 years were 98.3% for patients in the radiation plus surgery group and 97.4% for those with no radiation. At 10 years, the respective rates were 95.5% and 93.3% (P less than .0001 for both comparisons).

The median length of survival also was greater with the addition of radiotherapy – 13.1 years vs. 11.1 years with lumpectomy alone.

Radiation Was Independent Predictor

In multivariate analysis that controlled for age, tumor size, race, ductal histology, lymph nodes and marital status, hazard ratios also showed significantly worse outcomes without radiation – 1.56 in the overall survival analysis and 1.41 in the cause-specific survival analysis.

The results are similar to those in a meta-analysis from the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), said Dr. Cohen. That study showed an absolute benefit for adding radiation of 3% at 10 years, compared with 2.2% at 10 years in the current study.

Dr. Cohen said the review was prompted by questions raised in a 2004 study from the Cancer and Leukemia Group B (CALGB). In that trial, investigators looked at whether adding radiation to lumpectomy plus tamoxifen would have an effect on overall or breast cancer–specific survival in 630 women 70 years and older with early-stage disease. They found that at a median follow-up of 10.5 years, there was an absolute reduction of 6% in same-breast tumor recurrence with radiation, but no difference overall of disease-free survival.

In the much larger EBTCG study and the current study, however, the disease-specific survival advantages with the addition of radiation were likely related to greater locoregional control. Dr. Cohen said that the overall survival advantage in her study was probably due to selection of healthier patients with longer predicted life expectancy for radiotherapy.

She noted, however, that the study was limited by a lack of data on recurrence rates or hormonal therapy.

Strength of Benefit Questioned

"It’s highly unlikely that the magnitude of the benefits of cause-specific survival can be attributed to just radiation alone," said Dr. Meema Moran, the invited discussant. She noted that in EBCTCG study, there was only about a 3% benefit at 15 years in a seemingly low-risk population with shorter follow-up. The favorable survival in the meta-analysis may therefore be partly attributable to treatment selections bias, said Dr. Moran, a radiation oncologist at Yale University in New Haven, Conn.

She also noted that because local recurrence data are not collected in SEER, mastectomy-free survival is used as a surrogate for relapse, but mastectomy rates may vary due to differences in management of ipsilateral recurrence, such as mastectomy or repeat breast-conserving surgery.

The funding source for Dr. Cohen’s study was not disclosed. She reported no conflicts of interest. Dr. Moran reported serving on the Genomic Health Advisory Board.

BOSTON – A review of data on nearly 30,000 women suggests older age by itself should not be a barrier to radiotherapy after lumpectomy for early-stage breast cancer.

Older patients treated with both modalities had higher rates of overall and breast cancer–specific survival at 5 and 10 years compared with women who underwent lumpectomy alone, investigators reported at the annual meeting of the American Society for Radiation Oncology.

Courtesy American Society for Radiation Oncology

"The improvement in cause-specific survival with the addition or radiation suggests that in healthy, elderly women, adjuvant radiation should be strongly considered as part of their breast cancer treatment," said Dr. Randi J. Cohen, a radiation oncologist at the University of Maryland in Baltimore.

The review examined Surveillance, Epidemiology, and End Results (SEER) database records on 29,949 women, who were aged 70-84 years at diagnosis with clinical stage I, estrogen receptor–positive breast cancer and survived at least 1 year. About three-fourths underwent radiation after lumpectomy.

Women treated with lumpectomy and radiation had an overall survival rate of 88.6% at 5 years vs. 73.1% among those with no radiation (P less than .0001), Dr. Cohen reported. Overall survival rates at 10 years were 65.0% and 41.7%, respectively.

Cause-specific survival rates at 5 years were 98.3% for patients in the radiation plus surgery group and 97.4% for those with no radiation. At 10 years, the respective rates were 95.5% and 93.3% (P less than .0001 for both comparisons).

The median length of survival also was greater with the addition of radiotherapy – 13.1 years vs. 11.1 years with lumpectomy alone.

Radiation Was Independent Predictor

In multivariate analysis that controlled for age, tumor size, race, ductal histology, lymph nodes and marital status, hazard ratios also showed significantly worse outcomes without radiation – 1.56 in the overall survival analysis and 1.41 in the cause-specific survival analysis.

The results are similar to those in a meta-analysis from the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), said Dr. Cohen. That study showed an absolute benefit for adding radiation of 3% at 10 years, compared with 2.2% at 10 years in the current study.

Dr. Cohen said the review was prompted by questions raised in a 2004 study from the Cancer and Leukemia Group B (CALGB). In that trial, investigators looked at whether adding radiation to lumpectomy plus tamoxifen would have an effect on overall or breast cancer–specific survival in 630 women 70 years and older with early-stage disease. They found that at a median follow-up of 10.5 years, there was an absolute reduction of 6% in same-breast tumor recurrence with radiation, but no difference overall of disease-free survival.

In the much larger EBTCG study and the current study, however, the disease-specific survival advantages with the addition of radiation were likely related to greater locoregional control. Dr. Cohen said that the overall survival advantage in her study was probably due to selection of healthier patients with longer predicted life expectancy for radiotherapy.

She noted, however, that the study was limited by a lack of data on recurrence rates or hormonal therapy.

Strength of Benefit Questioned

"It’s highly unlikely that the magnitude of the benefits of cause-specific survival can be attributed to just radiation alone," said Dr. Meema Moran, the invited discussant. She noted that in EBCTCG study, there was only about a 3% benefit at 15 years in a seemingly low-risk population with shorter follow-up. The favorable survival in the meta-analysis may therefore be partly attributable to treatment selections bias, said Dr. Moran, a radiation oncologist at Yale University in New Haven, Conn.

She also noted that because local recurrence data are not collected in SEER, mastectomy-free survival is used as a surrogate for relapse, but mastectomy rates may vary due to differences in management of ipsilateral recurrence, such as mastectomy or repeat breast-conserving surgery.

The funding source for Dr. Cohen’s study was not disclosed. She reported no conflicts of interest. Dr. Moran reported serving on the Genomic Health Advisory Board.

BOSTON – The combination of radiation and hormonal therapy for locally advanced prostate cancer results in significantly better overall and disease-specific survival outcomes than hormonal therapy alone, according to the final results of a long-term study.

At a median follow-up of 8 years, the addition of radiation therapy (RT) to androgen deprivation therapy (ADT) was associated with significantly better overall survival (hazard ratio 0.70, P = .0003) and disease-specific survival (HR 0.46, P less than .0001) compared with ADT alone, Dr. Padraig Warde reported at the annual meeting of the American Society for Radiation Oncology.

"We believe our study results support the recommendation that for patients with locally advanced prostate cancer who are suitable for a curative treatment approach, combined-modality treatment should be considered the standard of care," said Dr. Warde, a professor of radiation oncology at Princess Margaret Hospital and the University of Toronto.

"Clearly the optimal duration of androgen deprivation therapy needs to be defined. However, the benefit of radiation therapy may be greater in the modern era with dose escalation," he added.

The findings of the study are consistent with those of a similarly designed study, the randomized Scandinavian Prostate Cancer Group (SPCG) 7 study, noted Dr. Jason A. Efstathiou, a radiation oncologist at Massachusetts General Hospital in Boston, the invited discussant.

"External-beam radiation and hormonal therapy should now be the gold standard against which interventions for high-risk and locally advanced prostate cancer are compared, including radical prostatectomy," he said.

The Final Word

Dr. Warde presented final data from the NCIC Clinical Trials Group (NCIC CTG) PR.3/Medical Research Council (MRC) UK PR07 trial. Results of an interim analysis of the trial published last year showed a similar benefit for adding RT to ADT at 7 years.

From 1995 through 2005, investigators enrolled a total of 1,205 patients, most of whom (1,057) had locally advanced (T3, T4, N0/NX stage) prostate cancer. A smaller number had organ-confined disease (T2, N0/NX) with either a prostate-specific antigen (PSA) level greater than 40 mcg/L or a PSA greater than 20 mcg/L and a Gleason score of 8 or higher.

The patients were randomly assigned to receive lifelong therapy with either a bilateral orchiectomy or a luteinizing hormone releasing hormone agonist with or without 65- to 69-Gy RT to the prostate (with or without a dose to the seminal vesicles), and with or without 45 Gy to pelvic lymph nodes. In all, 602 patients were assigned to ADT only, and 603 to both ADT and RT.

At a median follow-up of 8 years, 260 patients on ADT alone and 205 on the combined therapy had died. Of these patients, 199 (43%) died from disease and/or treatment; 134 had been treated with ADT alone, and 65 with ADT plus radiation.

The 10-year overall survival rates were 55% for the combined therapy, and 49% for RT alone.

Treatment Well Tolerated

Although the radiation group had a moderate worsening of bowel scores at 6 months, "consistent with clinical expectations," the men who received radiotherapy generally tolerated it well, Dr. Warde said.

By 24 months there were no significant between-group differences in bowel or rectum domain on the EORTC (European Organisation for Research and Treatment of Cancer) quality-of-life questionnaire. Results in the urinary function quality-of-life domain were similar, Dr. Warde said. He did not provide specifics.

An exploratory analysis within the radiation arm showed that there were no significant differences in either overall or disease-specific survival with the addition of pelvic radiation to prostate radiation; in this analysis the hazard ratio was adjusted for geographic region of treatment, PSA, Gleason score, nodal staging, and prior hormonal therapy.

The study was supported by grants from the U.S. National Cancer Institute, U.K. Medical Research Council, and U.K. National Cancer Research Network. Dr. Warde and Dr. Efstathiou reported having no conflicts of interest.

BOSTON – The combination of radiation and hormonal therapy for locally advanced prostate cancer results in significantly better overall and disease-specific survival outcomes than hormonal therapy alone, according to the final results of a long-term study.

At a median follow-up of 8 years, the addition of radiation therapy (RT) to androgen deprivation therapy (ADT) was associated with significantly better overall survival (hazard ratio 0.70, P = .0003) and disease-specific survival (HR 0.46, P less than .0001) compared with ADT alone, Dr. Padraig Warde reported at the annual meeting of the American Society for Radiation Oncology.

"We believe our study results support the recommendation that for patients with locally advanced prostate cancer who are suitable for a curative treatment approach, combined-modality treatment should be considered the standard of care," said Dr. Warde, a professor of radiation oncology at Princess Margaret Hospital and the University of Toronto.

"Clearly the optimal duration of androgen deprivation therapy needs to be defined. However, the benefit of radiation therapy may be greater in the modern era with dose escalation," he added.

The findings of the study are consistent with those of a similarly designed study, the randomized Scandinavian Prostate Cancer Group (SPCG) 7 study, noted Dr. Jason A. Efstathiou, a radiation oncologist at Massachusetts General Hospital in Boston, the invited discussant.

"External-beam radiation and hormonal therapy should now be the gold standard against which interventions for high-risk and locally advanced prostate cancer are compared, including radical prostatectomy," he said.

The Final Word

Dr. Warde presented final data from the NCIC Clinical Trials Group (NCIC CTG) PR.3/Medical Research Council (MRC) UK PR07 trial. Results of an interim analysis of the trial published last year showed a similar benefit for adding RT to ADT at 7 years.

From 1995 through 2005, investigators enrolled a total of 1,205 patients, most of whom (1,057) had locally advanced (T3, T4, N0/NX stage) prostate cancer. A smaller number had organ-confined disease (T2, N0/NX) with either a prostate-specific antigen (PSA) level greater than 40 mcg/L or a PSA greater than 20 mcg/L and a Gleason score of 8 or higher.

The patients were randomly assigned to receive lifelong therapy with either a bilateral orchiectomy or a luteinizing hormone releasing hormone agonist with or without 65- to 69-Gy RT to the prostate (with or without a dose to the seminal vesicles), and with or without 45 Gy to pelvic lymph nodes. In all, 602 patients were assigned to ADT only, and 603 to both ADT and RT.

At a median follow-up of 8 years, 260 patients on ADT alone and 205 on the combined therapy had died. Of these patients, 199 (43%) died from disease and/or treatment; 134 had been treated with ADT alone, and 65 with ADT plus radiation.

The 10-year overall survival rates were 55% for the combined therapy, and 49% for RT alone.

Treatment Well Tolerated

Although the radiation group had a moderate worsening of bowel scores at 6 months, "consistent with clinical expectations," the men who received radiotherapy generally tolerated it well, Dr. Warde said.

By 24 months there were no significant between-group differences in bowel or rectum domain on the EORTC (European Organisation for Research and Treatment of Cancer) quality-of-life questionnaire. Results in the urinary function quality-of-life domain were similar, Dr. Warde said. He did not provide specifics.

An exploratory analysis within the radiation arm showed that there were no significant differences in either overall or disease-specific survival with the addition of pelvic radiation to prostate radiation; in this analysis the hazard ratio was adjusted for geographic region of treatment, PSA, Gleason score, nodal staging, and prior hormonal therapy.

The study was supported by grants from the U.S. National Cancer Institute, U.K. Medical Research Council, and U.K. National Cancer Research Network. Dr. Warde and Dr. Efstathiou reported having no conflicts of interest.

BOSTON – The combination of radiation and hormonal therapy for locally advanced prostate cancer results in significantly better overall and disease-specific survival outcomes than hormonal therapy alone, according to the final results of a long-term study.

At a median follow-up of 8 years, the addition of radiation therapy (RT) to androgen deprivation therapy (ADT) was associated with significantly better overall survival (hazard ratio 0.70, P = .0003) and disease-specific survival (HR 0.46, P less than .0001) compared with ADT alone, Dr. Padraig Warde reported at the annual meeting of the American Society for Radiation Oncology.

"We believe our study results support the recommendation that for patients with locally advanced prostate cancer who are suitable for a curative treatment approach, combined-modality treatment should be considered the standard of care," said Dr. Warde, a professor of radiation oncology at Princess Margaret Hospital and the University of Toronto.

"Clearly the optimal duration of androgen deprivation therapy needs to be defined. However, the benefit of radiation therapy may be greater in the modern era with dose escalation," he added.

The findings of the study are consistent with those of a similarly designed study, the randomized Scandinavian Prostate Cancer Group (SPCG) 7 study, noted Dr. Jason A. Efstathiou, a radiation oncologist at Massachusetts General Hospital in Boston, the invited discussant.

"External-beam radiation and hormonal therapy should now be the gold standard against which interventions for high-risk and locally advanced prostate cancer are compared, including radical prostatectomy," he said.

The Final Word

Dr. Warde presented final data from the NCIC Clinical Trials Group (NCIC CTG) PR.3/Medical Research Council (MRC) UK PR07 trial. Results of an interim analysis of the trial published last year showed a similar benefit for adding RT to ADT at 7 years.

From 1995 through 2005, investigators enrolled a total of 1,205 patients, most of whom (1,057) had locally advanced (T3, T4, N0/NX stage) prostate cancer. A smaller number had organ-confined disease (T2, N0/NX) with either a prostate-specific antigen (PSA) level greater than 40 mcg/L or a PSA greater than 20 mcg/L and a Gleason score of 8 or higher.

The patients were randomly assigned to receive lifelong therapy with either a bilateral orchiectomy or a luteinizing hormone releasing hormone agonist with or without 65- to 69-Gy RT to the prostate (with or without a dose to the seminal vesicles), and with or without 45 Gy to pelvic lymph nodes. In all, 602 patients were assigned to ADT only, and 603 to both ADT and RT.

At a median follow-up of 8 years, 260 patients on ADT alone and 205 on the combined therapy had died. Of these patients, 199 (43%) died from disease and/or treatment; 134 had been treated with ADT alone, and 65 with ADT plus radiation.

The 10-year overall survival rates were 55% for the combined therapy, and 49% for RT alone.

Treatment Well Tolerated

Although the radiation group had a moderate worsening of bowel scores at 6 months, "consistent with clinical expectations," the men who received radiotherapy generally tolerated it well, Dr. Warde said.

By 24 months there were no significant between-group differences in bowel or rectum domain on the EORTC (European Organisation for Research and Treatment of Cancer) quality-of-life questionnaire. Results in the urinary function quality-of-life domain were similar, Dr. Warde said. He did not provide specifics.

An exploratory analysis within the radiation arm showed that there were no significant differences in either overall or disease-specific survival with the addition of pelvic radiation to prostate radiation; in this analysis the hazard ratio was adjusted for geographic region of treatment, PSA, Gleason score, nodal staging, and prior hormonal therapy.

The study was supported by grants from the U.S. National Cancer Institute, U.K. Medical Research Council, and U.K. National Cancer Research Network. Dr. Warde and Dr. Efstathiou reported having no conflicts of interest.

BOSTON – New Englanders pride themselves on being a hardy lot, facing blizzards wearing only a light sweater and a scarf. A major East Coast hurricane is another matter, however.

Attendees of the annual meeting of the American Society for Radiation Oncology (ASTRO) here in Boston crossed their fingers and did a collective breath hold, hoping to carry on in the midst of the maelstrom. But the City of Boston and the storm named Sandy had other plans.

The MBTA, or "T," as the transportation system is known in these parts, shut down today, Monday, Oct. 29, at 2 pm, and ASTRO officials announced that their shuttle buses would do likewise, threatening to leave high but not dry many of the estimated 12,000 attendees – most of whom are not staying at a hotel within walking distance of the Boston Convention and Exhibition Center.

Boston is at the outer edge of the predicted high-wind zone, and is expected to have less rain than places just a bit farther south, such as the Connecticut coast and the north shore of Long Island, but experience from previous storms, and from Hurricane Irene last year, has Boston-area emergency officials on guard. Hope for the best; expect the worst.

As of this writing, it’s up in the air (pun intended) as to when things will resume, but keep your eyes on this website: as long as you (and we) have power, we’ll be posting stories from the ASTRO meeting.

* ASTRO resumed on Tuesday, October 30.

BOSTON – New Englanders pride themselves on being a hardy lot, facing blizzards wearing only a light sweater and a scarf. A major East Coast hurricane is another matter, however.

Attendees of the annual meeting of the American Society for Radiation Oncology (ASTRO) here in Boston crossed their fingers and did a collective breath hold, hoping to carry on in the midst of the maelstrom. But the City of Boston and the storm named Sandy had other plans.

The MBTA, or "T," as the transportation system is known in these parts, shut down today, Monday, Oct. 29, at 2 pm, and ASTRO officials announced that their shuttle buses would do likewise, threatening to leave high but not dry many of the estimated 12,000 attendees – most of whom are not staying at a hotel within walking distance of the Boston Convention and Exhibition Center.

Boston is at the outer edge of the predicted high-wind zone, and is expected to have less rain than places just a bit farther south, such as the Connecticut coast and the north shore of Long Island, but experience from previous storms, and from Hurricane Irene last year, has Boston-area emergency officials on guard. Hope for the best; expect the worst.

As of this writing, it’s up in the air (pun intended) as to when things will resume, but keep your eyes on this website: as long as you (and we) have power, we’ll be posting stories from the ASTRO meeting.

* ASTRO resumed on Tuesday, October 30.

BOSTON – New Englanders pride themselves on being a hardy lot, facing blizzards wearing only a light sweater and a scarf. A major East Coast hurricane is another matter, however.

Attendees of the annual meeting of the American Society for Radiation Oncology (ASTRO) here in Boston crossed their fingers and did a collective breath hold, hoping to carry on in the midst of the maelstrom. But the City of Boston and the storm named Sandy had other plans.

The MBTA, or "T," as the transportation system is known in these parts, shut down today, Monday, Oct. 29, at 2 pm, and ASTRO officials announced that their shuttle buses would do likewise, threatening to leave high but not dry many of the estimated 12,000 attendees – most of whom are not staying at a hotel within walking distance of the Boston Convention and Exhibition Center.

Boston is at the outer edge of the predicted high-wind zone, and is expected to have less rain than places just a bit farther south, such as the Connecticut coast and the north shore of Long Island, but experience from previous storms, and from Hurricane Irene last year, has Boston-area emergency officials on guard. Hope for the best; expect the worst.

As of this writing, it’s up in the air (pun intended) as to when things will resume, but keep your eyes on this website: as long as you (and we) have power, we’ll be posting stories from the ASTRO meeting.

* ASTRO resumed on Tuesday, October 30.

BOSTON – Men who receive proton beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient, investigators found.

At 2-3 months follow-up, patients treated with proton beam therapy (PBT) reported minimal decrements in bowel function, compared with patients treated with either 3D conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT), who reported modest yet clinically meaningful decrements in bowel function, lead author Dr. Phillip J. Gray reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

All three patient groups also had significantly lower urinary quality-of-life (QoL) scores at early follow-up compared with baseline, but these changes were considered clinically meaningful only for IMRT, said Dr. Gray, a resident in the Harvard Radiation Oncology program in Boston.

"Though significant, these differences appear transient, with all three groups showing clinically meaningful decrements in bowel quality of life at 2 years following the start of treatment, and minimally lingering urinary symptoms," he said.

The retrospective study looked at three cohorts of men treated with the different modalities: 153 treated with IMRT monotherapy in the PROST-QA consortium, 94 patients treated with PBT at Massachusetts General Hospital (MGH), and 123 treated with 3D-CRT at MGH and other Harvard-affiliated hospitals.

Patients treated with IMRT and PBT were evaluated with the Expanded Prostate Cancer Index Composite (EPIC) instrument; patients treated with 3D-CRT were assessed using the Prostate Cancer Symptoms Index (PCSI); PCSI scores were inverted to match those of the EPIC scale.

Treatment dose ranges were 75.6-79.2 Gy for IMRT, 74-82 Gy relative biological effectiveness values for PBT, and 66.4-79.2 Gy for 3D-CRT.

Mean patient-reported bowel QoL scores in the immediate post-treatment period were 93.3 on a scale of 0-100 for PBT, 78.5 for IMRT, and 88.2 for 3D-CRT (P vs. PBT less than .001 for both comparisons). The differences from baseline in IMRT and 3D-CRT, but not in PBT, were considered clinically significant.

At 24 months, mean respective bowel QoL scores were 91.8, 87.6, and 90.2, respectively, with clinically significant differences between PBT and the other two modalities.

Dr. Gray acknowledged that the retrospective nature of the study and the use of different scoring instruments muddy the comparison waters. He noted that things may become clearer when the results of a recently launched randomized trial comparing PBT and IMRT become available. The study will look at 6-month efficacy outcomes, cost effectiveness, and toxicities at 2 years, and survival and other end points out to 10 years.

Protons Are a Costly Choice

Although the relative long-term benefits of PBT for prostate cancer may not be known for several years, one thing is sure: PBT is about 70% more expensive than IMRT, said Dr. James Yu, a radiation oncologist at Yale University in New Haven, Conn.

Neil Osterweil/IMNG Medical Media

Dr. Yu and colleagues looked at data on patients who received IMRT or PBT as primary therapy for prostate cancer in the Medicare Chronic Condition Data Warehouse, a national database that captures 100% of Medicare fee-for-service claims for patients with specific chronic conditions.

They found that the median interquartile range amount that Medicare reimbursed for PBT was $32,428 vs. $18,575 for IMRT.

In early follow-up (0-6 months) genitourinary complications were significantly lower among 421 patients with who had received PBT than among 842 patients who received IMRT (5.9% vs. 9.5%; odds ratio 0.60; P = .03). Neither gastrointestinal nor other complications were significantly different, however, and at 12 months follow-up there were no significant differences between treatment types, Dr. Yu noted.

"A continued longitudinal study of the comparative effectiveness of proton radiation is needed, and we also believe that further study is needed before widespread application of proton radiation can be justified," he said.

PBT Benefit Proven in Other Cancers

A radiation oncologist who was not involved in the study commented that in the absence of evidence of a therapeutic benefit for PBT in prostate cancer over other modalities, proton therapy may better be reserved for the treatment of other cancers.

"If you have a resource that’s limited, you want to use it where you know there’s a benefit," said Dr, Jeffrey Bradley, professor of radiation oncology at Washington University in St. Louis.

His center is building a single-vault proton-beam facility that is expected to open in the summer of 2013. Dr. Bradley said that although they will likely treat patients with prostate cancer, he envisions the main role of the center to be treatment of pediatric and adult tumors of the central nervous system, sarcomas, ocular neoplasms, and other conditions where the benefits of PBT are better documented.

Dr Gray, Dr. Yu, and Dr. Bradley each reported no conflicts of interest.

BOSTON – Men who receive proton beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient, investigators found.

At 2-3 months follow-up, patients treated with proton beam therapy (PBT) reported minimal decrements in bowel function, compared with patients treated with either 3D conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT), who reported modest yet clinically meaningful decrements in bowel function, lead author Dr. Phillip J. Gray reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

All three patient groups also had significantly lower urinary quality-of-life (QoL) scores at early follow-up compared with baseline, but these changes were considered clinically meaningful only for IMRT, said Dr. Gray, a resident in the Harvard Radiation Oncology program in Boston.

"Though significant, these differences appear transient, with all three groups showing clinically meaningful decrements in bowel quality of life at 2 years following the start of treatment, and minimally lingering urinary symptoms," he said.

The retrospective study looked at three cohorts of men treated with the different modalities: 153 treated with IMRT monotherapy in the PROST-QA consortium, 94 patients treated with PBT at Massachusetts General Hospital (MGH), and 123 treated with 3D-CRT at MGH and other Harvard-affiliated hospitals.

Patients treated with IMRT and PBT were evaluated with the Expanded Prostate Cancer Index Composite (EPIC) instrument; patients treated with 3D-CRT were assessed using the Prostate Cancer Symptoms Index (PCSI); PCSI scores were inverted to match those of the EPIC scale.

Treatment dose ranges were 75.6-79.2 Gy for IMRT, 74-82 Gy relative biological effectiveness values for PBT, and 66.4-79.2 Gy for 3D-CRT.

Mean patient-reported bowel QoL scores in the immediate post-treatment period were 93.3 on a scale of 0-100 for PBT, 78.5 for IMRT, and 88.2 for 3D-CRT (P vs. PBT less than .001 for both comparisons). The differences from baseline in IMRT and 3D-CRT, but not in PBT, were considered clinically significant.

At 24 months, mean respective bowel QoL scores were 91.8, 87.6, and 90.2, respectively, with clinically significant differences between PBT and the other two modalities.

Dr. Gray acknowledged that the retrospective nature of the study and the use of different scoring instruments muddy the comparison waters. He noted that things may become clearer when the results of a recently launched randomized trial comparing PBT and IMRT become available. The study will look at 6-month efficacy outcomes, cost effectiveness, and toxicities at 2 years, and survival and other end points out to 10 years.

Protons Are a Costly Choice

Although the relative long-term benefits of PBT for prostate cancer may not be known for several years, one thing is sure: PBT is about 70% more expensive than IMRT, said Dr. James Yu, a radiation oncologist at Yale University in New Haven, Conn.

Neil Osterweil/IMNG Medical Media

Dr. Yu and colleagues looked at data on patients who received IMRT or PBT as primary therapy for prostate cancer in the Medicare Chronic Condition Data Warehouse, a national database that captures 100% of Medicare fee-for-service claims for patients with specific chronic conditions.

They found that the median interquartile range amount that Medicare reimbursed for PBT was $32,428 vs. $18,575 for IMRT.

In early follow-up (0-6 months) genitourinary complications were significantly lower among 421 patients with who had received PBT than among 842 patients who received IMRT (5.9% vs. 9.5%; odds ratio 0.60; P = .03). Neither gastrointestinal nor other complications were significantly different, however, and at 12 months follow-up there were no significant differences between treatment types, Dr. Yu noted.

"A continued longitudinal study of the comparative effectiveness of proton radiation is needed, and we also believe that further study is needed before widespread application of proton radiation can be justified," he said.

PBT Benefit Proven in Other Cancers

A radiation oncologist who was not involved in the study commented that in the absence of evidence of a therapeutic benefit for PBT in prostate cancer over other modalities, proton therapy may better be reserved for the treatment of other cancers.

"If you have a resource that’s limited, you want to use it where you know there’s a benefit," said Dr, Jeffrey Bradley, professor of radiation oncology at Washington University in St. Louis.

His center is building a single-vault proton-beam facility that is expected to open in the summer of 2013. Dr. Bradley said that although they will likely treat patients with prostate cancer, he envisions the main role of the center to be treatment of pediatric and adult tumors of the central nervous system, sarcomas, ocular neoplasms, and other conditions where the benefits of PBT are better documented.

Dr Gray, Dr. Yu, and Dr. Bradley each reported no conflicts of interest.

BOSTON – Men who receive proton beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient, investigators found.

At 2-3 months follow-up, patients treated with proton beam therapy (PBT) reported minimal decrements in bowel function, compared with patients treated with either 3D conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT), who reported modest yet clinically meaningful decrements in bowel function, lead author Dr. Phillip J. Gray reported at the annual meeting of the American Society for Radiation Oncology.

Neil Osterweil/IMNG Medical Media

All three patient groups also had significantly lower urinary quality-of-life (QoL) scores at early follow-up compared with baseline, but these changes were considered clinically meaningful only for IMRT, said Dr. Gray, a resident in the Harvard Radiation Oncology program in Boston.

"Though significant, these differences appear transient, with all three groups showing clinically meaningful decrements in bowel quality of life at 2 years following the start of treatment, and minimally lingering urinary symptoms," he said.

The retrospective study looked at three cohorts of men treated with the different modalities: 153 treated with IMRT monotherapy in the PROST-QA consortium, 94 patients treated with PBT at Massachusetts General Hospital (MGH), and 123 treated with 3D-CRT at MGH and other Harvard-affiliated hospitals.

Patients treated with IMRT and PBT were evaluated with the Expanded Prostate Cancer Index Composite (EPIC) instrument; patients treated with 3D-CRT were assessed using the Prostate Cancer Symptoms Index (PCSI); PCSI scores were inverted to match those of the EPIC scale.

Treatment dose ranges were 75.6-79.2 Gy for IMRT, 74-82 Gy relative biological effectiveness values for PBT, and 66.4-79.2 Gy for 3D-CRT.

Mean patient-reported bowel QoL scores in the immediate post-treatment period were 93.3 on a scale of 0-100 for PBT, 78.5 for IMRT, and 88.2 for 3D-CRT (P vs. PBT less than .001 for both comparisons). The differences from baseline in IMRT and 3D-CRT, but not in PBT, were considered clinically significant.

At 24 months, mean respective bowel QoL scores were 91.8, 87.6, and 90.2, respectively, with clinically significant differences between PBT and the other two modalities.

Dr. Gray acknowledged that the retrospective nature of the study and the use of different scoring instruments muddy the comparison waters. He noted that things may become clearer when the results of a recently launched randomized trial comparing PBT and IMRT become available. The study will look at 6-month efficacy outcomes, cost effectiveness, and toxicities at 2 years, and survival and other end points out to 10 years.

Protons Are a Costly Choice

Although the relative long-term benefits of PBT for prostate cancer may not be known for several years, one thing is sure: PBT is about 70% more expensive than IMRT, said Dr. James Yu, a radiation oncologist at Yale University in New Haven, Conn.

Neil Osterweil/IMNG Medical Media

Dr. Yu and colleagues looked at data on patients who received IMRT or PBT as primary therapy for prostate cancer in the Medicare Chronic Condition Data Warehouse, a national database that captures 100% of Medicare fee-for-service claims for patients with specific chronic conditions.

They found that the median interquartile range amount that Medicare reimbursed for PBT was $32,428 vs. $18,575 for IMRT.

In early follow-up (0-6 months) genitourinary complications were significantly lower among 421 patients with who had received PBT than among 842 patients who received IMRT (5.9% vs. 9.5%; odds ratio 0.60; P = .03). Neither gastrointestinal nor other complications were significantly different, however, and at 12 months follow-up there were no significant differences between treatment types, Dr. Yu noted.

"A continued longitudinal study of the comparative effectiveness of proton radiation is needed, and we also believe that further study is needed before widespread application of proton radiation can be justified," he said.

PBT Benefit Proven in Other Cancers

A radiation oncologist who was not involved in the study commented that in the absence of evidence of a therapeutic benefit for PBT in prostate cancer over other modalities, proton therapy may better be reserved for the treatment of other cancers.

"If you have a resource that’s limited, you want to use it where you know there’s a benefit," said Dr, Jeffrey Bradley, professor of radiation oncology at Washington University in St. Louis.

His center is building a single-vault proton-beam facility that is expected to open in the summer of 2013. Dr. Bradley said that although they will likely treat patients with prostate cancer, he envisions the main role of the center to be treatment of pediatric and adult tumors of the central nervous system, sarcomas, ocular neoplasms, and other conditions where the benefits of PBT are better documented.

Dr Gray, Dr. Yu, and Dr. Bradley each reported no conflicts of interest.

NEW YORK – Electronic health records are here to stay, and that’s a good thing for psychiatrists and their patients, experts said at the American Psychiatric Association’s Institute on Psychiatric Services.

Dr. Daniel J. Balog said the benefits of using EHRs are numerous. They are convenient, encourage patient participation in their care, help improve diagnostics and health outcomes, facilitate care coordination, and help large and small practices achieve greater efficiencies and cost savings, said Dr. Balog, a psychiatrist at Andrews Air Force Base in Maryland.

©Brian Jackson/iStockphoto.com

He noted that in a 2008 EHR survey from the Office of the National Coordinator for Health Information Technology, 90% of respondents said that they were satisfied with their systems and that they found it easier to attract and retain staff. In addition, patients seem to buy in to participation in their care.

"Patients equate new technology with quality," Dr. Balog commented.

For providers, EHRs offer quick access to records either on site or remotely, and many systems are equipped with decision-support and performance-improvement tools. EHRs also offer safer prescribing, and eliminate the need for callbacks to clarify an order.

Patients can use their EHRs to collaborate in informed decision making, and the electronic records are essential for two-way communication for managing chronic conditions, he said. EHRs give patients access to full information on their medical evaluation, follow-up information, self-care advice, and reminders, and allow patients and their providers to follow medication levels.

Another advantage to using EHRs is that they can support clinical diagnosis and treatment by giving clinicians complete, accurate, and up-to-date information.

"It makes it easier to identify operational problems within a clinic. Back when there was a paper record, it was more difficult in a systemized way to see what was happening in your own clinics. But here, you can look at different records and see if certain actions are being taken for your patients – an example might be measurements of metabolic status of patients on atypical antipsychotics," Dr. Balog suggested.

Computerized records also can reduce medication errors, and make it easier to check for patient allergies and potential medical cross reactions.

To take some of the economic sting out of converting a records system from paper to pixels, the federal government offers economic incentives that will likely benefit psychiatrists who treat a large number of patients insured by Medicare or Medicaid, said Dr. Robert Plovnick, director of quality and improvement and psychiatric services at the American Psychiatric Association.

Full incentives of up to $18,000 structured as a rebate are available only to those physicians who started participation by Oct. 1, 2012. However, incentives of up to $15,000 are available to those who demonstrate at least 90 consecutive days of meaningful use in 2013, and up to $12,000 for those who get the ball rolling in 2014.

On the other hand, what the feds give they can take away: Starting in 2015, physicians who have not demonstrated implementation and "meaningful use" of a certified EHR system by October 2014 will have Medicare and Medicaid reimbursements reduced by 1%, and the penalties could increase to as much as 5% over time.

Meaningful use of an EHR system would include prescribing electronically, recording patient demographics, documenting smoking status, and providing patients with copies of their records on request, Dr. Plovnick said.

Dr. Lori Simon, a psychiatrist in solo practice in New York City, spent 18 years in software development and implementation in the health industry before becoming a physician.

She advised clinicians to think carefully about what they want an EHR system to do, such as scheduling appointments, billing, clinical charting, order entry, and patient access. Other considerations include how and what data to move into an electronic form. For example, is it better to move all patient records to an electronic form or only those of current patients? Similarly, is it better to move entire charts or subsets of critical data?

Questions that clinicians need to ask include whether the system is certified and qualifies for meaningful use; whether files can be accessed remotely, and if so, how easily; and where the data will be stored, whether on a local or central server or in "the cloud" (that is, a remote server).

In addition, the buyer will need to consider the computer platform (PC or Mac) and whether the software is compatible or can interface with other systems within or outside the institution.

The purchaser should ask the vendor about up-front and continuing costs, what discounts and warranties are available, and what’s included in the package (software, hardware, data conversion services, customization, training, and/or implementation support).

"Solid work before implementation means minimal problems after implementation," she concluded.

Dr. Balog has received royalties from Concept Therapeutics. Dr. Plovnick reported no conflicts of interest. Dr. Simon is on the advisory board of Valant Medical Solutions, maker of an EHR system for psychiatrists.

NEW YORK – Electronic health records are here to stay, and that’s a good thing for psychiatrists and their patients, experts said at the American Psychiatric Association’s Institute on Psychiatric Services.

Dr. Daniel J. Balog said the benefits of using EHRs are numerous. They are convenient, encourage patient participation in their care, help improve diagnostics and health outcomes, facilitate care coordination, and help large and small practices achieve greater efficiencies and cost savings, said Dr. Balog, a psychiatrist at Andrews Air Force Base in Maryland.

©Brian Jackson/iStockphoto.com

He noted that in a 2008 EHR survey from the Office of the National Coordinator for Health Information Technology, 90% of respondents said that they were satisfied with their systems and that they found it easier to attract and retain staff. In addition, patients seem to buy in to participation in their care.

"Patients equate new technology with quality," Dr. Balog commented.

For providers, EHRs offer quick access to records either on site or remotely, and many systems are equipped with decision-support and performance-improvement tools. EHRs also offer safer prescribing, and eliminate the need for callbacks to clarify an order.

Patients can use their EHRs to collaborate in informed decision making, and the electronic records are essential for two-way communication for managing chronic conditions, he said. EHRs give patients access to full information on their medical evaluation, follow-up information, self-care advice, and reminders, and allow patients and their providers to follow medication levels.

Another advantage to using EHRs is that they can support clinical diagnosis and treatment by giving clinicians complete, accurate, and up-to-date information.

"It makes it easier to identify operational problems within a clinic. Back when there was a paper record, it was more difficult in a systemized way to see what was happening in your own clinics. But here, you can look at different records and see if certain actions are being taken for your patients – an example might be measurements of metabolic status of patients on atypical antipsychotics," Dr. Balog suggested.

Computerized records also can reduce medication errors, and make it easier to check for patient allergies and potential medical cross reactions.

To take some of the economic sting out of converting a records system from paper to pixels, the federal government offers economic incentives that will likely benefit psychiatrists who treat a large number of patients insured by Medicare or Medicaid, said Dr. Robert Plovnick, director of quality and improvement and psychiatric services at the American Psychiatric Association.

Full incentives of up to $18,000 structured as a rebate are available only to those physicians who started participation by Oct. 1, 2012. However, incentives of up to $15,000 are available to those who demonstrate at least 90 consecutive days of meaningful use in 2013, and up to $12,000 for those who get the ball rolling in 2014.

On the other hand, what the feds give they can take away: Starting in 2015, physicians who have not demonstrated implementation and "meaningful use" of a certified EHR system by October 2014 will have Medicare and Medicaid reimbursements reduced by 1%, and the penalties could increase to as much as 5% over time.

Meaningful use of an EHR system would include prescribing electronically, recording patient demographics, documenting smoking status, and providing patients with copies of their records on request, Dr. Plovnick said.

Dr. Lori Simon, a psychiatrist in solo practice in New York City, spent 18 years in software development and implementation in the health industry before becoming a physician.

She advised clinicians to think carefully about what they want an EHR system to do, such as scheduling appointments, billing, clinical charting, order entry, and patient access. Other considerations include how and what data to move into an electronic form. For example, is it better to move all patient records to an electronic form or only those of current patients? Similarly, is it better to move entire charts or subsets of critical data?

Questions that clinicians need to ask include whether the system is certified and qualifies for meaningful use; whether files can be accessed remotely, and if so, how easily; and where the data will be stored, whether on a local or central server or in "the cloud" (that is, a remote server).

In addition, the buyer will need to consider the computer platform (PC or Mac) and whether the software is compatible or can interface with other systems within or outside the institution.

The purchaser should ask the vendor about up-front and continuing costs, what discounts and warranties are available, and what’s included in the package (software, hardware, data conversion services, customization, training, and/or implementation support).

"Solid work before implementation means minimal problems after implementation," she concluded.

Dr. Balog has received royalties from Concept Therapeutics. Dr. Plovnick reported no conflicts of interest. Dr. Simon is on the advisory board of Valant Medical Solutions, maker of an EHR system for psychiatrists.

NEW YORK – Electronic health records are here to stay, and that’s a good thing for psychiatrists and their patients, experts said at the American Psychiatric Association’s Institute on Psychiatric Services.

Dr. Daniel J. Balog said the benefits of using EHRs are numerous. They are convenient, encourage patient participation in their care, help improve diagnostics and health outcomes, facilitate care coordination, and help large and small practices achieve greater efficiencies and cost savings, said Dr. Balog, a psychiatrist at Andrews Air Force Base in Maryland.

©Brian Jackson/iStockphoto.com

He noted that in a 2008 EHR survey from the Office of the National Coordinator for Health Information Technology, 90% of respondents said that they were satisfied with their systems and that they found it easier to attract and retain staff. In addition, patients seem to buy in to participation in their care.

"Patients equate new technology with quality," Dr. Balog commented.

For providers, EHRs offer quick access to records either on site or remotely, and many systems are equipped with decision-support and performance-improvement tools. EHRs also offer safer prescribing, and eliminate the need for callbacks to clarify an order.

Patients can use their EHRs to collaborate in informed decision making, and the electronic records are essential for two-way communication for managing chronic conditions, he said. EHRs give patients access to full information on their medical evaluation, follow-up information, self-care advice, and reminders, and allow patients and their providers to follow medication levels.

Another advantage to using EHRs is that they can support clinical diagnosis and treatment by giving clinicians complete, accurate, and up-to-date information.

"It makes it easier to identify operational problems within a clinic. Back when there was a paper record, it was more difficult in a systemized way to see what was happening in your own clinics. But here, you can look at different records and see if certain actions are being taken for your patients – an example might be measurements of metabolic status of patients on atypical antipsychotics," Dr. Balog suggested.

Computerized records also can reduce medication errors, and make it easier to check for patient allergies and potential medical cross reactions.

To take some of the economic sting out of converting a records system from paper to pixels, the federal government offers economic incentives that will likely benefit psychiatrists who treat a large number of patients insured by Medicare or Medicaid, said Dr. Robert Plovnick, director of quality and improvement and psychiatric services at the American Psychiatric Association.

Full incentives of up to $18,000 structured as a rebate are available only to those physicians who started participation by Oct. 1, 2012. However, incentives of up to $15,000 are available to those who demonstrate at least 90 consecutive days of meaningful use in 2013, and up to $12,000 for those who get the ball rolling in 2014.

On the other hand, what the feds give they can take away: Starting in 2015, physicians who have not demonstrated implementation and "meaningful use" of a certified EHR system by October 2014 will have Medicare and Medicaid reimbursements reduced by 1%, and the penalties could increase to as much as 5% over time.

Meaningful use of an EHR system would include prescribing electronically, recording patient demographics, documenting smoking status, and providing patients with copies of their records on request, Dr. Plovnick said.

Dr. Lori Simon, a psychiatrist in solo practice in New York City, spent 18 years in software development and implementation in the health industry before becoming a physician.

She advised clinicians to think carefully about what they want an EHR system to do, such as scheduling appointments, billing, clinical charting, order entry, and patient access. Other considerations include how and what data to move into an electronic form. For example, is it better to move all patient records to an electronic form or only those of current patients? Similarly, is it better to move entire charts or subsets of critical data?

Questions that clinicians need to ask include whether the system is certified and qualifies for meaningful use; whether files can be accessed remotely, and if so, how easily; and where the data will be stored, whether on a local or central server or in "the cloud" (that is, a remote server).

In addition, the buyer will need to consider the computer platform (PC or Mac) and whether the software is compatible or can interface with other systems within or outside the institution.

The purchaser should ask the vendor about up-front and continuing costs, what discounts and warranties are available, and what’s included in the package (software, hardware, data conversion services, customization, training, and/or implementation support).

"Solid work before implementation means minimal problems after implementation," she concluded.

Dr. Balog has received royalties from Concept Therapeutics. Dr. Plovnick reported no conflicts of interest. Dr. Simon is on the advisory board of Valant Medical Solutions, maker of an EHR system for psychiatrists.

NEW YORK – Just as early detection of cancer increases the odds of a favorable outcome, diagnosis and intervention for patients in the early phases of schizophrenia or other primary psychotic disorders might help them to preserve a high level of mental and social function, investigators reported at the American Psychiatric Association’s Institute on Psychiatric Services.

Early results from a small study of adolescents and young adults considered to be at clinical high risk for developing psychosis suggest that a combination of individualized therapies plus group, family, educational, vocational, and social interventions can significantly reduce overall psychotic symptoms, decrease depression and anxiety, and lower patient perceptions of the disruptions that psychosis causes in their lives, said Dr. Michael Birnbaum, a psychiatry resident at Columbia University in New York.

Neil Osterweil/IMNG Medical Media

"Early intervention is based on the idea that mental illness is a progressive pathologic process, that there are very distinct stages, and that each stage requires very specific interventions for that stage," he said.

Psychosis is a clinical manifestation of a progressive pathological process that begins prenatally and progresses until the second or third decade of life when a psychotic episode occurs and a threshold is reached, he said.

The course of schizophrenia moves from the premorbid phase of asymptomatic genetic and environmental vulnerability, to the prodromal phase that might range from generalized, nonspecific symptoms to subthreshold symptoms and mild functional decline, to the first full-threshold psychotic episode with significant functional decline, and finally to remission and relapse.

Early intervention in at-risk patients aims to delay or prevent progression to psychosis and its deleterious effects on social, educational, and occupational functioning. With early treatment, patients might be more engaged and trusting of their therapists, and have a "less risky and traumatic mode of entry into psychiatric care," Dr. Birnbaum said.

Risks High During Critical Period

During the critical period – the first 2-5 years after an initial psychotic episode – an early intervention plan can set the parameters for long-term recovery and outcome. It is during this critical period, Dr. Birnbaum said, that there is the highest risk for disengagement, relapse, and suicide, and the most pronounced functional decline (Schizophr. Bull. 1996;22:201-22).

In this phase, the goals of treatment are management of symptoms through medication, psychosocial interventions aimed at minimizing disability and maximizing functional outcome, reducing stigma, allowing the patient and family to mourn and adapt, and for the clinician to provide the patient with hope.

"We know that reducing the duration of untreated psychosis has a huge impact," he said.

Columbia University has established an early intervention program dubbed PEER, for Prevention, Education, Evaluation, and Rehabilitation. The program is a subspecialty service in which research is translated into clinical practice aimed at early detection and targeted interventions with a multidisciplinary team.

Treatment domains in the program include individualized interventions to help patients recover by exploring personal goals and providing education about the disease and treatments; medication aimed at improving mood and lessening anxiety and symptoms of psychosis, as well as preventing exacerbations; group interventions for improving social skills, decreasing isolation, and reducing stigma; family interventions to promote involvement, reduce stress, and teach crisis management skills; and educational and vocation interventions to help patients achieve their employment goals.

Short-Term Improvements Seen

Dr. Birnbaum and his colleagues conducted a small clinical study of 16 male and 4 female participants in the PEER program. The patients were 12-30 years old, had been diagnosed with a primary psychotic disorder within the last 5 years, and were considered to be at clinical high risk for developing psychosis as identified by the Structured Interview for Prodromal Symptoms and the Scale of Prodromal Symptoms.

Patients were assessed with a wide variety of validated scales for substance abuse, intelligence, disability, and depression and other symptoms.

At baseline, the patients presented with clinically significant anxiety and depression, 70% met criteria for suicide risk, and 23% were considered to be at high risk of suicide. Two-thirds of the sample said their symptoms were disrupting their lives, and more than half reported regular use of alcohol and marijuana.

At 3 months’ follow-up, however, investigators saw significant reductions on the Brief Psychiatric Rating Scale, from a baseline mean of 34.1 to 30.87 (P less than .01), and significant reductions in the rates of depression and anxiety as measured by the Beck Depression Inventory, revision 2, and Self-Report for Childhood Anxiety Related Emotional Disorders (SCARED) rating scales.

In addition, decreases were found in overall symptoms of psychosis, in perceived disruption of school or work (from 75% at baseline to 55% at 3 months), and in disruptions in social life or leisure activities (from 85% to 54.5%). The interventions did not, however, make a difference in use of either alcohol or marijuana.

"It’s hard to draw too many conclusions from this; it’s just preliminary data, but we like to think that joining the PEER program has been helpful, and contributes to decreasing the perceived distress and stabilizing the psychotic symptoms, depression, and anxiety. We’re happy to find out that there’s less disruption, or at least less perceived disruption, in their lives, and we clearly have to focus more on alcohol- and marijuana-focused treatments," said Dr. Birnbaum.

The investigators hope to follow the patients longitudinally to determine what works and what does not, and, ideally, to be able to contribute to future guidelines on intervention in psychosis, he concluded.

Dr. Birnbaum disclosed no relevant conflicts of interest.

NEW YORK – Just as early detection of cancer increases the odds of a favorable outcome, diagnosis and intervention for patients in the early phases of schizophrenia or other primary psychotic disorders might help them to preserve a high level of mental and social function, investigators reported at the American Psychiatric Association’s Institute on Psychiatric Services.

Early results from a small study of adolescents and young adults considered to be at clinical high risk for developing psychosis suggest that a combination of individualized therapies plus group, family, educational, vocational, and social interventions can significantly reduce overall psychotic symptoms, decrease depression and anxiety, and lower patient perceptions of the disruptions that psychosis causes in their lives, said Dr. Michael Birnbaum, a psychiatry resident at Columbia University in New York.

Neil Osterweil/IMNG Medical Media

"Early intervention is based on the idea that mental illness is a progressive pathologic process, that there are very distinct stages, and that each stage requires very specific interventions for that stage," he said.

Psychosis is a clinical manifestation of a progressive pathological process that begins prenatally and progresses until the second or third decade of life when a psychotic episode occurs and a threshold is reached, he said.

The course of schizophrenia moves from the premorbid phase of asymptomatic genetic and environmental vulnerability, to the prodromal phase that might range from generalized, nonspecific symptoms to subthreshold symptoms and mild functional decline, to the first full-threshold psychotic episode with significant functional decline, and finally to remission and relapse.

Early intervention in at-risk patients aims to delay or prevent progression to psychosis and its deleterious effects on social, educational, and occupational functioning. With early treatment, patients might be more engaged and trusting of their therapists, and have a "less risky and traumatic mode of entry into psychiatric care," Dr. Birnbaum said.

Risks High During Critical Period

During the critical period – the first 2-5 years after an initial psychotic episode – an early intervention plan can set the parameters for long-term recovery and outcome. It is during this critical period, Dr. Birnbaum said, that there is the highest risk for disengagement, relapse, and suicide, and the most pronounced functional decline (Schizophr. Bull. 1996;22:201-22).

In this phase, the goals of treatment are management of symptoms through medication, psychosocial interventions aimed at minimizing disability and maximizing functional outcome, reducing stigma, allowing the patient and family to mourn and adapt, and for the clinician to provide the patient with hope.

"We know that reducing the duration of untreated psychosis has a huge impact," he said.

Columbia University has established an early intervention program dubbed PEER, for Prevention, Education, Evaluation, and Rehabilitation. The program is a subspecialty service in which research is translated into clinical practice aimed at early detection and targeted interventions with a multidisciplinary team.

Treatment domains in the program include individualized interventions to help patients recover by exploring personal goals and providing education about the disease and treatments; medication aimed at improving mood and lessening anxiety and symptoms of psychosis, as well as preventing exacerbations; group interventions for improving social skills, decreasing isolation, and reducing stigma; family interventions to promote involvement, reduce stress, and teach crisis management skills; and educational and vocation interventions to help patients achieve their employment goals.

Short-Term Improvements Seen

Dr. Birnbaum and his colleagues conducted a small clinical study of 16 male and 4 female participants in the PEER program. The patients were 12-30 years old, had been diagnosed with a primary psychotic disorder within the last 5 years, and were considered to be at clinical high risk for developing psychosis as identified by the Structured Interview for Prodromal Symptoms and the Scale of Prodromal Symptoms.

Patients were assessed with a wide variety of validated scales for substance abuse, intelligence, disability, and depression and other symptoms.

At baseline, the patients presented with clinically significant anxiety and depression, 70% met criteria for suicide risk, and 23% were considered to be at high risk of suicide. Two-thirds of the sample said their symptoms were disrupting their lives, and more than half reported regular use of alcohol and marijuana.

At 3 months’ follow-up, however, investigators saw significant reductions on the Brief Psychiatric Rating Scale, from a baseline mean of 34.1 to 30.87 (P less than .01), and significant reductions in the rates of depression and anxiety as measured by the Beck Depression Inventory, revision 2, and Self-Report for Childhood Anxiety Related Emotional Disorders (SCARED) rating scales.

In addition, decreases were found in overall symptoms of psychosis, in perceived disruption of school or work (from 75% at baseline to 55% at 3 months), and in disruptions in social life or leisure activities (from 85% to 54.5%). The interventions did not, however, make a difference in use of either alcohol or marijuana.

"It’s hard to draw too many conclusions from this; it’s just preliminary data, but we like to think that joining the PEER program has been helpful, and contributes to decreasing the perceived distress and stabilizing the psychotic symptoms, depression, and anxiety. We’re happy to find out that there’s less disruption, or at least less perceived disruption, in their lives, and we clearly have to focus more on alcohol- and marijuana-focused treatments," said Dr. Birnbaum.

The investigators hope to follow the patients longitudinally to determine what works and what does not, and, ideally, to be able to contribute to future guidelines on intervention in psychosis, he concluded.

Dr. Birnbaum disclosed no relevant conflicts of interest.

NEW YORK – Just as early detection of cancer increases the odds of a favorable outcome, diagnosis and intervention for patients in the early phases of schizophrenia or other primary psychotic disorders might help them to preserve a high level of mental and social function, investigators reported at the American Psychiatric Association’s Institute on Psychiatric Services.

Early results from a small study of adolescents and young adults considered to be at clinical high risk for developing psychosis suggest that a combination of individualized therapies plus group, family, educational, vocational, and social interventions can significantly reduce overall psychotic symptoms, decrease depression and anxiety, and lower patient perceptions of the disruptions that psychosis causes in their lives, said Dr. Michael Birnbaum, a psychiatry resident at Columbia University in New York.

Neil Osterweil/IMNG Medical Media

"Early intervention is based on the idea that mental illness is a progressive pathologic process, that there are very distinct stages, and that each stage requires very specific interventions for that stage," he said.

Psychosis is a clinical manifestation of a progressive pathological process that begins prenatally and progresses until the second or third decade of life when a psychotic episode occurs and a threshold is reached, he said.

The course of schizophrenia moves from the premorbid phase of asymptomatic genetic and environmental vulnerability, to the prodromal phase that might range from generalized, nonspecific symptoms to subthreshold symptoms and mild functional decline, to the first full-threshold psychotic episode with significant functional decline, and finally to remission and relapse.

Early intervention in at-risk patients aims to delay or prevent progression to psychosis and its deleterious effects on social, educational, and occupational functioning. With early treatment, patients might be more engaged and trusting of their therapists, and have a "less risky and traumatic mode of entry into psychiatric care," Dr. Birnbaum said.

Risks High During Critical Period

During the critical period – the first 2-5 years after an initial psychotic episode – an early intervention plan can set the parameters for long-term recovery and outcome. It is during this critical period, Dr. Birnbaum said, that there is the highest risk for disengagement, relapse, and suicide, and the most pronounced functional decline (Schizophr. Bull. 1996;22:201-22).

In this phase, the goals of treatment are management of symptoms through medication, psychosocial interventions aimed at minimizing disability and maximizing functional outcome, reducing stigma, allowing the patient and family to mourn and adapt, and for the clinician to provide the patient with hope.

"We know that reducing the duration of untreated psychosis has a huge impact," he said.

Columbia University has established an early intervention program dubbed PEER, for Prevention, Education, Evaluation, and Rehabilitation. The program is a subspecialty service in which research is translated into clinical practice aimed at early detection and targeted interventions with a multidisciplinary team.

Treatment domains in the program include individualized interventions to help patients recover by exploring personal goals and providing education about the disease and treatments; medication aimed at improving mood and lessening anxiety and symptoms of psychosis, as well as preventing exacerbations; group interventions for improving social skills, decreasing isolation, and reducing stigma; family interventions to promote involvement, reduce stress, and teach crisis management skills; and educational and vocation interventions to help patients achieve their employment goals.

Short-Term Improvements Seen

Dr. Birnbaum and his colleagues conducted a small clinical study of 16 male and 4 female participants in the PEER program. The patients were 12-30 years old, had been diagnosed with a primary psychotic disorder within the last 5 years, and were considered to be at clinical high risk for developing psychosis as identified by the Structured Interview for Prodromal Symptoms and the Scale of Prodromal Symptoms.

Patients were assessed with a wide variety of validated scales for substance abuse, intelligence, disability, and depression and other symptoms.

At baseline, the patients presented with clinically significant anxiety and depression, 70% met criteria for suicide risk, and 23% were considered to be at high risk of suicide. Two-thirds of the sample said their symptoms were disrupting their lives, and more than half reported regular use of alcohol and marijuana.

At 3 months’ follow-up, however, investigators saw significant reductions on the Brief Psychiatric Rating Scale, from a baseline mean of 34.1 to 30.87 (P less than .01), and significant reductions in the rates of depression and anxiety as measured by the Beck Depression Inventory, revision 2, and Self-Report for Childhood Anxiety Related Emotional Disorders (SCARED) rating scales.

In addition, decreases were found in overall symptoms of psychosis, in perceived disruption of school or work (from 75% at baseline to 55% at 3 months), and in disruptions in social life or leisure activities (from 85% to 54.5%). The interventions did not, however, make a difference in use of either alcohol or marijuana.

"It’s hard to draw too many conclusions from this; it’s just preliminary data, but we like to think that joining the PEER program has been helpful, and contributes to decreasing the perceived distress and stabilizing the psychotic symptoms, depression, and anxiety. We’re happy to find out that there’s less disruption, or at least less perceived disruption, in their lives, and we clearly have to focus more on alcohol- and marijuana-focused treatments," said Dr. Birnbaum.

The investigators hope to follow the patients longitudinally to determine what works and what does not, and, ideally, to be able to contribute to future guidelines on intervention in psychosis, he concluded.

Dr. Birnbaum disclosed no relevant conflicts of interest.