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Comparison of Low-Dose Platinum vs High-Dose Platinum vs Cetuximab and Intensity-Modulated Radiation Therapy in Advanced Head and Neck Cancers
Purpose: High-dose cisplatin is standard in head and neck cancers. Recently, weekly low-dose platinum alone or with cetuximab has been used. All patients received 70 Gy standard fraction intensity-modulated radiation therapy. We are comparing the former used at the VAMC with the latter regimens used in the department of Oncology at the University of Mississippi. We will present the toxicity, response, patterns of failure, and survival by the use of the different types of chemotherapy.
Purpose: High-dose cisplatin is standard in head and neck cancers. Recently, weekly low-dose platinum alone or with cetuximab has been used. All patients received 70 Gy standard fraction intensity-modulated radiation therapy. We are comparing the former used at the VAMC with the latter regimens used in the department of Oncology at the University of Mississippi. We will present the toxicity, response, patterns of failure, and survival by the use of the different types of chemotherapy.
Purpose: High-dose cisplatin is standard in head and neck cancers. Recently, weekly low-dose platinum alone or with cetuximab has been used. All patients received 70 Gy standard fraction intensity-modulated radiation therapy. We are comparing the former used at the VAMC with the latter regimens used in the department of Oncology at the University of Mississippi. We will present the toxicity, response, patterns of failure, and survival by the use of the different types of chemotherapy.
Blastic Plasmacytoid Dendritic Cell Neoplasm: A Case Successfully Treated With HyperCVAD Followed by Allogeneic Stem Cell Transplantation
Introduction: Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare, clinically aggressive tumor derived from the precursors of palsmacytoid dendritic cells with a high frequency of cutaneous and bone marrow involvement and leukaemic dissemination. The prognosis is poor, and an optimal treatment approach has not been defined. We describe a case of BPDCN that has been successfully treated with acute leukaemia-type induction (hyperCVAD) followed by allogeneic stem cell transplantation (ASCT).
Purpose: To evaluate the efficacy of hyperCVAD and ASCT in treatment of BPDCN.
Method: A case report and literature review. Result: An African American male, aged 49 years, presented with firm violaceous nodules on the left calf, back, and shoulders, accompanied by 40 lb weight loss. Patient did not experience night sweats, fevers, and chill. Complete blood cell count and serum lactate dehydrogenase were normal. A skin biopsy revealed dense dermal infiltrates consisting of intermediate-sized cells with high N:C ratio. The tumor cells were strongly positive for CD4, CD56; partially positive for TdT; weakly positive for CD45 and CD43; and negative for CD3, CD20, CD30, MPO, CD34, CD117. Bone marrow biopsy and aspirate smear showed hypercellular marrow with predominant blastic cells with high nuclear-cytoplasmic ratio, finely chromatin, and prominent nucleoli. Flow cytometric analysis demonstrated 85% blasts that were positive for HLA-DR, CD4, CD56, CD38, and TdT (partial); but negative for CD34, CD117, CD33, CD13, CD14, CD15, CD2, CD3, CD5, CD11c, CD7, CD19, CD10, CD20, CD22, CD24, Kappa, Lambda, CD25, CD52, and MPO. Cyotogenetic analysis reported an abnormal complex chromosome abnormality: 46, XY, add (7)(q22), add (8)(p11.2), add (9)(q13), psu dic(13:6)(p12;q16), del(13)(q12q22), -17, +21, +mar[9]. The peripheral blood smear revealed rare blasts. The patient responded well to hyperCVAD chemo followed by ASCT. He has remained disease free for > 5 years.
Conclusions: Aggressive chemotherapy followed by ASCT is a favorable treatment plan for BPDCN.
Introduction: Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare, clinically aggressive tumor derived from the precursors of palsmacytoid dendritic cells with a high frequency of cutaneous and bone marrow involvement and leukaemic dissemination. The prognosis is poor, and an optimal treatment approach has not been defined. We describe a case of BPDCN that has been successfully treated with acute leukaemia-type induction (hyperCVAD) followed by allogeneic stem cell transplantation (ASCT).
Purpose: To evaluate the efficacy of hyperCVAD and ASCT in treatment of BPDCN.
Method: A case report and literature review. Result: An African American male, aged 49 years, presented with firm violaceous nodules on the left calf, back, and shoulders, accompanied by 40 lb weight loss. Patient did not experience night sweats, fevers, and chill. Complete blood cell count and serum lactate dehydrogenase were normal. A skin biopsy revealed dense dermal infiltrates consisting of intermediate-sized cells with high N:C ratio. The tumor cells were strongly positive for CD4, CD56; partially positive for TdT; weakly positive for CD45 and CD43; and negative for CD3, CD20, CD30, MPO, CD34, CD117. Bone marrow biopsy and aspirate smear showed hypercellular marrow with predominant blastic cells with high nuclear-cytoplasmic ratio, finely chromatin, and prominent nucleoli. Flow cytometric analysis demonstrated 85% blasts that were positive for HLA-DR, CD4, CD56, CD38, and TdT (partial); but negative for CD34, CD117, CD33, CD13, CD14, CD15, CD2, CD3, CD5, CD11c, CD7, CD19, CD10, CD20, CD22, CD24, Kappa, Lambda, CD25, CD52, and MPO. Cyotogenetic analysis reported an abnormal complex chromosome abnormality: 46, XY, add (7)(q22), add (8)(p11.2), add (9)(q13), psu dic(13:6)(p12;q16), del(13)(q12q22), -17, +21, +mar[9]. The peripheral blood smear revealed rare blasts. The patient responded well to hyperCVAD chemo followed by ASCT. He has remained disease free for > 5 years.
Conclusions: Aggressive chemotherapy followed by ASCT is a favorable treatment plan for BPDCN.
Introduction: Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare, clinically aggressive tumor derived from the precursors of palsmacytoid dendritic cells with a high frequency of cutaneous and bone marrow involvement and leukaemic dissemination. The prognosis is poor, and an optimal treatment approach has not been defined. We describe a case of BPDCN that has been successfully treated with acute leukaemia-type induction (hyperCVAD) followed by allogeneic stem cell transplantation (ASCT).
Purpose: To evaluate the efficacy of hyperCVAD and ASCT in treatment of BPDCN.
Method: A case report and literature review. Result: An African American male, aged 49 years, presented with firm violaceous nodules on the left calf, back, and shoulders, accompanied by 40 lb weight loss. Patient did not experience night sweats, fevers, and chill. Complete blood cell count and serum lactate dehydrogenase were normal. A skin biopsy revealed dense dermal infiltrates consisting of intermediate-sized cells with high N:C ratio. The tumor cells were strongly positive for CD4, CD56; partially positive for TdT; weakly positive for CD45 and CD43; and negative for CD3, CD20, CD30, MPO, CD34, CD117. Bone marrow biopsy and aspirate smear showed hypercellular marrow with predominant blastic cells with high nuclear-cytoplasmic ratio, finely chromatin, and prominent nucleoli. Flow cytometric analysis demonstrated 85% blasts that were positive for HLA-DR, CD4, CD56, CD38, and TdT (partial); but negative for CD34, CD117, CD33, CD13, CD14, CD15, CD2, CD3, CD5, CD11c, CD7, CD19, CD10, CD20, CD22, CD24, Kappa, Lambda, CD25, CD52, and MPO. Cyotogenetic analysis reported an abnormal complex chromosome abnormality: 46, XY, add (7)(q22), add (8)(p11.2), add (9)(q13), psu dic(13:6)(p12;q16), del(13)(q12q22), -17, +21, +mar[9]. The peripheral blood smear revealed rare blasts. The patient responded well to hyperCVAD chemo followed by ASCT. He has remained disease free for > 5 years.
Conclusions: Aggressive chemotherapy followed by ASCT is a favorable treatment plan for BPDCN.
Liver grafts donated after circulatory death increase early risk of diabetes
SAN FRANCISCO – The type of liver graft used in transplantation plays a large role in early development of new-onset diabetes, according to a retrospective study of 430 patients from the United Kingdom.
A team led by Dr. Hermien Hartog, an honorary clinical fellow in the Liver Unit, Queen Elizabeth Hospital, Birmingham, England, studied patients undergoing primary liver transplant between 2008 and 2012. Patients were excluded from the study if they had preexisting diabetes, had died, or had undergone retransplantation within 90 days.
The investigators assessed both the development of new-onset diabetes after transplant (NODAT), using criteria adapted from a published article (Transplantation 2013;96:58-64), and its resolution, defined as the date of cessation of antihyperglycemic therapy or the last episode of hyperglycemia.
Seventy-nine percent of the patients received grafts donated after brain death (DBD), Dr. Hartog reported at the annual meeting of the 2014 World Transplant Congress. Among the recipients of grafts donated after circulatory death (DCD), the mean warm ischemic time was 21 minutes.
With a median follow-up of 2.5 years, the cumulative 1-year incidence of NODAT was 19% in the entire cohort, with a median time to onset of 30 days. In the 44% of affected patients whose NODAT resolved, the median time to resolution was 150 days post transplantation, Dr. Hartog reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The cumulative 1-year incidence of NODAT was 23% in DCD graft recipients and 18% in DBD graft recipients, a nonsignificant difference. But when patients were stratified by graft type, "we saw an early occurrence and high peak incidence of NODAT in DCD graft recipients. Also, a larger proportion of these patients resolved their NODAT over time," she commented.
The overall temporal pattern suggested that "the effect that we see of graft type seems to be temporary and [lessens] over time when multifactorial factors come into play," according to Dr. Hartog.
In multivariate analyses, the risk of NODAT within 90 days of transplantation was higher for patients who received a DCD graft (hazard ratio, 1.8). More detailed analysis showed that the elevation of risk was greatest within the first 15 days.
"Our study confirms known associations with NODAT after liver transplantation but identifies DCD graft as a novel risk factor. This causes a temporary effect in the early post-transplant period that is independent from known risk factors," Dr. Hartog commented.
"Based on our observations, we hypothesize that hyperglycemia may be related to liver graft function through ischemia-reperfusion–induced hepatic insulin resistance," she added. "We are currently trying to confirm our data in an independent data set, which will also include postreperfusion glucose levels and correlation with the insulin receptor pathway in time-zero liver biopsies."
"The clinical relevance of our findings is as yet unknown," she acknowledged. However, they may help inform new approaches for graft optimization and selection.
Session cochair Dr. Darius Mirza, also of the University of Birmingham, asked, "Why does the pattern of recovery seem to be different in the DCDs versus the DBDs? Also, why are the cumulative incidence and the time frame so different?"
"Actually, in the literature, I have not seen any reports looking at the early post-transplant period. So most reports look at one time point, normally 1 year," Dr. Hartog replied. "What I think is that there is an early peak caused by DCD grafts that would explain why there is an early peak, but also why those patients recover later on. I think this peak is a bit obscure because there are also other factors that come into play, maybe after a while, that will obscure that first peak. If you would take those other factors out of the equation, I think you would just see a peak in the early period."
Dr. Mirza also wondered about the role of using DCD grafts that are accepted under extended criteria. "So you start off using mainly young, fit DCD livers. Now, the vast majority are extended-criteria DCD livers. Do you think that plays a role, or is it too early to say?"
"Yes, I think so," Dr. Hartog said, while adding that this phenomenon is likely not restricted to DCD grafts. "From earlier literature, there is a clear difference between a living donated graft and deceased donation. And it might also be that the extended grafts or the more steatotic grafts may exhibit this effect more than the better grafts."
Dr. Hartog disclosed no conflicts of interest relevant to the research.
SAN FRANCISCO – The type of liver graft used in transplantation plays a large role in early development of new-onset diabetes, according to a retrospective study of 430 patients from the United Kingdom.
A team led by Dr. Hermien Hartog, an honorary clinical fellow in the Liver Unit, Queen Elizabeth Hospital, Birmingham, England, studied patients undergoing primary liver transplant between 2008 and 2012. Patients were excluded from the study if they had preexisting diabetes, had died, or had undergone retransplantation within 90 days.
The investigators assessed both the development of new-onset diabetes after transplant (NODAT), using criteria adapted from a published article (Transplantation 2013;96:58-64), and its resolution, defined as the date of cessation of antihyperglycemic therapy or the last episode of hyperglycemia.
Seventy-nine percent of the patients received grafts donated after brain death (DBD), Dr. Hartog reported at the annual meeting of the 2014 World Transplant Congress. Among the recipients of grafts donated after circulatory death (DCD), the mean warm ischemic time was 21 minutes.
With a median follow-up of 2.5 years, the cumulative 1-year incidence of NODAT was 19% in the entire cohort, with a median time to onset of 30 days. In the 44% of affected patients whose NODAT resolved, the median time to resolution was 150 days post transplantation, Dr. Hartog reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The cumulative 1-year incidence of NODAT was 23% in DCD graft recipients and 18% in DBD graft recipients, a nonsignificant difference. But when patients were stratified by graft type, "we saw an early occurrence and high peak incidence of NODAT in DCD graft recipients. Also, a larger proportion of these patients resolved their NODAT over time," she commented.
The overall temporal pattern suggested that "the effect that we see of graft type seems to be temporary and [lessens] over time when multifactorial factors come into play," according to Dr. Hartog.
In multivariate analyses, the risk of NODAT within 90 days of transplantation was higher for patients who received a DCD graft (hazard ratio, 1.8). More detailed analysis showed that the elevation of risk was greatest within the first 15 days.
"Our study confirms known associations with NODAT after liver transplantation but identifies DCD graft as a novel risk factor. This causes a temporary effect in the early post-transplant period that is independent from known risk factors," Dr. Hartog commented.
"Based on our observations, we hypothesize that hyperglycemia may be related to liver graft function through ischemia-reperfusion–induced hepatic insulin resistance," she added. "We are currently trying to confirm our data in an independent data set, which will also include postreperfusion glucose levels and correlation with the insulin receptor pathway in time-zero liver biopsies."
"The clinical relevance of our findings is as yet unknown," she acknowledged. However, they may help inform new approaches for graft optimization and selection.
Session cochair Dr. Darius Mirza, also of the University of Birmingham, asked, "Why does the pattern of recovery seem to be different in the DCDs versus the DBDs? Also, why are the cumulative incidence and the time frame so different?"
"Actually, in the literature, I have not seen any reports looking at the early post-transplant period. So most reports look at one time point, normally 1 year," Dr. Hartog replied. "What I think is that there is an early peak caused by DCD grafts that would explain why there is an early peak, but also why those patients recover later on. I think this peak is a bit obscure because there are also other factors that come into play, maybe after a while, that will obscure that first peak. If you would take those other factors out of the equation, I think you would just see a peak in the early period."
Dr. Mirza also wondered about the role of using DCD grafts that are accepted under extended criteria. "So you start off using mainly young, fit DCD livers. Now, the vast majority are extended-criteria DCD livers. Do you think that plays a role, or is it too early to say?"
"Yes, I think so," Dr. Hartog said, while adding that this phenomenon is likely not restricted to DCD grafts. "From earlier literature, there is a clear difference between a living donated graft and deceased donation. And it might also be that the extended grafts or the more steatotic grafts may exhibit this effect more than the better grafts."
Dr. Hartog disclosed no conflicts of interest relevant to the research.
SAN FRANCISCO – The type of liver graft used in transplantation plays a large role in early development of new-onset diabetes, according to a retrospective study of 430 patients from the United Kingdom.
A team led by Dr. Hermien Hartog, an honorary clinical fellow in the Liver Unit, Queen Elizabeth Hospital, Birmingham, England, studied patients undergoing primary liver transplant between 2008 and 2012. Patients were excluded from the study if they had preexisting diabetes, had died, or had undergone retransplantation within 90 days.
The investigators assessed both the development of new-onset diabetes after transplant (NODAT), using criteria adapted from a published article (Transplantation 2013;96:58-64), and its resolution, defined as the date of cessation of antihyperglycemic therapy or the last episode of hyperglycemia.
Seventy-nine percent of the patients received grafts donated after brain death (DBD), Dr. Hartog reported at the annual meeting of the 2014 World Transplant Congress. Among the recipients of grafts donated after circulatory death (DCD), the mean warm ischemic time was 21 minutes.
With a median follow-up of 2.5 years, the cumulative 1-year incidence of NODAT was 19% in the entire cohort, with a median time to onset of 30 days. In the 44% of affected patients whose NODAT resolved, the median time to resolution was 150 days post transplantation, Dr. Hartog reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The cumulative 1-year incidence of NODAT was 23% in DCD graft recipients and 18% in DBD graft recipients, a nonsignificant difference. But when patients were stratified by graft type, "we saw an early occurrence and high peak incidence of NODAT in DCD graft recipients. Also, a larger proportion of these patients resolved their NODAT over time," she commented.
The overall temporal pattern suggested that "the effect that we see of graft type seems to be temporary and [lessens] over time when multifactorial factors come into play," according to Dr. Hartog.
In multivariate analyses, the risk of NODAT within 90 days of transplantation was higher for patients who received a DCD graft (hazard ratio, 1.8). More detailed analysis showed that the elevation of risk was greatest within the first 15 days.
"Our study confirms known associations with NODAT after liver transplantation but identifies DCD graft as a novel risk factor. This causes a temporary effect in the early post-transplant period that is independent from known risk factors," Dr. Hartog commented.
"Based on our observations, we hypothesize that hyperglycemia may be related to liver graft function through ischemia-reperfusion–induced hepatic insulin resistance," she added. "We are currently trying to confirm our data in an independent data set, which will also include postreperfusion glucose levels and correlation with the insulin receptor pathway in time-zero liver biopsies."
"The clinical relevance of our findings is as yet unknown," she acknowledged. However, they may help inform new approaches for graft optimization and selection.
Session cochair Dr. Darius Mirza, also of the University of Birmingham, asked, "Why does the pattern of recovery seem to be different in the DCDs versus the DBDs? Also, why are the cumulative incidence and the time frame so different?"
"Actually, in the literature, I have not seen any reports looking at the early post-transplant period. So most reports look at one time point, normally 1 year," Dr. Hartog replied. "What I think is that there is an early peak caused by DCD grafts that would explain why there is an early peak, but also why those patients recover later on. I think this peak is a bit obscure because there are also other factors that come into play, maybe after a while, that will obscure that first peak. If you would take those other factors out of the equation, I think you would just see a peak in the early period."
Dr. Mirza also wondered about the role of using DCD grafts that are accepted under extended criteria. "So you start off using mainly young, fit DCD livers. Now, the vast majority are extended-criteria DCD livers. Do you think that plays a role, or is it too early to say?"
"Yes, I think so," Dr. Hartog said, while adding that this phenomenon is likely not restricted to DCD grafts. "From earlier literature, there is a clear difference between a living donated graft and deceased donation. And it might also be that the extended grafts or the more steatotic grafts may exhibit this effect more than the better grafts."
Dr. Hartog disclosed no conflicts of interest relevant to the research.
AT THE 2014 WORLD TRANSPLANT CONGRESS
Key clinical point: Recipients of liver grafts donated after circulatory death are at a slightly higher risk for post-transplant new-onset diabetes.
Major finding: The risk of new-onset diabetes within 90 days of transplantation was 1.8-fold higher for patients who received a DCD graft than for peers who received a DBD graft.
Data source: A retrospective cohort study of 430 primary liver transplant recipients
Disclosures: Dr. Hartog disclosed no relevant conflicts of interest.
Survival of Patients With Untreated Early Stage Non-Small Cell Lung Cancer
Method: A retrospective chart review was conducted in patients diagnosed with stage 1 and 2 NSCLC in Samuel S. Stratton VAMC in Albany from January 1, 1999, to January 1, 2009. Patients who were not treated were identified. Recorded data included demographic information, including age at diagnosis and gender, stage at presentation, pathology, smoking history, performance status, reason for nontreatment, vital status, cause of death, and time from diagnosis to death.
Results: There were 256 patients of early stage NSCLC diagnosed; 39 of them did not receive any therapy. All the patients were male: 95% of them were smokers; 35.9% of patients had ECOG performance status 3 or 4. The reasons that they did not get any treatment included poor functional status, poor cardiac or lung function, other comorbidities, or simple refusal. Mean age at diagnosis was 76.9 ± 8.2 years. Mean survival length was 24.36 ± 28.07 months. Five-year survival rate was 12.8%.
Conclusions: Untreated early stage NSCLC has a much lower 5-year survival rate than that of stage-matched resected disease (32%-63%). Newer molecular target oral agents might be an option for those patients who are not candidates for standard lobectomy or definitive radiation therapy. Further studies are needed in this field.
Method: A retrospective chart review was conducted in patients diagnosed with stage 1 and 2 NSCLC in Samuel S. Stratton VAMC in Albany from January 1, 1999, to January 1, 2009. Patients who were not treated were identified. Recorded data included demographic information, including age at diagnosis and gender, stage at presentation, pathology, smoking history, performance status, reason for nontreatment, vital status, cause of death, and time from diagnosis to death.
Results: There were 256 patients of early stage NSCLC diagnosed; 39 of them did not receive any therapy. All the patients were male: 95% of them were smokers; 35.9% of patients had ECOG performance status 3 or 4. The reasons that they did not get any treatment included poor functional status, poor cardiac or lung function, other comorbidities, or simple refusal. Mean age at diagnosis was 76.9 ± 8.2 years. Mean survival length was 24.36 ± 28.07 months. Five-year survival rate was 12.8%.
Conclusions: Untreated early stage NSCLC has a much lower 5-year survival rate than that of stage-matched resected disease (32%-63%). Newer molecular target oral agents might be an option for those patients who are not candidates for standard lobectomy or definitive radiation therapy. Further studies are needed in this field.
Method: A retrospective chart review was conducted in patients diagnosed with stage 1 and 2 NSCLC in Samuel S. Stratton VAMC in Albany from January 1, 1999, to January 1, 2009. Patients who were not treated were identified. Recorded data included demographic information, including age at diagnosis and gender, stage at presentation, pathology, smoking history, performance status, reason for nontreatment, vital status, cause of death, and time from diagnosis to death.
Results: There were 256 patients of early stage NSCLC diagnosed; 39 of them did not receive any therapy. All the patients were male: 95% of them were smokers; 35.9% of patients had ECOG performance status 3 or 4. The reasons that they did not get any treatment included poor functional status, poor cardiac or lung function, other comorbidities, or simple refusal. Mean age at diagnosis was 76.9 ± 8.2 years. Mean survival length was 24.36 ± 28.07 months. Five-year survival rate was 12.8%.
Conclusions: Untreated early stage NSCLC has a much lower 5-year survival rate than that of stage-matched resected disease (32%-63%). Newer molecular target oral agents might be an option for those patients who are not candidates for standard lobectomy or definitive radiation therapy. Further studies are needed in this field.
Gender Disparity in Breast Cancer: A Veteran Population Based Comparison
Introduction: Male breast cancer (MBC) comprises < 1% of all cancers in men and continues to rise. Because of MBC rarity, there is paucity in the literature. Management of MBC is generalized from female breast cancer (FBC). The Veterans Affairs Central Cancer Registry (VACCR) provides a unique source for the study of MBC. The objective of this retrospective analysis was to compare and contrast the characteristics and outcomes of MBC with FBC in the VA population.
Methods: VACCR data from 153 VAMCs were used to analyze the database of VA patients who had breast cancer diagnosed between 1998 and 2013. Primary site codes were identified for breast cancer (50.0-50.9). Data were entered and analyzed using biostatistical software (SAS 9.3).
Results: In total, 6,443 patient records were reviewed, and 1,123 MBC patients were compared with 5,320 FBC patients. The mean age at diagnosis was 70 years for MBS and 57 years for FBC (P < .0001). In patients aged > 50 years, higher numbers of MBC diagnosis (95%) were made compared with FBC diagnosis (72%). Seventy-five percent of patients with breast cancer were white in both genders. More MBC patients (40% in men vs 24% in women) presented with higher disease stage (3 and 4) compared with FBC (21% had ductal carcinoma in situ and 53% stage 1). The dominant histology was ductal carcinoma. No difference in laterality was observed. Estrogen and progesterone receptor-positive tumors were more common in MBC compared with FBC. Forty-five percent and 36% of patients with MBC or FBC, respectively, received hormonal treatment as first course, but fewer MBC patients received chemotherapy and radiation. The mean follow up time was 754 days. As of December 2013, 355 (32%) MBC and 791 (15%) FBC patients died during the course of the study. Males had higher odds of death compared with that of females, but when adjusted for age, race, stage, and grade, survival was better among males.
Conclusions: To the authors’ knowledge, this is the largest series of MBC and FBC completed to date in the veteran population. The results suggested that males were older at presentation and had higher stage of breast cancer compared with that of FBC. The higher mortality rate in MBC may be due to higher stage and/or tumor biology.
Introduction: Male breast cancer (MBC) comprises < 1% of all cancers in men and continues to rise. Because of MBC rarity, there is paucity in the literature. Management of MBC is generalized from female breast cancer (FBC). The Veterans Affairs Central Cancer Registry (VACCR) provides a unique source for the study of MBC. The objective of this retrospective analysis was to compare and contrast the characteristics and outcomes of MBC with FBC in the VA population.
Methods: VACCR data from 153 VAMCs were used to analyze the database of VA patients who had breast cancer diagnosed between 1998 and 2013. Primary site codes were identified for breast cancer (50.0-50.9). Data were entered and analyzed using biostatistical software (SAS 9.3).
Results: In total, 6,443 patient records were reviewed, and 1,123 MBC patients were compared with 5,320 FBC patients. The mean age at diagnosis was 70 years for MBS and 57 years for FBC (P < .0001). In patients aged > 50 years, higher numbers of MBC diagnosis (95%) were made compared with FBC diagnosis (72%). Seventy-five percent of patients with breast cancer were white in both genders. More MBC patients (40% in men vs 24% in women) presented with higher disease stage (3 and 4) compared with FBC (21% had ductal carcinoma in situ and 53% stage 1). The dominant histology was ductal carcinoma. No difference in laterality was observed. Estrogen and progesterone receptor-positive tumors were more common in MBC compared with FBC. Forty-five percent and 36% of patients with MBC or FBC, respectively, received hormonal treatment as first course, but fewer MBC patients received chemotherapy and radiation. The mean follow up time was 754 days. As of December 2013, 355 (32%) MBC and 791 (15%) FBC patients died during the course of the study. Males had higher odds of death compared with that of females, but when adjusted for age, race, stage, and grade, survival was better among males.
Conclusions: To the authors’ knowledge, this is the largest series of MBC and FBC completed to date in the veteran population. The results suggested that males were older at presentation and had higher stage of breast cancer compared with that of FBC. The higher mortality rate in MBC may be due to higher stage and/or tumor biology.
Introduction: Male breast cancer (MBC) comprises < 1% of all cancers in men and continues to rise. Because of MBC rarity, there is paucity in the literature. Management of MBC is generalized from female breast cancer (FBC). The Veterans Affairs Central Cancer Registry (VACCR) provides a unique source for the study of MBC. The objective of this retrospective analysis was to compare and contrast the characteristics and outcomes of MBC with FBC in the VA population.
Methods: VACCR data from 153 VAMCs were used to analyze the database of VA patients who had breast cancer diagnosed between 1998 and 2013. Primary site codes were identified for breast cancer (50.0-50.9). Data were entered and analyzed using biostatistical software (SAS 9.3).
Results: In total, 6,443 patient records were reviewed, and 1,123 MBC patients were compared with 5,320 FBC patients. The mean age at diagnosis was 70 years for MBS and 57 years for FBC (P < .0001). In patients aged > 50 years, higher numbers of MBC diagnosis (95%) were made compared with FBC diagnosis (72%). Seventy-five percent of patients with breast cancer were white in both genders. More MBC patients (40% in men vs 24% in women) presented with higher disease stage (3 and 4) compared with FBC (21% had ductal carcinoma in situ and 53% stage 1). The dominant histology was ductal carcinoma. No difference in laterality was observed. Estrogen and progesterone receptor-positive tumors were more common in MBC compared with FBC. Forty-five percent and 36% of patients with MBC or FBC, respectively, received hormonal treatment as first course, but fewer MBC patients received chemotherapy and radiation. The mean follow up time was 754 days. As of December 2013, 355 (32%) MBC and 791 (15%) FBC patients died during the course of the study. Males had higher odds of death compared with that of females, but when adjusted for age, race, stage, and grade, survival was better among males.
Conclusions: To the authors’ knowledge, this is the largest series of MBC and FBC completed to date in the veteran population. The results suggested that males were older at presentation and had higher stage of breast cancer compared with that of FBC. The higher mortality rate in MBC may be due to higher stage and/or tumor biology.
A Familial Cluster of Myelodysplasia and Myelofibrosis
Purpose: Familial clusters of either myelodysplasia (MDS) or myelofibrosis (MF) are well documented although uncommon. The inheritance of a somatic driver mutation presumably accounts for these kindreds, and DNA sequencing has revealed multiple candidate mutations (JAK2, ASXL1, TET2, EZH2, SRSF2) that are shared across the spectrum of these disorders. Given this overlap of nonrandom mutations in MDS and MF, it is surprising that clusters of both MDS and MF within the same family seem to be very rare. Recently, however, we observed a woman with MDS who reported a deceased sibling with MDS and a deceased paternal uncle with MF.
Methods: A careful family history and a review of the medical records, archived pathology, and clinical course were performed and compared with that of the index case.
Results: The index case is a woman aged 49 years presenting with severe anemia in July 2013. A bone marrow (BM) biopsy was mildly hypocellular with reduced erythroid maturation, dyspoietic hypolobated megakaryocytes and no increase in blasts. Cytogenetics revealed an isolated del(5)(q13q31) (in 20/20 cells) with del(7q) in 3/20 cells. Lenalidomide therapy resulted in initial transfusion independence. The deceased brother presented April 1994 with weakness at age 39. A CBC showed pancytopenia with a few blasts and nucleated rbc. A BM biopsy revealed predominantly extreme erythroid megaloblastosis with marked nuclear atypia, hypolobated megakaryocytes without fibrosis, mildly dyspoietic myeloid maturation, and 5% nonerythroid CD34+ blasts. Complex cytogenetic changes included monosomy 7 and der(5), likely a functional 5q deletion or duplication. Despite transfusion support, the patient died of infection and CNS hemorrhage after several months. The paternal uncle presented in June 1996 at age 60 with anemia. The CBC showed leukoerythro-blastosis with prominent dacrocytes, mild thrombo-cytopenia but no dyspoiesis. A BM biopsy revealed marked fibrosis, prominent osteosclerosis, and large hyperlobated hyperchromatic megakaryo-cytes. Overall the history, blood, and biopsy findings were consistent with primary MF but not MDS with fibrosis. Death occurred after 3 years of transfusion support.
Conclusions: Despite the extreme rarity of reported MDS and MF cases within a single family, the kindred reported here suggests the existence of an inherited gene defect that increases the risk of developing either MDS or MF. Presumably, the onset of clinically evident disease and its eventual phenotype is determined by the accumulation of additional different secondary genetic changes. The lack of disease in 6 other siblings and the deceased father aged 75 years, however, argues that any hypothetical driver mutation has incomplete penetrance, ie, a reduced likelihood of either disorder developing within a lifetime. Moreover, since this report cannot rule out either chance alone or a common environmental etiology despite substantial age and household differences, DNA sequencing studies will be necessary to identify a putative inherited gene mutation driving the development of both MDS or MF in this unusual kindred.
Purpose: Familial clusters of either myelodysplasia (MDS) or myelofibrosis (MF) are well documented although uncommon. The inheritance of a somatic driver mutation presumably accounts for these kindreds, and DNA sequencing has revealed multiple candidate mutations (JAK2, ASXL1, TET2, EZH2, SRSF2) that are shared across the spectrum of these disorders. Given this overlap of nonrandom mutations in MDS and MF, it is surprising that clusters of both MDS and MF within the same family seem to be very rare. Recently, however, we observed a woman with MDS who reported a deceased sibling with MDS and a deceased paternal uncle with MF.
Methods: A careful family history and a review of the medical records, archived pathology, and clinical course were performed and compared with that of the index case.
Results: The index case is a woman aged 49 years presenting with severe anemia in July 2013. A bone marrow (BM) biopsy was mildly hypocellular with reduced erythroid maturation, dyspoietic hypolobated megakaryocytes and no increase in blasts. Cytogenetics revealed an isolated del(5)(q13q31) (in 20/20 cells) with del(7q) in 3/20 cells. Lenalidomide therapy resulted in initial transfusion independence. The deceased brother presented April 1994 with weakness at age 39. A CBC showed pancytopenia with a few blasts and nucleated rbc. A BM biopsy revealed predominantly extreme erythroid megaloblastosis with marked nuclear atypia, hypolobated megakaryocytes without fibrosis, mildly dyspoietic myeloid maturation, and 5% nonerythroid CD34+ blasts. Complex cytogenetic changes included monosomy 7 and der(5), likely a functional 5q deletion or duplication. Despite transfusion support, the patient died of infection and CNS hemorrhage after several months. The paternal uncle presented in June 1996 at age 60 with anemia. The CBC showed leukoerythro-blastosis with prominent dacrocytes, mild thrombo-cytopenia but no dyspoiesis. A BM biopsy revealed marked fibrosis, prominent osteosclerosis, and large hyperlobated hyperchromatic megakaryo-cytes. Overall the history, blood, and biopsy findings were consistent with primary MF but not MDS with fibrosis. Death occurred after 3 years of transfusion support.
Conclusions: Despite the extreme rarity of reported MDS and MF cases within a single family, the kindred reported here suggests the existence of an inherited gene defect that increases the risk of developing either MDS or MF. Presumably, the onset of clinically evident disease and its eventual phenotype is determined by the accumulation of additional different secondary genetic changes. The lack of disease in 6 other siblings and the deceased father aged 75 years, however, argues that any hypothetical driver mutation has incomplete penetrance, ie, a reduced likelihood of either disorder developing within a lifetime. Moreover, since this report cannot rule out either chance alone or a common environmental etiology despite substantial age and household differences, DNA sequencing studies will be necessary to identify a putative inherited gene mutation driving the development of both MDS or MF in this unusual kindred.
Purpose: Familial clusters of either myelodysplasia (MDS) or myelofibrosis (MF) are well documented although uncommon. The inheritance of a somatic driver mutation presumably accounts for these kindreds, and DNA sequencing has revealed multiple candidate mutations (JAK2, ASXL1, TET2, EZH2, SRSF2) that are shared across the spectrum of these disorders. Given this overlap of nonrandom mutations in MDS and MF, it is surprising that clusters of both MDS and MF within the same family seem to be very rare. Recently, however, we observed a woman with MDS who reported a deceased sibling with MDS and a deceased paternal uncle with MF.
Methods: A careful family history and a review of the medical records, archived pathology, and clinical course were performed and compared with that of the index case.
Results: The index case is a woman aged 49 years presenting with severe anemia in July 2013. A bone marrow (BM) biopsy was mildly hypocellular with reduced erythroid maturation, dyspoietic hypolobated megakaryocytes and no increase in blasts. Cytogenetics revealed an isolated del(5)(q13q31) (in 20/20 cells) with del(7q) in 3/20 cells. Lenalidomide therapy resulted in initial transfusion independence. The deceased brother presented April 1994 with weakness at age 39. A CBC showed pancytopenia with a few blasts and nucleated rbc. A BM biopsy revealed predominantly extreme erythroid megaloblastosis with marked nuclear atypia, hypolobated megakaryocytes without fibrosis, mildly dyspoietic myeloid maturation, and 5% nonerythroid CD34+ blasts. Complex cytogenetic changes included monosomy 7 and der(5), likely a functional 5q deletion or duplication. Despite transfusion support, the patient died of infection and CNS hemorrhage after several months. The paternal uncle presented in June 1996 at age 60 with anemia. The CBC showed leukoerythro-blastosis with prominent dacrocytes, mild thrombo-cytopenia but no dyspoiesis. A BM biopsy revealed marked fibrosis, prominent osteosclerosis, and large hyperlobated hyperchromatic megakaryo-cytes. Overall the history, blood, and biopsy findings were consistent with primary MF but not MDS with fibrosis. Death occurred after 3 years of transfusion support.
Conclusions: Despite the extreme rarity of reported MDS and MF cases within a single family, the kindred reported here suggests the existence of an inherited gene defect that increases the risk of developing either MDS or MF. Presumably, the onset of clinically evident disease and its eventual phenotype is determined by the accumulation of additional different secondary genetic changes. The lack of disease in 6 other siblings and the deceased father aged 75 years, however, argues that any hypothetical driver mutation has incomplete penetrance, ie, a reduced likelihood of either disorder developing within a lifetime. Moreover, since this report cannot rule out either chance alone or a common environmental etiology despite substantial age and household differences, DNA sequencing studies will be necessary to identify a putative inherited gene mutation driving the development of both MDS or MF in this unusual kindred.
Myelodysplastic Syndrome Patients at a VAMC: Comorbidity and Survival
Purpose: To determine whether comorbidity indexes predict survival in myelodysplastic syndrome (MDS) patients.
Methods: In an IRB approved protocol, we reviewed the records of patients (pts) diagnosed with MDS at the VA New Jersey Health Care System in East Orange, New Jersey, from June 1998 to December 2009. Records were reviewed for demographic, clinical, and pathological data; Eastern Cooperative Oncology Group performance status; erythropoietin use and response; transfusion dependency; International Prognostic Scoring System (IPSS); total number of treatments; and survival. A Cox survival regression analysis was performed. Comorbidity was assessed with 3 comorbidity indexes: the Charlson Comorbidity Index (CMI), the Kaplan-Feinstein Index (KFI), and the Cumulative Illness Rating Scale (CIRS).
Results: There were 81 analyzable points with a median age of 74.5 (patients were aged 47-94). The median hemoglobin was 9.5 g/dL (4.3 to 16.9); median white blood cell count was 5.05 K/cmm (1.2-100); median platelets, 158.5 K/cmm (10-1346); median albumin, 3.9 g/dL (0-5); median ferritin, 378 ng/mL (0-7750); and median LDH, 188 IU/L (0-2426). The median CMI was 2 (0-8); median KFI 2 (0-3); median CIRS 15 4 (0-10); median CIRS 16 7 (0-19); median CIRS 17 1.7 (0-3); and median survival, 925 days (14 to 3871 days). Of the 63 patients, 77.8% received treatment, 34 (42.5%) received an erythroid stimulating agent, 9 (11.25%) lenalidomide, and 8 (10.1%) azacytidine. There were 28 patients (34.2%) who were transfusion dependent with the meidan number of transfusions of 4 (0-100). In the univariate survival analysis, hemoglobin, white blood cells, platelets, ferritin, LDH, albumin, and transfusion dependency were significant predictors of survival. Of the comorbidity indexes, only Charlson CMI and CIRS 19 were significant; age, race, KFI, CIRS 15, 16, 17, and 18 were not significant. In the multivariate analysis, hemoglobin (P < .0040), LDH (P < .0016), transfusion dependency (P < .0028), and CIRS 19 (P < .0303) were independent predictors of survival.
Conclusions: Severe comorbidity, as reflected in the CIRS19, may be an independent predictor of survival. Further analysis of a larger sample will be needed.
Purpose: To determine whether comorbidity indexes predict survival in myelodysplastic syndrome (MDS) patients.
Methods: In an IRB approved protocol, we reviewed the records of patients (pts) diagnosed with MDS at the VA New Jersey Health Care System in East Orange, New Jersey, from June 1998 to December 2009. Records were reviewed for demographic, clinical, and pathological data; Eastern Cooperative Oncology Group performance status; erythropoietin use and response; transfusion dependency; International Prognostic Scoring System (IPSS); total number of treatments; and survival. A Cox survival regression analysis was performed. Comorbidity was assessed with 3 comorbidity indexes: the Charlson Comorbidity Index (CMI), the Kaplan-Feinstein Index (KFI), and the Cumulative Illness Rating Scale (CIRS).
Results: There were 81 analyzable points with a median age of 74.5 (patients were aged 47-94). The median hemoglobin was 9.5 g/dL (4.3 to 16.9); median white blood cell count was 5.05 K/cmm (1.2-100); median platelets, 158.5 K/cmm (10-1346); median albumin, 3.9 g/dL (0-5); median ferritin, 378 ng/mL (0-7750); and median LDH, 188 IU/L (0-2426). The median CMI was 2 (0-8); median KFI 2 (0-3); median CIRS 15 4 (0-10); median CIRS 16 7 (0-19); median CIRS 17 1.7 (0-3); and median survival, 925 days (14 to 3871 days). Of the 63 patients, 77.8% received treatment, 34 (42.5%) received an erythroid stimulating agent, 9 (11.25%) lenalidomide, and 8 (10.1%) azacytidine. There were 28 patients (34.2%) who were transfusion dependent with the meidan number of transfusions of 4 (0-100). In the univariate survival analysis, hemoglobin, white blood cells, platelets, ferritin, LDH, albumin, and transfusion dependency were significant predictors of survival. Of the comorbidity indexes, only Charlson CMI and CIRS 19 were significant; age, race, KFI, CIRS 15, 16, 17, and 18 were not significant. In the multivariate analysis, hemoglobin (P < .0040), LDH (P < .0016), transfusion dependency (P < .0028), and CIRS 19 (P < .0303) were independent predictors of survival.
Conclusions: Severe comorbidity, as reflected in the CIRS19, may be an independent predictor of survival. Further analysis of a larger sample will be needed.
Purpose: To determine whether comorbidity indexes predict survival in myelodysplastic syndrome (MDS) patients.
Methods: In an IRB approved protocol, we reviewed the records of patients (pts) diagnosed with MDS at the VA New Jersey Health Care System in East Orange, New Jersey, from June 1998 to December 2009. Records were reviewed for demographic, clinical, and pathological data; Eastern Cooperative Oncology Group performance status; erythropoietin use and response; transfusion dependency; International Prognostic Scoring System (IPSS); total number of treatments; and survival. A Cox survival regression analysis was performed. Comorbidity was assessed with 3 comorbidity indexes: the Charlson Comorbidity Index (CMI), the Kaplan-Feinstein Index (KFI), and the Cumulative Illness Rating Scale (CIRS).
Results: There were 81 analyzable points with a median age of 74.5 (patients were aged 47-94). The median hemoglobin was 9.5 g/dL (4.3 to 16.9); median white blood cell count was 5.05 K/cmm (1.2-100); median platelets, 158.5 K/cmm (10-1346); median albumin, 3.9 g/dL (0-5); median ferritin, 378 ng/mL (0-7750); and median LDH, 188 IU/L (0-2426). The median CMI was 2 (0-8); median KFI 2 (0-3); median CIRS 15 4 (0-10); median CIRS 16 7 (0-19); median CIRS 17 1.7 (0-3); and median survival, 925 days (14 to 3871 days). Of the 63 patients, 77.8% received treatment, 34 (42.5%) received an erythroid stimulating agent, 9 (11.25%) lenalidomide, and 8 (10.1%) azacytidine. There were 28 patients (34.2%) who were transfusion dependent with the meidan number of transfusions of 4 (0-100). In the univariate survival analysis, hemoglobin, white blood cells, platelets, ferritin, LDH, albumin, and transfusion dependency were significant predictors of survival. Of the comorbidity indexes, only Charlson CMI and CIRS 19 were significant; age, race, KFI, CIRS 15, 16, 17, and 18 were not significant. In the multivariate analysis, hemoglobin (P < .0040), LDH (P < .0016), transfusion dependency (P < .0028), and CIRS 19 (P < .0303) were independent predictors of survival.
Conclusions: Severe comorbidity, as reflected in the CIRS19, may be an independent predictor of survival. Further analysis of a larger sample will be needed.
Cisplatin Is Associated With Prolonged Progression-Free Survival Compared With Cetuximab Among Veteran Patients With Stage 3 And 4 Head and Neck Cancer
Purpose: Concurrent cisplatin and radiation is currently the preferred therapy for stage 3 and 4 head and neck cancer. However, patient tolerability is poor. Concurrent cetuximab and radiation, on the other hand, is well tolerated. However, head-to-head comparative studies with cisplatin are lacking. The purpose of this study was to compare the efficacy, tolerability, and total health care costs of cisplatin- and cetuximab-based regimens among veteran patients with head and neck cancer.
Methods and Materials: We conducted a retrospective study of patients with stage 3 and 4 head and neck cancer at the VA Pittsburgh Healthcare System from 2009-2013. Patients were included if they had biopsy-proven disease treated with cisplatin or cetuximab (both with concurrent radiation). Patients receiving adjuvant chemoradiation, those with non-squamous cell carcinoma, or carcinoma of the nasopharynx were excluded. Baseline characteristics were compared by chi-square or Fisher’s exact tests for categorical variables and by Mann-Whitney for continuous variables. The primary outcome was average chemotherapy dose intensity. Secondary outcomes included progression-free survival (PFS) and overall survival (OS) , which were compared by Kaplan-Meier and the log-rank test. Results: Fifty-two patients were included; 30 received cisplatin and 22 cetuximab. Patients who received cetuximab were older (median age, 66 vs 63; P = .04) and more likely to have diabetes (36% vs 7%; P = .01) and a CrCl 2 (9 vs 7; P = .33) were comparable between both groups. Patients were followed for a median of 29 months (range 0.4-64). Average chemotherapy dose intensity was lower for cisplatin (88% vs 96%; P = .03). Progression-free survival was longer among cisplatin patients (median 21 months, range 0-57) compared with that of cetuximab (median 17 months, range 1-52; P = 0.03) and did not vary among patients who did or did not receive 100% chemotherapy dose-intensity cisplatin (median 18 vs 27 months; P = .16). There was no difference in OS (31 vs 18 months, P = .19). Neutropenia (47% vs 0%; P ≤ .0001), dehydration (33% vs 0%; P = .003), nausea/vomiting (30% vs 0%; P = .07), and hypotension (23% vs 0%; P = .02) were higher among cisplatin patients. Rash was more common with cetuximab (64% vs 7%; P ≤ .0001). The average health care costs were $3,495 and $27,148 for cisplatin and cetuximab, respectively.
Conclusions: Among veterans with stage 3 or 4 head and neck cancer, treatment with cisplatin-based chemotherapy is associated with PFS compared with cetuximab-based regimens despite cisplatin patients receiving only 88% of chemotherapy. Patients who received cetuximab experienced fewer adverse effects. However, total health care costs were significantly higher. Our data suggest that cisplatin should remain the front-line therapy for stage 3 and 4 head and neck cancer. Cetuximab is best reserved for patients who are intolerant of or have a contraindication to cisplatin.
Purpose: Concurrent cisplatin and radiation is currently the preferred therapy for stage 3 and 4 head and neck cancer. However, patient tolerability is poor. Concurrent cetuximab and radiation, on the other hand, is well tolerated. However, head-to-head comparative studies with cisplatin are lacking. The purpose of this study was to compare the efficacy, tolerability, and total health care costs of cisplatin- and cetuximab-based regimens among veteran patients with head and neck cancer.
Methods and Materials: We conducted a retrospective study of patients with stage 3 and 4 head and neck cancer at the VA Pittsburgh Healthcare System from 2009-2013. Patients were included if they had biopsy-proven disease treated with cisplatin or cetuximab (both with concurrent radiation). Patients receiving adjuvant chemoradiation, those with non-squamous cell carcinoma, or carcinoma of the nasopharynx were excluded. Baseline characteristics were compared by chi-square or Fisher’s exact tests for categorical variables and by Mann-Whitney for continuous variables. The primary outcome was average chemotherapy dose intensity. Secondary outcomes included progression-free survival (PFS) and overall survival (OS) , which were compared by Kaplan-Meier and the log-rank test. Results: Fifty-two patients were included; 30 received cisplatin and 22 cetuximab. Patients who received cetuximab were older (median age, 66 vs 63; P = .04) and more likely to have diabetes (36% vs 7%; P = .01) and a CrCl 2 (9 vs 7; P = .33) were comparable between both groups. Patients were followed for a median of 29 months (range 0.4-64). Average chemotherapy dose intensity was lower for cisplatin (88% vs 96%; P = .03). Progression-free survival was longer among cisplatin patients (median 21 months, range 0-57) compared with that of cetuximab (median 17 months, range 1-52; P = 0.03) and did not vary among patients who did or did not receive 100% chemotherapy dose-intensity cisplatin (median 18 vs 27 months; P = .16). There was no difference in OS (31 vs 18 months, P = .19). Neutropenia (47% vs 0%; P ≤ .0001), dehydration (33% vs 0%; P = .003), nausea/vomiting (30% vs 0%; P = .07), and hypotension (23% vs 0%; P = .02) were higher among cisplatin patients. Rash was more common with cetuximab (64% vs 7%; P ≤ .0001). The average health care costs were $3,495 and $27,148 for cisplatin and cetuximab, respectively.
Conclusions: Among veterans with stage 3 or 4 head and neck cancer, treatment with cisplatin-based chemotherapy is associated with PFS compared with cetuximab-based regimens despite cisplatin patients receiving only 88% of chemotherapy. Patients who received cetuximab experienced fewer adverse effects. However, total health care costs were significantly higher. Our data suggest that cisplatin should remain the front-line therapy for stage 3 and 4 head and neck cancer. Cetuximab is best reserved for patients who are intolerant of or have a contraindication to cisplatin.
Purpose: Concurrent cisplatin and radiation is currently the preferred therapy for stage 3 and 4 head and neck cancer. However, patient tolerability is poor. Concurrent cetuximab and radiation, on the other hand, is well tolerated. However, head-to-head comparative studies with cisplatin are lacking. The purpose of this study was to compare the efficacy, tolerability, and total health care costs of cisplatin- and cetuximab-based regimens among veteran patients with head and neck cancer.
Methods and Materials: We conducted a retrospective study of patients with stage 3 and 4 head and neck cancer at the VA Pittsburgh Healthcare System from 2009-2013. Patients were included if they had biopsy-proven disease treated with cisplatin or cetuximab (both with concurrent radiation). Patients receiving adjuvant chemoradiation, those with non-squamous cell carcinoma, or carcinoma of the nasopharynx were excluded. Baseline characteristics were compared by chi-square or Fisher’s exact tests for categorical variables and by Mann-Whitney for continuous variables. The primary outcome was average chemotherapy dose intensity. Secondary outcomes included progression-free survival (PFS) and overall survival (OS) , which were compared by Kaplan-Meier and the log-rank test. Results: Fifty-two patients were included; 30 received cisplatin and 22 cetuximab. Patients who received cetuximab were older (median age, 66 vs 63; P = .04) and more likely to have diabetes (36% vs 7%; P = .01) and a CrCl 2 (9 vs 7; P = .33) were comparable between both groups. Patients were followed for a median of 29 months (range 0.4-64). Average chemotherapy dose intensity was lower for cisplatin (88% vs 96%; P = .03). Progression-free survival was longer among cisplatin patients (median 21 months, range 0-57) compared with that of cetuximab (median 17 months, range 1-52; P = 0.03) and did not vary among patients who did or did not receive 100% chemotherapy dose-intensity cisplatin (median 18 vs 27 months; P = .16). There was no difference in OS (31 vs 18 months, P = .19). Neutropenia (47% vs 0%; P ≤ .0001), dehydration (33% vs 0%; P = .003), nausea/vomiting (30% vs 0%; P = .07), and hypotension (23% vs 0%; P = .02) were higher among cisplatin patients. Rash was more common with cetuximab (64% vs 7%; P ≤ .0001). The average health care costs were $3,495 and $27,148 for cisplatin and cetuximab, respectively.
Conclusions: Among veterans with stage 3 or 4 head and neck cancer, treatment with cisplatin-based chemotherapy is associated with PFS compared with cetuximab-based regimens despite cisplatin patients receiving only 88% of chemotherapy. Patients who received cetuximab experienced fewer adverse effects. However, total health care costs were significantly higher. Our data suggest that cisplatin should remain the front-line therapy for stage 3 and 4 head and neck cancer. Cetuximab is best reserved for patients who are intolerant of or have a contraindication to cisplatin.
Palliative Care and Oncology Advanced Lung Cancer Collaborative
Purpose: The purpose of this collaborative between the oncology service, palliative care service, and social work is to improve the quality of life (QOL) for patients with advanced lung cancer by improving the timeliness of palliative care involvement and minimizing visits to urgent care or the emergency department during the course of treatment. Early palliative care involvement in the care of patients with advanced cancer has been shown to allow for a longer opportunity to improve QOL and symptom control for these patients, as well as assist in identifying patients’ goals for their care.
Methods: The current practices of palliative care consultation for these patients were identified. It was found that palliative care was consulted for patients who are not candidates for palliative chemotherapy after their initial visit with oncology. This is followed by a hospice referral. On the other hand, patients who were found to be candidates for palliative chemotherapy are typically followed by oncology until their treatment has discontinued due to disease progression, severe toxicities, or poor performance status. The patients are then referred to palliative care and subsequently, hospice care. It was proposed that this practice be changed to a referral to palliative care after the patients with advanced lung cancer are seen for their initial visit in oncology, whether or not they are found qualified for palliative chemotherapy. The palliative care consult will take place within 3 weeks after the referral is received. For patients who are qualified to receive palliative chemotherapy, palliative care will follow the patient simultaneously along with oncology during the course of treatment as indicated by the patient or family’s need. This will continue until the patient is no longer a candidate for palliative chemotherapy and a referral for hospice care is made.
Results: Baseline data were obtained and compared to outcomes after the implementation of the collaborative that showed time from diagnosis to palliative care referral (from 80 to 30 days), time from initial out-patient oncology visit to initial palliative care appointment (from 78 to 15 days), time from palliative care consultation to hospice (from 13 to 98 days), time from hospice referral to death (from 40 to 23 days), and time from palliative care consultation to death (from 54 to 123 days). Patients who were not followed by palliative care had an average urgent care visit of 1.8 from the time of diagnosis to referral to hospice, whereas those who were followed by palliative care had an average of 0.9. Among the factors that were identified to contribute to the timeliness of palliative care involvement in the care of these patients were the lack of a formal process for referral, the absence of a dedicated oncology social worker, and patient misconception that palliative care is equivalent to hospice care. Only about 30 % of patients who were not followed by social work were referred to palliative care, whereas about 70 % of patients who were followed by social work received palliative care referrals.
Conclusions: The collaborative resulted in improved timeliness of palliative care involvement for patients with advanced lung cancer, as well as less urgent care visits. The patients were able to avail from the benefits of palliative care longer, before they are enrolled in hospice care. The time from hospice referral to death seems to be shorter. This may be due to different factors, including the fact that patients are able to benefit from palliative care longer before they enroll in hospice, resulting in an increase in the duration of palliative care involvement and a decrease in the duration of hospice involvement.
Purpose: The purpose of this collaborative between the oncology service, palliative care service, and social work is to improve the quality of life (QOL) for patients with advanced lung cancer by improving the timeliness of palliative care involvement and minimizing visits to urgent care or the emergency department during the course of treatment. Early palliative care involvement in the care of patients with advanced cancer has been shown to allow for a longer opportunity to improve QOL and symptom control for these patients, as well as assist in identifying patients’ goals for their care.
Methods: The current practices of palliative care consultation for these patients were identified. It was found that palliative care was consulted for patients who are not candidates for palliative chemotherapy after their initial visit with oncology. This is followed by a hospice referral. On the other hand, patients who were found to be candidates for palliative chemotherapy are typically followed by oncology until their treatment has discontinued due to disease progression, severe toxicities, or poor performance status. The patients are then referred to palliative care and subsequently, hospice care. It was proposed that this practice be changed to a referral to palliative care after the patients with advanced lung cancer are seen for their initial visit in oncology, whether or not they are found qualified for palliative chemotherapy. The palliative care consult will take place within 3 weeks after the referral is received. For patients who are qualified to receive palliative chemotherapy, palliative care will follow the patient simultaneously along with oncology during the course of treatment as indicated by the patient or family’s need. This will continue until the patient is no longer a candidate for palliative chemotherapy and a referral for hospice care is made.
Results: Baseline data were obtained and compared to outcomes after the implementation of the collaborative that showed time from diagnosis to palliative care referral (from 80 to 30 days), time from initial out-patient oncology visit to initial palliative care appointment (from 78 to 15 days), time from palliative care consultation to hospice (from 13 to 98 days), time from hospice referral to death (from 40 to 23 days), and time from palliative care consultation to death (from 54 to 123 days). Patients who were not followed by palliative care had an average urgent care visit of 1.8 from the time of diagnosis to referral to hospice, whereas those who were followed by palliative care had an average of 0.9. Among the factors that were identified to contribute to the timeliness of palliative care involvement in the care of these patients were the lack of a formal process for referral, the absence of a dedicated oncology social worker, and patient misconception that palliative care is equivalent to hospice care. Only about 30 % of patients who were not followed by social work were referred to palliative care, whereas about 70 % of patients who were followed by social work received palliative care referrals.
Conclusions: The collaborative resulted in improved timeliness of palliative care involvement for patients with advanced lung cancer, as well as less urgent care visits. The patients were able to avail from the benefits of palliative care longer, before they are enrolled in hospice care. The time from hospice referral to death seems to be shorter. This may be due to different factors, including the fact that patients are able to benefit from palliative care longer before they enroll in hospice, resulting in an increase in the duration of palliative care involvement and a decrease in the duration of hospice involvement.
Purpose: The purpose of this collaborative between the oncology service, palliative care service, and social work is to improve the quality of life (QOL) for patients with advanced lung cancer by improving the timeliness of palliative care involvement and minimizing visits to urgent care or the emergency department during the course of treatment. Early palliative care involvement in the care of patients with advanced cancer has been shown to allow for a longer opportunity to improve QOL and symptom control for these patients, as well as assist in identifying patients’ goals for their care.
Methods: The current practices of palliative care consultation for these patients were identified. It was found that palliative care was consulted for patients who are not candidates for palliative chemotherapy after their initial visit with oncology. This is followed by a hospice referral. On the other hand, patients who were found to be candidates for palliative chemotherapy are typically followed by oncology until their treatment has discontinued due to disease progression, severe toxicities, or poor performance status. The patients are then referred to palliative care and subsequently, hospice care. It was proposed that this practice be changed to a referral to palliative care after the patients with advanced lung cancer are seen for their initial visit in oncology, whether or not they are found qualified for palliative chemotherapy. The palliative care consult will take place within 3 weeks after the referral is received. For patients who are qualified to receive palliative chemotherapy, palliative care will follow the patient simultaneously along with oncology during the course of treatment as indicated by the patient or family’s need. This will continue until the patient is no longer a candidate for palliative chemotherapy and a referral for hospice care is made.
Results: Baseline data were obtained and compared to outcomes after the implementation of the collaborative that showed time from diagnosis to palliative care referral (from 80 to 30 days), time from initial out-patient oncology visit to initial palliative care appointment (from 78 to 15 days), time from palliative care consultation to hospice (from 13 to 98 days), time from hospice referral to death (from 40 to 23 days), and time from palliative care consultation to death (from 54 to 123 days). Patients who were not followed by palliative care had an average urgent care visit of 1.8 from the time of diagnosis to referral to hospice, whereas those who were followed by palliative care had an average of 0.9. Among the factors that were identified to contribute to the timeliness of palliative care involvement in the care of these patients were the lack of a formal process for referral, the absence of a dedicated oncology social worker, and patient misconception that palliative care is equivalent to hospice care. Only about 30 % of patients who were not followed by social work were referred to palliative care, whereas about 70 % of patients who were followed by social work received palliative care referrals.
Conclusions: The collaborative resulted in improved timeliness of palliative care involvement for patients with advanced lung cancer, as well as less urgent care visits. The patients were able to avail from the benefits of palliative care longer, before they are enrolled in hospice care. The time from hospice referral to death seems to be shorter. This may be due to different factors, including the fact that patients are able to benefit from palliative care longer before they enroll in hospice, resulting in an increase in the duration of palliative care involvement and a decrease in the duration of hospice involvement.
Creation of a Quality Improvement Tool to Track Timeliness and Quality of Breast Cancer Care
Purpose: Development of a quality improvement (QI) tracking tool that allows staff to monitor care on an ongoing basis and make changes and modify system processes to improve outcomes for breast cancer care. The National Quality Forum (NQF) of the Commission on Cancer and National Consortium of Breast Centers Program (NQMBC) have collaborated and defined breast cancer quality measures. Timeliness and quality of breast cancer care will have a direct impact on quality of life and survivorship. The West Palm Beach VAMC did not have a process in place for data collection and ongoing performance improvement for breast cancer care.
Methods: The major aims of the project are to (1)Identify collaborative team members; (2) identify standardized benchmarks that track timeliness and quality of care; and (3) create a tracking tool to enter data that automatically measures timeliness and quality of care. A collaborative group of staff from the cancer registry, women’s health department, radiology, oncology, pathology, and applied systems engineers met biweekly/monthly over 9 months to add, define, and continuously retest data entry sets within the tool. Several timeliness measures have been identified by the NQMBC. The final measures for our facility were chosen by a multidisciplinary breast cancer committee and approved by the cancer committee. Timeliness measures included (1) time between diagnostic mammogram and open surgical biopsy/excision; (2) time between diagnostic mammogram and needle/core biopsy; (3) time between needle biopsy and initial breast cancer surgery; (4) time between initial breast biopsy (core/needle or incisional/excisional) and pathology results; (5) time between open (incisional/excisional) and pathology results; and (6) time between initial breast cancer surgery and pathology results. Quality measures from the NQF include (1) radiation therapy administration within 1 year of diagnosis; (2) combination chemotherapy considered or administered within 4 months (120 days) of diagnosis; and (3) tamoxifen or third-generation aromatase inhibitor (AI) considered or administered within 4 months (120 days) of diagnosis.
Results: Outcomes for baseline data for n = 30 patients demonstrated (1) time between diagnostic mammogram and open surgical biopsy/excision—52 days; (2) time between diagnostic mammogram and needle/core biopsy—50 days; (3) time between needle biopsy and initial breast cancer surgery—32 days; (4) time between initial breast biopsy (core/needle or incisional/excisional); and (5) pathology results—8 days. Quality measures from the NQF include (1) radiation therapy administration within 1 year of diagnosis—92%; (2) combination chemotherapy considered or administered within 4 months (120 days) of diagnosis—72%; and (3) tamoxifen or third-generation AI is considered or administered within 4 months (120 days) of diagnosis—72%.
Conclusions: Verification of tool data indicated the need for additional columns and definitions to accurately report timeliness measures. Patient refusal of care was included in data, although it skewed the data. Refusal of care will be individually analyzed to make sure patients were educated regarding disease process and scope of treatment options, which indicate informed consent. Facility goals for timeliness range from 2 to 30 days. Quality measure goal is 100%. As a continual evaluation process occurs, monitoring and adjustment of processes will advance our facility closer to meeting its goal of providing comprehensive quality breast care to our women veterans.
Purpose: Development of a quality improvement (QI) tracking tool that allows staff to monitor care on an ongoing basis and make changes and modify system processes to improve outcomes for breast cancer care. The National Quality Forum (NQF) of the Commission on Cancer and National Consortium of Breast Centers Program (NQMBC) have collaborated and defined breast cancer quality measures. Timeliness and quality of breast cancer care will have a direct impact on quality of life and survivorship. The West Palm Beach VAMC did not have a process in place for data collection and ongoing performance improvement for breast cancer care.
Methods: The major aims of the project are to (1)Identify collaborative team members; (2) identify standardized benchmarks that track timeliness and quality of care; and (3) create a tracking tool to enter data that automatically measures timeliness and quality of care. A collaborative group of staff from the cancer registry, women’s health department, radiology, oncology, pathology, and applied systems engineers met biweekly/monthly over 9 months to add, define, and continuously retest data entry sets within the tool. Several timeliness measures have been identified by the NQMBC. The final measures for our facility were chosen by a multidisciplinary breast cancer committee and approved by the cancer committee. Timeliness measures included (1) time between diagnostic mammogram and open surgical biopsy/excision; (2) time between diagnostic mammogram and needle/core biopsy; (3) time between needle biopsy and initial breast cancer surgery; (4) time between initial breast biopsy (core/needle or incisional/excisional) and pathology results; (5) time between open (incisional/excisional) and pathology results; and (6) time between initial breast cancer surgery and pathology results. Quality measures from the NQF include (1) radiation therapy administration within 1 year of diagnosis; (2) combination chemotherapy considered or administered within 4 months (120 days) of diagnosis; and (3) tamoxifen or third-generation aromatase inhibitor (AI) considered or administered within 4 months (120 days) of diagnosis.
Results: Outcomes for baseline data for n = 30 patients demonstrated (1) time between diagnostic mammogram and open surgical biopsy/excision—52 days; (2) time between diagnostic mammogram and needle/core biopsy—50 days; (3) time between needle biopsy and initial breast cancer surgery—32 days; (4) time between initial breast biopsy (core/needle or incisional/excisional); and (5) pathology results—8 days. Quality measures from the NQF include (1) radiation therapy administration within 1 year of diagnosis—92%; (2) combination chemotherapy considered or administered within 4 months (120 days) of diagnosis—72%; and (3) tamoxifen or third-generation AI is considered or administered within 4 months (120 days) of diagnosis—72%.
Conclusions: Verification of tool data indicated the need for additional columns and definitions to accurately report timeliness measures. Patient refusal of care was included in data, although it skewed the data. Refusal of care will be individually analyzed to make sure patients were educated regarding disease process and scope of treatment options, which indicate informed consent. Facility goals for timeliness range from 2 to 30 days. Quality measure goal is 100%. As a continual evaluation process occurs, monitoring and adjustment of processes will advance our facility closer to meeting its goal of providing comprehensive quality breast care to our women veterans.
Purpose: Development of a quality improvement (QI) tracking tool that allows staff to monitor care on an ongoing basis and make changes and modify system processes to improve outcomes for breast cancer care. The National Quality Forum (NQF) of the Commission on Cancer and National Consortium of Breast Centers Program (NQMBC) have collaborated and defined breast cancer quality measures. Timeliness and quality of breast cancer care will have a direct impact on quality of life and survivorship. The West Palm Beach VAMC did not have a process in place for data collection and ongoing performance improvement for breast cancer care.
Methods: The major aims of the project are to (1)Identify collaborative team members; (2) identify standardized benchmarks that track timeliness and quality of care; and (3) create a tracking tool to enter data that automatically measures timeliness and quality of care. A collaborative group of staff from the cancer registry, women’s health department, radiology, oncology, pathology, and applied systems engineers met biweekly/monthly over 9 months to add, define, and continuously retest data entry sets within the tool. Several timeliness measures have been identified by the NQMBC. The final measures for our facility were chosen by a multidisciplinary breast cancer committee and approved by the cancer committee. Timeliness measures included (1) time between diagnostic mammogram and open surgical biopsy/excision; (2) time between diagnostic mammogram and needle/core biopsy; (3) time between needle biopsy and initial breast cancer surgery; (4) time between initial breast biopsy (core/needle or incisional/excisional) and pathology results; (5) time between open (incisional/excisional) and pathology results; and (6) time between initial breast cancer surgery and pathology results. Quality measures from the NQF include (1) radiation therapy administration within 1 year of diagnosis; (2) combination chemotherapy considered or administered within 4 months (120 days) of diagnosis; and (3) tamoxifen or third-generation aromatase inhibitor (AI) considered or administered within 4 months (120 days) of diagnosis.
Results: Outcomes for baseline data for n = 30 patients demonstrated (1) time between diagnostic mammogram and open surgical biopsy/excision—52 days; (2) time between diagnostic mammogram and needle/core biopsy—50 days; (3) time between needle biopsy and initial breast cancer surgery—32 days; (4) time between initial breast biopsy (core/needle or incisional/excisional); and (5) pathology results—8 days. Quality measures from the NQF include (1) radiation therapy administration within 1 year of diagnosis—92%; (2) combination chemotherapy considered or administered within 4 months (120 days) of diagnosis—72%; and (3) tamoxifen or third-generation AI is considered or administered within 4 months (120 days) of diagnosis—72%.
Conclusions: Verification of tool data indicated the need for additional columns and definitions to accurately report timeliness measures. Patient refusal of care was included in data, although it skewed the data. Refusal of care will be individually analyzed to make sure patients were educated regarding disease process and scope of treatment options, which indicate informed consent. Facility goals for timeliness range from 2 to 30 days. Quality measure goal is 100%. As a continual evaluation process occurs, monitoring and adjustment of processes will advance our facility closer to meeting its goal of providing comprehensive quality breast care to our women veterans.