Purpose: Stereotactic body radiotherapy (SBRT) is a safe and effective modality for treatment of early stage non-small cell lung cancer. We report our single institution experience in using protracted course of SBRT as a palliative treatment for lung tumors.

Methods: Patients with symptomatic lung lesions treated with palliative intent SBRT were retrospectively reviewed. These patients were not amenable to curative treatment due to previous irradiation, large-sized lesions, or advanced disease. Patients received 50-52 Gy in 10-12 fractions daily for 2 weeks.

Results: Ten patients, 5 males and 5 females, were treated over 3 years. Seven primary lesions, 2 metastatic lesions, and 1 recurrent primary lesion were treated. Patients ranged from aged 41-84 years with a mean age of 72 years. With a median follow-up of 11.5 months, the median overall survival was 18 months. Of 14 symptoms that were treated, 9 (64%) had complete resolution. Two patients (14%) had partial improvement, and 2 patients (14%) had no response. One patient (7%) had worsening symptoms following treatment. The median time to response was 27 days. Symptoms relapsed in 3 (21%) patients with median time of 3.7 months. A majority of patients (70%) remained symptom free until last follow-up. None of the patients experienced grade 3 or higher toxicity.

Conclusions: SBRT is a safe, effective, and durable treatment modality for palliating lung tumors that are not suitable for curative treatment.

Purpose: Stereotactic body radiotherapy (SBRT) is a safe and effective modality for treatment of early stage non-small cell lung cancer. We report our single institution experience in using protracted course of SBRT as a palliative treatment for lung tumors.

Methods: Patients with symptomatic lung lesions treated with palliative intent SBRT were retrospectively reviewed. These patients were not amenable to curative treatment due to previous irradiation, large-sized lesions, or advanced disease. Patients received 50-52 Gy in 10-12 fractions daily for 2 weeks.

Results: Ten patients, 5 males and 5 females, were treated over 3 years. Seven primary lesions, 2 metastatic lesions, and 1 recurrent primary lesion were treated. Patients ranged from aged 41-84 years with a mean age of 72 years. With a median follow-up of 11.5 months, the median overall survival was 18 months. Of 14 symptoms that were treated, 9 (64%) had complete resolution. Two patients (14%) had partial improvement, and 2 patients (14%) had no response. One patient (7%) had worsening symptoms following treatment. The median time to response was 27 days. Symptoms relapsed in 3 (21%) patients with median time of 3.7 months. A majority of patients (70%) remained symptom free until last follow-up. None of the patients experienced grade 3 or higher toxicity.

Conclusions: SBRT is a safe, effective, and durable treatment modality for palliating lung tumors that are not suitable for curative treatment.

Purpose: Stereotactic body radiotherapy (SBRT) is a safe and effective modality for treatment of early stage non-small cell lung cancer. We report our single institution experience in using protracted course of SBRT as a palliative treatment for lung tumors.

Methods: Patients with symptomatic lung lesions treated with palliative intent SBRT were retrospectively reviewed. These patients were not amenable to curative treatment due to previous irradiation, large-sized lesions, or advanced disease. Patients received 50-52 Gy in 10-12 fractions daily for 2 weeks.

Results: Ten patients, 5 males and 5 females, were treated over 3 years. Seven primary lesions, 2 metastatic lesions, and 1 recurrent primary lesion were treated. Patients ranged from aged 41-84 years with a mean age of 72 years. With a median follow-up of 11.5 months, the median overall survival was 18 months. Of 14 symptoms that were treated, 9 (64%) had complete resolution. Two patients (14%) had partial improvement, and 2 patients (14%) had no response. One patient (7%) had worsening symptoms following treatment. The median time to response was 27 days. Symptoms relapsed in 3 (21%) patients with median time of 3.7 months. A majority of patients (70%) remained symptom free until last follow-up. None of the patients experienced grade 3 or higher toxicity.

Conclusions: SBRT is a safe, effective, and durable treatment modality for palliating lung tumors that are not suitable for curative treatment.

Purpose: To evaluate the effects of feeding tube placement on patient weight and length of treatment breaks during definitive radiotherapy with at least 50 Gy to the bilateral necks of patients with head and neck (H&N) cancer.

Methods: Thirty-five H&N cancer patients underwent definitive radiotherapy at the Radiation Oncology Department at Michael E. DeBakey VA Medical Center from July 23, 2012 to April 25, 2013.  Twenty-three patients received doses of ≥ 50 Gy to bilateral necks, and constituted the study group. The remaining 12 patients did not receive ≥ 50 Gy and were excluded from the study. Among the 23 patients, 11 underwent feeding tube placement (group 1). Group 2 consisted of 12 patients without feeding tubes. All patients with feeding tube placement had concurrent chemotherapy. Some patients in group 2 received radiation treatment only.

Results: Twenty-two patients had weight loss, 1 patient gained 6.9 lb during the course of treatment. The median weight loss for group 1 was 17.8 lb (ranging from 4.4 to 34.4 lb), compared with 18.6 lb in patients in group 2. Those in group 2 who only received radiation therapy had the least median weight loss (5.4 lb). The average treatment break was 3.3 days for patients in group 1, 3.7 days for those in group 2 with concurrent chemo-radiotherapy (chemoRT), and 3.2 days for group 2 subjects receiving radiation therapy only.

Conclusions: In H&N cancer patients, feeding tube placement did not minimize weight loss and did not reduce average treatment breaks in those given concurrent chemoRT. An interesting additional finding of the study was that chemotherapy seems to have greater impact on a patient’s ability to tolerate radiation therapy. Our findings in this small, retrospective study, though suggestive, are insufficient to draw any definitive conclusions about the effectiveness of prophylactic feeding tube placement in the target patient population. Published studies on this subject are contradictory. Treatment decisions should be based on physician expertise and individualized to clinical needs of patients.

Purpose: To evaluate the effects of feeding tube placement on patient weight and length of treatment breaks during definitive radiotherapy with at least 50 Gy to the bilateral necks of patients with head and neck (H&N) cancer.

Methods: Thirty-five H&N cancer patients underwent definitive radiotherapy at the Radiation Oncology Department at Michael E. DeBakey VA Medical Center from July 23, 2012 to April 25, 2013.  Twenty-three patients received doses of ≥ 50 Gy to bilateral necks, and constituted the study group. The remaining 12 patients did not receive ≥ 50 Gy and were excluded from the study. Among the 23 patients, 11 underwent feeding tube placement (group 1). Group 2 consisted of 12 patients without feeding tubes. All patients with feeding tube placement had concurrent chemotherapy. Some patients in group 2 received radiation treatment only.

Results: Twenty-two patients had weight loss, 1 patient gained 6.9 lb during the course of treatment. The median weight loss for group 1 was 17.8 lb (ranging from 4.4 to 34.4 lb), compared with 18.6 lb in patients in group 2. Those in group 2 who only received radiation therapy had the least median weight loss (5.4 lb). The average treatment break was 3.3 days for patients in group 1, 3.7 days for those in group 2 with concurrent chemo-radiotherapy (chemoRT), and 3.2 days for group 2 subjects receiving radiation therapy only.

Conclusions: In H&N cancer patients, feeding tube placement did not minimize weight loss and did not reduce average treatment breaks in those given concurrent chemoRT. An interesting additional finding of the study was that chemotherapy seems to have greater impact on a patient’s ability to tolerate radiation therapy. Our findings in this small, retrospective study, though suggestive, are insufficient to draw any definitive conclusions about the effectiveness of prophylactic feeding tube placement in the target patient population. Published studies on this subject are contradictory. Treatment decisions should be based on physician expertise and individualized to clinical needs of patients.

Purpose: To evaluate the effects of feeding tube placement on patient weight and length of treatment breaks during definitive radiotherapy with at least 50 Gy to the bilateral necks of patients with head and neck (H&N) cancer.

Methods: Thirty-five H&N cancer patients underwent definitive radiotherapy at the Radiation Oncology Department at Michael E. DeBakey VA Medical Center from July 23, 2012 to April 25, 2013.  Twenty-three patients received doses of ≥ 50 Gy to bilateral necks, and constituted the study group. The remaining 12 patients did not receive ≥ 50 Gy and were excluded from the study. Among the 23 patients, 11 underwent feeding tube placement (group 1). Group 2 consisted of 12 patients without feeding tubes. All patients with feeding tube placement had concurrent chemotherapy. Some patients in group 2 received radiation treatment only.

Results: Twenty-two patients had weight loss, 1 patient gained 6.9 lb during the course of treatment. The median weight loss for group 1 was 17.8 lb (ranging from 4.4 to 34.4 lb), compared with 18.6 lb in patients in group 2. Those in group 2 who only received radiation therapy had the least median weight loss (5.4 lb). The average treatment break was 3.3 days for patients in group 1, 3.7 days for those in group 2 with concurrent chemo-radiotherapy (chemoRT), and 3.2 days for group 2 subjects receiving radiation therapy only.

Conclusions: In H&N cancer patients, feeding tube placement did not minimize weight loss and did not reduce average treatment breaks in those given concurrent chemoRT. An interesting additional finding of the study was that chemotherapy seems to have greater impact on a patient’s ability to tolerate radiation therapy. Our findings in this small, retrospective study, though suggestive, are insufficient to draw any definitive conclusions about the effectiveness of prophylactic feeding tube placement in the target patient population. Published studies on this subject are contradictory. Treatment decisions should be based on physician expertise and individualized to clinical needs of patients.

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.

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.

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.

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.

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.

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.

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.

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.