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.

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.

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.

Purpose: Small-cell lung cancer (SCLC) is a rapidly-progressive and highly fatal disease, and new treatments are needed. Increased expression of ß-III tubulin (TUBB3) correlates with decreased response to paclitaxel in multiple cancers. We have discovered that TUBB3 is highly expressed in SCLC pathology samples. CK2 is a serine/threonine kinase with over 300 substrates and is overexpressed in many cancers. CK2 interacts with the microtubule apparatus and may be related to TUBB3-mediated drug resistance in cancer cells. Our hypothesis is that simultaneous targeting of microtubules and CK2 will be an effective strategy in decreasing SCLC proliferation.

Methods: Cell proliferation experiments were conducted as follows. SCLC cell lines H69 and H209 were maintained in appropriate media at 5% CO2 and 37°C. A 96-well microtiter plate was seeded with 100 μL of cell suspension at 1 x 104 cells/well. After 20 hours or 68 hours of incubation with Ixabepilone (LC Laboratories), 10 μL of Cell Counting Kit-8 (Dojindo) reagent was added to each well, followed by incubation for 4 hours for total incubations of 24 hours or 72 hours. Absorbance was read at 450 nm. All experiments were performed in triplicate. Cells were lysed in lysis buffer and cleared by centrifugation at 4°C. Proteins were resolved on 10% or 12% SDS PAGE gels, transferred onto PVDF membranes, and blocked with 5% nonfat dry milk in TBS-T followed by incubation with primary antibody diluted in TBS-T (mouse TUBB3 [MMS-435P, Covance] at a dilution of 1:2,000 or rabbit CK2α [A300-197A, Bethyl Laboratories]) plus Anti-CK2α’ (A300-199A, Bethyl Laboratories) at a dilution of 1:3,000. Blots were washed and incubated with horseradish peroxidase-conjugated secondary antibody diluted in TBS-T (Anti-mouse [Santa Cruz Biotech] at 1:25,000 and Anti-rabbit at 1:1,000). Antibody complexes were visualized, using an enhanced chemiluminescent Western blot detection system (Thermo Fisher Scientific).

Results: Previously, we demonstrated that TUBB3 is highly expressed in about 85% of SCLC cases. In the current study, multiple SCLC cell lines were evaluated for TUBB3 and CK2 expression via immunoblotting. In all cell lines, bands corresponding to the molecular weights of TUBB3 and CK2 were observed at multiple protein lysate concentrations. Ixabepilone is a microtubule-stabilizing analogue of epothilone B that is thought to preferentially bind the TUBB3 isotype. Incubation of ixabepilone with H69 and H209 SCLC cell lines at 25 mM resulted in 8.6% and 5.3% inhibition, respectively, after 24 hours and 14.0% and 20.6% inhibition, respectively, after 72 hours. Incubation of ixabepilone with H69 and H209 SCLC cell lines at 100 mM resulted in 29.2% and 7.0% inhibition, respectively, after 24 hours and 47.5% and 32.2% inhibition, respectively, after 72 hours.

Conclusions: TUBB3 and CK2 were expressed in SCLC cell lines. Ixabepilone has modest activity against SCLC cell lines and will be further evaluated to obtain IC50 values. We will further evaluate the effect of CK2 inhibition in the presence and absence of ixabepilone and paclitaxel. The work described here may contribute to new therapeutic strategies for SCLC.

Purpose: Small-cell lung cancer (SCLC) is a rapidly-progressive and highly fatal disease, and new treatments are needed. Increased expression of ß-III tubulin (TUBB3) correlates with decreased response to paclitaxel in multiple cancers. We have discovered that TUBB3 is highly expressed in SCLC pathology samples. CK2 is a serine/threonine kinase with over 300 substrates and is overexpressed in many cancers. CK2 interacts with the microtubule apparatus and may be related to TUBB3-mediated drug resistance in cancer cells. Our hypothesis is that simultaneous targeting of microtubules and CK2 will be an effective strategy in decreasing SCLC proliferation.

Methods: Cell proliferation experiments were conducted as follows. SCLC cell lines H69 and H209 were maintained in appropriate media at 5% CO2 and 37°C. A 96-well microtiter plate was seeded with 100 μL of cell suspension at 1 x 104 cells/well. After 20 hours or 68 hours of incubation with Ixabepilone (LC Laboratories), 10 μL of Cell Counting Kit-8 (Dojindo) reagent was added to each well, followed by incubation for 4 hours for total incubations of 24 hours or 72 hours. Absorbance was read at 450 nm. All experiments were performed in triplicate. Cells were lysed in lysis buffer and cleared by centrifugation at 4°C. Proteins were resolved on 10% or 12% SDS PAGE gels, transferred onto PVDF membranes, and blocked with 5% nonfat dry milk in TBS-T followed by incubation with primary antibody diluted in TBS-T (mouse TUBB3 [MMS-435P, Covance] at a dilution of 1:2,000 or rabbit CK2α [A300-197A, Bethyl Laboratories]) plus Anti-CK2α’ (A300-199A, Bethyl Laboratories) at a dilution of 1:3,000. Blots were washed and incubated with horseradish peroxidase-conjugated secondary antibody diluted in TBS-T (Anti-mouse [Santa Cruz Biotech] at 1:25,000 and Anti-rabbit at 1:1,000). Antibody complexes were visualized, using an enhanced chemiluminescent Western blot detection system (Thermo Fisher Scientific).

Results: Previously, we demonstrated that TUBB3 is highly expressed in about 85% of SCLC cases. In the current study, multiple SCLC cell lines were evaluated for TUBB3 and CK2 expression via immunoblotting. In all cell lines, bands corresponding to the molecular weights of TUBB3 and CK2 were observed at multiple protein lysate concentrations. Ixabepilone is a microtubule-stabilizing analogue of epothilone B that is thought to preferentially bind the TUBB3 isotype. Incubation of ixabepilone with H69 and H209 SCLC cell lines at 25 mM resulted in 8.6% and 5.3% inhibition, respectively, after 24 hours and 14.0% and 20.6% inhibition, respectively, after 72 hours. Incubation of ixabepilone with H69 and H209 SCLC cell lines at 100 mM resulted in 29.2% and 7.0% inhibition, respectively, after 24 hours and 47.5% and 32.2% inhibition, respectively, after 72 hours.

Conclusions: TUBB3 and CK2 were expressed in SCLC cell lines. Ixabepilone has modest activity against SCLC cell lines and will be further evaluated to obtain IC50 values. We will further evaluate the effect of CK2 inhibition in the presence and absence of ixabepilone and paclitaxel. The work described here may contribute to new therapeutic strategies for SCLC.

Purpose: Small-cell lung cancer (SCLC) is a rapidly-progressive and highly fatal disease, and new treatments are needed. Increased expression of ß-III tubulin (TUBB3) correlates with decreased response to paclitaxel in multiple cancers. We have discovered that TUBB3 is highly expressed in SCLC pathology samples. CK2 is a serine/threonine kinase with over 300 substrates and is overexpressed in many cancers. CK2 interacts with the microtubule apparatus and may be related to TUBB3-mediated drug resistance in cancer cells. Our hypothesis is that simultaneous targeting of microtubules and CK2 will be an effective strategy in decreasing SCLC proliferation.

Methods: Cell proliferation experiments were conducted as follows. SCLC cell lines H69 and H209 were maintained in appropriate media at 5% CO2 and 37°C. A 96-well microtiter plate was seeded with 100 μL of cell suspension at 1 x 104 cells/well. After 20 hours or 68 hours of incubation with Ixabepilone (LC Laboratories), 10 μL of Cell Counting Kit-8 (Dojindo) reagent was added to each well, followed by incubation for 4 hours for total incubations of 24 hours or 72 hours. Absorbance was read at 450 nm. All experiments were performed in triplicate. Cells were lysed in lysis buffer and cleared by centrifugation at 4°C. Proteins were resolved on 10% or 12% SDS PAGE gels, transferred onto PVDF membranes, and blocked with 5% nonfat dry milk in TBS-T followed by incubation with primary antibody diluted in TBS-T (mouse TUBB3 [MMS-435P, Covance] at a dilution of 1:2,000 or rabbit CK2α [A300-197A, Bethyl Laboratories]) plus Anti-CK2α’ (A300-199A, Bethyl Laboratories) at a dilution of 1:3,000. Blots were washed and incubated with horseradish peroxidase-conjugated secondary antibody diluted in TBS-T (Anti-mouse [Santa Cruz Biotech] at 1:25,000 and Anti-rabbit at 1:1,000). Antibody complexes were visualized, using an enhanced chemiluminescent Western blot detection system (Thermo Fisher Scientific).

Results: Previously, we demonstrated that TUBB3 is highly expressed in about 85% of SCLC cases. In the current study, multiple SCLC cell lines were evaluated for TUBB3 and CK2 expression via immunoblotting. In all cell lines, bands corresponding to the molecular weights of TUBB3 and CK2 were observed at multiple protein lysate concentrations. Ixabepilone is a microtubule-stabilizing analogue of epothilone B that is thought to preferentially bind the TUBB3 isotype. Incubation of ixabepilone with H69 and H209 SCLC cell lines at 25 mM resulted in 8.6% and 5.3% inhibition, respectively, after 24 hours and 14.0% and 20.6% inhibition, respectively, after 72 hours. Incubation of ixabepilone with H69 and H209 SCLC cell lines at 100 mM resulted in 29.2% and 7.0% inhibition, respectively, after 24 hours and 47.5% and 32.2% inhibition, respectively, after 72 hours.

Conclusions: TUBB3 and CK2 were expressed in SCLC cell lines. Ixabepilone has modest activity against SCLC cell lines and will be further evaluated to obtain IC50 values. We will further evaluate the effect of CK2 inhibition in the presence and absence of ixabepilone and paclitaxel. The work described here may contribute to new therapeutic strategies for SCLC.

Purpose: Recent studies have suggested that incorporation of palliative care concomitantly with therapy for metastatic cancer may be beneficial. The American Society of Clinical Oncology has published a provisional clinical opinion recommending incorporation of palliative care alongside chemotherapy in patients with metastatic cancer or a high symptom burden from cancer. In this project, we evaluate the feasibility of incorporation of palliative care in patients with head and neck (H&N) cancer treated with concurrent chemotherapy and radiation.

Methods: The primary goal of this quality improvement project is to assess the feasibility of participation in a palliative care program for patients with H&N cancer undergoing treatment. Patients are recommended for palliative care consultation if they have squamous cell carcinoma of the head and neck and are treated with concurrent chemotherapy and radiation (definitive or adjuvant therapy). Patients are offered palliative care consultation in their first week of treatment. They are approached in person to discuss goals and potential benefits of concomitant palliative care and chemotherapy/radiation. All patients are provided with informational material to review. If interested in palliative care, the participant is asked to fill out 5 non-mandatory questionnaires. These include the FACT-H&N, FACIT-Sp-12, PHQ-9, EAT-10, and HADS. Patients are seen by the palliative care service at 6, 12, 26, and 52 weeks after starting chemotherapy/radiation, and patients are asked to fill out the questionnaires at those time points as well. In addition, data on several potential quality elements (weight, use of enteral nutrition, laboratory values, site of disease, p16ink4a status, etc) are collected for comparison with a retrospective cohort.

Results: Retrospective data from the charts of 51 patients have been abstracted and analyzed for comparison with the prospective quality improvement cohort. The median age was 63 (range 48 to 87). Forty-four patients were either stage IVa or IVb. The location of primary tumors included the oropharynx (59%), oral cavity (11.8%), hypopharynx (9.8%), larynx (9.8%), and the nasopharnyx (7.8%). Forty-four of the 51 patients had a percutaneous endoscopic gastrostomy tube (for potential enteral nutrition) placed either prophylactically (before or within the first week of treatment, 19 patients) or reactively (after the first week of treatment, 25 patients). In the prospective cohort, 14 patients have thus far been offered palliative care consultation. Six patients agreed to palliative care consultation and 8 declined. The median age was 62, and all patients were male. Data collection and analysis are ongoing.

Conclusions: The results of this project may be able to guide incorporation of routine palliative care with the treatment of patients with (H&N) cancer. Barriers to enrolling in palliative care concomitantly with chemotherapy and radiation should be considered to aid incorporation of early palliative care for patients with H&N cancer.

Purpose: Recent studies have suggested that incorporation of palliative care concomitantly with therapy for metastatic cancer may be beneficial. The American Society of Clinical Oncology has published a provisional clinical opinion recommending incorporation of palliative care alongside chemotherapy in patients with metastatic cancer or a high symptom burden from cancer. In this project, we evaluate the feasibility of incorporation of palliative care in patients with head and neck (H&N) cancer treated with concurrent chemotherapy and radiation.

Methods: The primary goal of this quality improvement project is to assess the feasibility of participation in a palliative care program for patients with H&N cancer undergoing treatment. Patients are recommended for palliative care consultation if they have squamous cell carcinoma of the head and neck and are treated with concurrent chemotherapy and radiation (definitive or adjuvant therapy). Patients are offered palliative care consultation in their first week of treatment. They are approached in person to discuss goals and potential benefits of concomitant palliative care and chemotherapy/radiation. All patients are provided with informational material to review. If interested in palliative care, the participant is asked to fill out 5 non-mandatory questionnaires. These include the FACT-H&N, FACIT-Sp-12, PHQ-9, EAT-10, and HADS. Patients are seen by the palliative care service at 6, 12, 26, and 52 weeks after starting chemotherapy/radiation, and patients are asked to fill out the questionnaires at those time points as well. In addition, data on several potential quality elements (weight, use of enteral nutrition, laboratory values, site of disease, p16ink4a status, etc) are collected for comparison with a retrospective cohort.

Results: Retrospective data from the charts of 51 patients have been abstracted and analyzed for comparison with the prospective quality improvement cohort. The median age was 63 (range 48 to 87). Forty-four patients were either stage IVa or IVb. The location of primary tumors included the oropharynx (59%), oral cavity (11.8%), hypopharynx (9.8%), larynx (9.8%), and the nasopharnyx (7.8%). Forty-four of the 51 patients had a percutaneous endoscopic gastrostomy tube (for potential enteral nutrition) placed either prophylactically (before or within the first week of treatment, 19 patients) or reactively (after the first week of treatment, 25 patients). In the prospective cohort, 14 patients have thus far been offered palliative care consultation. Six patients agreed to palliative care consultation and 8 declined. The median age was 62, and all patients were male. Data collection and analysis are ongoing.

Conclusions: The results of this project may be able to guide incorporation of routine palliative care with the treatment of patients with (H&N) cancer. Barriers to enrolling in palliative care concomitantly with chemotherapy and radiation should be considered to aid incorporation of early palliative care for patients with H&N cancer.

Purpose: Recent studies have suggested that incorporation of palliative care concomitantly with therapy for metastatic cancer may be beneficial. The American Society of Clinical Oncology has published a provisional clinical opinion recommending incorporation of palliative care alongside chemotherapy in patients with metastatic cancer or a high symptom burden from cancer. In this project, we evaluate the feasibility of incorporation of palliative care in patients with head and neck (H&N) cancer treated with concurrent chemotherapy and radiation.

Methods: The primary goal of this quality improvement project is to assess the feasibility of participation in a palliative care program for patients with H&N cancer undergoing treatment. Patients are recommended for palliative care consultation if they have squamous cell carcinoma of the head and neck and are treated with concurrent chemotherapy and radiation (definitive or adjuvant therapy). Patients are offered palliative care consultation in their first week of treatment. They are approached in person to discuss goals and potential benefits of concomitant palliative care and chemotherapy/radiation. All patients are provided with informational material to review. If interested in palliative care, the participant is asked to fill out 5 non-mandatory questionnaires. These include the FACT-H&N, FACIT-Sp-12, PHQ-9, EAT-10, and HADS. Patients are seen by the palliative care service at 6, 12, 26, and 52 weeks after starting chemotherapy/radiation, and patients are asked to fill out the questionnaires at those time points as well. In addition, data on several potential quality elements (weight, use of enteral nutrition, laboratory values, site of disease, p16ink4a status, etc) are collected for comparison with a retrospective cohort.

Results: Retrospective data from the charts of 51 patients have been abstracted and analyzed for comparison with the prospective quality improvement cohort. The median age was 63 (range 48 to 87). Forty-four patients were either stage IVa or IVb. The location of primary tumors included the oropharynx (59%), oral cavity (11.8%), hypopharynx (9.8%), larynx (9.8%), and the nasopharnyx (7.8%). Forty-four of the 51 patients had a percutaneous endoscopic gastrostomy tube (for potential enteral nutrition) placed either prophylactically (before or within the first week of treatment, 19 patients) or reactively (after the first week of treatment, 25 patients). In the prospective cohort, 14 patients have thus far been offered palliative care consultation. Six patients agreed to palliative care consultation and 8 declined. The median age was 62, and all patients were male. Data collection and analysis are ongoing.

Conclusions: The results of this project may be able to guide incorporation of routine palliative care with the treatment of patients with (H&N) cancer. Barriers to enrolling in palliative care concomitantly with chemotherapy and radiation should be considered to aid incorporation of early palliative care for patients with H&N cancer.

Purpose: For the definitive treatment of stage III NSCLC, the optimal chemotherapy regimen to use with radiation is not clearly defined. Using a large cohort of patients treated across VHAs, we compare the outcome of patents treated with cisplatin and etoposide (EP) vs those treated with carboplatin and paclitaxel (CP).

Methods: Using the VA Central Cancer Registry, patients with stage III non-small cell lung cancer (NSCLC) diagnosed between 2001 and 2010 were identified. For analysis, patients were included if concurrent chemoradiotherapy was initiated within 4 months of diagnosis and excluded if treated with surgery or sequential chemoradiotherapy (ie, chemotherapy was not started within 7 days of the start of radiotherapy).

Results: Out of 17,010 patients identified, 1,856 patients were eligible for analysis of which 28% (n = 565) received EP. In multivariable analysis, the use of EP was not associated with any survival advantage (HR 0.88; 95% CI 0.79-0.99; P = .0254). In a propensity score analysis that matched 382 patients treated with EP with the same number of patients treated with CP, there was no survival advantage for EP (HR 0.96; 95% CI 0.83-1.11; P = .5572). Subsequently, a multivariate model weighted on the inverse propensity for being treated with EP was fitted and similarly showed no survival advantage for EP (HR 0.95; 95% CI, 0.84-1.08; P = .4525). Finally, an instrumental variable analysis was used to compare matched patients between 8 VHAs that were “EP-encouraged” (ie, > 50% received EP, mean 71.1%) with 11 VHAs that were “EP-discouraged” (ie, < 10% received EP, mean 2.8%). This analysis found no survival advantage for EP (HR 1.06; 95% CI, 0.90-1.26; P = .4766). When adverse events were compared with CP, patients treated with EP had increased hospitalization (2.4 vs 1.7, P < .01), outpatient visits (17.6 vs 12.6, P <.01), infectious complications (47.6% vs 39.6%, P < .0001), acute renal failure (30.3 vs 21.3%, P <.0001), and mucositis/esophagitis (18.7 vs 14.5%, P = 0.0251).

Conclusions: After accounting for various prognostic variables, matched cohorts, and regional differences, there were no differences in survival between patients treated with EP and CP; however, EP was associated with increased morbidity.

Purpose: For the definitive treatment of stage III NSCLC, the optimal chemotherapy regimen to use with radiation is not clearly defined. Using a large cohort of patients treated across VHAs, we compare the outcome of patents treated with cisplatin and etoposide (EP) vs those treated with carboplatin and paclitaxel (CP).

Methods: Using the VA Central Cancer Registry, patients with stage III non-small cell lung cancer (NSCLC) diagnosed between 2001 and 2010 were identified. For analysis, patients were included if concurrent chemoradiotherapy was initiated within 4 months of diagnosis and excluded if treated with surgery or sequential chemoradiotherapy (ie, chemotherapy was not started within 7 days of the start of radiotherapy).

Results: Out of 17,010 patients identified, 1,856 patients were eligible for analysis of which 28% (n = 565) received EP. In multivariable analysis, the use of EP was not associated with any survival advantage (HR 0.88; 95% CI 0.79-0.99; P = .0254). In a propensity score analysis that matched 382 patients treated with EP with the same number of patients treated with CP, there was no survival advantage for EP (HR 0.96; 95% CI 0.83-1.11; P = .5572). Subsequently, a multivariate model weighted on the inverse propensity for being treated with EP was fitted and similarly showed no survival advantage for EP (HR 0.95; 95% CI, 0.84-1.08; P = .4525). Finally, an instrumental variable analysis was used to compare matched patients between 8 VHAs that were “EP-encouraged” (ie, > 50% received EP, mean 71.1%) with 11 VHAs that were “EP-discouraged” (ie, < 10% received EP, mean 2.8%). This analysis found no survival advantage for EP (HR 1.06; 95% CI, 0.90-1.26; P = .4766). When adverse events were compared with CP, patients treated with EP had increased hospitalization (2.4 vs 1.7, P < .01), outpatient visits (17.6 vs 12.6, P <.01), infectious complications (47.6% vs 39.6%, P < .0001), acute renal failure (30.3 vs 21.3%, P <.0001), and mucositis/esophagitis (18.7 vs 14.5%, P = 0.0251).

Conclusions: After accounting for various prognostic variables, matched cohorts, and regional differences, there were no differences in survival between patients treated with EP and CP; however, EP was associated with increased morbidity.

Purpose: For the definitive treatment of stage III NSCLC, the optimal chemotherapy regimen to use with radiation is not clearly defined. Using a large cohort of patients treated across VHAs, we compare the outcome of patents treated with cisplatin and etoposide (EP) vs those treated with carboplatin and paclitaxel (CP).

Methods: Using the VA Central Cancer Registry, patients with stage III non-small cell lung cancer (NSCLC) diagnosed between 2001 and 2010 were identified. For analysis, patients were included if concurrent chemoradiotherapy was initiated within 4 months of diagnosis and excluded if treated with surgery or sequential chemoradiotherapy (ie, chemotherapy was not started within 7 days of the start of radiotherapy).

Results: Out of 17,010 patients identified, 1,856 patients were eligible for analysis of which 28% (n = 565) received EP. In multivariable analysis, the use of EP was not associated with any survival advantage (HR 0.88; 95% CI 0.79-0.99; P = .0254). In a propensity score analysis that matched 382 patients treated with EP with the same number of patients treated with CP, there was no survival advantage for EP (HR 0.96; 95% CI 0.83-1.11; P = .5572). Subsequently, a multivariate model weighted on the inverse propensity for being treated with EP was fitted and similarly showed no survival advantage for EP (HR 0.95; 95% CI, 0.84-1.08; P = .4525). Finally, an instrumental variable analysis was used to compare matched patients between 8 VHAs that were “EP-encouraged” (ie, > 50% received EP, mean 71.1%) with 11 VHAs that were “EP-discouraged” (ie, < 10% received EP, mean 2.8%). This analysis found no survival advantage for EP (HR 1.06; 95% CI, 0.90-1.26; P = .4766). When adverse events were compared with CP, patients treated with EP had increased hospitalization (2.4 vs 1.7, P < .01), outpatient visits (17.6 vs 12.6, P <.01), infectious complications (47.6% vs 39.6%, P < .0001), acute renal failure (30.3 vs 21.3%, P <.0001), and mucositis/esophagitis (18.7 vs 14.5%, P = 0.0251).

Conclusions: After accounting for various prognostic variables, matched cohorts, and regional differences, there were no differences in survival between patients treated with EP and CP; however, EP was associated with increased morbidity.