1616 Background: Aggressive non-Hodgkin lymphomas (NHLs) are commonly treated with anthracycline-containing combination chemotherapy regimens. Although a proportion of patients can be cured, 40 –50% of patients relapse or are refractory to frontline therapy. High dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) is the current standard of care of relapsed aggressive lymphomas in eligible patients. Many patients cannot proceed to HDT as a result of reasons like advanced age, significant co morbidities and resistance to salvage chemotherapy. Moreover, the optimal salvage regimen is not known. Hence there is need to develop novel regimens that are likely to benefit these patients. Gemcitabine and rituximab are active agents in relapsed or refractory lymphoma and have demonstrated synergistic effects. GMCSF has been shown to potentiate the efficacy of Rituximab. In this study we evaluated the clinical activity, toxicity and tolerability of a salvage regimen that incorporated sequential combination of gemcitabine, rituximab and GMCSF (Sargramostim, Leukine). Methods: This trial was designed as a prospective, open and uncontrolled phase II study. 13 patients with relapsed or refractory B cell lymphoma were enrolled from Nov 2001 to Mar 2006 at Rush University Medical Center, Chicago, IL. All patients were scheduled to receive up to 6 cycles of Gemcitabine 800mg/m2 IV infusion over 120 minutes on days 1 and 8, GMCSF 250mcg/m2 subcutaneously once daily on day 9 through 15 (7doses) and Rituximab 375mg/m2 IV infusion on day 16. Cycles were repeated every 21 days to a total of 6 cycles. Responses were evaluated by CT scans and bone marrow exam (if involved) after the third course and at the end of the study. Primary endpoint was response rate. Secondary endpoints were toxicity evaluation, progression free survival (PFS) and overall survival (OS). Patients were followed for toxicity, response, PFS and OS. Results: Of the 13 patients in the study, 9 patients completed 6 cycles of therapy and were evaluable for response. The median age was 43 years (range 24 –75 years) with 6 males (66.6%) and 3 females (33.3%). 92% of patients had very advanced disease with stage III or IV disease (Stage IV-61.5% and stage III-30.8%), and 30.8% were poor risk (IPI 3–5). Major histological subtypes were diffuse large B-cell lymphoma (33.3%), Hodgkin lymphoma (33.3%) and follicular lymphoma (11.1%). Eight patients (88%) demonstrated extra nodal disease at one or more sites at presentation indicating a more aggressive lymphoma. Most of the patients were heavily pretreated with multiple combination chemotherapy or chemo immunotherapy with a median of 3 prior chemotherapy regimens (range 2–6). The majority of patients were complete responders after first line induction therapy. In the intent to treat analysis of responses, the overall response rate was 55.5% with 4 complete responses (44.5%) and 1 partial response (11.1%). Disease progression occurred in 4 patients (44%). Progression free survival ranged from 2 to 71 with a median of 6 months. Overall survival measured from 2 to 102 months with a median of 10 months. At last follow-up 22% of (2 of 9) were alive. Toxicity profile of this regimen was similar to other salvage therapies used in this patient population with an increased incidence of grade 3/4 anemia (15.3%) and thrombocytopenia (7.6%).No grade 3 and 4 non-hematologic toxicities were observed. Conclusions: Based on the result of our study, we conclude that gemcitabine combined with GMCSF and rituximab is an effective, feasible and tolerable regimen in heavily pre-treated aggressive relapsed lymphomas. Long-term remissions are possible in patients with heavily pre-treated relapsed/refractory lymphoma with complete remissions lasting for 78–102 months even in patients who relapsed after autologous peripheral blood stem cell transplantation. Disclosures: Shammo: Celgene Corporation: Honoraria, Research Funding, Speakers Bureau.
3693 Introduction: Stroger Hospital of Cook County (CCH) and the Ruth M. Rothstein CORE Center (CC) are the largest health provider for HIV + patients in Chicago and one of the largest in the United States. Together, the CC and CCH treats over 5500 HIV + individuals per year. Insights into the type of cancer and patient characteristics in the inner city and underserved populations have been underrepresented in the literature. To this end, a retrospective study of all HIV-associated cancers at CCH and the CC for the past 13 years was initiated, the CHAMP study (Stroger Hospital of C ook County (CCH) A IDS M alignancy P roject). In total, 413 malignancies were identified. Here we present the analysis of the HIV-associated hematological cancers of the CHAMP cohort. Methods: We identified via CCH and CC databases all HIV-infected patients with a cancer from 1998–2011. We then identified the HIV characteristics, cancer type, overall survival (OS) data, and patient demographics for all of hematological malignancies. Statistics: 149 patients were studied as a retrospective cohort for clinical presentation, prognostic characteristics, and OS. Survival data was analyzed using Kaplan-Meier analysis and Cox Proportional Hazards model. Results: In the CHAMP cohort, 149 HIV-associated hematological malignancies were identified, representing 16 cancers. The racial composition was 58% African American (AA), 25% Hispanic (Hsp), and 14% Caucasians with a Male (86%):Female (14%) ratio of 6:1. Of the 149 cancers, 71% (n=108) were ADC, non-hodgkins lymphoma. Diffuse large B cell lymphoma (DLBCL) 32%(n=49), Burkitt's lymphoma (BL) 15% (n=22), and primary CNS lymphoma (PCNSL) 8% (n=11) were the most common. Of the NADC, Hodgkin lymphoma (HL), 21%(n=32) was the most frequent. Seventy two percent of the patients with DLBC had stage III/IV disease, 50% had CD4 counts <100, and 75% had extra nodal disease. Sixty percent of the patients whose OS data were available, were still alive at 24 months, similar to historical controls. The average OS for BL and PCNSL was 18 and 6 months, respectively. Only two variables were found to adversely affect OS for DLBCL; the IPI score (p<0.034) and the CD4 count <200 (p < 0.027). No such factors were identified for BL. Survival for HL also equaled historical controls where 72% of the patients were alive at 24 months. As in DLBCL, the HL patients presented very late with aggressive disease. Fifty six percent of the HL patients had stage III/IV with 48% of these patients presented with an IPS score of 5 or 6. Primary effusion, follicular, T cell, plasmablastic lymphomas, multiple myeloma, multicentric castlemans, acute lymphoblastic and myeloid leukemias were all identified as 1–4% of the cases. The only form of myeloid leukemia identified was acute promyelocytic leukemia (n=2). CD4 counts for the various cancers showed specific trends, where 64% of PCNSL had CD4 #< 50, 54% DLBCL had CD4 # < 100, 55% of HL had CD4 # >150, and 58% of BL had CD4# > 200. In contrast to historical controls, the number of cases/year/individual and the average age/year of patients with DLBCL, BL, and PCNSL for the past 8 years have not changed. Thirty-six, 50, and 47% of the patients for DLBCL, BL, and PCNS lymphoma respectively, were diagnosed with AIDS at the time of diagnosis. Conclusions: In assessing the hematological cancers of the CHAMP cohort, we identified 149 patients encompassing 16 different malignancies. There were 83% minorities (58% AA, 25% Hsp) and 86% male, an overwhelming AA male condition, contrary to most studies. Compared to the AA population of Chicago of only 26%, a clear racial disparity exists. Of concern is that while the rates of NHL in HIV + patients have declined in almost every study; the rate of NHL in our cohort (inner city) has remained stable for the last 8 years. This could be secondary to our population that is HAART naïve or non compliant at presentation. For example, 36, 50, and 47% of the patients for DLBCL, BL, and PCNS lymphoma respectively, are diagnosed with AIDS at presentation. The OS data for HL, DLBCL, and PCNSL were equal to historical controls. We also showed that IPI score and a CD4 count below 200 were prognostic in determining OS in DLBCL. Late presentations were also seen in HL, where 48% of the patients with advanced stage had an IPS score of 5 or 6. Education and screening are needed to prevent late presentations of both HIV and lymphoma in the AA and Hsp communities. Disclosures: No relevant conflicts of interest to declare.
e14186 Background: Overall survival in colorectal cancer is influenced by obesity, age, gender and stage at diagnosis. However, in minority based populations, effect of the above factors on overall survival has not been studied in any detail. Hence, we undertook this retrospective study to evaluate effect of above factors on overall survival in young colorectal cancer patients. Methods: 1,195 subjects with colorectal cancer treated at John H. Stroger Hospital of Cook County between 2000 and 2008 were retrospectively analyzed. 179 subjects with age 50 years and younger were identified. 146 of 179 subjects with available Body Mass Index (BMI) in kg/m2 were included in the study. Effect of BMI, age, sex, race, LDH and CEA levels, stage, site of tumor, smoking and family history on overall survival was evaluated using standard statistical multivariate analysis. Results: In our population, 22 of 146(15%) were underweight (BMI<20), 56 of 146(38.4%) were normal weight (BMI 20-24.9), 46 of 146(31.5%) were overweight (BMI 25-29.9) and 22 of 146(15%) were obese (BMI >30). Male: female ratio was 1.4:1. 75 of 146(51.7%) were African American, 23 of 146(15.9%) were Caucasians. 50 of 146(34.2%) were stage IV colorectal cancer at diagnosis. On univariate analysis, BMI<20(p=0.031, HR 2.1, 95% CI 1.15-3.82), CEA >4ng/ml (p=0.005, HR 1.93, 95% CI 1.21-3.08) and stage IV colorectal cancer (p<0.001, HR 6.1, 95% CI 2.42-15.53) were significantly associated with decreased overall survival. LDH<200 U/L was significantly associated with improved overall survival (p 0.029, HR 0.6, 95% CI 0.391-0.950). On multivariate analysis, stage IV colorectal cancer was a single significant independent predictor of overall survival (p=0.001, 95% CI 2.47-27.78). CEA>4ng/ml was marginally significant for decreased overall survival (p=0.06, 95% CI 0.978-3.015). On the contrary, no statistically significant difference was found on overall survival with age, BMI>20, gender, race, tumor location, smoking and family history. Conclusions: Advanced stage and CEA >4ng/ml are independent prognostic variables for decreased overall survival in minority based population of young colorectal cancer.
4422 Background: In the era when the Sokal score was developed (1984), Tyrosine kinase inhibitors (TKI's) were not available for treatment of Chronic Myelogenous Leukemia (CML). With the treatments available then, the 2-year survival in the low risk group was 90% and in the intermediate and high-risk groups was 65%. Since TKI's were approved for treatment of CML in 2001, overall estimated survival at 5 years has improved to 89%. Aim: To evaluate risk stratification by Sokal score as an indicator of prognosis in patients with CML in the present era of tyrosine kinase inhibitors. Methods: Sokal Score is a prognostic score used to risk stratify patients as low-risk, intermediate-risk and high-risk based on diagnosis based on the spleen size, platelet count, age and blast count. Seventy-eight (78) subjects diagnosed with CML and treated at John H. Stroger Hospital of Cook County between 2000 and 2011 were retrospectively analyzed after institutional review board approval. Ten (10) subjects with blast crisis at diagnosis were excluded from this study. Effect of race, sex, age, white cell count, amount of reticulin fibrosis in bone marrow biopsy, total peripheral blood eosinophil and basophil counts, Lactate Dehydrogenase level, spleen and liver size at diagnosis and, risk stratification by Sokal score on overall survival was evaluated using standard statistical analysis. Results: In our population, 27/68 (39.7%) were more than 45 years old, 30/68 (44.11%) were African American, 20/68 (29.4%) were Hispanic, male to female ratio was 2.4:1. WBC>100,000 was observed in 25/68 (51.4%), 57/68 (83.8%) had LDH>200IU/L, 50/68 (73.5%) had palpable splenomegaly >5cm at the time of diagnosis and 67/68 (99%) of subjects had reticulin fibrosis in bone marrow. Of these, 35/67 (52.2%) had mild, 12/67 (17.9%) had moderate and 20/67 (29.8%) had severe fibrosis. According to Sokal score risk stratification, 22/68 (32.3%) were low risk, 40/68 (58.8%) were intermediate risk and 6/68 (8.8%) were high risk at diagnosis. Five year overall survival (OS) in our population was 90%. On univariate analysis, risk stratification by Sokal score at diagnosis was statistically significant for Overall Survival. Subjects with low risk score had better OS as compared to intermediate and high-risk subjects (P=0.007, HR 11.596, 95%CI 1.946–69.103). Similarly, subjects with intermediate score had better OS compared to high-risk group (P=0.007, HR 0.140, 95%CI 0.020–0.539). Conclusion: Sokal Score is still a valid predictor of prognosis in this new age of tyrosine kinase inhibitors and can still be used for risk stratification at diagnosis for chronic phase CML patients. Disclosures: No relevant conflicts of interest to declare.
e14590 Background: In the non-HIV population, radiotherapy (RT), fluorouracil (5FU) with mitomycin (MMC) has become the standard in the non-metastatic setting for anal carcinomas (AC). To date, most studies with AC in HIV patients (pts) are small case series where multiple chemoradiation (CRT) regimens were used and analyzed as one cohort. In addition, little data exists on the inner city HIV population. Cook County Hospital (CCH) is the largest health provider for HIV pts in Chicago and together with its outpatient clinic, the Ruth M. Rothstein CORE Center (CC) 5,500 HIV+ pts are treated per year. The County Hospital (CCH) AIDS Malignancy Project (CHAMP Study) is a retrospective study of all HIV cancer pts treated for the past 14 years. Methods: We identified all HIV+ pts with invasive AC in CHAMP cohort. We analyzed HIV characteristics, overall survival (OS), PFS and pt demographics and compared it to a HIV- cohort from the same institution. All AC treated without MMC/5FU/RT were excluded. Statistics: Time to local recurrence (TLR), time to distant metastasis (TDM), and OS data was analyzed using Kaplan-Meier analysis and a Cox Proportional Hazards model. Results: 35 HIV + and 52 HIV - pts were included. Of the HIV+ vs. HIV- pts, 89 vs. 52% were male, 82 vs. 48% were AA and the average age in HIV+ vs. HIV- was 44 vs. 52 yrs. 45 % of the HIV pts presented with stage IIIA or IIIB disease vs. 46% in HIV- pts. 15 % HIV- pts had stage IV vs. 0% HIV +. The median survival in the HIV+ vs. HIV- was 34 vs. 39 mo (p>0.5). In the HIV- population, 22% survived 120 months, while no HIV pt survived over 90 months. TLR was 20 months shorter in the HIV+ arm (p<0.5). OS based on CD4 count did not differ. Conclusions: HIV associated AC is an AA male disease compared to HIV- pts in the inner city. More stage IV disease was reported in the HIV- cohort, but the median survival was equal with no long-term survivors in the HIV+ arm, possibly due to TLR, which was 20 months shorter, implying more aggressive disease. Both inner city groups present late but tolerate chemotherapy equally well. Education is needed in both HIV+ and HIV- pts to diagnose the cancers early so the OS can match the national average.
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