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.
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