1779 Introduction: Tumor Lysis Syndrome (TLS) is an oncologic emergency that leads to a host of metabolic disturbances which can ultimately result in acute renal failure and death. Currently rasburicase, Elitek™, is FDA approved for the treatment of TLS in patients with leukemia, lymphoma, and solid tumor malignancies which have risk factors for TLS. The approved adult dose is 0.2mg/kg/day over 30 minutes for up to 5 days. Chemotherapy should be initiated within 24 hours of rasburicase administration. Since rasburicase's introduction to the market, various studies have examined single dose use (3mg and 6mg) in the adult population, trying to resolve the dilemma of determining a dosing regimen for adults that is as effective as the FDA approved dosing regimen, while minimizing cost. This study was aimed at determining if a single 4.5mg dose of rasburicase would be adequate in reducing uric acid levels (UAL) as compared to the FDA approved conventional weight based approach; it also sought to determine the cost-effectiveness of this approach. Method: This is a retrospective study of the John H. Stroger Jr. Hospital of Cook County (JHS) patients who were administered a single dose of 4.5 mg rasburicase for TLS from 12/2007 to 06/2010. We included patients ≥ 18 years old, with a hematologic malignancy and on chemotherapy or about to start receiving chemotherapy within 24 hours of rasburicase administration. Patients with low risk for TLS or an indication other than prevention and management of TLS were excluded. Result: Demographics: Characteristics: Responders are defined as patients that achieved more than 50% reduction in the UAL at 24 hours, 48 hours or 96 hours or a decrease of UAL to normal levels. Two patients required a second dose to achieve response. The non-responders did not receive any additional doses for unclear reasons. No adverse events were noted. Conclusion: This retrospective study provides evidence that a single 4.5mg dose of rasburicase effectively reduced plasma UAL to within normal limits. In addition, decrease in plasma UAL was observed within 24 hours after administration. No effect on electrolytes and serum creatinine was noted. The cost-effectiveness of a single 4.5mg dose of rasburicase was evaluated based on dose and drug cost. The potential cost saving was substantial when compared with the FDA approved dose. In our opinion, this study validates the use of a single dose of 4.5mg rasburicase in the treatment and prophylaxis of TLS. This dose can be considered as a possible alternative to the FDA approved adult dosing regimen. Disclosures: No relevant conflicts of interest to declare.
18510 Background: There is scant literature on the characteristics of Hodgkin’s disease in Hispanics. We studied the characteristics of this disease in Hispanics compared to other ethnic-racial groups in our large multiethnic Hodgkin’s disease caseload. Methods: A retrospective analysis of all the Hodgkin’s disease cases diagnosed between 2003 and 2006 was undertaken, using Fisher exact test. Results: Of 289 cases of lymphoma diagnosed, 65 (23%) were Hodgkin’s disease compared to SEER data of 11%; Hispanics 40%, African Americans (AA) 41%, Caucasians 19%. Median age at diagnosis: Hispanics 26, AA 27, Caucasians 38. Among the AA: 85% were men 15% women, Hispanics: 58% men 42% women, Caucasians: 33% men, 67% women (p value 0.004). Histological subtypes: Nodular sclerosis 82 % (58): AA 45%, Hispanics 34%, Caucasians 21%; Mixed cellularity 21% (8): Hispanics 75%, AA 12.5%, Caucasians12.5% (p value 0.079). Among Hispanics 62% were clinical stage 1 or 2, 38% stage 3 or 4; Caucasians 75% stage 1 or 2, 25% stage 3 or 4; AA 33% stage 1 or 2 and 66% stage 3 or 4 (p value 0.029). Among the 16 patients with limited stage disease 50% were Hispanics, 25% Caucasians and 25% AA. Of the 49 patients with advanced stage disease, 70% of the Hispanics had IPS Score 0–3, 30% had Score 4–7. Among the AA, 70% had IPS Score 0–3, 30% Score 4–7, while 33% of the Caucasians had IPS Score 0–3, 67% had Score 4–7 (p value 0.077). Conclusions: Mixed cellularity subtype is more common in the Hispanics while the nodular sclerosis subtype is relatively common in African Americans. Hispanics had early clinical and limited stage disease at diagnosis. Among the patients with advance stage disease, Caucasians had a higher IPS Score than the Hispanics. The clinical relevance of these observations remains to be determined with further studies. No significant financial relationships to disclose.
Background: Outcomes of therapy for adult population diagnosed with acute lymphoblastic leukemia (ALL) remain unsatisfactory. Chemotherapy with or without bone marrow transplant (BMT) is the mainstay of treatment. We sought to describe the outcomes of chemotherapy in our population of adults with ALL who were not eligible for bone marrow transplant due to socio-economic reasons. Methods: Data from 50 patients (pts) with ALL over an 8-year period were studied as a retrospective cohort for clinical presentation, response, remission duration and long-term survival. Clinical and survival data were analyzed via Student’s T test and Fisher’s exact test. Time to relapse was analyzed with Kaplan-Meier life table analyses and Log Rank test. Results: There were 16 (32%) women and 34 (68%) men diagnosed with ALL. Median age at diagnosis was 31 years. Hispanics were the majority group with 27 pts (54%), African Americans 11 (22%), Caucasians 8 (16%), and Asian 4 (8%). B precursor ALL was present in 39 pts (78%), T precursor ALL in 8 (16%), and Burkitt’s leukemia in 3 (6%). Cytogenetics were available in 42 pts (84%): 29 pts (58%) were intermediate risk, 12 (24%) poor risk, and 1(2%) good risk. Ph chromosome was present in 6 pts (12%). A WBC above 30,000/dL was seen in 13 pts (25.49%). Myeloid markers were present in 9 (17.64%), CD10 in 45 (88.23%), and CD34 in 34 (66.6%) pts. Four pts (7.84%) had CNS disease at presentation and 3 (5.9%) had mediastinal disease. Based on age, WBC count, cytogenetics, and CNS disease at diagnosis, there were 28 high-risk pts (56%) and 22 standard-risk pts (44%). Majority of pts 38 (76%) received a 4-drug induction chemotherapy (BFM protocol). Hyper-CVAD, and CALGB protocols were used in 6 pts each (12%). A total of 42 pts (84%) achieved remission after first induction chemotherapy. There were 3 deaths (6%) and 5 (10%) nonresponders (NR). After the induction protocol, 19 pts remained in remission but 21 pts (50%) relapsed. Median time to first relapse (TTR) was 12 months. Relapsed pts were re-induced with 2nd line chemotherapy: Hyper-CVAD regimen in 10 pts (47.6%), BFM protocol in 4 (19%), and 33% with other regimens. Eleven pts (52.3%) entered a 2nd remission, 3 died, and 7 NR. Out of 11 pts who achieved a second remission, 5 pts later relapsed, 1 was still in remission at the last follow up, 2 underwent BMT and 3 were lost to follow up. TTR was analyzed according to age, gender, ethnicity, immunophenotype, cytogenetics, WBC count, presence of CD10, CD34, myeloid markers and induction protocol and no significant differences were found. Median overall survival was 16 months (range 1–97 months). Significant differences in survival were found with regards to cytogenetics (poor vs. intermediate risk, p= 0.027), presence of Ph chromosome (p= 0.0002), CNS disease at diagnosis (p= 0.0046), and response to first chemotherapy (p= 0.0032). There were no differences in overall survival according to age, gender, Hispanics vs. other ethnic groups, immunophenotype (B vs. T ALL), WBC count, presence of CD10, CD34, and myeloid markers. Also, the choice of chemotherapy regimen did not impact survival significantly. Conclusions: This cohort of patients revealed a predominance of younger male adults (median age 31 years), Hispanics (54%) and high-risk disease (56%). Remission rate after induction was 84% and early death rate (6%), comparable to those reported in the literature. 50% of responders relapsed after a median TTR of 12 months. No factors were found to impact the TTR significantly. Median survival was 16 months lower than historical cohort (30 months). Cytogenetics, Ph +, CNS disease at diagnosis and response to chemotherapy had a significant impact on survival but not on TTR. More investigation of factors which affect long-term outcome in minority population is needed.
4791 Background Response and factors affecting response in patients with aggressive Non Hodgkin's Gastro Intestinal (GI) tract lymphoma to upfront Rituximab based chemotherapy is not well characterized. Methods 41 consecutive pts diagnosed and treated with GI tract lymphoma in 2002 to 2009 were studied as a retrospective cohort for clinical presentation, prognostic characteristics and long term survival. Prognostic characteristics and survival was analyzed using logistic regression and Cox Proportional Hazards model. Multiple imputation methods were used for missing data. Results 41 pts, median age at presentation was 58 yr (28-80). 10 (24.4%) were African Americans, 22 (51.2%) were Hispanics and 10 (24.4%) were Caucasians. 35 (85.4%) had gastric lymphoma and 6 (14.6%) had intestinal lymphoma. 33 pts had aggressive NHL. 31 had Diffuse large B cell lymphoma, 2 Mantel cell lymphoma and 1 Burkitt's lymphoma. 6 (17.6%) presented with stage IE, 4 (11.8) stage II1, 6(17.6%) Stage II2, 7(20.6%) Stage IIE, and 10 (29.4%) Stage IV. 28(82.3%) pts were diagnosed by endoscope. 5 (14.7%) pts underwent surgery as they presented with obstruction or bleeding, none underwent curative resection. All pts received Rituximab based chemotherapy upfront. 29 received CHOPR, 2 CVPR and 2 Hyper CVAD R. Mean follow up was 23.7 months. 22 (64.8%) pts had a complete response, 6 (17.6%) partial response and 6 (17.6%) had progressive disease. 11 pts relapsed. The median disease free survival (DFS) was 13 months (1-105). Age was the sole significant prognostic factor that influenced DFS OR 1.047 CI 1.003-1.094). Age (OR 1.164 CI 1.045-1.296), stage (OR 1.743 CI 1.053-2.888) and performance status (OR 2.703 CI 1.030-7.097) were factors which significantly affect survival. Survival function was 100%, 55.6% and 58.3% for low, intermediate and high risk group of stage modified IPI for gastric lymphoma. 100%, 70% 58.3% for low intermediate and high risk group as per the revised IPI but survival functions are not significant. 12 (35.3%) of pts tolerated chemotherapy with no grade 3 or 4 adverse events. 13 (38%) had g 3or 4 hematological toxicity. 5 (15%) had surgery post chemotherapy. 2 (6%) has GI perforation and 3 (9%) developed GI bleeding post chemotherapy. Surgical complications occurred after the 1st cycle of chemotherapy. Conclusion Aggressive Non Hodgkins GI lymphoma can be effectively treated with Rituximab based chemotherapy as upfront therapy with a response rate of 83%. Age, stage and performance status significantly effect survival. R IPI may need to be revised to predict survival in gastric lymphoma. 15% treated with chemotherapy upfront may need surgery for complications. Perforation rate was about 3% and most surgical complications occur after 1st cycle of chemotherapy. Disclosures: No relevant conflicts of interest to declare.
4757 Background The response of patients with relapse/refractory (s/p CHOPR) Diffuse large B Cell Lymphoma (DLBCL) to RICE chemotherapy in transplant ineligible patients (pts) is not well studied. Methods 28 consecutive pts with DLBCL, relapsed/refractory to CHOPR chemotherapy diagnosed in 2003 to 2008 were studied as a retrospective cohort for clinical presentation, prognostic characteristics and long term survival. Prognostic characteristics and survival was analyzed using fisher's exact test, exact logistic regression and Kaplan Meier analysis. Multiple imputation methods were used for missing data. Results 28 pts, 11(39%) were female, 17(61%) male. 11 (39.3%) African Americans, 12 (42.9%) Hispanic, 3 (11%) Caucasian and 2 (7%) Asians. 3 (10.7%) presented with stage I at diagnosis, 1(3.6%) stage II, 5(17.9%) stage III and 19 (67.9%) stage IV. The median age at diagnosis was 50.5 years (yrs) (22-71). 4 (14.3%) presented with stage I, 5(17.9%) stage II, 9(32.1%) stage III, 10(35.7%) stage IV. 14(50%) had intermediate risk Revised IPI score, 14 (50%) had high risk disease at presentation. 21(75%) had relapse and 7(25%) had refractory disease. Median time to relapse was 12 months (0-40). Median age at relapse was 51.5 yrs (23-72). 4 (14.3%) presented with stage I at relapse, 5 (17.9%) stage II, 9(32.1%) stage III and 10 (35.7%) stage IV. 12(42.8%) had intermediate risk R-IPI score at relapse and 16(57.2%) had high risk R-IPI score. The median follow up was 30 months (8-60). All patients received first line therapy with CHOPR 6-8 cycles. RICE was used as second line therapy. Median number of cycles was 4 (1-7). 10 (35.7%) had a complete response. 13 (46.4%) had partial response and 5 (17.9%) had progression of disease. Disease free survival was 10 months (0-55). Median overall survival was 30.5 months (8-60). There was no treatment related mortality. Extra nodal involvement (p=0.0094) was the only factor that significantly influenced response to RICE chemotherapy. Race (p=0.081) had boarder line significance with African American having poor response compared to other race. Pt with relapsed disease (p=0.013) and extra nodal involvement at relapse (p=0.049) had better disease free survival. The LDH at presentation (p=0.012), no extra nodal involvement at presentation (p=0.004), relapsed disease (p=0.048) and CR to RICE (0.001) significantly influenced overall survival. Conclusion In transplant ineligible patients with relapsed/refractory Diffuse Large B Cell Lymphoma, RICE can be considered as a second line therapy with a response rate of over 80%. The median disease free survival was 10 months, overall survival was 30.5 months. Pt with lower LDH and chemo sensitive disease had better over all survival. Poor response of African Americans to second line chemotherapy needs to be further investigated. Disclosures: No relevant conflicts of interest to declare.
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