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• W2243670597 abstract "6521 Background: To improve on outcomes achieved with OFAR1 in CLL/RS (Tsimberidou et al J Clin Oncol 26:196), we designed OFAR2 (phase I/II). Methods: OFAR2 consisted of oxaliplatin 30 mg/m2 D1-4; fludarabine 30 mg/m2; Ara- C 0.5 g/m2; rituximab 375 mg/m2 D3; and pelfigrastim 6 mg D6. Fludarabine and Ara-C were given on D2-3 (level 1), D2-4 (level 2), or D2-5 (level 3) (phase I) every 4 wks. Tumor lysis, DNA virus, and PCP prophylaxis were given. Results: Overall, 94 pts (CLL, 67; RS, 27) were treated. DLT occurred in 2/3 of pts at level 3 (G4 diarrhea and G4 sepsis); level 2 was the MTD; 82 pts (CLL, 60; RS, 22) were treated in phase II (age > 60 yrs, 65%; 17p del, 38%; 11q del, 13%; 13q del, 16%; +12, 21%; normal, 12%; unmutated IgVH, 80%; ZAP70(+), 75%; CD38(+) > 30%, 58%). Response rates in phase II were: RS (n = 18), 39% (CR, 6%); CLL (n = 54), 54% (CR, 4%); and 17p and 11q del, 36% and 50%, respectively. With a median follow-up of 15 months, the median survival was 20 months (95%CI 13-27+) and the median PFS 7 months (95% CI 5-20+); 12 pts underwent SCT after OFAR2 (post-remission, 10). Overall, 216 cycles were administered. G3-4 neutropenia, thrombocytopenia and anemia were noted in 67%, 74% and 44% of pts (51%, 64% and 25% of cycles) and G3-4 infections in 19% of pts. In multivariate analyses (MVA) of pts with cytogenetics (n=293) treated on protocols OFAR2, FCR or CFAR, independent factors associated with (a) response were higher Hgb level (p < 0.0001), no 17p del (p = 0.0001), fewer prior therapies (p = 0.01); (b) longer PFS were no 17p del (p < 0.0001), lower β2-microglobulin level (p = 0.0002), no refractoriness to fludarabine (p=.0008), fewer prior therapies (p = 0.04); and (c) survival were no 17p del (p < 0.0001), no refractoriness to fludarabine (p = 0.0007), fewer prior therapies (p = 0.01), higher Hgb level (p = 0.02), lower LDH level (p = 0.04), younger age (p = 0.04). In MVA type of therapy was not significant for response (CFAR vs. FCR, p = 0.94; OFAR2 vs. FCR, p = 0.88), PFS (CFAR vs. FCR, p = 0.63; OFAR2 vs. FCR, p = 0.74) or survival (CFAR vs. FCR, p = 0.11; OFAR2 vs. FCR, p = 0.98). Conclusions: The OFAR2 regimen had antileukemic activity in pts with 17p del and was equivalent to the CFAR and FCR salvage programs. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Abbott Laboratories, Celgene, Genentech, GlaxoSmithKline, Igenica, Ligand, MedImmune, Trubion Genentech, NMCR, Physicians' Education Resource PER Abbott Laboratories, ASCO CDA, Bristol-Myers Squibb, Celgene, Genentech, Genmab, GlaxoSmithKline, Novartis, sanofi-aventis, Wyeth Celgene, Genzyme" @default.
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• W2243670597 date "2010-05-20" @default.
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• W2243670597 title "Evaluation of oxaliplatin, fludarabine, cytarabine, and rituximab (OFAR) combination therapy in aggressive chronic lymphocytic leukemia (CLL) and Richter's syndrome (RS)." @default.
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