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- W4255393983 abstract "6592 Background: High-dose therapy with autologous stem cell support (HDT) is now an established treatment for chemosensitive relapse in aggressive lymphoma. However, not all patients are candidates for HDT because of age, comorbidities or previous HDT. Effective and well-tolerated salvage therapies with minimal toxicities are needed. Methods: We designed the R-GEMOX regimen, with rituximab 375mg/m2 d1, gemcitabine 1000 mg/m2 d2 and oxaliplatin 100 mg/m2 d2 (recycling on d15). Between January 2002 and August 2003, 24 patients with refractory/relapsing B-cell lymphoma not eligible for HDT were enrolled in an open unicenter pilot study whose primary objective was to determine the overall response rate (ORR) after 4 cycles of R-GEMOX. Patients were planned to receive 8 cycles if a good response (at least PR) was observed after 4 cycles. Median age was 64 years (range: 43–77) and histological subtypes were : diffuse large B-cell lymphoma (n=16), follicular (n=6) and mantle cell (n=2). Prior treatment included anthracyclin (n=22), rituximab (n=11) and HDT (n=6). The median number of prior treatments was 2 (range : 1 to 5) and 8 patients had received at least 3 prior regimens. Results: 172 cycles were given. The dose administered was 100% of the intended dose for the three drugs in all patients but 4, for whom the dose of oxaliplatin was reduced due to neurotoxicity (n=3) or preexisting renal insufficiency (n=1). Two patients progressed after 3 cycles. After 4 cycles, observed responses were: 6 CR, 4 CRu, 11 PR and 1 failure resulting in an ORR of 88 %. Among the 21 responders after 4 cycles, 17 achieved CR or CRu, 2 remained in PR after completion of 8 cycles. Treatment was stopped after 5 cycles in 2 patients because of physician decision. As of December 2003, 22 patients are alive, 15 in continuous complete remission, 3 in CRu, 2 in PR and 2 in progression. NCIC grade 3–4 neutropenia and thrombocytopenia were reported in 50% and 21% of cycles. Two patients developed a grade 4 infection. There was no renal toxicity. Conclusion: The R-GEMOX regimen shows promising activity with an acceptable toxicity. It is evaluated in an ongoing multicentric phase II study. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi-Synthelabo" @default.
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- W4255393983 date "2004-07-15" @default.
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- W4255393983 title "Rituximab, gemcitabine and oxaliplatin (R-GEMOX): A promising regimen for refractory/relapsed B-cell lymphoma" @default.
- W4255393983 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.6592" @default.
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