Biweekly dose-dense gemcitabine-oxaliplatin and dexamethasone for relapsed/refractory aggressive non-Hodgkin lymphoma: A multicenter, single-arm, phase II trial

Aim: We performed a phase II study to evaluate the efficacy of combination chemotherapy consisting of gemcitabine, dexamethasone and oxaliplatin ( GemDOx) as a biweekly regimen and salvage therapy in patients with relapsed or refractory aggressive non-Hodgkin lymphoma ( NHL). Methods: Gemcitabine ( 1000 mg/m(2)) and oxaliplatin ( 85 mg/m(2)) were administered intravenously on days 1 and 15, and dexamethasone ( 40 mg) was administered orally on days 1-4. Results: Twenty-nine patients were enrolled, and most patients had diffuse large B-cell lymphoma ( n = 18). The median age of the patients and median prior number of chemotherapy cycles were 53 ( range, 26-74) years and 1 ( range, 1-4) cycle, respectively. Only 17 ( 58.6%) and 9 ( 31.0%) patients completed two or more and four or more cycles, respectively, and the median number of received cycles was two ( range, 1-8). Overall response rates were 27.6% ( complete response in 13.8%) among intent-to-treat patients and 47.1% ( complete response in 23.5%) among patients who had received at least two GemDOx cycles. Median progression-free survival and median overall survival were 3.9 and 20.5 months, respectively. The most-frequent grade 3 or 4 toxicity was neutropenia ( 22.9%), and no grade 3 or 4 peripheral neurotoxicity was noted. Conclusion: GemDOx chemotherapy, therefore, showed modest activity against relapsed or refractory aggressive NHL, although toxicities were acceptable.