© 2006 European Society for Medical Oncology
symposium article |
Gemcitabine, ifosfamide, oxaliplatin and rituximab (R-GIFOX), a new effective cytoreductive/mobilizing salvage regimen for relapsed and refractory aggressive non-Hodgkin's lymphoma: results of a pilot study
Hematology-Oncology Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, Naples, Italy
* Correspondence to: Dr A. Pinto, Hematology-Oncology Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCS, Via Mariano Semmola, I-80131, Naples, Italy. Tel: +39-081-5903-382; Fax: +39-081-5903-833; E-mail: apinto.int.napoli{at}tin.it
Background: The prognosis of patients with aggressive non-Hodgkin's lymphoma (NHL) relapsing or progressing after front-line therapy remains poor. Since high-dose therapy (HDT) with autologous stem cell transplantation (ASCT) can cure a proportion of such patients, provided that a substantial tumor shrinkage is achieved, the development of more effective and less toxic salvage regimens remains a major challenge. We evaluated the clinical activity, toxicity and mobilizing capacity of a new salvage regimen, which combines gemcitabine and oxaliplatin with ifosfamide and rituximab (R-GIFOX) in patients with relapsed and refractory CD20+ NHL.
Patients and methods: Patients were scheduled to receive three courses of therapy followed by mobilization and ASCT or three more courses if ineligible for ASCT. R-GIFOX consisted of rituximab (375 mg/m2 on day 1), gemcitabine (1000 mg/m2 on day 2), oxaliplatin (130 mg/m2 on day 3) and ifosfamide (5 g/m2 on day 3) as a 24-h single infusion in patients aged 
65 years, or fractionated over 3 days (days 3–5) in patients aged >65 years. Treatment was given every 2 weeks with G-CSF support (5 µg/kg/day or 10 µg/kg/day at the end of the third course for stem cell mobilization). Responses were evaluated by the integrated FDG-PET/IWC criteria after the third course and at the end of the entire program.
Results: Fourteen patients (median age 63 years, range 37–78 years) with relapsed (n = 9) or primary progressive (n = 5) aggressive (diffuse large cell, mantle cell, follicular G3), advanced (stage IV 71%), poor risk (IPI 3–5 50%) NHL were accrued in this pilot study. Patients had received a median of two previous treatment lines (range 1–4). The median number of R-GIFOX courses delivered was 4 (range 1–6). Thirteen patients completed at least three courses of therapy and were evaluable for response. The overall response rate assessed after three courses of R-GIFOX was 77%, with seven complete responses and three partial responses. Effective CD34+ cell mobilization was obtained in four of six eligible patients and two had ASCT. Hematologic and extra-hematologic toxicity was tolerable. Failure-free survival was 79.6% at median follow-up of 6 months (range 2–12). Molecular remissions were documented in two patients with mantle cell NHL.
Conclusions: Based on the results of this pilot study, we conclude that the R-GIFOX regimen is feasible, tolerable, effective and able to mobilize peripheral stem cells in patients with relapsed and refractory aggressive NHL.
Key words: lymphoma, salvage therapy, mobilization, gemcitabine, ifosfamide, oxaliplatin
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  T El Gnaoui, J Dupuis, K Belhadj, J-P Jais, A Rahmouni, C Copie-Bergman, I Gaillard, M Divine, I Tabah-Fisch, F Reyes, et al. Rituximab, gemcitabine and oxaliplatin: an effective salvage regimen for patients with relapsed or refractory B-cell lymphoma not candidates for high-dose therapy Ann. Onc., August 1, 2007; 18(8): 1363 - 1368. [Abstract] [Full Text] [PDF]
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