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Annals of Oncology Advance Access originally published online on May 11, 2007
Annals of Oncology 2007 18(8):1363-1368; doi:10.1093/annonc/mdm133
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© 2007 European Society for Medical Oncology

hematologic malignancies

Rituximab, gemcitabine and oxaliplatin: an effective salvage regimen for patients with relapsed or refractory B-cell lymphoma not candidates for high-dose therapy

T El Gnaoui1,{dagger}{dagger}, J Dupuis1,{dagger}{dagger}, K Belhadj1, J-P Jais2, A Rahmouni3, C Copie-Bergman4, I Gaillard1, M Diviné1, I Tabah-Fisch5, F Reyes1,{dagger} and C Haioun1,*

1 Department of Clinical Hematology, Henri Mondor Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP) and Paris XII University, Créteil
2 Department of Biostatistics, Necker Hospital, AP-HP and Paris V University, Paris
3 Department of Radiology
4 Department of Pathology, Henri Mondor Hospital, AP-HP and Paris XII University, Créteil
5 Sanofi-Aventis, Paris, France

* Correspondence to: Dr C. Haioun, Service d'Hématologie Clinique, Hôpital Henri Mondor, 51, Ave de Lattre de Tassigny, 94000 Créteil, France. Tel: +33-1-49-81-20-51; Fax: +33-1-49-81-29-67; E-mail: corinne.haioun{at}hmn.aphp.fr

Background: High-dose therapy (HDT) with stem-cell support is the reference treatment for relapsed lymphoma, but is not appropriate for all patients. Conventional salvage chemotherapies have been used with limited efficacy and significant toxicity. Rituximab, gemcitabine and oxaliplatin are active as single agents in relapsed or refractory lymphoma, and have demonstrated synergistic effects in vitro and in vivo.

Patients and methods: Forty-six patients with relapsed or refractory B-cell lymphoma received up to eight cycles of R-GemOx (rituximab 375 mg/m2 on day 1, gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on day 2). The majority (72%) had diffuse large B-cell lymphoma.

Results: After four cycles of R-GemOx, the overall response rate was 83% [50% complete response (CR)/unconfirmed CR (CRu)]. High CR/CRu rates were observed in all histological subtypes. In patients who had previously received rituximab, the CR/CRu rate after eight cycles was 65%. The 2-year event-free and overall survival rates (median follow-up of 28 months) were 43% and 66%, respectively. Among responders, the probability of being disease free for 2 years was 62%. Treatment was generally well tolerated.

Conclusion: R-GemOx shows promising activity with acceptable toxicity in patients with relapsed/refractory B-cell lymphoma who are not eligible for HDT.

Key words: gemcitabine, lymphoma, oxaliplatin, refractory, R-GemOx, rituximab

{dagger} FR passed away on August 13th, 2006.

{dagger}{dagger} Both contributed equally to this study.

Received for publication March 16, 2007. Accepted for publication March 21, 2007.


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