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Annals of Oncology Advance Access originally published online on October 30, 2006
Annals of Oncology 2007 18(2):370-375; doi:10.1093/annonc/mdl395
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© 2006 European Society for Medical Oncology

hematologic malignancies

Phase II study of gemcitabine–dexamethasone with or without cisplatin in relapsed or refractory mantle cell lymphoma

F Morschhauser1, S Depil1, E Jourdan2, M Wetterwald3, R Bouabdallah4, G Marit5, P Solal-Céligny6, C Sebban7, B Coiffier8, N Chouaki9, F Bauters1 and C Dumontet8,*

1 Service des Maladies du Sang, Lille, France
2 Service d'Hématologie, Nîmes, France
3 Service d'Hématologie, Dunkerque, France
4 Service d'Hématologie, Marseille, France
5 Service des Maladies du Sang, Bordeaux, France
6 Service Oncologie-Maladies du Sang, Le Mans, France
7 Centre Léon Bérard, Lyon, France
8 Service d'Hématologie, Pierre Bénite, France
9 Eli Lilly, Paris, France

* Correspondence to: Prof C. Dumontet, Service d'Hématologie, Centre Hospitalier Lyon Sud, 69310 Pierre Bénite Cedex, France. Tel: +33-4-78-86-64-30; Fax: +33-4-78-86-21-35; E-mail: charles.dumontet{at}chu-lyon.fr.

Single-agent gemcitabine has shown encouraging results in patients with mantle cell lymphoma (MCL). This phase II study further explored the potential of a gemcitabine-based regimen in patients with relapsed or refractory MCL. Patients <70 years old received the PDG regimen: gemcitabine (1000 mg/m2, days 1 and 8), dexamethasone (40 mg/m2, days 1–4), and cisplatin (100 mg/m2, day 1). Patients ≥70 years of age received dexamethasone and gemcitabine only (DG regimen). Thirty patients (12 in the DG group, 18 in the PDG group) with a median age 66.5 years (range, 47–81) received a median of six cycles in both groups. The overall response rate was 36.4% [95% confidence interval (CI), 15.2% to 64.6%] with the DG regimen and 44.4% (95% CI 24.6% to 66.3%) with the PDG regimen. The median progression-free survival was 3 months (95% CI 0.0–7.9) in the DG group and 8.5 months (95% CI 4.8–12.2) in the PDG group. With a median follow-up of 38.8 months, 13 patients (including 11 given PDG) are still alive. DG was well tolerated, and thrombocytopenia was the most prevalent toxicity in patients receiving PDG. Both regimens deserve to be further investigated as a backbone for combination chemotherapy in patients with MCL.

Key words: cisplatin, dexamethasone, gemcitabine, mantle cell lymphoma

Received for publication June 13, 2006. Revision received September 6, 2006. Accepted for publication September 14, 2006.


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