BMSEHA15
Published online 10 March 2010
(Haematologica 2010, 10.3324/haematol.2009.011759)
Copyright © 2010 by Ferrata Storti Foundation
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Article

Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed Mantle Cell Lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group

Rémy Gressin1,2, Sylvie Caulet-Maugendre3, Eric Deconinck4, Olivier Tournilhac5, Emmanuel Gyan6, Marie Pierre Moles7, Abderrazak El Yamani8, Jerome Cornillon9, Jean François Rossi10, Steven Le Gouill11, Gérard Lepeu12, Ghandi Damaj13, Philippe Solal Celigny14, Hervé Maisonneuve15, Bernadette Corront16, Jean Pierre Vilque17, Philippe Casassus18, Thierry Lamy-de-La-Chapelle3, Marc Colonna19, Philippe Colombat6 for the French GOELAMS group

1 Centre hospitalo-universitaire (CHU) de Grenoble, France and
2 INSERM, U 823, Institut Albert Bonniot, Grenoble, France
3 CHU de Rennes
4 CHU de Besançon
5 CHU de Clermont-Ferrand
6 CHU de Tours
7 CHU d'Angers
8 Centre Hospitalier (CH) de Le Mans
9 Institut de cancérologie de la Loire, Saint Etienne
10 CHU Montpellier
11 CHU Nantes
12 CH d’Avignon
13 CHU d’Amiens
14 clinique Victor Hugo de Le Mans
15 CH La Roche sur Yon
16 CH d’Annecy
17 Centre anticancéreux Baclesse de Caen
18 CHU de Bobigny and
19 Isere’s Cancer Registry, Grenoble

Correspondence: Rémy Gressin, Département d’Onco-Hématologie, CHU Michallon, BP217, 38043 Grenoble cedex 09 France/Team 7, INSERM-Université Joseph Fourier Research Centre Unité 823, Institut Albert Bonniot, Grenoble, France. Phone: international +33.04.76765333. Fax: international +33.04.76765661. E-mail: RGressin{at}chu-grenoble.fr

ABSTRACT

Background: There is currently no international consensus for first line treatment [prior to autologous stem cells transplantation (auto-SCT)] in mantle cell lymphoma (MCL) patients. Here, we investigated the efficacy and tolerance of VAD associated with chlorambucil (VAD+C) and rituximab or not [before auto-SCT]

Design and Methods: Between 1996 and 2005, 113 previously untreated MCL-patients were enrolled in two consecutive prospective phase II studies. Responses and response factors to the (R)VAD+C regimen were evaluated. The survival prognostic value of the MIPI score and Ki67 were also analyzed.

RESULTS: The induction phase [4 courses of (R)VAD+C] showed very low hematologic and extra-hematological toxicity (grade 3–4 thrombopenia and neutropenia, 9% and 2.7% respectively and grade 3–4 extra-haematological toxicities, 1.6%). Overall (ORR) and complete response (CR) rates were 73% and 46%, respectively and raised to 83% and 51% for the 70% of patients with less than two independent response factors (LDH, B symptoms and lymphocytosis). At the end of treatment 65% of patients were in CR. PFS and OS were significantly better in the transplanted population. The MIPI score was confirmed as a predictor of survival. Ki67, serum LDH, Performance Status (PS) and B-symptoms were identified as independent prognostic factors of survival. A prognostic scoring system could stratify patients into three risks groups with markedly different median OS of 112, 44 and 11 months, respectively.

CONCLUSION: The (R)VAD+C is an effective regimen with very low toxicity. In addition to the MIPI score, Ki67 expression provides additional independent prognostic information for the prediction of OS.