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.

Abstract : Background There is currently no international consensus for first-line treatment (prior to autologous stem cell transplantation) in mantle cell lymphoma patients. Here, we investigated the efficacy and tolerance of VAD associated with chlorambucil (VAD+C) and rituximab or not before autologous stem cell transplantation. DESIGN AND METHODS: Between 1996 and 2005, 113 previously untreated mantle cell lymphoma 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 of 4 courses of (R)VAD+C showed very low hematologic and extra-hematologic toxicity (grade 3-4 thrombopenia and neutropenia, 9% and 2.7%, respectively and grade 3-4 extra-hematologic toxicities, 1.6%). Overall and complete response rates were 73% and 46%, respectively, and rose 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 complete remission. Progression free and overall survival 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 risk groups with markedly different median overall survival of 112, 44 and 11 months, respectively. Conclusions 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 overall survival (ClinicalTrials.gov Identifier: NCT00285389).
Type de document :
Article dans une revue
Haematologica, Ferrata Storti Foundation, 2010, 95 (8), pp.1350-7. 〈10.3324/haematol.2009.011759〉
Liste complète des métadonnées

Littérature citée [38 références]  Voir  Masquer  Télécharger

http://www.hal.inserm.fr/inserm-00508037
Contributeur : Philippe Saas <>
Soumis le : mardi 28 décembre 2010 - 11:07:15
Dernière modification le : vendredi 27 juillet 2018 - 15:20:02
Document(s) archivé(s) le : mardi 29 mars 2011 - 02:35:32

Fichier

1350.pdf
Fichiers éditeurs autorisés sur une archive ouverte

Identifiants

Citation

Rémy Gressin, Sylvie Caulet-Maugendre, Eric Deconinck, Olivier Tournilhac, Emmanuel Gyan, et al.. 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.. Haematologica, Ferrata Storti Foundation, 2010, 95 (8), pp.1350-7. 〈10.3324/haematol.2009.011759〉. 〈inserm-00508037〉

Partager

Métriques

Consultations de la notice

1895

Téléchargements de fichiers

1081