Combination of rituximab, bortezomib, doxorubicin, dexamethasone and chlorambucil (RiPAD+C) as first-line therapy for elderly mantle cell lymphoma patients: results of a phase II trial from the GOELAMS.

Abstract

BACKGROUND:

There is no consensual first-line chemotherapy for elderly patients with mantle cell lymphoma (MCL). The GOELAMS (Groupe Ouest-Est des Leucémies Aiguës et Maladies du Sang) group previously developed the (R)VAD+C regimen (rituximab, vincristine, doxorubicin, dexamethasone and chlorambucil), which appeared as efficient as R-CHOP (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone) while less toxic. Based on this protocol, we now added bortezomib (RiPAD+C: rituximab, bortezomib, doxorubicin, dexamethasone and chlorambucil) given its efficacy in relapsed/refractory MCL patients. The goal of the current phase II trial was to evaluate the feasibility and efficacy of the RiPAD+C regimen as frontline therapy for elderly patients with MCL.

PATIENTS AND METHODS:

Patients between 65 and 80 years of age with newly diagnosed MCL received up to six cycles of RiPAD+C.

RESULTS:

Thirty-nine patients were enrolled. Median age was 72 years (65-80). After four cycles of RiPAD+C, the overall response rate was 79%, including 51% complete responses (CRs). After six cycles, CR rate increased up to 59%. After a 27-month follow-up, median progression-free survival (PFS) is 26 months and median overall survival has not been reached. Four patients (10%) discontinued the treatment because of a severe toxicity and seven patients (18%) experienced grade 3 neurotoxicity.

CONCLUSION:

The bortezomib-containing RiPAD+C regimen results in high CR rates and prolonged PFS with predictable and manageable toxic effects in elderly patients with MCL.

• Authors: R Houot, S Le Gouill, M Ojeda Uribe, C Mounier, S Courby, C Dartigeas, K Bouabdallah, M Alexis Vigier, M P Moles, O Tournilhac, N Arakelyan, P Rodon, A El Yamani, L Sutton, L Fornecker, D Assouline, J L Harousseau, H Maisonneuve, S Caulet-Maugendre, R Gressin, French GOELAMS group
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 23 Issue 6 Pg. 1555-61 (Jun 2012) ISSN: 1569-8041 [Electronic] England
• PMID: 22012966 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Antibodies, Monoclonal, Murine-Derived
• Boronic Acids
• Pyrazines
• Chlorambucil
• Rituximab
• Bortezomib
• Dexamethasone
• Doxorubicin

Topics

• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Murine-Derived (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Boronic Acids (administration & dosage)
• Bortezomib
• Chlorambucil (administration & dosage)
• Dexamethasone (administration & dosage)
• Disease-Free Survival
• Doxorubicin (administration & dosage)
• Female
• Humans
• Kaplan-Meier Estimate
• Lymphoma, Mantle-Cell (drug therapy, mortality)
• Male
• Pyrazines (administration & dosage)
• Rituximab
• Treatment Outcome