Efficacy and safety of frontline rituximab, cyclophosphamide, doxorubicin and prednisone plus bortezomib (VR-CAP) or vincristine (R-CHOP) in a subset of newly diagnosed mantle cell lymphoma patients medically eligible for transplantation in the randomized, phase 3 LYM-3002 study.

Abstract

This post-hoc subanalysis of the LYM-3002 phase 3 study assessed the efficacy and safety of substituting vincristine in rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHOP; n = 42) for bortezomib (VR-CAP; n = 38) in a subgroup of 80 mantle cell lymphoma (MCL) patients aged <60 years who did not receive stem cell transplantation (SCT) despite medical eligibility. Complete response (CR)/unconfirmed CR (CRu) rates were 67 vs. 39% (odds ratio 3.69 [95% CI(confidence interval): 1.31, 10.41]; p = .012). After 40 months median follow-up, median progression-free survival by independent radiology committee with VR-CAP vs. R-CHOP was 32.6 vs. 12.0 months (hazard ratio (HR) 0.59 [95% CI: 0.31, 1.13]; p = .108); median overall survival was not reached vs. 47.3 months (HR 0.81 [95% CI: 0.33, 1.96]; p = .634). Adverse events included neutropenia (92/76%), thrombocytopenia (70/10%) and leukopenia (65/50%). VR-CAP represents a potential alternative to R-CHOP in combined and/or alternating regimens for younger, SCT-eligible MCL patients.

• Authors: Johannes Drach, Huiqiang Huang, Olga Samoilova, Andrew Belch, Charles Farber, André Bosly, Jan Novak, Jan Zaucha, Angela Dascalescu, Udomsak Bunworasate, Zvenyslava Masliak, Kateryna Vilchevskaya, Tadeusz Robak, Lixia Pei, Brendan Rooney, Helgi van de Velde, Franco Cavalli
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 59 Issue 4 Pg. 896-903 (04 2018) ISSN: 1029-2403 [Electronic] United States
• PMID: 29338540 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Murine-Derived
• R-CHOP protocol
• Rituximab
• Vincristine
• Bortezomib
• Doxorubicin
• Cyclophosphamide
• Prednisone

Topics

• Adult
• Age Factors
• Antibodies, Monoclonal, Murine-Derived (adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bortezomib (adverse effects, therapeutic use)
• Cyclophosphamide (adverse effects, therapeutic use)
• Doxorubicin (adverse effects, therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Leukopenia (chemically induced, epidemiology)
• Lymphoma, Mantle-Cell (mortality, therapy)
• Male
• Middle Aged
• Neutropenia (chemically induced, epidemiology)
• Practice Guidelines as Topic
• Prednisone (adverse effects, therapeutic use)
• Progression-Free Survival
• Rituximab (adverse effects, therapeutic use)
• Stem Cell Transplantation (standards)
• Thrombocytopenia (chemically induced, epidemiology)
• Treatment Outcome
• Vincristine (adverse effects, therapeutic use)