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.
Keywords:
Bortezomib; frontline; mantle cell lymphoma; phase 3.
Publication types
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Clinical Trial, Phase III
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Comparative Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Age Factors
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Antibodies, Monoclonal, Murine-Derived / adverse effects
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Antibodies, Monoclonal, Murine-Derived / therapeutic use
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Bortezomib / adverse effects
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Bortezomib / therapeutic use*
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Cyclophosphamide / adverse effects
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Cyclophosphamide / therapeutic use
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Doxorubicin / adverse effects
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Doxorubicin / therapeutic use
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Female
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Follow-Up Studies
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Humans
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Leukopenia / chemically induced
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Leukopenia / epidemiology
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Lymphoma, Mantle-Cell / mortality
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Lymphoma, Mantle-Cell / therapy*
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Male
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Middle Aged
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Neutropenia / chemically induced
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Neutropenia / epidemiology
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Practice Guidelines as Topic
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Prednisone / adverse effects
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Prednisone / therapeutic use
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Progression-Free Survival
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Rituximab / adverse effects
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Rituximab / therapeutic use*
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Stem Cell Transplantation / standards
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Thrombocytopenia / chemically induced
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Thrombocytopenia / epidemiology
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Treatment Outcome
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Vincristine / adverse effects
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Vincristine / therapeutic use
Substances
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Antibodies, Monoclonal, Murine-Derived
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R-CHOP protocol
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Rituximab
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Vincristine
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Bortezomib
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Doxorubicin
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Cyclophosphamide
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Prednisone