1. Phase 2 trial of bortezomib in combination with rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with bortezomib, rituximab, methotrexate, and cytarabine for untreated mantle cell lymphoma.
- Author
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Romaguera JE, Wang M, Feng L, Fayad LE, Hagemeister F, McLaughlin P, Rodriguez MA, Fanale M, Orlowski R, Kwak LW, Neelapu S, Oki Y, Pro B, Younes A, Samaniego F, Fowler N, Hartig K, Valentinetti M, Smith J, Ford P, Naig A, Medeiros LJ, Kantarjian HM, and Goy A
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Bortezomib administration & dosage, Bortezomib adverse effects, Chemotherapy-Induced Febrile Neutropenia etiology, Cyclophosphamide administration & dosage, Cyclophosphamide adverse effects, Cytarabine administration & dosage, Cytarabine adverse effects, Dexamethasone administration & dosage, Dexamethasone adverse effects, Dose-Response Relationship, Drug, Doxorubicin administration & dosage, Doxorubicin adverse effects, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Incidence, Kaplan-Meier Estimate, Lymphoma, Mantle-Cell mortality, Male, Methotrexate administration & dosage, Methotrexate adverse effects, Middle Aged, Neoplasm Recurrence, Local prevention & control, Prospective Studies, Rituximab administration & dosage, Rituximab adverse effects, Survival Rate, Time Factors, Treatment Failure, Vincristine administration & dosage, Vincristine adverse effects, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Chemotherapy-Induced Febrile Neutropenia epidemiology, Lymphoma, Mantle-Cell drug therapy, Neoplasm Recurrence, Local epidemiology
- Abstract
Background: Although the outcomes of patients with mantle cell lymphoma (MCL) have improved, there is still no cure. Bortezomib has a 33% response rate in relapsed/refractory MCL and has shown additive and/or synergistic effects in preclinical trials with known effective agents., Methods: This is a report of a prospective phase 2 trial of bortezomib added to rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (BzR-hyperCVAD)/rituximab, high-dose methotrexate, and high-dose cytarabine (BzR-MA) for 95 patients with newly diagnosed MCL., Results: The overall and complete response rates were 100% and 82%, respectively. Hematologic toxicity was high but expected and did not lead to an increased incidence of neutropenic fever or dose reductions in comparison with a similar reported regimen without bortezomib. After a median follow-up of 44 months, the median overall survival had not been reached, and the time to treatment failure (TTF) was 55 months, which is not different from that of historical controls., Conclusions: BzR-hyperCVAD/BzR-MA at the dose and schedule studied produced high rates of response and a TTF similar to that of historical reports without bortezomib. Cancer 2018;124:2561-9. © 2018 American Cancer Society., (© 2018 American Cancer Society.)
- Published
- 2018
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