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

Autor: Sattva S. Neelapu, Judy Smith, M. Alma Rodriguez, Michelle A. Fanale, Anas Younes, Andre Goy, L. Jeffrey Medeiros, Peggy Ford, Felipe Samaniego, Barbara Pro, Lei Feng, Frederick B. Hagemeister, Robert Z. Orlowski, Nathan Fowler, Larry W. Kwak, Jorge E. Romaguera, Adam Naig, Marisa Valentinetti, Luis Fayad, Michael Wang, Yasuhiro Oki, Hagop M. Kantarjian, Kimberly Hartig, Peter McLaughlin
Rok vydání: 2018
Předmět:
Male
0301 basic medicine
Oncology
Cancer Research
Time Factors
Kaplan-Meier Estimate
Lymphoma
Mantle-Cell
Dexamethasone
Bortezomib
0302 clinical medicine
immune system diseases
hemic and lymphatic diseases
Antineoplastic Combined Chemotherapy Protocols
Prospective Studies
Treatment Failure
Chemotherapy-Induced Febrile Neutropenia
Incidence
Cytarabine
Middle Aged
Survival Rate
Vincristine
030220 oncology & carcinogenesis
Female
Rituximab
medicine.drug
Adult
medicine.medical_specialty
Cyclophosphamide
Drug Administration Schedule
03 medical and health sciences
Internal medicine
medicine
Humans
Aged
Dose-Response Relationship
Drug
business.industry
medicine.disease
Regimen
Methotrexate
030104 developmental biology
Doxorubicin
Mantle cell lymphoma
Neoplasm Recurrence
Local
business
Follow-Up Studies
Zdroj: Cancer. 124:2561-2569
ISSN: 0008-543X
DOI: 10.1002/cncr.31361
Popis: 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.
Databáze: OpenAIRE
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