TY - JOUR
T1 - 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
AU - Romaguera, Jorge E.
AU - Wang, Michael
AU - Feng, Lei
AU - Fayad, Luis E.
AU - Hagemeister, Frederick
AU - McLaughlin, Peter
AU - Rodriguez, M. Alma
AU - Fanale, Michelle
AU - Orlowski, Robert
AU - Kwak, Larry W.
AU - Neelapu, Sattva
AU - Oki, Yasuhiro
AU - Pro, Barbara
AU - Younes, Anas
AU - Samaniego, Felipe
AU - Fowler, Nathan
AU - Hartig, Kimberly
AU - Valentinetti, Marisa
AU - Smith, Judy
AU - Ford, Peggy
AU - Naig, Adam
AU - Medeiros, L. Jeffrey
AU - Kantarjian, Hagop M.
AU - Goy, Andre
N1 - Publisher Copyright:
© 2018 American Cancer Society
PY - 2018/6/15
Y1 - 2018/6/15
N2 - 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.
AB - 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.
KW - and dexamethasone (R-hyperCVAD)
KW - bortezomib
KW - doxorubicin
KW - mantle cell lymphoma
KW - rituximab plus hyperfractionated cyclophosphamide
KW - vincristine
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U2 - 10.1002/cncr.31361
DO - 10.1002/cncr.31361
M3 - Article
C2 - 29723393
AN - SCOPUS:85046343216
SN - 0008-543X
VL - 124
SP - 2561
EP - 2569
JO - Cancer
JF - Cancer
IS - 12
ER -