A dose increased once-weekly bortezomib-based combination therapy for multiple myeloma
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Daolin Wei1, Yin Tong1, Haitao Bai1, Qi Cai1, Yanrong Gao1, Chun Wang1
1Department of Hematology, Shanghai General Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200080, China
Chun Wang, email: [email protected]
Keywords: multiple myeloma, bortezomib, response rate, adverse event
Received: April 21, 2016 Accepted: September 14, 2016 Published: September 21, 2016
Background: The purpose of the current study was to evaluate the efficacy and safety of a dose increased weekly Bortezomib (Bor) based combination therapy in multiple myeloma (MM) patients.
Results: The overall response rate (ORR) in the modified Bor group was 76.6%, composed of 40% complete response (CR), 3.3% very good partial response (VGPR) and 33.3% partial response (PR). The ORR was 82.3%, with 26.5% CR, 5.9% VGPR and 50% PR in control. A subgroup analysis showed both groups had equal efficacy in newly diagnosed MM patients ( P = 1.000). The median progression free survival was 16 (11.7–20.3) months for the modified Bor group and 12 (10.5–13.5) months for the control (P = 0.503), and the median overall survival was 36 (9.4–62.6) vs 28 (21.6–34.4) months (P = 0.759). The incidences of AEs were similar except grade 1–4 peripheral neuropathy (PN) rate was 10% in modified regime group and 32.4% in control (P = 0.038).
Materials and Methods: This was a monocentric, prospective, non-randomized, phase IV, non-inferiority trial. Thirty MM patients were treated with modified Bor-based combination therapy (Bor 1.6 mg/m2 on day 1, 8), with 34 MM patients on conventional Bor-based combination therapy (1.3 mg/m2 on day 1, 4, 8, 11) as control. The responses and adverse events (AEs) were compared.
Conclusions: The increased-dose weekly Bor-based combination therapies were not inferior to conventional ones in terms of response and survival benefit, but showed lower rate of peripheral neuropathy (PN).
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