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).
Keywords: adverse event; bortezomib; multiple myeloma; response rate.