Li-Li Zhang1, Yi-Hao Wang2, Zong-Hong Shao2, Jun Ma3. 1. Tianjin Medical University, Tianjin 300070, China. 2. Department of Hematology, Tianjin Medical University General Hospital, Tianjin 300052, China. 3. Tianjin Medical University, Tianjin 300070, China. E-mail: majun@tmu.edu.cn.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of high-dose intravenous mecobalamin (HDIME) for the treatment of bortezomib-induced peripheral neuropathy(BIPN) in the patients with multiple myeloma (MM). METHODS: A total of 65 newly diagonsed patients with multiple myeloma receiving bortezomib in Tianjin Medical University General Hospital were enrolled in this single-centre randomized clinical trial from July 2012 to May 2016. Out of 65 patients 38 in control group received bortezomib-based chemotherapy and 27 patients in HDIME group received the additional high-dose intravenous mecobalamin. RESULTS: The incidence of BIPN in HDIME group was lower than that in control group(29.63% vs 55.26%, χ2=4.197,P<0.05). Whether the BIPN rate of Grade 2 or 3 and above in HDIME group significantly decreased as compared with control group(18.52% vs 47.37%,χ2=5.746,P<0.05) (3.71% vs 21.05%, χ2=3.983,P<0.05). The BIPN rate of less than 5 cycles of bortezomib was not significantly different between HDIME and control groups(χ2=2.714,P>0.05). Overall effective rate of HDIME group and control group was 77.78% and 73.68%(P>0.05) respectively. Neither PFS nor OS was significantly different between HDIME group and control group(P>0.05). Treatment-related toxicity was only mild rash in 1 case. No other side-effects including nausea, abdominal pain, and hypotension occurred. CONCLUSION: HDIME has a good efficacy for the prophylaxis BIPN and and without serious side effects.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of high-dose intravenous mecobalamin (HDIME) for the treatment of bortezomib-induced peripheral neuropathy(BIPN) in the patients with multiple myeloma (MM). METHODS: A total of 65 newly diagonsed patients with multiple myeloma receiving bortezomib in Tianjin Medical University General Hospital were enrolled in this single-centre randomized clinical trial from July 2012 to May 2016. Out of 65 patients 38 in control group received bortezomib-based chemotherapy and 27 patients in HDIME group received the additional high-dose intravenous mecobalamin. RESULTS: The incidence of BIPN in HDIME group was lower than that in control group(29.63% vs 55.26%, χ2=4.197,P<0.05). Whether the BIPN rate of Grade 2 or 3 and above in HDIME group significantly decreased as compared with control group(18.52% vs 47.37%,χ2=5.746,P<0.05) (3.71% vs 21.05%, χ2=3.983,P<0.05). The BIPN rate of less than 5 cycles of bortezomib was not significantly different between HDIME and control groups(χ2=2.714,P>0.05). Overall effective rate of HDIME group and control group was 77.78% and 73.68%(P>0.05) respectively. Neither PFS nor OS was significantly different between HDIME group and control group(P>0.05). Treatment-related toxicity was only mild rash in 1 case. No other side-effects including nausea, abdominal pain, and hypotension occurred. CONCLUSION:HDIME has a good efficacy for the prophylaxis BIPN and and without serious side effects.
Authors: Marta Maschio; Alessia Zarabla; Andrea Maialetti; Francesco Marchesi; Diana Giannarelli; Svitlana Gumenyuk; Francesco Pisani; Daniela Renzi; Edvina Galiè; Andrea Mengarelli Journal: Integr Cancer Ther Date: 2018-10-08 Impact factor: 3.279