Yanhong Su1, Jiajia Huang1, Shusen Wang1, Joseph M Unger2, Jonathan Arias-Fuenzalida3, Yanxia Shi1, Jibin Li4, Yongxiang Gao5, Wei Shi1, Xinyue Wang1, Roujun Peng1, Fei Xu1, Xin An1, Cong Xue1, Wen Xia1, Ruoxi Hong1, Yongyi Zhong1, Ying Lin6, Heng Huang7, Anqin Zhang8, Lehong Zhang9, Li Cai10, Jinxin Zhang5, Zhongyu Yuan1. 1. Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China. 2. Department of Health Services Research, Fred Hutchinson Cancer Research Center, Seattle, WA. 3. Department of Biosciences and Nutrition, Karolinska Institutet, Stockholm, Sweden. 4. Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. 5. Department of Medical Statistics and Epidemiology, Sun Yat-sen University, Guangzhou, Guangdong, China. 6. Department of Breast Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China. 7. Department of Breast Surgery, Lianjiang People's Hospital, Lianjiang, Guangdong, China. 8. Breast Disease Center, Guangdong Women and Children's Hospital, Guangzhou, Guangdong, China. 9. Department of Breast Surgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China. 10. The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.
Abstract
BACKGROUND:Taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. We assessed the effects of GM1 on the prevention of TIPN in breast cancer patients. METHODS: We conducted a randomized, double-blind, placebo-controlled trial including 206 patients with early-stage breast cancer planning to receivetaxane-based adjuvant chemotherapywith a follow-up of more than 1 year. Subjects were randomly assigned to receive GM1 (80 mg, day -1 to day 2) or placebo. The primary endpoint was the Functional Assessment of Cancer Treatment Neurotoxicity subscale score after four cycles of chemotherapy. Secondary endpoints included neurotoxicity evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 and the Eastern Cooperative Oncology Group neuropathy scale. All statistical tests were two-sided. RESULTS: In 183 evaluable patients, the GM1 group reported better mean Functional Assessment of Cancer Treatment Neurotoxicity subscale scores than patients in the placebo group after four cycles of chemotherapy (43.27, 95% confidence interval [CI] = 43.05 to 43.49 vs 34.34, 95% CI = 33.78 to 34.89; mean difference = 8.96, 95% CI = 8.38 to 9.54, P < .001). Grade 1 or higher peripheral neurotoxicity in Common Terminology Criteria for Adverse Events v4.0 scale was statistically significantly lower in the GM1 group (14.3% vs 100.0%, P < .001). Additionally, the GM1 group had a statistically significantly lower incidence of grade 1 or higher neurotoxicity assessed by Eastern Cooperative Oncology Group neuropathy scale sensory neuropathy (26.4% vs 97.8%, P < .001) and motor neuropathy subscales (20.9% vs 81.5%, P < .001). CONCLUSIONS: The treatment with GM1 resulted in a reduction in the severity and incidence of TIPN after four cycles of taxane-containing chemotherapy in patients with breast cancer.
RCT Entities:
BACKGROUND:Taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. We assessed the effects of GM1 on the prevention of TIPN in breast cancerpatients. METHODS: We conducted a randomized, double-blind, placebo-controlled trial including 206 patients with early-stage breast cancer planning to receive taxane-based adjuvant chemotherapy with a follow-up of more than 1 year. Subjects were randomly assigned to receive GM1 (80 mg, day -1 to day 2) or placebo. The primary endpoint was the Functional Assessment of Cancer Treatment Neurotoxicity subscale score after four cycles of chemotherapy. Secondary endpoints included neurotoxicity evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 and the Eastern Cooperative Oncology Group neuropathy scale. All statistical tests were two-sided. RESULTS: In 183 evaluable patients, the GM1 group reported better mean Functional Assessment of Cancer Treatment Neurotoxicity subscale scores than patients in the placebo group after four cycles of chemotherapy (43.27, 95% confidence interval [CI] = 43.05 to 43.49 vs 34.34, 95% CI = 33.78 to 34.89; mean difference = 8.96, 95% CI = 8.38 to 9.54, P < .001). Grade 1 or higher peripheral neurotoxicity in Common Terminology Criteria for Adverse Events v4.0 scale was statistically significantly lower in the GM1 group (14.3% vs 100.0%, P < .001). Additionally, the GM1 group had a statistically significantly lower incidence of grade 1 or higher neurotoxicity assessed by Eastern Cooperative Oncology Group neuropathy scale sensory neuropathy (26.4% vs 97.8%, P < .001) and motor neuropathy subscales (20.9% vs 81.5%, P < .001). CONCLUSIONS: The treatment with GM1 resulted in a reduction in the severity and incidence of TIPN after four cycles of taxane-containing chemotherapy in patients with breast cancer.
Authors: Kathryn J Ruddy; Jennifer Le-Rademacher; Mario E Lacouture; Mary Wilkinson; Adedayo A Onitilo; Amy C Vander Woude; Maria T Grosse-Perdekamp; Travis Dockter; Angelina D Tan; Andreas Beutler; Charles L Loprinzi Journal: Breast Date: 2019-09-19 Impact factor: 4.380