Ganglioside-monosialic acid (GM1) prevents oxaliplatin-induced peripheral neurotoxicity in patients with gastrointestina
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WORLD JOURNAL OF SURGICAL ONCOLOGY
RESEARCH
Open Access
Ganglioside-monosialic acid (GM1) prevents oxaliplatin-induced peripheral neurotoxicity in patients with gastrointestinal tumors Yanyun Zhu†, Junlan Yang†, Shunchang Jiao* and Tiefeng Ji
Abstract Background: Oxaliplatin, an effective antineoplastic agent againstgastrointestinal tumors, can cause severe peripheral neurotoxicity, which seriously limits its clinical application. To date, there are no effective treatments for this complication. Ganglioside-monosialic acid (GM1) has been shown to protect neurons against injuries and degeneration. The aim of this study was to evaluate the effects of GM1 on preventing oxaliplatin-induced neurotoxicity in patients with gastrointestinal tumors. Methods: In this study, 120 patients with gastrointestinal tumors were enrolled, andthey received the treatment of XELOX (oxaliplatin and capecitabine) and FOLFOX4 (oxaliplatin, leukovolin and 5-fluorouracil). The patients were randomly divided into two groups, the experimental group and control group, with60 patients ineach. On the day chemotherapy was initiated, the experimental group received GM1 intravenously (100 mg once daily) for 3 days, while no neuroprotective agents were applied in the control group. The incidence rates and classification of neurotoxicity in the two groups were evaluated and the differences between the two groups were examined. Furthermore, whether GM1 affected the therapeutic effects of chemotherapy was also examined. Results: The grade of neurotoxicity in the experimental group was significantly lower than in the control group (P3 months; ECOG performance status of 0 to 1; tumors demonstrated as gastric cancer or colorectal cancer by pathology, and treated by chemotherapy containing oxaliplatin; routine blood tests performed 0 to 3 days before chemotherapy (absolute neutrophil ≥1.5 × 109/L, platelets ≥100 × 109/L and hemoglobin ≥9 g/dL); hepatic function test (aspartate aminotransaminase and alanine aminotransferase lower than 1.5 fold of the upper limit of normal values, and lower than 2.5 fold of the upper limit of normal values in patients with known hepatic metastases); renal function test (a calculated creatinine clearance rate 10% weight loss in the previous 6 weeks, or other serious concomitant disorders were excluded from the therapy. Patients were discontinued from the therapy in the case of
Zhu et al. World Journal of Surgical Oncology 2013, 11:19 http://www.wjso.com/content/11/1/19
evidence of progressive disease or unacceptable toxicity despite dose adjustment. This study was conducted according to the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, including obtaining written informed consent from all patients. This study was registered at the Department of Scientific Research, Chinese PLA General Hospital (register number: 2007–3048). Sample size
The sample size was calculated based on significant neurotoxicity relief. Considering a 0.05 two-sided significance level, a power of 80% and an
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