Abstract 336P
Background
CIPN is a dose-limiting and disabling side effect of oxaliplatin and/or paclitaxel. We prospectively evaluated the efficacy of methylcobalamin administered intravenously for CIPN.
Methods
Thirty patients with gastrointestinal cancer who were receiving oxaliplatin and/or paclitaxel and had peripheral neuropathy of CTCAE ≥ 2 were enrolled to the trial. Each patient recieving chemotherapy containing oxaliplatin and/or paclitaxel and devoloping CIPN>Grade 1 was assessed CIPN on day 3 and (T1) a day before the next cycle (T2) with Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) for two cycles. Methylcobalamin intramuscularly was used for the first cycle and intravenously for the second cycle in the first 15 patients. Injection order was reversed in the latter 15 patients. Methylcobalamin 5 mg/d was given from day 3 to a day before the next cycle. The primary end point was a change of CIPNAT score between T1 and T2.
Results
Thirty patients were enrolled and completed the trial. Median age was 62 (range, 31- 76), male/female was 20/10. Most primary sites were gastric cancer (n=13), colorectal cancer (n=12). Most regimens were paclitaxel/oxaliplatin/5-FU (n=13), FOLFOXIRI (n=11), FOLFOX (n=3), paclitaxel/5-FU (n=2), nab-paclitaxel (n=1). The mean number of cycles of chemotherapy before the start of methylcobalamin injection was 6 (1-12). The total CIPNAT scores (mean±SD) were 148.90±56.09 for T1, 41.40±37.52 for T2 in the intravenous cycle, 158.90±57.02 for T1, 120.20±56.02 for T2 in the intramuscular cycle. A decline in CIPNAT score (mean±SD) between T1 and T2 was 107.50±42.04 in the intravenous cycle, and 38.70±30.33 in the intramuscular cycle (Z=5.715, P<0.001). No significant drug and injection-related side effects were observed in both groups.
Conclusions
Intravenous methylcobalamin is more effective than intramuscular injection in oxaliplatin and/or paclitaxel-induced peripheral neurotoxicity.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Rongbo Lin.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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