Pyridoxine Is Effective for Preventing Hand-Foot Syndrome Induced by Pegylated Liposomal Doxorubicin for Multiple Myeloma: The Results of a Randomized Study

Abstract Purpose: Pegylated liposomal doxorubicin (PLD) is highly effective for treating multiple myeloma (MM). Hand-foot syndrome (HFS) is a dose-limiting adverse event of PLD that may reduce a patient’s quality of life or prevent certain patients from receiving PLD. Several researchers have discovered that pyridoxine, an activated form of vitamin B6, may prevent PLD-associated HFS. We designed a prospective randomized trial to examine whether prophylactic pyridoxine might prevent the incidence or delay the occurrence of PLD-induced HFS in patients with MM.Methods: Patients who met the trial’s eligibility requirements were randomized and then administered either pyridoxine 100 mg twice daily or no pyridoxine, in both cases accompanied by their PLD-containing chemotherapeutic agent. Follow-up of patients was performed until the completion of induction therapy, the development of HFS or disease progression.Results: Between January 1, 2017, and January 1, 2019, 105 patients were randomly assigned to the pyridoxine group (n = 52) or the no pyridoxine group (n = 53). In the pyridoxine and no pyridoxine groups, HFS developed after a median of four and three chemotherapeutic cycles, respectively. There were no grade 3 incidents recorded. Overall, 13.3% of patients experienced HFS (all grades). Eleven of 53 (20.7%) patients in the pyridoxine group experienced HFS, compared to 3 of 52 (5.7%) patients in the no pyridoxine group (p=0.042); there was no difference in HFS grades (p=0.725).Conclusions: When administered concomitantly with PLD-containing chemotherapy, prophylactic pyridoxine is effective in reducing the incidence of HFS in patients with MM.Clinical Trial Registration: ChiCTR2100050294