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