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A double-blind, randomized trial of pyridoxine versus placebo for the prevention of pegylated liposomal doxorubicin-related hand-foot syndrome in gynecologic oncology patients†
Article first published online: 13 JUL 2010
Copyright © 2010 American Cancer Society
Volume 116, Issue 20, pages 4735–4743, 15 October 2010
How to Cite
von Gruenigen, V., Frasure, H., Fusco, N., DeBernardo, R., Eldermire, E., Eaton, S. and Waggoner, S. (2010), A double-blind, randomized trial of pyridoxine versus placebo for the prevention of pegylated liposomal doxorubicin-related hand-foot syndrome in gynecologic oncology patients. Cancer, 116: 4735–4743. doi: 10.1002/cncr.25262
Presented at the 2009 Annual Meeting of the American Society of Clinical Oncology, Orlando, Florida, May 29 to June 2, 2009.
- Issue published online: 13 JUL 2010
- Article first published online: 13 JUL 2010
- Manuscript Accepted: 11 JAN 2010
- Manuscript Revised: 10 DEC 2009
- Manuscript Received: 26 OCT 2009
- hand-foot syndrome;
- pegylated liposomal doxorubicin;
- ovarian cancer;
- quality of life
The objective of this study was to compare the incidence of hand-foot syndrome (HFS) in patients who received pyridoxine versus placebo during pegylated liposomal doxorubicin (PLD) chemotherapy for recurrent ovarian, breast, or endometrial cancer.
Patients received PLD 40 mg/m2 for a maximum of 6 cycles. Patients were assigned randomly to receive pyridoxine 100 mg twice daily (Group A) or placebo (Group B) and received standard HFS education. Patients completed the Functional Assessment of Cancer Therapy quality-of-life (QOL) questionnaire. The incidence of HFS as measured by common toxicity criteria was compared between groups. Analyses were conducted according to an intent-to-treat basis. Chi-square tests or Fisher exact tests were used.
Thirty-four patients were enrolled (18 in Group A and 16 in Group B), and 5 patients were unevaluable for HFS assessment. Overall, 15 of 29 patients (52%) had HFS (all grades), and 10 of 29 patients (35%) had grade 2/3 events. Eight of 15 patients in Group A (53%) and 7 of 14 patients in Group B (50%) had HFS (P = .857). For grade 2/3 events, there was no difference between groups: Six of 15 events (40%) occurred in Group A, and 4 of 14 events (29%) occurred in Group B (P = .70). There was no difference in QOL scores between patients who had grade 2/3 HFS and patients who had grade 0/1 HFS. QOL analysis revealed that all patients had elevated social well being.
Pyridoxine as administered in the current study did not prevent HFS in patients who received PLD. It is possible that QOL is not compromised in patients with HFS because they may have increased social well being while coping with their disease. Cancer 2010. © 2010 American Cancer Society.