A double-blind, randomized trial of pyridoxine versus placebo for the prevention of pegylated liposomal doxorubicin-related hand-foot syndrome in gynecologic oncology patients.
BACKGROUND
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.


METHODS
Patients received PLD 40 mg/m(2) 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.


RESULTS
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.


CONCLUSIONS
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.
von Gruenigen
Vivian
V
Department of Obstetrics and Gynecology, Summa Akron City Hospital, Akron, Ohio 44309-2090, USA. vongruev@summa-health.org
Frasure
Heidi
H
Fusco
Nancy
N
DeBernardo
Robert
R
Eldermire
Elisa
E
Eaton
Susan
S
Waggoner
Steven
S
D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D004311:Double-Blind Method; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives*; D016889:Endometrial Neoplasms / Q000188:drug therapy; D005260:Female; D005533:Foot Dermatoses / Q000139:chemically induced / Q000188:drug therapy*; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D006229:Hand Dermatoses / Q000139:chemically induced / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D011092:Polyethylene Glycols / Q000009:adverse effects*; D011736:Pyridoxine / Q000627:therapeutic use*; D011788:Quality of Life; D014803:Vitamin B Complex / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D010919:Placebos; C506643:liposomal doxorubicin; D014803:Vitamin B Complex; D011092:Polyethylene Glycols; D004317:Doxorubicin; D011736:Pyridoxine