Background: The authors reviewed the incidence of toxic skin reactions in patients with metastatic breast carcinoma (MBC) treated with vinorelbine as a continuous infusion.
Methods: A Phase I/II protocol was designed in which vinorelbine was given as an 8-mg intravenous bolus followed by a 96-hour CI of 7-14 mg/m2/day. Sixty patients were enrolled in the study: all had MBC and had received prior chemotherapy, and they had no known dermatologic disorder.
Results: Hand-foot syndrome (HFS) developed in 4 of the 60 patients. Patient 1 started with vinorelbine at 12 mg/m2/day. She developed typical HFS. In the second course, her dose was decreased to 11 mg/m2/day, but again she experienced HFS. In the third course, dexamethasone was added to the regimen, and no HFS was observed in the remaining six courses. Patient 2 started with a dose of 9 mg/m2/ day. She received four courses without complications; but when the vinorelbine dose was escalated to 10 mg/m2/day, HFS developed. Patient 3 started with a vinorelbine dose of 14 mg/m2/day. She developed mucositis during the first two courses and HFS during the third. Patient 4 received vinorelbine at a dose of 13 mg/m2/day and developed significant HFS. All patients had complete dermatologic recovery. No toxic skin reactions were observed in 14 patients receiving vinorelbine doses of <10 mg/m2/day, whereas 4 of 46 treated at 10-14 mg/m2/day developed HFS, suggesting a relationship of dose to HFS occurrence.
Conclusions: Longer infusions of vinorelbine are occasionally associated with HFS. The pathophysiology is not completely clear, but a relationship of HFS occurrence to dose is suggested. Steroids were effective as prophylaxis in one patient.