Absence of major peripheral neuropathy in a phase II trial of ifosfamide with vinorelbine in patients with ovarian cancer previously treated with platinum and paclitaxel.

ABSTRACT

Both ifosfamide and vinorelbine have been shown to produce responses in women with previously treated ovarian cancer. However, vinorelbine has been reported to cause severe neuropathy in patients previously treated with paclitaxel. We assessed a regimen consisting of ifosfamide 1.6 g/m2/d and vinorelbine 30 mg/m2/d for 3 days consecutively every 21 days. Because these doses resulted in severe neutropenia despite the use of granulocyte colony-stimulating factor, doses were reduced to a final level of ifosfamide 960 mg/m2/d and vinorelbine 20 mg/m2/d. Peripheral sensory neuropathy was evaluated by questionnaire. A total of 30 women were treated. All had previously been treated with both a platinum compound and paclitaxel. One partial response was observed among 23 patients with measurable disease, and two CA-125 responses were noted among seven patients without measurable disease. Severe progressive neurotoxicity was not observed. Despite the fact that almost half the patients had not been exposed to cyclophosphamide, this regimen produced few responses. Superior response rates have been reported with single-agent vinorelbine at doses that do not require growth factor support. With this dose and schedule, vinorelbine is reasonably safe therapy for patients who have received prior paclitaxel and who have have mild baseline sensory neuropathy.