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

Both ifosfamide and vinorelbine have been shown to produce responses in wom en with previously treated ovarian cancer. However, vinorelbine has been re ported to cause severe neuropathy in patients previously treated with pacli taxel. We assessed a regimen consisting of ifosfamide 1.6 g/m(2)/d and vino relbine 30 mg/m(2)/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 m g/m(2)/d and vinorelbine 20 mg/m(2)/d. Peripheral sensory neuropathy was ev aluated by questionnaire. A total of 30 women were treated. All had previou sly 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 al most half the patients had not been exposed to cyclophosphamide, this regim en 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 p atients who have received prior paclitaxel and who have have mild baseline sensory neuropathy.