Weekly 1 hour paclitaxel infusion in patients with recurrent gynecologicaltumors: a pilot study

Background: Intensifying the dose of paclitaxel given in a weekly schedule is useful towards improving the therapeutic index of paclitaxel in treating a variety of advanced and recurrent malignancies and is suitable for outpa tient administration. This pilot study was carried out to evaluate the safe ty of weekly paclitaxel administration by 1 h infusion in the outpatient se tting. Methods: Eleven patients with recurrent gynecological tumors who had previo usly been treated with at least one platinum-based chemotherapy regimen par ticipated in the study between May 1999 and March 2000. Paclitaxel was give n at a dose of 70 mg/m(2) as a 1 h infusion every week for at least 20 cons ecutive weeks unless lesions became progressive. Intravenous dexamethasone and cimetidine and oral diphenhydramine were administered 30 min before pac litaxel infusion. Results: The 11 patients received a total of 166 cycles of therapy. All pat ients received 70 mg/m(2) doses of paclitaxel without treatment delay. No h ypersensitivity reactions were elicited. Grade 3 or 4 leukopenia and neutro penia occurred in 9 and 36% of the patients, respectively. Granulocyte colo ny-stimulating factor was required for only one patient and no patients exp erienced febrile neutropenia. Neurotoxicity was the most serious adverse ef fect and all patients experienced grade 1 or 2 peripheral neuropathy. Grade 1 or 2 myalgias were observed in 45% of the patients. Alopecia was univers al. No Grade 3 or higher non-hematological toxicities were observed. Conclusion: Weekly 1 h paclitaxel administration is considered safe as a sa lvage therapy for recurrent gynecological tumors, making its use more conve nient and easier in the outpatient setting. The current results support fur ther evaluation.