AUSTRALASIAN MULTICENTER PHASE-II STUDY OF PACLITAXEL (TAXOL) IN RELAPSED OVARIAN-CANCER

Background: Until recently there has been no effective therapy for pat ients with relapsed ovarian carcinoma following standard platinum base d chemotherapy. Paclitaxel has recently been approved for clinical use in this malignancy. Aims: To evaluate the objective response rate and toxicity of paclitaxel in patients with relapsed ovarian cancer. Meth ods: Paclitaxel was given on an outpatient basis as a three hour infus ion every 21 days for a maximum of ten cycles to 72 patients with adva nced ovarian cancer previously treated with at least one platinum cont aining regimen. The starting dose, was either 175 mg/m(2) (patients wi th one or two prior chemotherapy regimens) or 135 mg/m(2) (three previ ous regimens). Premedication was given because of the documented risk of hypersensitivity reactions to paclitaxel.Results: The overall respo nse rate was 22% (95% confidence interval [CI] 13% to 34%) in the 72 p atients enrolled in the study: four patients had a complete response. Three patients (4%) ceased treatment due to hypersensitivity reactions . Other significant (WHO grade 3 or 4) toxicities included neutropenia (51%), myalgia (14%), neurological (3%), alopecia (93%) and nausea an d vomiting (3%). The estimated median survival of all patients was 9.8 months (95% CI: 9.1-13.0 months) with 44% alive at one year (standard error [SE] 7%). Conclusions: This study confirms that paclitaxel give n as a three hour infusion has significant activity and acceptable tox icity in advanced ovarian carcinoma previously treated with platinum r egimens.