Australasian multicentre phase II study of paclitaxel (Taxol) in relapsed ovarian cancer.

BACKGROUND

Until recently there has been no effective therapy for patients with relapsed ovarian carcinoma following standard platinum based 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.

METHODS

Paclitaxel was given on an outpatient basis as a three hour infusion every 21 days for a maximum of ten cycles to 72 patients with advanced ovarian cancer previously treated with at least one platinum containing regimen. The starting dose was either 175 mg/m2 (patients with one or two prior chemotherapy regimens) or 135 mg/m2 (three previous regimens). Premedication was given because of the documented risk of hypersensitivity reactions to paclitaxel.

RESULTS

The overall response rate was 22% (95% confidence interval [CI] 13% to 34%) in the 72 patients 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 and 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 given as a three hour infusion has significant activity and acceptable toxicity in advanced ovarian carcinoma previously treated with platinum regimens.