PACLITAXEL (TAXOL) IN RELAPSED AND REFRACTORY OVARIAN-CANCER - THE UKAND EIRE EXPERIENCE

The purpose of our study was to investigate the efficacy and toxicity of paclitaxel in patients with relapsed or refractory epithelial ovari an cancer in the context of a large multicentre study performed in the UK and fire. Patients with previously treated epithelial carcinoma of the ovary or fallopian tube who fulfilled the eligibility criteria we re entered in the study. Eligibility criteria included: measurable or evaluable disease; Eastern Cooperative Oncology Group (ECOG) performan ce status 0-2; up to three prior chemotherapy regimens, one of which h ad to contain a platinum agent; adequate haematological, renal and hep atic function; and no significant cardiac history. Patients received e ither 175 mg m(-2) or 135 mg m(-2) paclitaxel. The lower dose was admi nistered to patients who had received more than two prior chemotherapy regimens. Paclitaxel was given by i.v. infusion over 3 h every 21 day s. Response was assessed at three-cycle intervals or earlier if requir ed. A total of 155 patients were registered for the study in the UK of whom 140 were eligible for response and toxicity evaluation, and 12 p atients were assessed for toxicity only. Hair loss was the most freque ntly reported toxicity, with 74% (119/152) of patients reporting grade 3 alopecia. The most frequently reported serious toxicity was neutrop enia, with 49% (74/152) of patients experiencing neutropenia grade 3 o r 4. The response rate was 16% [two complete responders (CR), 20 parti al responders (PR)], the median duration of response was 275 days acid median survival was 244 days. Paclitaxel is active in relapsed and pl atinum-resistant epithelial ovarian cancer. It is well tolerated and c an be given in an out-patient setting. The UK and fire experience is v ery similar to that of US investigators in this group of patients. Fur ther work is required to assess the optimal use of the drug in both fi rst- and second-line therapy.