PHASE-II STUDY OF PACLITAXEL AS SALVAGE TREATMENT IN ADVANCED ENDOMETRIAL CANCER

Objective: to evaluate the antitumour activity of paclitaxel in patien ts with endometrial cancer pretreated with cisplatin, doxorubicin and cyclophosphamide (PAC). Materials and methods: Eligible patients had c omplete initial surgery, expected survival greater than or equal to 3 months, performance status less than or equal to 1, measurable or eval uable disease. Paclitaxel was given over three hours at the dose of 17 5 mg/m(2), repeated every 3 weeks. Tumour response was first evaluated after 3 cycles. A maximum of 10 cycles was given in responders.Result s: 19 patients entered the study and a total of 105 cycles were admini stered. Complete and partial responses were achieved in 2 and 5 patien ts, respectively, for an overall response rate of 37% (95% CI: 16%-62% ). The response rate in patients refractory to platinum was 22%. One p atient is alive without evidence of disease 16 months after the start of treatment. The most common side effects were mild to moderate myalg ia and peripheral neuropathy, which occurred in 31% and 47% of patient s, respectively. in only 1 patient treatment had to be discontinued be cause of severe myalgia. Conclusion: Paclitaxel is active in patients with endometrial cancer pretreated with PAC. Further studies with pacl itaxel incorporated in the initial treatment for advanced disease are warranted.