Abstract
5083 Background: Patients with recurrent or metastatic endometrial cancer have a poor prognosis. It has been shown that taxanes are active in this situation. The Aim of this study was to evaluate the safety, toxicity and efficacy of docetaxel administered weekly as first line chemotherapy in patients with recurrent or metastatic endometrial cancer. Methods: Between December 2000 and March 2004 35 patients with recurrent or metastatic endometrial cancer without previous chemotherapy were enrolled to receive three 6-week cycles of docetaxel 35 mg/m2/week with 2-week breaks between the cycles. Eligible patients had histologically confirmed and bi-dimensional measurable manifestations of metastatic or recurrent endometrial cancer, which were not locally controllable by surgery or radiation. Therapy response was evaluated after every 6-week cycle. Toxicities were evaluated by the NCI common toxicity criteria. Results: 35 patients were evaluable for toxicity assessment, one patient presented with severe anaphylactic reaction during the second application of docetaxel and therapy was discontinued. Thus, 34 patients were assessable for response. Overall response rate was 20.6% (3 PR and 4 CR). Clinical benefit (SD + PR + CR) was 29.4% (4 SD). One year overall survival was 47% (16/34). Median TTP and OAS were 30.7 weeks and 51.8 weeks, respectively. No grade 3 or 4 hematological toxicities occurred. Grade 3 toxicities included 1 pt with mucositis, 3 pts with non specific pain, 3 pts with alopecia, 1 pt with onychodystrophy, and 1 case of severe epistaxis. Conclusion: Docetaxel weekly has a favourable toxicity profile, is well tolerated and, compared with other single agent therapies, shows encouraging activity in patients with advanced endometrial cancer. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis
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