24P A phase II trial of docetaxel/cisplatin chemotherapy followed by pelvic radiation therapy in patients with high-risk endometrial carcinoma after staging surgery

Abstract

The purpose of this study was to evaluate the efficacy of docetaxel/cisplatin chemotherapy followed by pelvic radiation therapy after staging surgery in high-risk endometrial cancer patients. This was a prospective, phase 2, multicenter clinical trial. Eligible patients included surgically staged stage I-II endometrial cancer with high-risk factors and stage III-IV endometrial cancer. Three cycles of chemotherapy consisting of docetaxel (70 mg/m2) and cisplatin (60mg/m2) was started within 5 weeks after staging surgery. Pelvic radiation therapy (45-50.4Gy) was started within 4 weeks after chemotherapy. The primary endpoint was progression-free survival (PFS). A total of 67 patients were enrolled but 9 were excluded. Median age was 54 years (range, 31-73 years). Forty patients (69%) had endometrioid adenocarcinoma. Stage was IIIC in 9 (15%), IVA in 15 (26%), and IVB in 11 patients (19%). Staging surgery was performed by open surgery in 27 patients (46%), laparoscopic surgery in 23 patients (40%), and robotic surgery in 8 patients (14%). Grade 3 and 4 hematologic toxicity was reported in 26 and 43 patients, grade 3 non-hematologic toxicity was reported in 13 patients. After a median follow-up of 58 months (range, 2-101 months), 11 patients had recurrence and 2 of them died of disease. PFS (± SE) was 90% (± 4%), 84.3% (± 4.8 %), 79.9% (± 5.5 %) at 1, 3, and 5 year, respectively. Overall survival (± SE) was 98.3% (± 1.7%), 96.2%, (± 2.6%), 96.2 (± 2.6%) at 1, 3, and 5 year, respectively. Endometrial cancer with high risk factors could benefit from adjuvant chemotherapy using docetaxel/cisplatin followed by radiation therapy with manageable toxicities. Further studies are needed with the incorporation of biological agents to estimate the real benefit of these treatment strategy.