Abstract 24P
Background
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.
Methods
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).
Results
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.
Conclusions
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.
Clinical trial identification
NCT01461746.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.