2022-RA-1091-ESGO A phase II trial of Docetaxel/cisplatin chemotherapy followed by pelvic radiation therapy in patients with high-risk endometrial carcinoma after staging surgery. (20th October 2022)

• Record Type: Journal Article
• Authors: Cho, Yoon-Jung; Park, Jeong-Yeol; Cheol, Lim Myong; Lee, Yeon Jee; Park, Sang-Yoon; Nam, Joo-Hyun
• Is Part Of: International journal of gynecological cancer. Volume 32(2022)Supplement 2
• Page Start: A134
• Page End: A134
• Publication Date: 2022-10-20
• Subjects: Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2022-ESGO.288
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : Introduction/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. Methodology: This was a prospective, phase 2, multicenter clinical trial (Clinical trial identifier: NCT01461746 ). 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/m 2 ) and cisplatin (60 mg/m 2 ) 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. Conclusion: 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.