Phase III trial: Adjuvant pelvic radiation therapy vs vaginal brachytherapy plus paclitaxel/carboplatin in high-intermediate and high-risk early stage endometrial cancer
Journal of Clinical Oncology Jul 24, 2019
Randall ME, et al. - In patients with high-intermediate and high-risk early-stage endometrial carcinoma, researchers examined if increased recurrence-free survival could be achieved with vaginal cuff brachytherapy and chemotherapy (VCB/C) vs pelvic radiation therapy (RT). To be included in this randomized phase 3 trial, patients were required to have International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33–based high-intermediate–risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Using randomization, patients were administered RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m2 (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles. Findings did not reveal any superiority of VCB/C vs pelvic RT, though with VCB/C, greater acute toxicity and comparable late toxicity were observed. For high-risk early-stage endometrial carcinomas of all histologies, good tolerability, effectiveness, as well as the suitability of pelvic RT alone as adjuvant therapy was shown in this study.
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