Phase III trial: Adjuvant pelvic radiation therapy versus vaginal brachytherapy plus paclitaxel/carboplatin in high-intermediate and high-risk early stage endometrial cancer Journal Article


Authors: Randall, M. E.; Filiaci, V.; McMeekin, D. S.; von Gruenigen, V.; Huang, H.; Yashar, C. M.; Mannel, R. S.; Kim, J. W.; Salani, R.; DiSilvestro, P. A.; Burke, J. J.; Rutherford, T.; Spirtos, N. M.; Terada, K.; Anderson, P. R.; Brewster, W. R.; Small, W.; Aghajanian, C. A.; Miller, D. S.
Article Title: Phase III trial: Adjuvant pelvic radiation therapy versus vaginal brachytherapy plus paclitaxel/carboplatin in high-intermediate and high-risk early stage endometrial cancer
Abstract: PURPOSEThe primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma.PATIENTS AND METHODSA randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had 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. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m(2) (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles.RESULTSThe median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9% v 4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated.CONCLUSIONSuperiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.
Keywords: chemotherapy; radiotherapy; irradiation; outcomes; chemoradiotherapy; quality-of-life; papillary serous carcinoma; multicenter; open-label; portec-3
Journal Title: Journal of Clinical Oncology
Volume: 37
Issue: 21
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2019-07-20
Start Page: 1810
End Page: 1818
Language: English
ACCESSION: WOS:000479011100006
DOI: 10.1200/jco.18.01575
PROVIDER: wos
PUBMED: 30995174
Notes: Article -- Source: Wos
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