Adjuvant Pelvic Radiation Therapy vs Vaginal Brachytherapy Plus Chemotherapy in Endometrial Cancer
As reported in the Journal of Clinical Oncology by Randall et al, the phase III Gynecologic Oncology Group (GOG)-0249 trial showed similar outcomes with adjuvant pelvic radiation therapy vs vaginal brachytherapy plus paclitaxel/carboplatin in high-intermediate and high-risk early-stage endometrial cancer.
Study Details
In the open-label study, 601 patients were randomly assigned between 2009 and 2013 to receive pelvic radiotherapy at 45 to 50.4 Gy over 5 weeks (n = 301) or vaginal cuff brachytherapy (VCB) followed by paclitaxel 175 mg/m2 plus carboplatin (area under the curve = 6) every 21 days for 3 cycles (n = 300). Eligible patients had International Federation of Gynecology and Obstetrics stage I endometrioid histology with GOG protocol 33–based high intermediate-risk criteria, stage II disease, or stage I to II serous or clear cell tumors. The primary outcome measure was recurrence-free survival. Patients had a median age of 63 years and 74% had stage I disease; histologies included endometrioid (71%), serous (15%), and clear cell (5%).
Recurrence-Free Survival
Median follow-up was 53 months. Recurrence-free survival at 60 months was 76% in the pelvic radiotherapy group vs 76% in the VCB/chemotherapy group (hazard ratio [HR] = 0.92, P = .31). Recurrence-free survival at 12, 24, and 36 months was 93% vs 91%, 85% vs 86%, and 82% vs 82%. Overall survival at 60 months was 87% vs 85% (HR = 1.04, P = .57). Pelvic or para-aortic nodal recurrences were more common with VCB/chemotherapy (9% vs 4% at 5 years, HR = 0.47, 95% confidence interval = 0.24–0.94). Rates of vaginal and distant recurrences were similar between the groups. No heterogeneity of treatment effect in recurrence-free or overall survival was identified among evaluated clinical and pathologic factors.
Adverse Events
The VCB/chemotherapy group had more frequent and severe acute adverse events, with late toxicities being similar between the groups. Adverse events of grade ≥ 2 occurred in 94% of the VCB/chemotherapy group vs 44% of the pelvic radiotherapy group. At 24 months, sensory neuropathy of grade ≥ 2 had occurred in 10% vs < 1% of patients.
The investigators concluded: “Superiority of VCB/[chemotherapy] compared with pelvic radiotherapy was not demonstrated. Acute toxicity was greater with VCB/[chemotherapy]; late toxicity was similar. Pelvic radiotherapy alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.”
Marcus E. Randall, MD, of the Department of Radiation Medicine, University of Kentucky, Lexington, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit jco.ascopubs.org.
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