Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer
Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer
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DOI：
10.1200/jco.18.01575
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发表时间：
2019-07-20
影响因子：
45.3
通讯作者：
Miller, David S.
中科院分区：
文献类型：
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作者：
Randall, Marcus E.;Filiaci, Virginia;Miller, David S.
ESSEThe主要目的是确定阴道断端近距离放射治疗和化疗（VCB/C）增加无复发生存率（RFS）相比，盆腔放射治疗（RT）在高，中，高风险的早期子宫内膜癌。患者和方法在符合条件的子宫内膜癌患者进行随机III期试验。符合条件的患者为国际妇产科联合会（2009）I期类肉瘤组织学，妇科肿瘤组方案33基于高中风险标准，II期疾病，或I至II期浆液性或透明细胞肿瘤。治疗随机分为RT（45 ~ 50.4戈伊，5周）或VCB，随后静脉注射紫杉醇175 mg/m2（3小时）加卡铂（曲线下面积6），每21天1次，共3个周期。组织学类型包括类浆液性（71%）、浆液性（15%）和透明细胞（5%）。中位随访时间为53个月，RT和VCB/C的60个月RFS分别为0.76（95% CI，0.70 - 0.81）和0.76（95% CI，0.70 - 0.81）（风险比，0.92; 90%置信限，0.69 - 1.23）。RT组和VCB/C组的60个月总生存率分别为0.87（95% CI，0.83 - 0.91）和0.85（95% CI，0.81 - 0.90）（风险比，1.04; 90%置信限，0.71 - 1.52）。两组的阴道和远处复发率相似。盆腔或主动脉旁淋巴结复发在VCB/C组更常见（9% vs4%）。在临床或病理学变量评估中，RFS或总生存率的治疗效果无异质性。VCB/C的急性毒性更大;晚期毒性相似。单独盆腔放疗仍然是所有组织学类型的高危早期子宫内膜癌的有效、耐受性良好和适当的辅助治疗。
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.