1 University of Kentucky, Lexington, KY.
2 NRG Oncology Statistical and Data Center, Buffalo, NY.
J Clin Oncol. 2019 Jul 20;37(21):1810-1818. doi: 10.1200/JCO.18.01575. Epub 2019 Apr 17.
The 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.
A 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 (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles.
The 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% 4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated.
Superiority 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.
本研究的主要目的是比较阴道残端近距离放疗联合化疗（VCB/C）与盆腔放疗（RT）在中高危早期子宫内膜癌患者中的无复发生存率（RFS）。
在符合条件的子宫内膜癌患者中进行了一项随机 III 期临床试验。符合条件的患者为国际妇产科联盟（2009 年）I 期子宫内膜样组织学，根据妇科肿瘤组 33 号协议具有中高危标准，II 期疾病，或 I 期至 II 期浆液性或透明细胞肿瘤。治疗方案在 RT（5 周内 45 至 50.4 Gy）与 VCB 后静脉注射紫杉醇 175 mg/m2（3 小时）联合卡铂（曲线下面积，6），每 21 天 3 个周期之间随机分配。
601 例患者的中位年龄为 63 岁，74%为 I 期疾病。组织学包括子宫内膜样（71%）、浆液性（15%）和透明细胞（5%）。中位随访 53 个月时，RT 的 60 个月 RFS 为 0.76（95%CI，0.70 至 0.81），VCB/C 为 0.76（95%CI，0.70 至 0.81）（风险比，0.92；90%置信区间，0.69 至 1.23）。RT 的 60 个月总生存率为 0.87（95%CI，0.83 至 0.91），VCB/C 为 0.85（95%CI，0.81 至 0.90）（风险比，1.04；90%置信区间，0.71 至 1.52）。阴道和远处复发率在两组之间相似。VCB/C 后盆腔或Para-aortic 淋巴结复发更为常见（9% 4%）。在评估的临床或病理变量中，VCB/C 与 RFS 或总生存率之间没有治疗效果的异质性。
与盆腔 RT 相比，VCB/C 的优越性并未得到证明。VCB/C 的急性毒性更大，而晚期毒性相似。盆腔 RT 单独治疗仍然是所有组织学类型的高危早期子宫内膜癌有效的、可耐受的和适当的辅助治疗方法。
