Final analysis of RTOG 9708: Adjuvant postoperative irradiation combined with cisplatin/paclitaxel chemotherapy following surgery for patients with high-risk endometrial cancer
Final analysis of RTOG 9708: Adjuvant postoperative irradiation combined with cisplatin/paclitaxel chemotherapy following surgery for patients with high-risk endometrial cancer
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DOI：
10.1016/j.ygyno.2006.02.007
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发表时间：
2006-10-01
影响因子：
4.7
通讯作者：
Burke, Tom
中科院分区：
文献类型：
--
作者：
Greven, Kathryn;Winter, Kathryn;Burke, Tom
目的。 RTOG 完成了一项 11 期研究，以评估高危子宫内膜癌患者化疗联合辅助放疗的可行性、安全性、毒性以及复发和生存模式。材料和方法。病理学要求包括 2 级或 3 级子宫内膜腺癌，伴 > 50% 子宫肌层浸润、宫颈间质浸润或盆腔局限性宫外疾病。第 1 天和第 28 天，骨盆接受 45 Gy 25 次放射治疗，同时使用顺铂 (50 mg/m(2))。外部束放射后进行阴道近距离放射治疗。放疗完成后，每隔 4 周给予四个疗程的顺铂 (50 mg/m(2)) 和紫杉醇 (175 mg/m(2))。 结果。 10/97 至 4/99 期间纳入了 46 名患者。随访时间范围为 6.8 至 72 个月，中位随访时间为 4.3 年。最大晚期毒性为 1 级（16%）、2 级（41%）、3 级（16%）和 4 级（5%）。 4 年时盆腔、区域和远处复发率分别为 2%、2% 和 19%。 4 年总生存率和无病生存 (DFS) 率分别为 85% 和 81%。 III 期患者的四年生存率和 DFS 率分别为 77% 和 72%。 IC、IIA 或 IIB 期患者未出现复发。结论。所有患者的联合治疗后局部区域控制效果良好，表明化疗和放疗具有累加效应。在晚期患者中继续发生远处转移。该方案似乎合理，可以在随机研究中测试其疗效。 (c) 2006 Elsevier Inc. 保留所有权利。
Purpose. A phase 11 study was completed by the RTOG to assess the feasibility, safety, toxicity, and patterns of recurrence and survival when chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.Materials and methods. Pathologic requirements included grade 2 or 3 endometrial adenocarcinoma with either > 50% myometrial invasion, cervical stromal invasion, or pelvic-confined extrauterine disease. Radiation included 45 Gy in 25 fractions to the pelvis along with cisplatin (50 mg/m(2)) on days 1 and 28. Vaginal brachytherapy was performed after the external beam radiation. Four courses of cisplatin (50 mg/m(2)) and paclitaxel (175 mg/m(2)) were given at 4-week intervals following completion of radiotherapy.Results. Forty-six patients were entered between 10/97 and 4/99. Follow-up times range from 6.8 to 72 months with a median of 4.3 years. Maximum late toxicity was grade 1 in 16%, grade 2 in 41%, grade 3 in 16%, and grade 4 in 5%. At 4 years pelvic, regional and distant recurrence rates are 2%, 2%, and 19%, respectively. Overall survival and disease-free survival (DFS) rates at 4 years are 85% and 81%, respectively. Four-year rates for survival and DFS for Stage III patients are 77% and 72%, respectively. There have been no recurrences for patients with stage IC, IIA, or IIB.Conclusion. Local-regional control is excellent following combined modality treatment in all patients suggesting additive effects of chemotherapy and radiation. Distant metastases continue to occur in more advanced staged patients. This regimen appears reasonable to be tested for efficacy in randomized studies. (c) 2006 Elsevier Inc. All rights reserved.