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放疗联合或不联合顺铂治疗子宫内膜癌局部复发:一项 NRG 肿瘤学/GOG 前瞻性随机多中心临床试验的结果。

Radiation Therapy With or Without Cisplatin for Local Recurrences of Endometrial Cancer: Results From an NRG Oncology/GOG Prospective Randomized Multicenter Clinical Trial.

机构信息

Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.

Clinical Trials Development Division, Roswell Park Comprehensive Cancer Center, Buffalo, NY.

出版信息

J Clin Oncol. 2024 Jul 10;42(20):2425-2435. doi: 10.1200/JCO.23.01279. Epub 2024 Apr 25.

Abstract

PURPOSE

Pelvic recurrence is a frequent pattern of relapse for women with endometrial cancer. A randomized trial compared progression-free survival (PFS) after treatment with radiation therapy alone as compared with concurrent chemotherapy.

MATERIALS AND METHODS

Between February 2008 and August 2020, 165 patients were randomly assigned 1:1 to receive either radiation treatment alone or a combination of chemotherapy and radiation treatment. The primary objective of this study was to determine whether chemoradiation therapy was more effective than radiation therapy alone at improving PFS.

RESULTS

The majority of patients had low-grade (1 or 2) endometrioid histology (82%) and recurrences confined to the vagina (86%). External beam with either the three-dimensional or intensity modulated radiation treatment technique was followed by a boost delivered with brachytherapy or external beam. Patients randomly assigned to receive chemotherapy were treated with once weekly cisplatin (40 mg/m). Rates of acute toxicity were higher in patients treated with chemoradiation as compared with radiation treatment alone. Median PFS was longer for patients treated with radiation therapy alone as compared with chemotherapy and radiation (median PFS was not reached for RT 73 months for chemoradiation, hazard ratio of 1.25 (95% CI, 0.75 to 2.07). At 3 years, 73% of patients treated definitively with radiation and 62% of patients treated with chemoradiation were alive and free of disease progression.

CONCLUSION

Excellent outcomes can be achieved for women with localized recurrences of endometrial cancer when treated with radiation therapy. The addition of chemotherapy does not improve PFS for patients treated with definitive radiation therapy for recurrent endometrial cancer and increases acute toxicity. Patients with low-grade and vaginal recurrences who constituted the majority of those enrolled are best treated with radiation therapy alone.

摘要

目的

盆腔复发是子宫内膜癌女性复发的常见模式。一项随机试验比较了单纯放疗与同期化疗治疗后的无进展生存期(PFS)。

材料和方法

2008 年 2 月至 2020 年 8 月,165 例患者被随机分配 1:1 接受单纯放疗或化疗联合放疗。本研究的主要目的是确定放化疗是否比单纯放疗更能改善 PFS。

结果

大多数患者为低级别(1 级或 2 级)子宫内膜样组织学(82%),复发局限于阴道(86%)。采用三维或调强放疗技术进行外照射后,采用近距离或外照射进行推量。随机接受化疗的患者每周接受一次顺铂(40mg/m)治疗。与单纯放疗相比,放化疗患者的急性毒性发生率更高。与单纯放疗相比,接受放疗的患者中位 PFS 更长(中位 PFS 未达到 RT 73 个月,化疗和放疗为 73 个月,危险比为 1.25(95%CI,0.75 至 2.07)。3 年时,73%接受根治性放疗的患者和 62%接受放化疗的患者存活且无疾病进展。

结论

对于接受放疗的局限性子宫内膜癌复发患者,可获得良好的疗效。对于接受根治性放疗的复发性子宫内膜癌患者,化疗并不能改善 PFS,反而会增加急性毒性。大多数入组患者为低级别和阴道复发患者,最好单独接受放疗。

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