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立体定向体部放疗治疗寡转移型子宫癌(MITO-RT2/RAD)的疗效和安全性:与意大利放射肿瘤学会、多中心意大利卵巢癌试验以及 Mario Negri 妇科肿瘤学组合作开展的大型真实世界研究。

Efficacy and Safety of Stereotactic Body Radiation Therapy in Oligometastatic Uterine Cancer (MITO-RT2/RAD): A Large, Real-World Study in Collaboration With Italian Association of Radiation Oncology, Multicenter Italian Trials in Ovarian Cancer, and Mario Negri Gynecologic Oncology Group Groups.

机构信息

Radiation Oncology Unit, Gemelli Molise Hospital, Campobasso, Italy.

Radiation Oncology Unit, Gemelli Molise Hospital, Campobasso, Italy.

出版信息

Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):321-332. doi: 10.1016/j.ijrobp.2023.04.025. Epub 2023 May 6.

DOI:10.1016/j.ijrobp.2023.04.025
PMID:37150261
Abstract

PURPOSE

This retrospective, multicenter study analyzes the efficacy and safety of stereotactic body radiation therapy in a large cohort of patients with oligometastatic/persistent/recurrent uterine cancer.

METHODS AND MATERIALS

Clinical and radiation therapy data from several radiation therapy centers treating patients by stereotactic body radiation therapy between March 2006 and October 2021 were collected. Objective response rate was defined as complete and partial response, and clinical benefit included objective response rate plus stable disease. Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer and Common Terminology Criteria for Adverse Events scales were used to grade toxicities. Primary endpoints were the rate of complete response to stereotactic body radiation therapy, and the 2-year actuarial local control rate "per-lesion" basis. Secondary endpoints were progression-free survival and overall survival, as well as toxicity.

RESULTS

In the study, 157 patients with oligometastatic/persistent/recurrent uterine cancer bearing 272 lesions treated by stereotactic body radiation therapy at 14 centers were analyzed. Lymph node metastases (137, 50.4%) were prevalent, followed by parenchyma lesions (135, 49.6%). Median total dose was 35 Gy (10-75.2), in 5 fractions (range, 1-10). Complete and partial responses were 174 (64.0%), and 54 (19.9%), respectively. Stable disease was registered in 29 (10.6%), and 15 (5.5%) lesions progressed. Type of lesion (lymph node), volume (≤13.7 cc) and total dose (BED >59.5 Gy) were significantly associated with a higher probability of achieving complete response. Patients achieving complete response (CR) "per-lesion" basis experienced a 2-year actuarial local control rate of 92.4% versus 33.5% in lesions not achieving complete response (NCR; P < .001). Moreover, the 2-year actuarial progression-free survival rate in patients with CR was 45.4%, and patients with NCR had a 2-year rate of 17.6% (P < .001). Finally, patients who had a CR had a 2-year overall survival rate of 82.7%, compared with 56.5% for NCR patients (P <.001). Severe acute toxicity was around 2%, including one toxic death due to gastric perforation, and severe late toxicity around 4%.

CONCLUSIONS

The efficacy of stereotactic body radiation therapy in this setting was confirmed. The low toxicity profile and the high local control rate in complete responder patients encourage the wider use of this approach.

摘要

目的

本回顾性多中心研究分析了立体定向体部放射治疗在一大群寡转移/持续性/复发性子宫癌患者中的疗效和安全性。

方法和材料

收集了 2006 年 3 月至 2021 年 10 月期间,由多个放射治疗中心采用立体定向体部放射治疗治疗的患者的临床和放射治疗数据。客观缓解率定义为完全缓解和部分缓解,临床获益包括客观缓解率加稳定疾病。采用放射治疗肿瘤学组/欧洲癌症研究与治疗组织和常见不良事件术语标准对毒性进行分级。主要终点是立体定向体部放射治疗的完全缓解率,以及基于“每病灶”的 2 年局部无进展率。次要终点是无进展生存期和总生存期以及毒性。

结果

在这项研究中,分析了 14 个中心的 157 名患有寡转移/持续性/复发性子宫癌的患者,这些患者的 272 个病灶接受了立体定向体部放射治疗。淋巴结转移(137 例,50.4%)较为常见,其次是实质病变(135 例,49.6%)。中位总剂量为 35 Gy(10-75.2),分 5 次(范围 1-10 次)给予。完全缓解和部分缓解分别为 174 例(64.0%)和 54 例(19.9%)。稳定疾病的比例为 29 例(10.6%),15 例(5.5%)病灶进展。病灶类型(淋巴结)、体积(≤13.7 cc)和总剂量(BED >59.5 Gy)与更高的完全缓解概率显著相关。基于“每病灶”的完全缓解(CR)的患者,2 年局部无进展率为 92.4%,而非完全缓解(NCR)的患者为 33.5%(P<.001)。此外,CR 患者的 2 年无进展生存率为 45.4%,NCR 患者为 17.6%(P<.001)。最后,CR 患者的 2 年总生存率为 82.7%,而 NCR 患者为 56.5%(P<.001)。严重急性毒性约为 2%,包括 1 例因胃穿孔导致的毒性死亡,严重晚期毒性约为 4%。

结论

立体定向体部放射治疗在该治疗环境中的疗效得到了证实。完全缓解患者的低毒性和高局部控制率鼓励更广泛地使用这种方法。

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