2024 年 7 月 13 日（星期六）上午 10:30 - 11:30 GPP01 演讲时间：上午 10:30

IF 1.7 4区医学 Q4 ONCOLOGY

Brachytherapy Pub Date : 2024-10-25 DOI:10.1016/j.brachy.2024.08.087

Kara D. Romano MD , Gabriella Macchia MD , Melissa Christiaens MD , Susan Lalondrelle MD , Xiang Zhang MD , Andréia Cristina De Melo MD, PhD , Klaudia Reginacova MD, PhD , Limor Helpman MD , Ali Ayhan MD , Flora Zagouri MD, PhD , Linn Woelber MD , Kristina Hellman MD, PhD , Nicoletta Colombo MD, PhD , Margarita Romeo Marin MD, PhD , Regina Berger PhD , Emma Fields MD , Karla Alejandra Lopez MD , Vincent Castonguay MD , Kazuhiro Takehara MD, PhD , Ting-Chang Chang MD , Domenica Lorusso MD, PhD

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引用次数: 0

摘要

目的ENGOT-cx11/GOGG-3047/KEYNOTE-A18（NCT04221945）评估了pembro+CCRT在高危LACC患者（pts）中的应用。材料与方法既往未经治疗的高危 LACC 患者（FIGO 2014 IB2-IIB 期，结节阳性或 III-IVA 期）按 1:1 随机分配接受 5 个周期的 pembro 200 毫克或安慰剂（pbo）Q3W + CCRT，然后再接受 15 个周期的 pembro 400 毫克或 pbo Q6W。CCRT为5个周期（可选择第6次剂量）顺铂40 mg/m2 QW + EBRT，然后是近距离放射治疗。主要终点为经研究者或组织病理学确认的RECIST v1.1标准PFS和OS.Results1060名患者被随机分配到pembro + CCRT（n = 529）或pbo + CCRT（n = 531）。两组患者均接受了中位11个周期的pembro或pbo治疗和5个周期的顺铂治疗。大多数患者完成了放疗（pembro + CCRT，97.9%；pbo + CCRT，98.3%）；两组患者的总体中位治疗时间均为 52 天。表 1 总结了 CCRT 治疗。Pembro + CCRT 与 pbo + CCRT 相比改善了 PFS（HR 0.70 [95% CI 0.55-0.89]; P = 0.0020）。两组均未达到中位生存期。在预设的亚组中，PFS获益情况基本一致。Pembro + CCRT仅发生了103起事件（42.9%为成熟期），在OS方面具有良好的趋势（HR 0.73 [95% CI 0.49-1.07]）。治疗相关AEs（TRAEs）在pembro单药治疗阶段（72.7%）与pembro + CCRT联合治疗阶段（94.5%）之间的发生率较低；pbo治疗组的发生率为60.0%与95.7%。结论在高危LACC患者中，Pembro + CCRT与pbo + CCRT相比，PFS有统计学意义和临床意义的改善，OS有良好趋势。Pembro + CCRT具有可控的安全性，大多数TRAE发生在联合治疗阶段。Pembro + CCRT有望成为这一高风险人群的新治疗标准。

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Saturday, July 13, 202410:30 AM - 11:30 AM GPP01 Presentation Time: 10:30 AM

Purpose

ENGOT-cx11/GOG-3047/KEYNOTE-A18 (NCT04221945) evaluated pembro + CCRT in patients (pts) with high-risk LACC.

Materials and Methods

Pts with previously untreated, high-risk LACC (FIGO 2014 stage IB2‒IIB with node-positive disease or stage III‒IVA) were randomized 1:1 to receive 5 cycles of pembro 200 mg or placebo (pbo) Q3W + CCRT then 15 cycles of pembro 400 mg or pbo Q6W. CCRT was 5 cycles (optional 6th dose) of cisplatin 40 mg/m² QW + EBRT then brachytherapy. Primary endpoints were PFS per RECIST v1.1 by investigator or histopathologic confirmation and OS.

Results

1060 pts were randomized to pembro + CCRT (n = 529) or pbo + CCRT (n = 531). At IA1 (data cutoff: Jan 9, 2023), median follow-up was 17.9 mo. Pts received a median of 11 cycles of pembro or pbo and 5 cycles of cisplatin in both arms. Most pts completed radiation treatment (pembro + CCRT, 97.9%; pbo + CCRT, 98.3%); overall median treatment duration was 52 d in both arms. Table 1 summarizes the CCRT treatment. Pembro + CCRT improved PFS vs pbo + CCRT (HR 0.70 [95% CI 0.55‒0.89]; P = 0.0020). Median PFS was not reached in either arm. PFS benefit was generally consistent across prespecified subgroups. With only 103 events (42.9% maturity), pembro + CCRT had a favorable trend in OS (HR 0.73 [95% CI 0.49‒1.07]). Treatment-related AEs (TRAEs) were less common in the pembro monotherapy phase (72.7%) vs pembro + CCRT combination therapy phase (94.5%); results in the pbo arm were 60.0% vs 95.7%. Safety profiles were consistent with the known profiles of pembro monotherapy and chemoradiotherapy.

Conclusions

Pembro + CCRT showed a statistically significant and clinically meaningful improvement in PFS and a favorable trend in OS vs pbo + CCRT in pts with high-risk LACC. Pembro + CCRT had manageable safety, with most TRAEs occurring during the combination phase of therapy. Pembro + CCRT has potential as a new standard of care for this high-risk population.

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来源期刊

Brachytherapy 医学-核医学

CiteScore

3.40

自引率

21.10%

发文量

119

审稿时长

9.1 weeks

期刊介绍： Brachytherapy is an international and multidisciplinary journal that publishes original peer-reviewed articles and selected reviews on the techniques and clinical applications of interstitial and intracavitary radiation in the management of cancers. Laboratory and experimental research relevant to clinical practice is also included. Related disciplines include medical physics, medical oncology, and radiation oncology and radiology. Brachytherapy publishes technical advances, original articles, reviews, and point/counterpoint on controversial issues. Original articles that address any aspect of brachytherapy are invited. Letters to the Editor-in-Chief are encouraged.