Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008.

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology Pub Date : 2025-09-12 DOI:10.1016/j.annonc.2025.09.003

S Y Ryu, W Deng, K Albuquerque, W-J Koh, J Mayadev, A Heugel, B-J Kim, D-Y Kim, C-H Cho, J-W Kim, J H No, R S Mannel, K Miller, D Fabian, D M Chase, K M Gil, W Small, W Rodgers, C A Leath, B J Monk

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引用次数: 0

Abstract

Background: To determine whether adjuvant chemoradiation (CRT) with weekly cisplatin improves recurrence-free survival (RFS) compared with radiation (RT) in pathologically proven intermediate risk early-stage cervical cancer following radical hysterectomy and lymphadenectomy.

Methods: Post-surgical patients with stage I-IIA cervical cancer with pathologically noted intermediate risk factors including combinations of capillary lymphatic space involvement, stromal invasion, and tumor size were randomly assigned in a 1 : 1 ratio to receive either adjuvant CRT or RT (NCT01101451). Patients received conformal RT, or intensity modulated radiation therapy. In the CRT arm, 6 weekly cycles of cisplatin 40 mg/m² were administered during RT. RFS was the primary endpoint in randomized and eligible patients. Secondary endpoints included overall survival (OS), quality of life (QoL), and adverse events (AEs).

Results: Of the 340 randomized patients, 316 were eligible and most had Federation of Gynecology and Obstetrics (2009) stage IB₁ and squamous cell carcinoma histology. Out of 316 patients, 292 (92.4%) received 28 fractions of RT with a median dose of 50.4 Gy and a median treatment duration of 39 days. Three-year RFS was 88.5% in the CRT arm and 85.4% in the RT arm. Both RFS [hazard ratio (HR) 0.698, 95% confidence interval (CI) 0.408-1.192, P = 0.09], as well as OS [HR 0.586, 95% CI 0.286-1.199, P = 0.07] favored CRT compared with RT alone. Grade 3 or 4 AEs occurred in 43% and 15% in the CRT and RT arms, respectively (P < 0.01). A transient decline in QoL occurred in the CRT arm compared with RT after starting treatments and recovered to pre-treatment level by 36 weeks.

Conclusion: Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients with intermediate pathological risk factors following radical hysterectomy and lymphadenectomy. CRT increased grade 3 and 4 AEs with a transient decline in QoL.

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辅助放疗与放化疗在中危早期宫颈癌根治性子宫切除和淋巴结切除术后的随机III期试验：来自NRG Oncology/GOG-263/KGOG1008的结果

背景：确定与放射治疗（RT）相比，每周一次的顺铂辅助放化疗（CRT）是否能改善病理证实的中度危险早期宫颈癌根治性子宫切除术和淋巴结切除术后的无复发生存率（RFS）。方法：术后I-IIA期宫颈癌患者，病理上注意到的中间危险因素包括毛细血管淋巴间隙（CLS）受损伤、间质浸润和肿瘤大小，随机按1:1的比例分配，接受辅助CRT或RT （NCT01101451）。患者接受了适形放疗或调强放疗。在CRT组中，每6周给予顺铂40mg /m2， RFS是随机和符合条件的患者的主要终点。次要终点包括总生存期（OS）、生活质量（QOL）和不良事件（AE）。结果：340例随机患者中，316例符合条件，大多数为FIGO (2009) IB1期和鳞状细胞癌组织学。316例患者中有292例（92.4%）接受了28组放疗，中位剂量为50.4 Gy，中位治疗持续时间为39天。CRT组3年RFS为88.5%，RT组为85.4%。RFS[风险比（HR） 0.698, 95% CI 0.408-1.192, p=0.09]和OS [HR 0.586, 95% CI: 0.286-1.199, p= 0.07]均优于单纯RT。CRT组和RT组3级和4级ae发生率分别为43%和15% （p < 0.01）。与RT组相比，CRT组的生活质量在开始治疗后出现短暂下降，并在36周后恢复到治疗前水平。结论：虽然RFS和OS有利于CRT，但在RT期间添加顺铂并没有统计学意义上改善具有中间病理危险因素的宫颈癌根治性子宫切除术和淋巴结切除术后的RFS和OS。CRT增加了3级和4级ae，但生活质量短暂下降。

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来源期刊

Annals of Oncology 医学-肿瘤学

CiteScore

63.90

自引率

1.00%

发文量

3712

审稿时长

2-3 weeks

期刊介绍： Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine. The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings. Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.