ImportanceProspective data assessing the safety of hypofractionated (40 Gy in 16 fractions) radiotherapy (RT) among patients who receive postoperative concurrent chemoradiotherapy for cervical cancer are lacking.ObjectiveTo evaluate the acute toxic effects of hypofractionated pelvic intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy among women with cervical cancer who underwent radical hysterectomy.Design, Setting, and ParticipantsThe POHIM-CCRT (Postoperative Hypofractionated Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer) study was designed as a multicenter, phase 2 nonrandomized controlled trial that accrued and followed up patients from June 1, 2017, to February 28, 2023. In total, 84 patients were enrolled from 5 institutions affiliated with the Korean Radiation Oncology Group. Eligible patients experienced lymph node metastasis, parametrial invasion, or positive resection margins after radical hysterectomy for treatment of confirmed cervical cancer.InterventionPostoperative pelvic radiation using hypofractionated IMRT with 40 Gy in 16 fractions to the whole pelvis combined with concurrent chemotherapy.Main Outcomes and MeasuresThe primary end point was incidence of acute grade 3 or higher gastrointestinal tract, genitourinary, and hematologic toxic effects (based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0) in the evaluable population during RT or within 3 months after RT completion.ResultsOf 84 patients enrolled, 5 dropped out prior to RT, and data from 79 patients were analyzed. The patients’ median (IQR) age was 48 (42-58) years, and the median (IQR) tumor size was 3.7 (2.7-4.5) cm. Of these patients, 31 (39.7%) had lymph node metastasis, 4 (5.1%) had positive resection margins, and 43 (54.4%) had parametrial invasion. Grade 3 or higher acute toxic effects occurred in 2 patients (2.5% [90% CI, 0%-4.8%]). After a median (IQR) follow-up of 43.0 (21.1-59.0) months, the 3-year disease-free survival rate was 79.3%, and the overall survival rate was 98.0%.ConclusionsFindings from this nonrandomized control trial indicated that postoperative pelvic irradiation combined with concurrent chemotherapy using hypofractionated IMRT with 40 Gy in 16 fractions was safe and well-tolerated in women with cervical cancer. Studies assessing long-term toxic effects and oncological outcomes with longer follow-up periods are needed.Trial RegistrationClinicalTrials.gov Identifier: NCT03239613

中文翻译：

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宫颈癌术后大分割调强放疗联合化疗

重要性缺乏评估宫颈癌术后同步放化疗患者大分割（40 Gy，16次）放疗（RT）安全性的前瞻性数据。 目的评价大分割盆腔调强放疗（IMRT）联合同步化疗的急性毒性作用设计、设置和参与者POHIM-CCRT（宫颈癌术后大分割调强放射治疗与同步化疗）研究被设计为一项多中心、2 期非随机对照试验，该试验积累并进行了随访从2017年6月1日到2023年2月28日，共有84名患者入组，来自韩国放射肿瘤学组附属的5个机构。符合条件的患者在根治性子宫切除术治疗确诊的宫颈癌后出现淋巴结转移、宫旁侵犯或切缘阳性。干预术后盆腔放疗采用大分割IMRT，16次40Gy全盆腔联合同步化疗。主要结果和措施终点是放疗期间或放疗完成后 3 个月内可评估人群中急性 3 级或以上胃肠道、泌尿生殖和血液毒性反应（基于美国国家癌症研究所不良事件通用术语标准 4.0 版）的发生率。结果 84 名患者入组，5 名患者在放疗前退出，并对 79 名患者的数据进行了分析。患者的中位 (IQR) 年龄为 48 (42-58) 岁，中位 (IQR) 肿瘤大小为 3.7 (2.7-4.5) cm。其中，31例（39.7%）有淋巴结转移，4例（5.1%）切缘阳性，43例（54.4%）有宫旁侵犯。 2 名患者出现 3 级或以上急性毒性反应（2.5% [90% CI，0%-4.8%]）。中位（IQR）随访 43.0（21.1-59.0）个月后，3 年无病生存率为 79.3%，总生存率为 98.0%。 结论 这项非随机对照试验的结果表明，术后盆腔对于宫颈癌女性来说，采用 40 Gy 分 16 次的大分割 IMRT 进行放疗联合同步化疗是安全且耐受性良好的。需要进行评估长期毒性作用和肿瘤学结果以及较长随访期的研究。试验注册ClinicalTrials.gov 标识符：NCT03239613