Overall Severe Morbidity After Chemo-Radiation Therapy and Magnetic Resonance Imaging-Guided Adaptive Brachytherapy in Locally Advanced Cervical Cancer: Results From the EMBRACE-I Study.
Overall Severe Morbidity After Chemo-Radiation Therapy and Magnetic Resonance Imaging-Guided Adaptive Brachytherapy in Locally Advanced Cervical Cancer: Results From the EMBRACE-I Study.
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DOI：
10.1016/j.ijrobp.2023.01.002
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发表时间：
2023-07-15
期刊：
影响因子：
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通讯作者：
Tanderup, Kari
中科院分区：
文献类型：
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作者：
Vittrup, Anders Schwartz;Kirchheiner, Kathrin;Tanderup, Kari
目得：评价在前瞻性EMBRACE-I研究中接受放化疗和磁共振图像引导自适应近距离放射治疗的局部晚期宫颈癌患者的总体重度晚期发病率（≥3级），并将结果与标准放射学近距离放射治疗（BT）后的已发表文献进行比较。方法和材料：从2008年至2015年，EMBRACE-I研究招募了1416例患者。第1年每3个月评估一次发病率（不良事件通用术语标准第3.0版），第2年和第3年每6个月评估一次，此后每年评估一次，1251例患者对晚期发病率进行了随访。将死亡事件（3-5级）总结为随访期间的最高等级（粗发生率）以及3年和5年时的精算估计值。为了与已发表的基于标准X线片的BT的文献进行比较，将EMBRACE-I研究的不良事件通用术语标准评分回顾性地转换为放射治疗肿瘤学组和欧洲癌症研究和治疗组织系统的相应评分。429起事件为3级，105起为4级。5年时≥3级胃肠道（GI）、泌尿生殖系统（GU）、阴道和瘘管事件的精算估计值为8.5%（95%置信区间[CI]，6.9%-10.6%）、6.8%（95% CI，5.4%-8.6%）、5.7%（95% CI，4.3%-7.6%）和3.2%（95% CI，2.2%-4.5%）。器官相关事件（GI、GU、阴道或瘘管）的5年精算估计值为18.4%（95% CI，16.0%-21.2%）。当汇总所有G≥3终点（GI、GU、阴道、瘘管和非GI/GU/阴道）时，5年精算估计值为26.6%（95% CI，23.8%-29.6%）。13例患者有治疗相关的死亡，其中8例与胃肠道发病率。结论：本报告评估严重的发病率从最大的前瞻性研究化疗放射治疗和图像引导自适应近距离放射治疗局部晚期宫颈癌的日期。根据终点和器官类别，重度晚期发病率有限，但当跨器官和所有终点汇总时，重度晚期发病率相当高。EMBRACE-I研究中的晚期发病率结果与已发表的基于标准X线片的BT的GI发病率、阴道发病率和瘘的文献相比更为有利。
PURPOSE: To evaluate overall severe late morbidity (grade ≥3) in patients with locally advanced cervical cancer treated with chemo-radiation therapy and magnetic resonance image guided adaptive brachytherapy within the prospective EMBRACE-I study, and to compare the results with published literature after standard radiograph based brachytherapy (BT).METHODS AND MATERIALS: From 2008 to 2015 the EMBRACE-I study enrolled 1416 patients. Morbidity was assessed (Common Terminology Criteria for Adverse Events version 3.0) every 3 months the 1st year, every 6 months the second and third year, and yearly thereafter and 1251 patients had available follow-up on late morbidity. Morbidity events (grade 3-5) were summarized as the maximum grade during follow-up (crude incidence rates) and actuarial estimates at 3 and 5 years. To compare with the published literature on standard radiograph based BT, Common Terminology Criteria for Adverse Events scores from the EMBRACE-I study were retrospectively converted into a corresponding score in the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer system.RESULTS: In total, 534 severe events occurred in 270 patients; 429 events were grade 3 and 105 were grade 4 events. Actuarial estimates for grade ≥3 gastrointestinal (GI), genitourinary (GU), vaginal and fistula events at 5 years were 8.5% (95% confidence interval [CI], 6.9%-10.6%), 6.8% (95% CI, 5.4%-8.6%), 5.7% (95% CI, 4.3%-7.6%), and 3.2% (95% CI, 2.2%-4.5%), respectively. The 5-year actuarial estimate for organ-related events (GI, GU, vaginal, or fistula) was 18.4% (95% CI, 16.0%-21.2%). The 5-year actuarial estimate when aggregating all G≥3 endpoints (GI, GU, vaginal, fistulas, and non-GI/GU/vaginal) was 26.6% (95% CI, 23.8%-29.6%). Thirteen patients had a treatment-related death, 8 of which were associated with GI morbidity.CONCLUSIONS: This report assesses severe morbidity from the largest prospective study on chemo-radiation therapy and image guided adaptive brachytherapy for locally advanced cervical cancer to date. Severe late morbidity was limited per endpoint and organ category, but considerable when aggregated across organs and all endpoints. The late morbidity results in the EMBRACE-I study compare favorably with published literature on standard radiograph based BT for GI morbidity, vaginal morbidity, and fistulas.