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Derivation of Dose/Volume Constraints for the Anorectum from Clinician- and Patient-Reported Outcomes in the CHHiP Trial of Radiation Therapy Fractionation.
International Journal of Radiation Oncology • Biology • Physics ( IF 7 ) Pub Date : 2020-01-24 , DOI: 10.1016/j.ijrobp.2020.01.003
Anna Wilkins 1 , Olivia Naismith 2 , Douglas Brand 3 , Katie Fernandez 4 , Emma Hall 5 , David Dearnaley 3 , Sarah Gulliford 4 ,
Affiliation  

PURPOSE The CHHiP trial randomized 3216 men with localized prostate cancer (1:1:1) to 3 radiation therapy fractionation schedules: 74 Gy in 37 fractions over 7.4 weeks; 60 Gy in 20 fractions over 4 weeks; and 57 Gy in 19 fractions over 3.8 weeks. Literature-based dose constraints were applied with arithmetic adjustment for the hypofractionated arms. This study aimed to derive anorectal dose constraints using prospectively collected clinician-reported outcomes (CROs) and patient-reported outcomes (PROs) and to assess the added predictive value of spatial dose metrics. METHODS AND MATERIALS A case-control study design was used; 7 CRO and 5 PRO bowel symptoms were evaluated. Cases experienced a moderate or worse symptom 1 to 5 years after-radiation therapy and did not have the symptom before radiation therapy. Controls did not experience the symptom at baseline or between 1 to 5 years after radiation therapy. The anorectum was recontoured from the anal verge to the rectosigmoid junction; dose/volume parameters were extracted. Univariate logistic regression, atlases of complication indices, and bootstrapped receiver-operating-characteristic analysis (1000 replicates, balanced outcomes) were used to derive dose constraints for the whole cohort (hypofractionated schedules were converted to 2-Gy equivalent schedules using α/β = 3 Gy) and separate hypofractionated/conventional fractionation cohorts. Only areas under the curve with 95% confidence interval lower limits >0.5 were considered statistically significant. Any constraint derived in <95% to 99% of bootstraps was excluded. RESULTS Statistically significant dose constraints were derived for CROs but not PROs. Intermediate to high doses were important for rectal bleeding, whereas intermediate doses were important for increased bowel frequency, fecal incontinence, and rectal pain. Spatial dose metrics did not improve prediction of CROs or PROs. A new panel of dose constraints for hypofractionated schedules to 60 Gy or 57 Gy are V20Gy <85%, V30Gy <57%, V40Gy <38%, V50Gy <22%, and V60Gy <0.01%. CONCLUSIONS Dose constraints differed among symptoms, indicating potentially different pathogenesis of radiation-induced side effects. Derived dose constraints were stricter than those used in CHHiP and may reduce bowel symptoms after radiation therapy.

中文翻译:

在放射治疗分割的 CHHiP 试验中,从临床医生和患者报告的结果推导肛门直肠的剂量/体积限制。

目的 CHHiP 试验将 3216 名患有局限性前列腺癌的男性 (1:1:1) 随机分配至 3 种放射治疗分割方案:74 Gy,7.4 周内 37 次分割;4 周内 20 次 60 Gy;在 3.8 周内分 19 次接受 57 Gy。基于文献的剂量限制适用于大分割组的算术调整。本研究旨在使用前瞻性收集的临床医生报告结果 (CRO) 和患者报告结果 (PRO) 推导出肛门直肠剂量限制,并评估空间剂量指标的附加预测值。方法和材料 采用病例对照研究设计;评估了 7 例 CRO 和 5 例 PRO 肠道症状。病例在放射治疗后 1 至 5 年出现中度或更严重的症状,而在放射治疗前没有症状。对照组在基线时或放射治疗后 1 至 5 年期间未出现症状。肛门直肠从肛门边缘到直肠乙状结肠交界处重新轮廓化;提取剂量/体积参数。单变量逻辑回归、并发症指数图谱和自举接受者操作特征分析(1000 次重复,平衡结果)用于推导整个队列的剂量限制(使用 α/β = 将大分割方案转换为 2 Gy 等效方案) 3 Gy)和单独的大分割/常规分割队列。只有 95% 置信区间下限 > 0.5 的曲线下区域才被认为具有统计学意义。在 <95% 到 99% 的引导程序中派生的任何约束都被排除在外。结果 统计学上显着的剂量限制是针对 CRO 而不是 PRO 得出的。中到高剂量对直肠出血很重要,而中等剂量对增加排便次数、大便失禁和直肠疼痛很重要。空间剂量指标并未改善 CRO 或 PRO 的预测。60 Gy 或 57 Gy 大分割方案的一组新剂量限制为 V20Gy <85%、V30Gy <57%、V40Gy <38%、V50Gy <22% 和 V60Gy <0.01%。结论 不同症状的剂量限制不同,表明辐射引起的副作用可能有不同的发病机制。衍生的剂量限制比 CHHiP 中使用的剂量限制更严格,并且可以减少放射治疗后的肠道症状。而中等剂量对于增加排便频率、大便失禁和直肠疼痛很重要。空间剂量指标并未改善 CRO 或 PRO 的预测。60 Gy 或 57 Gy 大分割方案的一组新剂量限制为 V20Gy <85%、V30Gy <57%、V40Gy <38%、V50Gy <22% 和 V60Gy <0.01%。结论 不同症状的剂量限制不同,表明辐射引起的副作用可能有不同的发病机制。衍生的剂量限制比 CHHiP 中使用的剂量限制更严格,并且可以减少放射治疗后的肠道症状。而中等剂量对于增加排便频率、大便失禁和直肠疼痛很重要。空间剂量指标并未改善 CRO 或 PRO 的预测。60 Gy 或 57 Gy 大分割方案的一组新剂量限制为 V20Gy <85%、V30Gy <57%、V40Gy <38%、V50Gy <22% 和 V60Gy <0.01%。结论 不同症状的剂量限制不同,表明辐射引起的副作用可能有不同的发病机制。衍生的剂量限制比 CHHiP 中使用的剂量限制更严格,并且可以减少放射治疗后的肠道症状。38%,V50Gy <22%,V60Gy <0.01%。结论 不同症状的剂量限制不同,表明辐射引起的副作用可能有不同的发病机制。衍生的剂量限制比 CHHiP 中使用的剂量限制更严格,并且可以减少放射治疗后的肠道症状。38%,V50Gy <22%,V60Gy <0.01%。结论 不同症状的剂量限制不同,表明辐射引起的副作用可能有不同的发病机制。衍生的剂量限制比 CHHiP 中使用的剂量限制更严格,并且可以减少放射治疗后的肠道症状。
更新日期:2020-03-27
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