Wen Li, Lan Ma, Fang Li, Kemin Li, Yang Zhang, Hongtao Ren, Xing Bao, Yuyan Guo, Ya Guo, Mincong Wang, Dan Li, Yuanqiong Duan, Xiulong Ma, Zhongwei Wang, Yali Wang, Rutie Yin
{"title":"前瞻性 II 期随机对照研究:针对局部晚期宫颈癌患者的骨髓疏松放疗对急性血液学毒性的影响","authors":"Wen Li, Lan Ma, Fang Li, Kemin Li, Yang Zhang, Hongtao Ren, Xing Bao, Yuyan Guo, Ya Guo, Mincong Wang, Dan Li, Yuanqiong Duan, Xiulong Ma, Zhongwei Wang, Yali Wang, Rutie Yin","doi":"10.1186/s13014-024-02432-7","DOIUrl":null,"url":null,"abstract":"To evaluate effects of bone marrow sparing (BMS) radiotherapy on decreasing the incidence of acute hematologic toxicity (HT) for locoregionally advanced cervical cancer (LACC) patients treated by pelvic irradiation. LACC patients were recruited prospectively from May 2021 to May 2022 at a single center and were evenly randomized into the BMS group and the control group. All patients received pelvic irradiation with concurrent cisplatin (40 mg/m2 weekly), followed by brachytherapy and BM V40 < 25% in the BMS group was additionally prescribed. Acute HT was assessed weekly. Binary logistic regression model and receiver operating characteristic (ROC) curve were used for predictive value analysis. The trial was registered with Chinese clinical trial registry (ChiCTR2200066485). A total of 242 patients were included in the analysis. Baseline demographic, disease and treatment characteristics were balanced between the two groups. In the intention-to-treat population, BMS was associated with a lower incidence of grade ≥ 2 and grade ≥ 3 acute HT, leukopenia and neutropenia s(72.70% v 90.90%, P < 0.001*; 16.50% vs. 65.30%, P < 0.001*; 66.10% vs. 85.10%, P = 0.001*; 13.20% vs. 54.50%, P < 0.001*; 37.20% vs. 66.10%, P < 0.001*; 10.70% vs. 43.80%, P < 0.001*). BMS also resulted in decreased dose delivered to the organs at risk (OARs) including rectum, bladder and left and right femoral head. Univariate and multivariate analyses showed that BM V40 was an independent risk factor for grade ≥ 3 acute HT (odds ratio [OR] = 2.734, 95% confidence interval [CI] = 1.959–3.815, P < 0.001*). Cutoff value was 25.036% and area under the curve (AUC) was 0.786. The nomogram was constructed, which was rigorously evaluated and internally cross-validated, showing good predictive performance. Receiving BMS pelvic irradiation could reduce the incidence of acute HT in LACC patients, and BM V40 < 25% may be a significant factor in reducing the risks of acute HT.","PeriodicalId":49639,"journal":{"name":"Radiation Oncology","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of bone marrow sparing radiotherapy on acute hematologic toxicity for patients with locoregionally advanced cervical cancer: a prospective phase II randomized controlled study\",\"authors\":\"Wen Li, Lan Ma, Fang Li, Kemin Li, Yang Zhang, Hongtao Ren, Xing Bao, Yuyan Guo, Ya Guo, Mincong Wang, Dan Li, Yuanqiong Duan, Xiulong Ma, Zhongwei Wang, Yali Wang, Rutie Yin\",\"doi\":\"10.1186/s13014-024-02432-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"To evaluate effects of bone marrow sparing (BMS) radiotherapy on decreasing the incidence of acute hematologic toxicity (HT) for locoregionally advanced cervical cancer (LACC) patients treated by pelvic irradiation. LACC patients were recruited prospectively from May 2021 to May 2022 at a single center and were evenly randomized into the BMS group and the control group. All patients received pelvic irradiation with concurrent cisplatin (40 mg/m2 weekly), followed by brachytherapy and BM V40 < 25% in the BMS group was additionally prescribed. Acute HT was assessed weekly. Binary logistic regression model and receiver operating characteristic (ROC) curve were used for predictive value analysis. The trial was registered with Chinese clinical trial registry (ChiCTR2200066485). A total of 242 patients were included in the analysis. Baseline demographic, disease and treatment characteristics were balanced between the two groups. In the intention-to-treat population, BMS was associated with a lower incidence of grade ≥ 2 and grade ≥ 3 acute HT, leukopenia and neutropenia s(72.70% v 90.90%, P < 0.001*; 16.50% vs. 65.30%, P < 0.001*; 66.10% vs. 85.10%, P = 0.001*; 13.20% vs. 54.50%, P < 0.001*; 37.20% vs. 66.10%, P < 0.001*; 10.70% vs. 43.80%, P < 0.001*). BMS also resulted in decreased dose delivered to the organs at risk (OARs) including rectum, bladder and left and right femoral head. Univariate and multivariate analyses showed that BM V40 was an independent risk factor for grade ≥ 3 acute HT (odds ratio [OR] = 2.734, 95% confidence interval [CI] = 1.959–3.815, P < 0.001*). Cutoff value was 25.036% and area under the curve (AUC) was 0.786. The nomogram was constructed, which was rigorously evaluated and internally cross-validated, showing good predictive performance. 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引用次数: 0
摘要
目的:评估对局部区域晚期宫颈癌(LACC)患者进行盆腔照射治疗时,骨髓间隔放疗(BMS)对降低急性血液学毒性(HT)发生率的影响。2021 年 5 月至 2022 年 5 月期间,一个中心前瞻性地招募了 LACC 患者,并将其平均随机分为 BMS 组和对照组。所有患者均接受盆腔照射,同时使用顺铂(每周40毫克/平方米),然后进行近距离放射治疗,BMS组患者的BM V40<25%为额外处方。每周评估急性 HT。采用二元逻辑回归模型和接收器操作特征曲线(ROC)进行预测值分析。该试验已在中国临床试验注册中心注册(ChiCTR2200066485)。共有 242 例患者纳入分析。两组患者的基线人口统计学特征、疾病和治疗特征均衡。在意向治疗人群中,BMS与较低的≥2级和≥3级急性HT、白细胞减少和中性粒细胞减少发生率相关(72.70% vs 90.90%,P < 0.001*; 16.50% vs. 65.30%, P < 0.001*; 66.10% vs. 85.10%, P = 0.001*; 13.20% vs. 54.50%, P < 0.001*; 37.20% vs. 66.10%, P < 0.001*; 10.70% vs. 43.80%, P < 0.001*)。BMS 还可减少直肠、膀胱和左右股骨头等危险器官(OAR)的剂量。单变量和多变量分析显示,BM V40 是急性 HT ≥ 3 级的独立风险因素(几率比 [OR] = 2.734,95% 置信区间 [CI] = 1.959-3.815,P < 0.001*)。临界值为 25.036%,曲线下面积(AUC)为 0.786。构建的提名图经过严格评估和内部交叉验证,显示出良好的预测性能。接受 BMS 盆腔照射可降低 LACC 患者急性 HT 的发生率,而 BM V40 < 25% 可能是降低急性 HT 风险的一个重要因素。
Effects of bone marrow sparing radiotherapy on acute hematologic toxicity for patients with locoregionally advanced cervical cancer: a prospective phase II randomized controlled study
To evaluate effects of bone marrow sparing (BMS) radiotherapy on decreasing the incidence of acute hematologic toxicity (HT) for locoregionally advanced cervical cancer (LACC) patients treated by pelvic irradiation. LACC patients were recruited prospectively from May 2021 to May 2022 at a single center and were evenly randomized into the BMS group and the control group. All patients received pelvic irradiation with concurrent cisplatin (40 mg/m2 weekly), followed by brachytherapy and BM V40 < 25% in the BMS group was additionally prescribed. Acute HT was assessed weekly. Binary logistic regression model and receiver operating characteristic (ROC) curve were used for predictive value analysis. The trial was registered with Chinese clinical trial registry (ChiCTR2200066485). A total of 242 patients were included in the analysis. Baseline demographic, disease and treatment characteristics were balanced between the two groups. In the intention-to-treat population, BMS was associated with a lower incidence of grade ≥ 2 and grade ≥ 3 acute HT, leukopenia and neutropenia s(72.70% v 90.90%, P < 0.001*; 16.50% vs. 65.30%, P < 0.001*; 66.10% vs. 85.10%, P = 0.001*; 13.20% vs. 54.50%, P < 0.001*; 37.20% vs. 66.10%, P < 0.001*; 10.70% vs. 43.80%, P < 0.001*). BMS also resulted in decreased dose delivered to the organs at risk (OARs) including rectum, bladder and left and right femoral head. Univariate and multivariate analyses showed that BM V40 was an independent risk factor for grade ≥ 3 acute HT (odds ratio [OR] = 2.734, 95% confidence interval [CI] = 1.959–3.815, P < 0.001*). Cutoff value was 25.036% and area under the curve (AUC) was 0.786. The nomogram was constructed, which was rigorously evaluated and internally cross-validated, showing good predictive performance. Receiving BMS pelvic irradiation could reduce the incidence of acute HT in LACC patients, and BM V40 < 25% may be a significant factor in reducing the risks of acute HT.
Radiation OncologyONCOLOGY-RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
CiteScore
6.50
自引率
2.80%
发文量
181
审稿时长
3-6 weeks
期刊介绍:
Radiation Oncology encompasses all aspects of research that impacts on the treatment of cancer using radiation. It publishes findings in molecular and cellular radiation biology, radiation physics, radiation technology, and clinical oncology.