单光子发射计算机断层扫描定义的活性骨髓保护容积调制弧放疗能够降低接受化学放疗的局部晚期宫颈癌患者急性血液毒性的发生率:一项单中心前瞻性随机对照试验。
Single-photon emission computed tomography-defined active bone marrow-sparing volumetric-modulated arc therapy reduces the incidence of acute hematologic toxicity in locally advanced cervical cancer patients who receive chemoradiotherapy: A single-center prospective randomized controlled trial.
发表日期:2023 Apr 12
作者:
ShanBing Wang, Jiapei Liu, Kaijian Lei, Yuming Jia, Chunxiu Wang, Xia Zhang, Ting Li
来源:
CANCER
摘要:
本研究旨在测试单光子发射计算机断层摄影(SPECT)定义的骨髓保护 (ABMS) 容积调制弧形放疗 (VMAT) 的疗效,以减少接受化学放疗的局部晚期宫颈癌患者出现3级或更高级别的急性血液学毒性(HT)。这是一项前瞻性、单中心、开放标签、随机临床试验,招募了局部晚期宫颈癌患者。参与者被随机分配到99m 苏打胶体SPECT定义的ABMS VMAT组(ABMS组)或对照组,对照组接受每周一次顺铂与放射治疗后的高剂量速率腔内放射治疗。ABMS组另外接受SPECT定义的ABM 打击约束。主要终点是ABMS组与对照组中3级或更高级别急性HT的发生率。共有192名妇产科联盟IB-IIIB期患者随机接受了治疗(每组96人)。随访时间中位数为24个月。ABMS组3级或更高级别急性HT的发生率显著低于对照组(32.3% vs. 53.1%,p < .01)。ABMS组完成5个周期顺铂的患者比例为88.5%,对照组为75%,差异显著(p = .02)。两组之间在计划目标值覆盖率、危及器官剂量参数、2年无进展生存率或2年总生存率上没有差异。对照组患者的2年远处转移比ABMS组非显著性更差(17.8% vs. 11.1%,p = .19)。ABMS VMAT相对于对照治疗显著降低了3级或更高级别的急性HT,并提高了化疗的传递。我们发现ABMS VMAT对远处转移的影响有弱证据。© 2023 American Cancer Society.
This study aims to test the efficacy of single-photon emission computed tomography (SPECT)-defined active bone marrow-sparing (ABMS) volumetric-modulated arc therapy (VMAT) in reducing grade 3+ acute hematologic toxicity (HT) in locally advanced cervical cancer patients treated with chemoradiotherapy.This was a prospective, single-center, open label, randomized clinical trial that enrolled locally advanced cervical cancer patients. Participants were randomized to the 99m Tc sulfur colloid SPECT-defined ABMS VMAT (ABMS group) or control group, who received weekly cisplatin concurrently with VMAT followed by high-dose-rate intracavitary brachytherapy. The ABMS group additionally received SPECT-defined ABM dose constraints. The primary end point was the incidence of grade 3+ acute HT.A total of 192 Federation of Gynaecology and Obstetrics stage IB-IIIB patients were randomly treated (96 each in the ABMS control groups). The median follow-up was 24.0 months. The incidence of grade 3+ acute HT in the ABMS group was significantly lower than that in the control group (32.3% vs. 53.1%, p < .01). The number of patients completing five cycles of cisplatin was 88.5% in the ABMS group and 75% in the control group, and the difference was significant (p = .02). There were no differences in planning target value coverage, organs at risk dosimetric parameters, 2-year progression-free survival, or 2-year overall survival between the two groups. Patients in the control group had nonsignificantly worse 2-year distant metastasis than patients in the ABMS group (17.8% vs. 11.1%, p = .19).ABMS VMAT significantly reduced grade 3+ acute HT and improved chemotherapy delivery compared with the control treatment. We found weak evidence of the effect of ABMS VMAT on distant metastasis.© 2023 American Cancer Society.