接受同步放化疗的肛管癌患者的骨髓保护调强放疗：一项前瞻性II期试验第一阶段的结果

Bone Marrow-Sparing IMRT in Anal Cancer Patients Undergoing Concurrent Chemo-Radiation: Results of the First Phase of a Prospective Phase II Trial.

作者信息

Arcadipane Francesca, Silvetti Patrick, Olivero Francesco, Gastino Alessio, De Luca Viola, Mistrangelo Massimiliano, Cassoni Paola, Racca Patrizia, Gallio Elena, Lesca Adriana, Fiandra Christian, Ricardi Umberto, Franco Pierfrancesco

机构信息

Department of Oncology, Radiation Oncology, Azienda Ospedaliero-Universitaria Citta' della Salute e della Scienza, 10126 Turin, Italy.

Department of Oncology, Radiation Oncology, University of Turin, 10126 Turin, Italy.

出版信息

Cancers (Basel). 2020 Nov 9;12(11):3306. doi: 10.3390/cancers12113306.

PURPOSE

to investigate the role of selective avoidance of hematopoietically active BM within the pelvis, as defined with FDG-PET, employing a targeted IMRT approach, to reduce acute hematologic toxicity (HT) profile in anal cancer patients undergoing concurrent chemo-radiation.

METHODS

a one-armed two-stage Simon's design was selected to test the hypothesis that BM-sparing approach would improve by 20% the rate of G0-G2 (vs. G3-G4) HT, from 42% of RTOG 0529 historical data to 62% (α = 0.05 and the β = 0.20). At the first stage, among 21 enrolled patients, at least 9 should report G0-G2 acute HT to further proceed with the trial. We employed FDG-PET to identify active BM within the pelvis. Acute HT was assessed via weekly blood counts and scored as per the Common Toxicity Criteria for Adverse Effects version 4.0.

RESULTS

from December 2017 to October 2019, 21 patients were enrolled. Maximum observed acute HT comprised 9% rate of ≥G3 leukopenia and 5% rate of ≥G3 neutropenia and anemia. Overall, only 4 out of 21 treated patients (19%) experienced ≥G3 acute HT. Conversely, 17 patients (81%) experienced G0-G2 events, way above the threshold set by the trial design.

CONCLUSION

FDG-PET-guided BM-sparing IMRT was able to reduce acute HT in anal cancer patients treated with concomitant chemo-radiation. These results prompted us to conclude the second part of this prospective phase II trial.

目的

采用靶向调强放射治疗（IMRT）方法，研究通过氟代脱氧葡萄糖正电子发射断层扫描（FDG-PET）定义的盆腔内造血活跃骨髓的选择性避让在降低接受同步放化疗的肛管癌患者急性血液学毒性（HT）方面的作用。

方法

采用单臂两阶段西蒙设计来检验以下假设，即骨髓避让方法将使G0-G2级（相对于G3-G4级）HT的发生率提高20%，从放射治疗肿瘤学组（RTOG）0529历史数据中的42%提高到62%（α = 0.05，β = 0.20）。在第一阶段，21名入组患者中至少9名应报告G0-G2级急性HT，才能进一步进行试验。我们使用FDG-PET来识别盆腔内的活跃骨髓。通过每周血常规评估急性HT，并根据《不良反应通用毒性标准》第4.0版进行评分。

结果

2017年12月至2019年10月，共入组21例患者。观察到的最大急性HT包括≥G3级白细胞减少症发生率为9%，≥G3级中性粒细胞减少症和贫血发生率为5%。总体而言，21例接受治疗的患者中只有4例（19%）经历了≥G3级急性HT。相反，17例患者（81%）经历了G0-G2级事件，远高于试验设计设定的阈值。