Van Hulle Hans, Vakaet Vincent, Post Giselle, Van Greveling Annick, Monten Chris, Hendrix An, Van de Vijver Koen, Van Dorpe Jo, De Visschere Pieter, Braems Geert, Vandecasteele Katrien, Denys Hannelore, De Neve Wilfried, Veldeman Liv
Department of Human Structure and Repair, Ghent University, Ghent, Belgium.
Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.
Pilot Feasibility Stud. 2020 Oct 10;6:154. doi: 10.1186/s40814-020-00693-z. eCollection 2020.
In early-stage breast cancer, the cornerstone of treatment is surgery. After breast-conserving surgery, adjuvant radiotherapy has shown to improve locoregional control and overall survival rates. The use of breast radiotherapy in the preoperative (preop) setting is far less common. Nevertheless, it might improve disease-free survival as compared to postoperative radiotherapy. There is also a possibility of downsizing the tumour which might lead to a lower need for mastectomy. There are some obstacles that complicate its introduction into daily practice. It may complicate surgery or lead to an increase in wound complications or delayed wound healing. Another fear of preop radiotherapy is delaying surgery for too long. At Ghent University Hospital, we have experience with a 5-fraction radiotherapy schedule allowing radiotherapy delivery in a very short time span.
Twenty female breast cancer patients with non-metastatic disease receiving preop chemotherapy will be randomized between preop or postoperative radiotherapy. The feasibility of preop radiotherapy will be evaluated based on overall treatment time. All patients will be treated in 5 fractions of 5.7 Gy to the whole breast with a simultaneous integrated boost to the tumour/tumour bed of 5 × 6.2 Gy. In case of lymph node irradiation, the lymph node regions will receive a dose of 27 Gy in 5 fractions of 5.4 Gy. The total duration of therapy will be 10 to 12 days. In the preop group, overall treatment time is defined as the time between diagnosis and the day of last surgery, in the postop group between diagnosis and last irradiation fraction. Toxicity related to surgery, radio-, and chemotherapy will be evaluated on dedicated case-report forms at predefined time points. Tumour response will be evaluated on the pathology report and on MRI at baseline and in the interval between chemotherapy and surgery.
The primary objective of the trial is to investigate the feasibility of preop radiotherapy. Secondary objectives are to search for biomarkers of response and toxicity and identify the involved cell death mechanisms and the effect of preop breast radiotherapy on the in-situ immune micro-environment.
在早期乳腺癌中，治疗的基石是手术。保乳手术后，辅助放疗已显示可改善局部区域控制率和总生存率。术前使用乳腺放疗的情况则远不常见。然而，与术后放疗相比，它可能会提高无病生存率。此外，还有使肿瘤缩小的可能性，这可能会降低乳房切除术的需求。但将其引入日常实践存在一些障碍。它可能会使手术复杂化，或导致伤口并发症增加或伤口愈合延迟。对术前放疗的另一个担忧是手术延迟过长。在根特大学医院，我们有使用5次分割放疗方案的经验，该方案可在非常短的时间内完成放疗。
20名接受术前化疗的非转移性女性乳腺癌患者将被随机分为术前放疗组或术后放疗组。将根据总治疗时间评估术前放疗的可行性。所有患者将接受全乳5次分割、每次5.7 Gy的放疗，同时对肿瘤/瘤床同步加量至5×6.2 Gy。如果进行淋巴结照射，淋巴结区域将接受5次分割、每次5.4 Gy、总剂量27 Gy的照射。治疗总时长为10至12天。在术前组，总治疗时间定义为从诊断到最后一次手术之日的时间；在术后组，定义为从诊断到最后一次放疗分割的时间。将在预定时间点使用专用病例报告表评估与手术、放疗和化疗相关的毒性。将根据病理报告以及基线时和化疗与手术间隔期的MRI评估肿瘤反应。
该试验的主要目的是研究术前放疗的可行性。次要目的是寻找反应和毒性的生物标志物，确定相关的细胞死亡机制，以及术前乳腺放疗对原位免疫微环境的影响。
