Department of Radiation Oncology, Regional Cancer Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Radiation Oncology, Regional Cancer Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India; Department of Radiotherapy, Maharishi Markandeshwar Institute of Medical Sciences and Research, Maharishi Markandeshwar University, Mullana-Ambala, India.
Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):874-881. doi: 10.1016/j.ijrobp.2017.12.015. Epub 2017 Dec 16.
To report the results in terms of feasibility and early toxicity of hypofractionated adjuvant whole breast/chest wall and/or regional nodal radiation therapy for patients with breast cancer.
From June 2013 to October 2014, 50 patients with breast cancer after mastectomy or after breast conservation surgery (BCS) were prospectively included. The institutional ethics committee approved the study, which was registered with ClinicalTrials.gov (ClinicalTrials.gov identifier no. NCT02460744). Treatment planning was performed using a simulator with 2 tangential fields to the breast/chest wall and an incident field to the supraclavicular fossa. The radiation dose delivered was 34 Gy in 10 fractions within 2 weeks, followed by a boost of 10 Gy in 5 fractions within 1 week for patients who underwent BCS. Acute skin toxicities were recorded during and after treatment according to the Radiation Therapy Oncology Group acute radiation toxicity scoring criteria. The primary objective was to obtain estimates of the acute toxicity rates and cosmetic outcomes that could be used to design a subsequent phase III comparative study. Acute skin and late toxicities were recorded during and after treatment. Cosmetic outcomes were assessed before and after treatment and during the regular follow-up period. A cost/benefit analysis was also performed and compared with that for standard treatment of 35 Gy in 15 fractions within 3 weeks.
The median follow-up was 39 months (range 14-48). The mean age was 51 years (range 26-75). A left-sided tumor was present in 25 patients (50%). Total mastectomy with axillary clearance was performed in 40 (80%) and BCS in 10 (20%) patients. Acute grade 2 and 3 skin toxicity was seen in 16 (32%) and 1 (2%) patient, respectively. In the BCS patients, grade 2 skin and subcutaneous toxicity was seen in 2 (20%) and 1 (10%) patient, respectively. Grade 2 edema was seen in 1 patient (10%). The cosmesis was excellent or good in 8 (80%) and fair or poor in 2 (20%) patients. The cost/benefit analysis revealed significantly less financial burden on the patients with 2 weeks of treatment. Disease-free and overall survival at 3 years was 94% and 96%, respectively.
Hypofractionated radiation therapy within 2 weeks appears to be feasible for patients with breast cancer and was associated with acute and late skin toxicity profiles similar to those observed with 3 weeks of treatment. The financial burden on the patient and family could be reduced with 2 weeks of treatment. Long-term follow-up data and a prospective comparative study are needed to strengthen these results. Hypofractionation might help radiation centers worldwide to meet the increasing need for radiation for breast cancer, especially in developing countries where resources are limited and patients must travel long distances for treatment.
报告采用低分割辅助全乳/胸壁和/或区域淋巴结放射治疗乳腺癌患者的可行性和早期毒性结果。
从 2013 年 6 月至 2014 年 10 月，前瞻性纳入 50 例乳腺癌根治术后或保乳手术后患者。机构伦理委员会批准了该研究，并在 ClinicalTrials.gov 上进行了注册（ClinicalTrials.gov 标识符：NCT02460744）。使用模拟机进行治疗计划，采用 2 个切线野照射乳房/胸壁和锁骨上野照射。给予 34 Gy 的剂量，10 次分割，2 周内完成，对于行保乳手术的患者，随后在 1 周内加量 10 Gy，共 5 次。根据放射治疗肿瘤学组急性放射毒性评分标准，在治疗期间和治疗后记录急性皮肤毒性。主要目的是获得急性毒性发生率和美容效果的估计值，以便为后续的 III 期比较研究设计提供依据。在治疗期间和治疗后记录急性和迟发性皮肤毒性。在治疗前、治疗后和定期随访期间评估美容效果。还进行了成本/效益分析，并与 3 周内 35 Gy、15 次分割的标准治疗进行了比较。
中位随访时间为 39 个月（14-48 个月）。患者平均年龄为 51 岁（26-75 岁）。左乳肿瘤 25 例（50%）。40 例（80%）患者行全乳切除术加腋窝清扫术，10 例（20%）患者行保乳手术。16 例（32%）患者出现急性 2 级和 3 级皮肤毒性，1 例（2%）患者出现急性 3 级皮肤毒性。保乳手术患者中，2 例（20%）出现 2 级皮肤和皮下毒性，1 例（10%）出现 2 级水肿。8 例（80%）患者美容效果为优或良，2 例（20%）患者为差或极差。成本/效益分析显示，2 周治疗可显著减轻患者的经济负担。3 年无病生存率和总生存率分别为 94%和 96%。
对于乳腺癌患者，2 周内的低分割放疗似乎是可行的，且急性和迟发性皮肤毒性与 3 周治疗相似。2 周治疗可减轻患者和家庭的经济负担。需要长期随访数据和前瞻性比较研究来加强这些结果。在全球范围内，低分割可能有助于放射治疗中心满足日益增长的乳腺癌放射治疗需求，特别是在资源有限且患者必须长途跋涉进行治疗的发展中国家。
