A Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation: First Report of Acute Toxicity, Feasibility, and Patient Satisfaction
A Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation: First Report of Acute Toxicity, Feasibility, and Patient Satisfaction
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DOI：
10.1016/j.ijrobp.2012.10.021
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发表时间：
2013-03-01
影响因子：
7
通讯作者：
Spanos, William J.
中科院分区：
文献类型：
--
作者：
Dragun, Anthony E.;Quillo, Amy R.;Spanos, William J.
目的：报告一项单机构2期试验的早期结果，该试验为接受保乳手术（BCS）的患者提供5次、每周一次的放射治疗方案。方法和材料：美国癌症联合委员会（American Joint Committee on Cancer） 0、I或II期乳腺癌手术切度阴性的患者接受BCS，有资格接受30 Gy剂量的全乳房放射治疗，每5周6 Gy，有或没有额外的增强。不允许选择性淋巴结照射。对于符合条件的患者，没有限制乳房大小或使用细胞毒性化疗。在基线、治疗完成和第一次治疗后随访时对患者进行评估，以评估急性毒性（不良事件通用术语标准，3.0版）和生活质量（欧洲癌症研究和治疗组织QLQ-BR23）。结果：2011年1月至9月期间，42例符合条件的患者在BCS后立即（69.0%）或在细胞毒性化疗结束时（31.0%）接受了每周低分割乳房照射。>= 2级放射性皮炎、疼痛、疲劳和乳房水肿的发生率分别为19.0%、11.9%、9.5%和2.4%。仅观察到1例3级毒性-需要一个疗程麻醉镇痛药的疼痛。1例患者出现浅表性蜂窝织炎（2级），口服抗生素解决。患者报告的中度至重度乳房症状（疼痛、肿胀和皮肤问题）在1个月内均从基线下降，而乳房敏感性在研究期间保持稳定。结论：每周低分割乳房照射的耐受性与最近报道的每日低分割全乳照射计划相比要好。该方案似乎可行且具有成本效益。需要持续的随访来评估晚期毒性、美容和疾病特异性结局。(C) 2013爱思唯尔公司
Purpose: To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS).Methods and Materials: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23).Results: Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade >= 2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity-pain requiring a course of narcotic analgesics-was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period.Conclusions: The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes. (C) 2013 Elsevier Inc.