Department of Radiation Medicine, Loma Linda University Medical Center, 11234 Anderson Street, Loma Linda, CA 92354, USA.
Clin Breast Cancer. 2011 Aug;11(4):241-5. doi: 10.1016/j.clbc.2011.03.023. Epub 2011 Jun 12.
A phase II trial sought to determine the safety and efficacy of proton beam irradiation to deliver partial breast radiotherapy after lumpectomy for early-stage breast cancer.
Eligible patients included women with invasive nonlobular carcinoma ≤ 3 cm. Surgical therapy included lumpectomy with negative margins and negative axillary lymph nodes on sampling. Postoperative proton radiotherapy to the surgical bed with an additional 1-cm margin was delivered by 40 Gy in 10 fractions over a 2-week course. Patients received systemic therapy as recommended after proton treatment. Patients had clinical evaluations every 6 months and annual mammograms.
Fifty patients were enrolled; median follow-up was 48 months. All patients completed the prescribed treatment. Acute toxicities were limited to mild radiation dermatitis. Late skin toxicities included 3 grade 1 telangiectasias. There were no posttreatment infections or ulcerations and no cases of fat necrosis, rib fractures, radiation pneumonitis, or cardiac events. Actuarial 5-year overall survival and disease-free survival rates were 96% and 92%, respectively. No local failures occurred. Ipsilateral breast cancer developed in 1 patient 5.5 years after treatment. Dose-volume histogram analysis showed near-complete elimination of dose to the contralateral breast, lung, and heart.
Proton partial breast radiotherapy appeared to be a feasible method of treatment and provided excellent disease control within the ipsilateral breast. Treatment-related toxicity was minimal and no technical limitations prevented treatment delivery. The incidence of posttreatment complications may be less than that reported when using more invasive techniques; comparative trials should be considered.
一项 II 期临床试验旨在确定质子束放疗在早期乳腺癌保乳术后局部放疗中的安全性和疗效。
符合条件的患者包括浸润性非小叶癌≤3cm的女性。手术治疗包括保乳术，切缘阴性，腋窝淋巴结取样阴性。术后质子放疗采用 40Gy/10 次/2 周的方案，在手术床部位给予 40Gy/10 次/2 周的剂量，外加 1cm 边缘。患者在质子治疗后接受推荐的全身治疗。患者每 6 个月进行临床评估，每年进行乳房 X 线检查。
共入组 50 例患者，中位随访时间为 48 个月。所有患者均完成了规定的治疗。急性毒性仅限于轻度放射性皮炎。晚期皮肤毒性包括 3 例 1 级毛细血管扩张症。无治疗后感染或溃疡，无脂肪坏死、肋骨骨折、放射性肺炎或心脏事件发生。5 年总生存率和无病生存率分别为 96%和 92%。无局部复发。1 例患者在治疗后 5.5 年同侧乳腺发生乳腺癌。剂量-体积直方图分析显示，对侧乳房、肺和心脏的剂量几乎完全消除。
质子部分乳腺放疗似乎是一种可行的治疗方法，在同侧乳腺中提供了极好的疾病控制。治疗相关的毒性极小，没有技术限制阻止治疗的实施。治疗后并发症的发生率可能低于使用更具侵袭性技术时的报告，应考虑进行比较试验。
