Arthur Douglas W, Winter Kathryn A, Kuerer Henry M, Haffty Bruce G, Cuttino Laurie W, Todor Dorin A, Simone Nicole L, Hayes Shelly B, Woodward Wendy A, McCormick Beryl, Cohen Randi J, Sahijdak Walter M, Canaday Daniel J, Brown Doris R, Currey Adam D, Fisher Christine M, Jagsi Reshma, White Julia
Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia.
NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Int J Radiat Oncol Biol Phys. 2017 Aug 1;98(5):1028-1035. doi: 10.1016/j.ijrobp.2017.03.016. Epub 2017 Mar 18.
To determine the associated toxicity, tolerance, and safety of partial-breast reirradiation.
Eligibility criteria included in-breast recurrence occurring >1 year after whole-breast irradiation, <3 cm, unifocal, and resected with negative margins. Partial-breast reirradiation was targeted to the surgical cavity plus 1.5 cm; a prescription dose of 45 Gy in 1.5 Gy twice daily for 30 treatments was used. The primary objective was to evaluate the rate of grade ≥3 treatment-related skin, fibrosis, and/or breast pain adverse events (AEs), occurring ≤1 year from re-treatment completion. A rate of ≥13% for these AEs in a cohort of 55 patients was determined to be unacceptable (86% power, 1-sided α = 0.07).
Between 2010 and 2013, 65 patients were accrued, and the first 55 eligible and with 1 year follow-up were analyzed. Median age was 68 years. Twenty-two patients had ductal carcinoma in situ, and 33 had invasive disease: 19 ≤1 cm, 13 >1 to ≤2 cm, and 1 >2 cm. All patients were clinically node negative. Systemic therapy was delivered in 51%. All treatment plans underwent quality review for contouring accuracy and dosimetric compliance. All treatment plans scored acceptable for tumor volume contouring and tumor volume dose-volume analysis. Only 4 (7%) scored unacceptable for organs at risk contouring and organs at risk dose-volume analysis. Treatment-related skin, fibrosis, and/or breast pain AEs were recorded as grade 1 in 64% and grade 2 in 7%, with only 1 (<2%) grade ≥3 and identified as grade 3 fibrosis of deep connective tissue.
Partial-breast reirradiation with 3-dimensional conformal radiation therapy after second lumpectomy for patients experiencing in-breast failures after whole-breast irradiation is safe and feasible, with acceptable treatment quality achieved. Skin, fibrosis, and breast pain toxicity was acceptable, and grade 3 toxicity was rare.
确定部分乳腺再照射相关的毒性、耐受性和安全性。
入选标准包括全乳照射后1年以上发生的乳腺内复发、肿瘤大小<3 cm、单灶且手术切缘阴性。部分乳腺再照射的靶区为手术腔加1.5 cm；采用的处方剂量为45 Gy，分30次，每日2次，每次1.5 Gy。主要目的是评估再治疗完成后≤1年发生的≥3级与治疗相关的皮肤、纤维化和/或乳腺疼痛不良事件（AE）的发生率。在55例患者队列中，这些AE的发生率≥13%被认为是不可接受的（检验效能86%，单侧α = 0.07）。
2010年至2013年期间，共纳入65例患者，对首批55例符合条件且有1年随访资料的患者进行分析。中位年龄为68岁。22例患者为导管原位癌，33例为浸润性疾病：19例肿瘤大小≤1 cm，13例>1至≤2 cm，1例>2 cm。所有患者临床腋窝淋巴结均为阴性。51%的患者接受了全身治疗。所有治疗计划均进行了轮廓勾画准确性和剂量学依从性的质量评估。所有治疗计划在肿瘤体积轮廓勾画和肿瘤体积剂量体积分析方面评分均可接受。只有4例（7%）在危及器官轮廓勾画和危及器官剂量体积分析方面评分不可接受。与治疗相关的皮肤、纤维化和/或乳腺疼痛AE中，64%记录为1级，7%记录为2级，只有1例（<2%）≥3级，诊断为深部结缔组织3级纤维化。
对于全乳照射后发生乳腺内复发的患者，二次肿块切除术后采用三维适形放射治疗进行部分乳腺再照射是安全可行的，治疗质量可接受。皮肤、纤维化和乳腺疼痛毒性可接受，3级毒性罕见。
