Khan Atif J, Poppe Matthew M, Goyal Sharad, Kokeny Kristine E, Kearney Thomas, Kirstein Laurie, Toppmeyer Deborah, Moore Dirk F, Chen Chunxia, Gaffney David K, Haffty Bruce G
Atif J. Khan, Sharad Goyal, Thomas Kearney, Deborah Toppmeyer, and Bruce G. Haffty, Rutgers Cancer Institute of New Jersey, New Brunswick; Dirk F. Moore and Chunxia Chen, Rutgers School of Public Health, Piscataway, NJ; Matthew M. Poppe, Kristine E. Kokeny, and David K. Gaffney, Huntsman Cancer Hospital, University of Utah, Salt Lake City, UT; and Laurie Kirstein, Memorial Sloan Kettering Cancer Center, NY.
J Clin Oncol. 2017 Jun 20;35(18):2037-2043. doi: 10.1200/JCO.2016.70.7158. Epub 2017 May 1.
Purpose Conventionally fractionated postmastectomy radiation therapy (PMRT) takes approximately 5 to 6 weeks. Data supporting hypofractionated PMRT is limited. We prospectively evaluated a short course of hypofractionated PMRT, in which therapy was completed in 15 treatment days. Patients and Methods We delivered PMRT at a dose of 36.63 Gy in 11 fractions of 3.33 Gy over 11 days to the chest wall and the draining regional lymph nodes, followed by an optional mastectomy scar boost of four fractions of 3.33 Gy. Our primary end point was freedom from any grade 3 or higher toxicities. We incorporated early stopping criteria on the basis of predefined toxicity thresholds. Results We enrolled 69 women with stage II to IIIa breast cancer, of whom 67 were eligible for analysis. After a median follow-up of 32 months, there were no grade 3 toxicities. There were 29 reported grade 2 toxicities, with grade 2 skin toxicities being the most frequent (16 of 67; 24%). There were two patients with isolated ipsilateral chest wall tumor recurrences (2 of 67; crude rate, 3%). Three-year estimated local recurrence-free survival was 89.2% (95% CI, 0.748 to 0.956). The 3-year estimated distant recurrence-free survival was 90.3% (95% CI, 0.797 to 0.956). Forty-one patients had chest wall reconstructions; three had expanders removed for infection before radiation therapy. The total rate of implant loss or failure was 24% (9 of 38), and the unplanned surgical correction rate was 8% (3 of 38), for a total complication rate of 32%. Conclusion To our knowledge, our phase II prospective study offers one of the shortest courses of PMRT reported, delivered in 11 fractions to the chest wall and nodes and 15 fractions inclusive of a boost. We demonstrated low toxicity and high local control with this schedule. On the basis of our data, we have designed a cooperative group phase III prospective, randomized trial of conventional versus hypofractionated PMRT that will activate soon.
目的 传统分割的乳房切除术后放射治疗（PMRT）大约需要5至6周。支持短程分割PMRT的数据有限。我们前瞻性地评估了短程分割PMRT，该治疗在15个治疗日完成。
患者与方法 我们对胸壁和引流区域淋巴结在11天内给予11次分割、每次3.33 Gy、总剂量36.63 Gy的PMRT，随后对乳房切除瘢痕进行4次每次3.33 Gy的选择性加量照射。我们的主要终点是无任何3级或更高等级的毒性反应。我们根据预先设定的毒性阈值纳入了早期终止标准。
结果 我们纳入了69例II至IIIa期乳腺癌女性患者，其中67例符合分析条件。中位随访32个月后，无3级毒性反应。报告了29例2级毒性反应，其中2级皮肤毒性最为常见（67例中的16例；24%）。有2例患者出现孤立的同侧胸壁肿瘤复发（67例中的2例；粗发病率，3%）。3年估计局部无复发生存率为89.2%（95%CI，0.748至0.956）。3年估计远处无复发生存率为90.3%（95%CI，0.797至0.956）。41例患者进行了胸壁重建；3例在放疗前因感染取出了扩张器。植入物丢失或失败的总发生率为24%（38例中的9例），计划外手术矫正率为8%（38例中的3例），总并发症发生率为32%。
结论 据我们所知，我们的II期前瞻性研究提供了报告的最短疗程的PMRT之一，对胸壁和淋巴结给予11次分割照射，包括加量照射在内共15次分割。我们证明了该方案毒性低且局部控制良好。基于我们的数据，我们设计了一项合作组III期前瞻性、随机对照试验，比较传统分割与短程分割PMRT，该试验即将启动。
