Department of Radiation Oncology, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Department of Radiation Oncology, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Int J Radiat Oncol Biol Phys. 2021 Feb 1;109(2):441-448. doi: 10.1016/j.ijrobp.2020.09.009. Epub 2020 Sep 16.
To perform a planned interim analysis of acute (within 12 months) and late (after 12 months) toxicities and cosmetic outcomes after proton accelerated partial breast irradiation (APBI).
A total of 100 patients with pTis or pT1-2 N0 (≤3cm) breast cancer status after segmental mastectomy were enrolled in a single-arm phase 2 study from 2010 to 2019. The clinically determined postlumpectomy target volume, including tumor bed surgical clips and operative-cavity soft-tissue changes seen on imaging plus a radial clinical expansion, was irradiated with passively scattered proton APBI (34 Gy in 10 fractions delivered twice daily with a minimum 6-hour interfraction interval). Patients were evaluated at protocol-specific time intervals for recurrence, physician reports of cosmetic outcomes and toxicities, and patient reports of cosmetic outcomes and satisfaction with the treatment or experience.
Median follow-up was 24 months (interquartile range [IQR], 12-43 months). Local control and overall survival were 100% at 12 and 24 months. There were no acute or late toxicities of grade 3 or higher; no patients experienced fat necrosis, fibrosis, infection, or breast shrinkage. Excellent or good cosmesis at 12 months was reported by 91% of patients and 94% of physicians; at the most recent follow-up, these were 94% and 87%, respectively. The most commonly reported late cosmetic effect was telangiectasis (17%). The total patient satisfaction rate for treatment and results at 12 and 24 months was 96% and 100%, respectively. Patients' mean time away from work was 5 days (IQR, 2-5 days), and the median out-of-pocket cost was $700 (IQR, $100-$1600). The mean left-sided heart dose was 2 cGy (range, 0.2-75 cGy), and the mean ipsilateral lung dose was 19 cGy (range, 0.2-164 cGy).
Proton APBI is a maturing treatment option with high local control, favorable intermediate-term cosmesis, high treatment satisfaction, low treatment burden, and exceptional heart and lung sparing.
对质子加速局部乳腺照射（APBI）后 12 个月内的急性毒性和 12 个月后的迟发性毒性及美容效果进行计划的中期分析。
2010 年至 2019 年，共纳入 100 例接受保乳手术后Tis 或 pT1-2N0（≤3cm）乳腺癌状态的患者，进行单臂 2 期研究。根据临床确定的保乳术后靶区，包括肿瘤床手术夹和影像学上看到的手术腔软组织变化，并加上放射性临床扩展，采用被动散射质子 APBI 进行照射（34 Gy，10 次分割，每天两次，间隔至少 6 小时）。根据方案规定的时间间隔，对患者进行复发、医生报告的美容效果和毒性、患者报告的美容效果和对治疗或治疗经历的满意度进行评估。
中位随访时间为 24 个月（四分位距[IQR]，12-43 个月）。12 个月和 24 个月时的局部控制率和总生存率均为 100%。无 3 级或以上的急性或迟发性毒性；无患者发生脂肪坏死、纤维化、感染或乳房缩小。12 个月时，91%的患者和 94%的医生报告美容效果优秀或良好；在最近的随访中，这一比例分别为 94%和 87%。最常见的迟发性美容效果是毛细血管扩张（17%）。12 个月和 24 个月时，患者对治疗和结果的总满意度分别为 96%和 100%。患者平均离开工作岗位的时间为 5 天（IQR，2-5 天），自付费用中位数为 700 美元（IQR，100-1600 美元）。左心剂量平均为 2 戈瑞（范围，0.2-75 戈瑞），同侧肺剂量平均为 19 戈瑞（范围，0.2-164 戈瑞）。
质子 APBI 是一种成熟的治疗选择，具有较高的局部控制率、良好的中期美容效果、较高的治疗满意度、较低的治疗负担和极好的心脏和肺保护。
