Department of Radiation Oncology, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.
Department of Surgery, Mayo Clinic, Rochester, MN, USA.
Radiat Oncol. 2019 Nov 21;14(1):211. doi: 10.1186/s13014-019-1417-7.
To report dosimetry and early adverse effects, aesthetic, and patient-reported outcomes of a prospective study of 3-fraction pencil-beam scanning (PBS) proton accelerated partial irradiation (APBI).
Eligibility included women age ≥ 50 years with estrogen receptor positive (ER+), sentinel lymph node negative invasive or in-situ breast cancer measuring ≤2.5 cm. The prescription was 21.9 Gy (RBE 1.1) in 3 daily fractions to the post-operative tumor bed with a 1 cm expansion. Toxicities were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, 10-point Linear Analog Scale Assessment, Patient-Reported Outcomes Version of the CTCAE, and the Harvard Breast Cosmesis Scale.
Seventy-six women were treated between 2015 and 2017. The median breast volume receiving 50% of prescription or more was 28%. Median mean heart, mean ipsilateral lung, and maximum skin dose were 0 Gy, 0.1 Gy, and 20.6 Gy, respectively. With a median follow-up of 12 months, no treatment-related toxicity grade ≥ 2 has been observed. Most common grade 1 adverse events were dermatitis (68%) and skin hyperpigmentation (18%). At 12 months, the only persistent toxicities were one patient with grade 1 breast edema and one patient with a grade 1 seroma. 90% of patients reported quality of life as ≥7 out of 10 (0 indicating "as bad as it can be" and 10 indicating "as good as it can be") and 98% of patients reported excellent or good cosmesis.
3-fraction PBS proton APBI is well tolerated with low rates of physician and patient reported early adverse effects. Follow-up is ongoing to assess late toxicities and disease control outcomes. Further investigation of this novel adjuvant treatment strategy is warranted.
报告 3 分次铅笔束扫描(PBS)质子加速部分照射(APBI)前瞻性研究的剂量学和早期不良反应、美学和患者报告的结果。
纳入标准为年龄≥50 岁、雌激素受体阳性(ER+)、前哨淋巴结阴性的侵袭性或原位乳腺癌,肿瘤最大直径≤2.5cm。处方剂量为 21.9Gy(RBE1.1),共 3 天,每天 1 次,靶区为术后肿瘤床,外加 1cm 扩展。采用美国国立癌症研究所不良事件通用术语标准(CTCAE)第 4.0 版、10 分线性模拟量表评估、CTCAE 患者报告结局版和哈佛乳房美容量表收集毒性反应。
2015 年至 2017 年期间,共治疗了 76 例患者。接受处方剂量 50%或以上的中位乳房体积为 28%。中位平均心脏剂量、中位同侧肺剂量和最大皮肤剂量分别为 0Gy、0.1Gy 和 20.6Gy。中位随访 12 个月,未观察到与治疗相关的毒性反应≥2 级。最常见的 1 级不良事件为皮炎(68%)和皮肤色素沉着(18%)。在 12 个月时,唯一持续性毒性反应为 1 例 1 级乳房水肿和 1 例 1 级血清肿。90%的患者报告生活质量≥10 分中的 7 分(0 分表示“最差”,10 分表示“最好”),98%的患者报告美容效果极好或良好。
3 分次 PBS 质子 APBI 耐受性良好,医生和患者报告的早期不良反应发生率低。目前正在进行随访以评估迟发性毒性和疾病控制结局。需要进一步研究这种新的辅助治疗策略。