Schild Steven E, Hillman Shauna L, Tan Angelina D, Ross Helen J, McGinnis William L, Garces Yolanda A, Graham David L, Adjei Alex A, Jett James R
Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona.
Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
J Thorac Oncol. 2017 Apr;12(4):697-703. doi: 10.1016/j.jtho.2016.12.021. Epub 2017 Jan 12.
This phase I/II trial was designed to determine the maximally tolerated dose of thoracic radiotherapy as part of a combined modality approach. This report includes the long-term outcomes of patients treated on this study. The phase II portion was never completed, as RTOG-0617 opened before it was concluded.
In this study, the maximally tolerated dose was defined as 74 Gy of radiation in 37 fractions. Twenty-five patients with unresectable NSCLC were treated with 2-Gy daily fractions and concurrent weekly carboplatin and paclitaxel. Of these patients, 20 had stage III disease and five had stage I or II disease.
Patients were followed until death or for a minimum of 5 years in the case of survivors. The median and 5-year survivals were 42.5 months and 20% for all patients, 52.9 months and 40% in patients with stages I or II disease, and 39.8 months and 15% in patients with stage III disease.
The median survival of the stage III patients was quite favorable. We believe that this may have been due to a robust central review program of radiotherapy plans before treatment, ensuring compliance with protocol guidelines along with very low exposure of the heart to radiotherapy. Further improvements in 5-year survival will likely require research on both systemic therapy and thoracic radiotherapy. Potential therapeutic modalities that may aid in these efforts include immunotherapy, targeted therapy, improved imaging, adaptive radiotherapy, simultaneous integrated boost techniques, novel dose fractionation regimens, and charged particle therapy.
本I/II期试验旨在确定作为联合治疗方法一部分的胸部放疗的最大耐受剂量。本报告包括在该研究中接受治疗的患者的长期结果。由于RTOG-0617在II期部分结束前就已开展，所以该部分从未完成。
在本研究中，最大耐受剂量定义为37次分割照射74 Gy。25例无法切除的非小细胞肺癌患者接受每日2 Gy分割照射，并同时每周给予卡铂和紫杉醇。这些患者中，20例为III期疾病，5例为I期或II期疾病。
对患者进行随访，直至死亡，或对幸存者至少随访5年。所有患者的中位生存期和5年生存率分别为42.5个月和20%，I期或II期疾病患者分别为52.9个月和40%，III期疾病患者分别为39.8个月和15%。
III期患者的中位生存期相当可观。我们认为，这可能是由于在治疗前对放疗计划进行了严格的中央审查程序，确保了方案指南的依从性，同时心脏接受放疗的暴露量极低。5年生存率的进一步提高可能需要对全身治疗和胸部放疗进行研究。可能有助于这些努力的潜在治疗方式包括免疫治疗、靶向治疗、改进的成像技术、自适应放疗、同步整合加量技术、新型剂量分割方案和带电粒子治疗。
