Department of Clinical Oncology, Northern Centre for Cancer Care, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Newcastle University, Newcastle upon Tyne, UK.
Clin Oncol (R Coll Radiol). 2019 Feb;31(2):e1-e10. doi: 10.1016/j.clon.2018.10.006. Epub 2018 Nov 8.
Concomitant chemoradiation is the standard of care in patients with inoperable non-small cell lung cancer. The purpose of this study was to analyse the survival outcome and toxicity data of using hypofractionated chemoradiation.
One hundred patients were treated from June 2011 to November 2016. Treatment consisted of 55 Gy in 20 daily fractions concurrently with split-dose cisplatin vinorelbine chemotherapy over 4 weeks followed by two cycles of cisplatin vinorelbine only. Survival was estimated using Kaplan-Meier and Cox regression was carried out for known prognostic factors. A systematic search of literature was conducted using Medline, Embase and Cochrane databases and relevant references included.
In total, 97% of patients completed radiotherapy and 73% of patients completed all four cycles of chemotherapy. One patient died of a cardiac event during consolidative chemotherapy. There were two cases of grade 4 toxicities (one sepsis, one renal impairment). Grade 3 toxicities included nausea/vomiting (17%), oesophagitis (15%), infection with neutropenia (12%) and pneumonitis (4%). Clinical benefit was seen in 86%. Two-year progression-free survival and overall survival rates were 49% and 58%, respectively. The median progression-free survival and overall survival were 23.4 and 43.4 months, respectively. The only significant prognostic factor was the number of chemotherapy cycles received (P = 0.02). The systematic review identified 13 relevant studies; a variety of regimens were assessed with variable reporting of outcomes and toxicity but with overall an improvement in survival over time.
Our experience compared with the original phase II trial showed improved treatment completion rates and survival with acceptable morbidity. With appropriate patient selection this regimen is an effective treatment option for locally advanced non-small cell lung cancer. This study helps to benchmark efficacy and toxicity rates while considering the addition of new agents to hypofractionated concurrent chemoradiotherapy. The agreement of a standard regimen for assessment in future trials would be beneficial.
同期放化疗是不可手术的非小细胞肺癌患者的标准治疗方法。本研究旨在分析采用低分割放化疗的生存结果和毒性数据。
从 2011 年 6 月至 2016 年 11 月，共治疗了 100 例患者。治疗方案为：20 次分割，55Gy 同期分割顺铂长春瑞滨化疗，4 周为 1 个周期，随后进行两个周期的顺铂长春瑞滨化疗。采用 Kaplan-Meier 法估计生存情况，并对已知的预后因素进行 Cox 回归分析。使用 Medline、Embase 和 Cochrane 数据库进行了系统的文献搜索，并纳入了相关参考文献。
共有 97%的患者完成了放疗，73%的患者完成了所有 4 个周期的化疗。1 例患者在巩固性化疗期间死于心脏事件。有 2 例 4 级毒性（1 例脓毒症，1 例肾功能损害）。3 级毒性包括恶心/呕吐（17%）、食管炎（15%）、中性粒细胞减少性感染（12%）和肺炎（4%）。临床获益率为 86%。2 年无进展生存率和总生存率分别为 49%和 58%。中位无进展生存期和总生存期分别为 23.4 个月和 43.4 个月。唯一有显著意义的预后因素是接受化疗周期数（P=0.02）。系统评价共纳入 13 项相关研究；评估了多种方案，结果和毒性的报告各不相同，但总体上随着时间的推移生存得到改善。
与原始的 II 期试验相比，我们的经验显示出更高的治疗完成率和生存改善，且发病率可接受。在适当的患者选择下，该方案是局部晚期非小细胞肺癌的有效治疗选择。本研究有助于在考虑将新药物加入低分割同期放化疗时，对疗效和毒性率进行基准测试。未来试验中采用标准方案进行评估将是有益的。
