Battisti Nicolò Matteo Luca, Sehovic Marina, Extermann Martine
Senior Adult Oncology Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Senior Adult Oncology Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Clin Lung Cancer. 2017 Sep;18(5):460-471. doi: 10.1016/j.cllc.2017.03.005. Epub 2017 Mar 21.
Non-small-cell lung cancer (NSCLC) is a disease of the elderly, who are under-represented in clinical trials. This challenges the external validity of the evidence base for its management and of current guidelines, that we evaluated in a population of older patients. We retrieved randomized clinical trials (RCTs) supporting the guidelines and identified 18 relevant topics. We matched a cohort of NSCLC patients aged older than 80 years from the Moffitt Cancer Center database with the studies' eligibility criteria to check their qualification for at least 2 studies. Eligibility > 60% was rated full validity, 30% to 60% partial validity, and < 30% limited validity. We obtained data from 760 elderly patients in stage-adjusted groups and collected 244 RCTs from the National Comprehensive Cancer Network (NCCN) and 148 from the European Society for Medical Oncology (ESMO) guidelines. External validity was deemed insufficient for neoadjuvant chemotherapy in stage III disease (27.37% and 25.26% of patients eligible for NCCN and ESMO guidelines, respectively) and use of bevacizumab (13.86% and 16.27% of patients eligible). For ESMO guidelines, it was inadequate regarding double-agent chemotherapy (25.90% of patients eligible), its duration (24.10%) and therapy for Eastern Cooperative Oncology Group performance status 2 patients (17.74%). For NCCN guidelines external validity was lacking for neoadjuvant chemoradiotherapy in stage IIIA disease (25.86% of patients eligible). Our analysis highlighted the effect of RCT eligibility criteria on guidelines' external validity in elderly patients. Eligibility criteria should be carefully considered in trial design and more studies that do not exclude elderly patients should be included in guidelines.
非小细胞肺癌（NSCLC）是一种老年疾病，而老年人在临床试验中的代表性不足。这对其治疗的证据基础以及当前指南的外部有效性提出了挑战，我们在老年患者群体中对此进行了评估。我们检索了支持这些指南的随机临床试验（RCT），并确定了18个相关主题。我们将莫菲特癌症中心数据库中80岁以上的NSCLC患者队列与研究的纳入标准进行匹配，以检查他们是否符合至少两项研究的条件。符合率>60%被评为完全有效性，30%至60%为部分有效性，<30%为有限有效性。我们从分期调整组的760名老年患者中获取了数据，并从美国国立综合癌症网络（NCCN）指南中收集了244项RCT，从欧洲医学肿瘤学会（ESMO）指南中收集了148项。对于III期疾病的新辅助化疗（分别有27.37%和25.26%的患者符合NCCN和ESMO指南的条件）以及贝伐单抗的使用（符合条件的患者分别为13.86%和16.27%），外部有效性被认为不足。对于ESMO指南，在双药化疗（符合条件的患者为25.90%）、其疗程（24.10%）以及东部肿瘤协作组体能状态为2的患者的治疗（17.74%）方面，外部有效性不足。对于NCCN指南，IIIA期疾病的新辅助放化疗缺乏外部有效性（符合条件的患者为25.86%）。我们的分析强调了RCT纳入标准对老年患者指南外部有效性的影响。在试验设计中应仔细考虑纳入标准，并且指南应纳入更多不排除老年患者的研究。
