Real World Outcomes versus Clinical Trial Results of Durvalumab Maintenance in Veterans with Stage III Non-Small Cell Lung Cancer.
Real World Outcomes versus Clinical Trial Results of Durvalumab Maintenance in Veterans with Stage III Non-Small Cell Lung Cancer.
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DOI：
10.3390/cancers14030614
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发表时间：
2022-01-26
期刊：
影响因子：
5.2
通讯作者：
Green MD
中科院分区：
文献类型：
--
作者：
Sankar K;Bryant AK;Strohbehn GW;Zhao L;Elliott D;Moghanaki D;Kelley MJ;Ramnath N;Green MD
根据PACIFIC试验的结果，III期非小细胞肺癌患者的标准治疗是同步放化疗，随后是durvalumab维持治疗。该方案在真实世界人群中的疗效尚未得到广泛研究。我们发现，与单独接受同步放化疗的退伍军人相比，durvalumab的添加显著改善了III期非小细胞肺癌退伍军人的无进展生存期和总生存期，但与PACIFIC试验中的患者相比，退伍军人的总生存期降低。需要进行额外的研究以了解这种疗效-有效性差距。同步放化疗后durvalumab治疗一年可改善III期非小细胞肺癌（NSCLC）患者的无进展（PFS）和总生存期（OS）。然而，durvalumab的实际疗效尚未确定。我们在退伍军人健康管理局进行了一项多中心观察性队列研究，包括接受同步放化疗和durvalumab的III期NSCLC患者，与接受单独同步放化疗的患者进行比较。Kaplan-Meier和考克斯回归方法用于确定与PFS和OS相关的因素。我们计算风险比和疗效-有效性因子，以比较退伍军人与参考临床试验人群的OS。将2017年11月至2021年4月期间接受同步放化疗和至少一剂durvalumab治疗的1006例III期NSCLC患者与2015年1月至2016年12月期间仅接受同步放化疗的989例患者进行了比较。佐剂durvalumab与更高的PFS（HR 0.62，95% CI 0.55-0.70，p < 0.001）和OS（HR 0.57，95% CI 0.50-0.66，p < 0.001）相关。与PACIFIC相比，退伍军人的OS较短（HR 1.24，95% CI 1.03-1.48，p = 0.02：EE差距0.73）。与现代对照药物相比，接受durvalumab辅助治疗的III期NSCLC退伍军人的OS有所改善，但与PACIFIC人群相比有所降低。
The standard of care for patients with stage III non-small cell lung cancer is concurrent chemoradiotherapy followed by maintenance durvalumab based on outcomes from the PACIFIC trial. The efficacy of this regimen in a real-world population has not been extensively studied. We found that the addition of durvalumab has significantly improved both progression-free and overall survival in veterans with stage III non-small cell lung cancer as compared to veterans who received concurrent chemoradiotherapy alone, but overall survival of veterans is reduced compared to patients in the PACIFIC trial. Additional studies will need to be performed to understand this efficacy-effectiveness gap. One year of durvalumab following concurrent chemoradiotherapy improves progression-free (PFS) and overall survival (OS) for patients with stage III non-small cell lung cancer (NSCLC). However, the real-world efficacy of durvalumab has not been determined. We conducted a multi-center observational cohort study across the Veterans Health Administration, including patients with stage III NSCLC who received concurrent chemoradiotherapy and durvalumab, compared to patients who received concurrent chemoradiotherapy alone. Kaplan–Meier and Cox regression approaches were used to identify factors associated with PFS and OS. We calculated a hazard ratio and efficacy-effectiveness factor to compare OS of veterans to the referenced clinical trial population. A total of 1006 patients with stage III NSCLC who received concurrent chemoradiotherapy and at least one dose of durvalumab from November 2017 to April 2021 were compared to 989 patients who received concurrent chemoradiotherapy alone from January 2015 to December 2016. Adjuvant durvalumab was associated with higher PFS (HR 0.62, 95% CI 0.55–0.70, p < 0.001) and OS (HR 0.57, 95% CI 0.50–0.66, p < 0.001). OS was shorter in veterans compared to PACIFIC (HR 1.24, 95% CI 1.03–1.48, p = 0.02: EE gap 0.73). OS of veterans with stage III NSCLC treated with adjuvant durvalumab is improved compared to a modern comparator but is reduced compared to the PACIFIC population.
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