Advanced non-small cell lung cancer patients harboring EGFR mutation or ALK fusion have achieved significant survival benefit with targeted agents. In contrast, EGFR-wild type and ALK negative lung adenocarcinoma still have poor survival outcome. This study assessed the impact of participating in clinical trials on clinical outcomes in patients with EGFR-wild-type and ALK-negative lung adenocarcinoma. This study included patients with advanced EGFR-wild-type and ALK-negative lung adenocarcinoma who received systemic treatment between March 2017 and June 2022. We compared clinical outcomes between patients who participated in clinical trials and those treated with standard-of-care (SOC) using propensity score matching (PSM). Overall, 1,686 patients with EGFR-wild-type and ALK-negative advanced lung adenocarcinoma were included in the final analysis. Of these, 1,380 (81.9 %) received SOC only and 306 (18.1 %) patients were enrolled in at least one clinical trial during their cancer journey. After PSM (1:1), 612 patients were matched to the SOC (n = 306) and clinical trial (n = 306) groups. Among those who participated in clinical trials, 27.8 % and 72.2 % were included in clinical trials involving targeted therapy and immunotherapy respectively. In the clinical trial group, more patients received targeted therapy (31.7 % vs. 5.5 %, p < 0.001) and immunotherapy (88.6 % vs. 62.8 %, p < 0.001) compared to the SOC group. The median overall survival was 17.1 months (95 % confidence interval [CI], 13.2–21.4) in the SOC group and 27.3 months (95 % CI, 22.1–32.4) in the clinical trial group (hazard ratio = 0.71, [95 % CI, 0.58–0.88, 0.002]). This study demonstrated that participating in clinical trials resulted in a survival benefit that reduced the risk of death by 29.6% compared to receiving SOC in EGFR-wild-type and ALK-negative lung adenocarcinoma.

中文翻译：

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与标准护理相比，参加临床试验的 EGFR 野生型和 ALK 阴性 NSCLC 患者的生存获益：倾向匹配分析

携带 EGFR 突变或 ALK 融合的晚期非小细胞肺癌患者通过靶向药物获得了显着的生存获益。相比之下，EGFR 野生型和 ALK 阴性肺腺癌的生存结果仍然较差。本研究评估了参与临床试验对 EGFR 野生型和 ALK 阴性肺腺癌患者临床结果的影响。本研究纳入了 2017 年 3 月至 2022 年 6 月期间接受全身治疗的晚期 EGFR 野生型和 ALK 阴性肺腺癌患者。我们比较了参与临床试验的患者与接受标准护理 (SOC) 治疗的患者之间的临床结果）使用倾向得分匹配（PSM）。总体而言，最终分析纳入了 1,686 名 EGFR 野生型和 ALK 阴性晚期肺腺癌患者。其中，1,380 名 (81.9%) 患者仅接受了 SOC，306 名 (18.1%) 患者在癌症治疗过程中至少参加了一项临床试验。 PSM (1:1) 后，612 名患者被匹配到 SOC (n = 306) 组和临床试验组 (n = 306)。参与临床试验的人群中，分别有27.8%和72.2%参与了涉及靶向治疗和免疫治疗的临床试验。与 SOC 组相比，在临床试验组中，更多患者接受靶向治疗（31.7% vs. 5.5%，p < 0.001）和免疫治疗（88.6% vs. 62.8%，p < 0.001）。 SOC 组的中位总生存期为 17.1 个月（95% 置信区间 [CI]，13.2–21.4），临床试验组的中位总生存期为 27.3 个月（95% CI，22.1–32.4）（风险比 = 0.71，[95%] CI，0.58–0.88，0.002]）。这项研究表明，在 EGFR 野生型和 ALK 阴性肺腺癌中，与接受 SOC 治疗相比，参与临床试验可带来生存获益，死亡风险降低 29.6%。