Checkpoint Inhibitor Monotherapy in Potentially Trial-Eligible or Trial-Ineligible Patients With Metastatic NSCLC in the German Prospective CRISP Registry Real-World Cohort (AIO-TRK-0315)

Frank Griesinger MD, PhD , Martin Sebastian MD , Wolfgang M. Brueckl MD, PhD , Horst-Dieter Hummel MD, PhD , Bastian Jaeschke MD , Jens Kern MD , Claas Wesseler MD , Martina Jänicke PdD , Annette Fleitz PhD , Stefan Zacharias PhD , Annette Hipper PhD , Annika Groth MD, PhD , Wilko Weichert MD, PhD , Steffen Dörfel , Volker Petersen MD , Jan Schröder MD , Jochen Wilke MD , Wilfried E.E. Eberhardt MD, PhD , Michael Thomas MD, PhD , Matthias Zeth
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Abstract

Introduction

Patients with metastatic NSCLC (mNSCLC) treated with immune checkpoint inhibitors in clinical practice may often not meet the strict inclusion criteria of clinical trials. Our aim was to assess the trial eligibility of patients with mNSCLC treated with pembrolizumab monotherapy in real-world and to compare the outcome of “trial-ineligible” and “potentially trial-eligible” patients.

Methods

Data from the prospective, clinical research platform CRISP were used to compare patient characteristics, treatment, and outcome of patients with programmed cell death-ligand 1 tumor proportion score greater than or equal to 50% tumors treated with pembrolizumab monotherapy who are deemed either “potentially trial-eligible” or “trial-ineligible” according to inclusion and exclusion criteria of the registrational studies (KEYNOTE-024 and -042).

Results

Of 746 patients included, 343 patients (46.0%) were classified as “trial-ineligible” and had significantly worse outcomes compared with “potentially trial-eligible” patients (n = 403, 54.0%): median progression-free survival: 6.2 (95% confidence interval [CI]: 5.2–8.4) versus 10.3 (95% CI: 8.4–13.8) months, hazard ratio (trial-ineligible versus potentially trial-eligible) of 1.43 (95% CI: 1.19–1.72), p less than 0.001; median overall survival: 15.9 (95% CI: 11.4–20.3) versus 25.3 (95% CI: 19.8–30.4) months, hazard ratio of 1.36 (95% CI: 1.10–1.67), p equals 0.004.

Conclusions

Our data reveal that a considerable proportion of patients with mNSCLC are not eligible to participate in a clinical trial and were found to have worse outcomes than potentially trial-eligible patients, whose outcomes were comparable with those obtained from pivotal clinical trials. This is of substantial clinical relevance for physicians discussing outcomes to be expected with their patients and stresses the need for real-world effectiveness analyses.

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在德国前瞻性 CRISP 登记处真实世界队列中对可能符合试验条件或不符合试验条件的转移性 NSCLC 患者进行检查点抑制剂单药治疗(AIO-TRK-0315)
导言:在临床实践中,接受免疫检查点抑制剂治疗的转移性 NSCLC(mNSCLC)患者往往不符合临床试验的严格纳入标准。我们的目的是评估在现实世界中接受 pembrolizumab 单药治疗的转移性 NSCLC 患者的试验资格,并比较 "不符合试验资格 "和 "可能符合试验资格 "患者的治疗效果。方法 使用前瞻性临床研究平台CRISP的数据,比较程序性细胞死亡配体1肿瘤比例评分大于或等于50%的肿瘤患者接受pembrolizumab单药治疗的患者特征、治疗和预后,根据注册研究(KEYNOTE-024和-042)的纳入和排除标准,这些患者被视为 "潜在符合试验条件 "或 "不符合试验条件".结果 在纳入的746例患者中,343例患者(46.结果 在纳入的746例患者中,有343例患者(46.0%)被归类为 "不符合试验条件",与 "可能符合试验条件 "的患者(n = 403,54.0%)相比,其预后明显较差:中位无进展生存期:6.2(95% 置信区间[CI]:5.2-8.4)个月对10.3(95% CI:8.4-13.8)个月,危险比(不符合试验条件对可能符合试验条件)为1.43(95% CI:1.19-1.72),P小于0.001;中位总生存期:15.结论我们的数据显示,相当一部分 mNSCLC 患者不符合参加临床试验的条件,他们的预后比可能符合试验条件的患者差,而后者的预后与关键临床试验的结果相当。这对医生与患者讨论预期疗效具有重要的临床意义,并强调了进行真实世界疗效分析的必要性。
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CiteScore
4.20
自引率
0.00%
发文量
145
审稿时长
19 weeks
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