德国前瞻性CRISP注册真实世界队列（AIO-TRK-0315）中对潜在符合或不符合试验条件的转移性非小细胞肺癌患者使用检查点抑制剂单药治疗
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).
作者信息
Griesinger Frank, Sebastian Martin, Brueckl Wolfgang M, Hummel Horst-Dieter, Jaeschke Bastian, Kern Jens, Wesseler Claas, Jänicke Martina, Fleitz Annette, Zacharias Stefan, Hipper Annette, Groth Annika, Weichert Wilko, Dörfel Steffen, Petersen Volker, Schröder Jan, Wilke Jochen, Eberhardt Wilfried E E, Thomas Michael
机构信息
Department of Hematology and Oncology, University Department Internal Medicine-Oncology, Pius-Hospital, University Medicine Oldenburg, Oldenburg, Germany.
Department of Medicine II, Hematology/Oncology, University Hospital Frankfurt, Frankfurt, Germany; German Cancer Consortium (DKTK), Partner Site Frankfurt/Mainz, Germany; Frankfurt Cancer Institute, Goethe University Frankfurt, Frankfurt, Germany.
出版信息
JTO Clin Res Rep. 2023 Dec 25;5(4):100626. doi: 10.1016/j.jtocrr.2023.100626. eCollection 2024 Apr.
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), 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), 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.
引言
在临床实践中接受免疫检查点抑制剂治疗的转移性非小细胞肺癌（mNSCLC）患者可能常常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帕博利珠单抗单药治疗的mNSCLC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”患者的结局。
方法
前瞻性临床研究平台CRISP的数据用于比较程序性细胞死亡配体1肿瘤比例评分大于或等于50%的肿瘤患者的特征、治疗及结局，这些患者根据注册研究（KEYNOTE-024和-042）的纳入和排除标准被判定为“可能符合试验资格”或“不符合试验资格”，均接受帕博利珠单抗单药治疗。
结果
在纳入的746例患者中，343例患者（46.0%）被归类为“不符合试验资格”，与“可能符合试验资格”的患者（n = 403，54.0%）相比，结局明显更差：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，风险比（不符合试验资格对可能符合试验资格）为1.43（95%CI：1.19 - 1.72），P < 0.001；中位总生存期：15.9（95%CI：11.4 - 20.3）个月对25.3（95%CI：19.8 - 30.4）个月，风险比为1.36（95%CI：1.10 - 1.67），P = 0.004。
结论
我们的数据显示，相当一部分mNSCLC患者没有资格参加临床试验，且其结局比可能符合试验资格的患者更差，而后者的结局与关键临床试验的结果相当。这对于医生与患者讨论预期结局具有重要的临床意义，并强调了进行真实世界有效性分析的必要性。
Zotero 插件