Clinical Trial Eligibility and Outcomes in Patients With Metastatic NSCLC Treated Outside of Clinical Trials.

IF 1.8 4区 医学 Q3 ONCOLOGY Oncology-New York Pub Date : 2024-12-03 DOI:10.46883/2024.25921032
Clayton K Oakley, Amulya Yellala, Sunil Tulpule, Robin High, Apar Kishor Ganti, Alissa S Marr
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Abstract

Introduction: There are limited data available regarding patient outcomes in those who would have been ineligible to receive therapy based on the original clinical trial eligibility criteria. We decided to conduct a retrospective study to evaluate outcomes based on clinical trial eligibility in patients with metastatic non-small cell lung cancer (NSCLC).

Methods: A retrospective chart review of all patients with metastatic NSCLC who received first-line systemic therapy at a single academic institution was performed. Each patient's chart was reviewed to determine if they would have qualified for the phase 3 clinical trial that led to the approval of the specific treatment regimen which they received. Data were analyzed to determine if there was a difference in survival time between those who would have been eligible compared with those who were ineligible for the clinical trial of the treatment regimen administered.

Results: There were 170 patients with a diagnosis of metastatic NSCLC who received first-line systemic therapy. Of these, 109 received combined chemotherapy, 25 received immunotherapy, and 36 received targeted therapy. There is a statistically significant difference in the restricted mean survival time between the eligible and ineligible groups in those who received combined chemotherapy (19.9 months vs 13.2 months; P  = .03), but not in either the immunotherapy group (22.4 months vs 12.9 months; P = .06) or the targeted therapy group (57.7 months vs 39.0 months; P  = .14).

Conclusion: These data support less restrictive clinical trial eligibility criteria for those with metastatic NSCLC. This is especially true regarding both targeted therapy and immunotherapy treatment regimens.

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转移性非小细胞肺癌临床试验外治疗的临床试验资格和结果
引言:根据最初的临床试验资格标准,那些不符合接受治疗资格的患者的结局数据有限。我们决定进行一项回顾性研究,以评估转移性非小细胞肺癌(NSCLC)患者临床试验资格的结果。方法:对在单一学术机构接受一线全身治疗的所有转移性非小细胞肺癌患者进行回顾性图表回顾。每个病人的病历都经过审查,以确定他们是否有资格进行三期临床试验,从而批准他们接受的特定治疗方案。对数据进行分析,以确定符合条件的患者与不符合临床试验治疗方案的患者之间的生存时间是否存在差异。结果:有170例被诊断为转移性NSCLC的患者接受了一线全身治疗。其中109人接受联合化疗,25人接受免疫治疗,36人接受靶向治疗。在接受联合化疗的患者中,合格组和不合格组的限制平均生存时间有统计学显著差异(19.9个月vs 13.2个月;P = .03),但两组均无差异(22.4个月vs 12.9个月;P = .06)或靶向治疗组(57.7个月vs 39.0个月;P = .14)。结论:这些数据支持对转移性非小细胞肺癌患者较少限制的临床试验资格标准。这对于靶向治疗和免疫治疗方案来说尤其如此。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Oncology-New York
Oncology-New York 肿瘤学-肿瘤学
CiteScore
1.60
自引率
0.00%
发文量
69
审稿时长
6-12 weeks
期刊介绍: Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.
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