Oncology (Williston Park, N.Y.) · 2024
Clinical Trial Eligibility and Outcomes in Patients With Metastatic NSCLC Treated Outside of Clinical Trials.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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История · было → стало
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Oakley Clayton K, Yellala Amulya, Tulpule Sunil, High Robin, Ganti Apar Kishor, Marr Alissa S
Аннотация
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.
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.