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Clinical Trial Eligibility and Outcomes in Patients With Metastatic NSCLC Treated Outside of Clinical Trials
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.
Insights
Clinical trial eligibility criteria may be too restrictive for patients with metastatic non-small cell lung cancer (NSCLC). Outcomes were similar for eligible and ineligible patients, especially for targeted therapy and immunotherapy.
Area of Science:
- Oncology
- Clinical Trials
- Cancer Research
Background:
- Limited data exist on patient outcomes for those ineligible for clinical trials.
- Clinical trial eligibility criteria may not reflect real-world patient populations with metastatic non-small cell lung cancer (NSCLC).
Purpose of the Study:
- To evaluate patient outcomes in metastatic NSCLC based on eligibility for clinical trials.
- To determine if survival times differ between patients eligible and ineligible for the clinical trial of their administered treatment.
Main Methods:
- Retrospective chart review of 170 metastatic NSCLC patients receiving first-line systemic therapy.
- Assessed patient eligibility for the phase 3 clinical trial that approved their treatment.
- Compared survival times between eligible and ineligible patient groups.
Main Results:
- Combined chemotherapy: Eligible patients survived longer (19.9 months) than ineligible (13.2 months; P=.03).
- Immunotherapy: No statistically significant difference in survival between eligible (22.4 months) and ineligible (12.9 months; P=.06) patients.
- Targeted therapy: No statistically significant difference in survival between eligible (57.7 months) and ineligible (39.0 months; P=.14) patients.
Conclusions:
- Findings suggest less restrictive clinical trial eligibility criteria for metastatic NSCLC.
- This is particularly relevant for immunotherapy and targeted therapy regimens.
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