The majority of non-small cell lung cancer (NSCLC) patients are ineligible for clinical trials. Nevertheless, very few studies report the profiles and treatment outcomes of such ineligible patients. Therefore, we investigated the characteristics, outcomes, and survival of advanced NSCLC patients who were ineligible for clinical trials.
We analyzed a retrospective cohort of 786 consecutive patients diagnosed with advanced NSCLC between January 2006 and December 2014. We reviewed the criteria in phase 3 clinical trials, and classified patients using the common first-line eligibility criteria for lung cancer.
Of the 786 patients, 469 (60%) were ineligible for clinical trials. The main reasons for ineligibility were brain metastasis (41%), a poor performance status (PS) (25%), and respiratory disease (24%). In all patients, ineligibility was identified as an independent predictor of overall survival (OS) (adjusted hazard ratio [HR] 0.78, 95% confidence interval [CI], 0.65–0.93, P = 0.008), even in patients with a good PS who received chemotherapy (HR 0.80, 95% CI, 0.65–0.99, P = 0.037). In subgroup analyses of ineligible patients, the survival varied depending on the reasons for their ineligibility. In particular, prior cancer history was not associated with a poor outcome, though this was a common reason for ineligibility (14.5%).
Most patients were ineligible for clinical trials and had shorter survival. The survival of ineligible patients varied depending on the reasons for their ineligibility. We should consider these results when applying clinical trial outcomes to real-world patients. More studies for ineligible patients are needed to improve real-world treatment.
Clinical trial identification
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All authors have declared no conflicts of interest.