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Year : 2017  |  Volume : 54  |  Issue : 1  |  Page : 132-135

Epidermal growth factor receptor positive lung cancer: The nontrial scenario

Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India

Correspondence Address:
Dr. K Prabhash
Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0019-509X.219583

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PURPOSE: The aim of this study was to report the median overall survival (OS) in epidermal growth factor receptor (EGFR) mutation-positive patients who were managed out of a clinical trial. METHODS: Nonsmall cell lung cancer patients harboring activating EGFR mutations who were either ineligible or refused participation in a clinical trial were selected for this analysis. The reason for not participating in trial, staging, treatment, and outcome details were obtained from a prospective lung cancer database. The Kaplan–Meier method was used to estimate OS. Log-rank test and Cox proportion hazard model were used for univariate and multivariate analysis, respectively. RESULTS: We included 225 patients in this analysis. The median age of the cohort was 56 years (range 29–85 years). A compromised Eastern Cooperative Oncology Group performance status (PS) of >2 was the major reason (83 patients, 36.9%) for ineligibility of patients in a clinical trial. The major reason provided by eligible patients for refusal to participate in a clinical trial was long distance of travel and inability to comply with the study-mandated follow-up visits (65 patients, 28.9%). The median OS in patients with PS 0–2 was 18.17 months (95% confidence interval [CI]: 15.6–20.8 months) and it was 12.1 months (95% CI: 9.0–15.2 months) in patients with PS 3–4 (hazard ratio - 0.579 [95% CI: 0.398–0.843] P = 0.004). CONCLUSION: EGFR positive patients who were ineligible for a clinical trial due to poor PS had lower survival; however, patients with good PS treated off-trial had similar OS to that reported in multiple clinical trials.


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