PurposePatients with advanced non—small-cell lung cancer (NSCLC) have no options for curative therapy; therefore, improving their quality of life (QOL) is also an important treatment goal. Patients with NSCLC and poor performance status (PS) are often excluded from clinical trials. Gefitinib, an epidermal growth factor (EGFR) inhibitor, is a safe oral agent that might benefit these patients. The aim of the study is to evaluate the effect of single-agent EGFR inhibitor gefitinib on the QOL of patients with advanced NSCLC and poor PS. Patients and MethodsNineteen patients with advanced NSCLC and poor PS who were unfit to receive chemotherapy were enrolled on this study of gefitinib 250 mg per day given orally until disease progression. All patients had no previous chemotherapy, an Eastern Cooperative Oncology Group PS of 3, and stage IIIB/IV NSCLC. Response rate, time to disease progression, and overall survival (OS) were calculated. We evaluated the QOL of all eligible patients using the Functional Assessment of Cancer-Lung (FACT-L) questionnaire. FACT-L was used to measure the physical, social/familial, emotional, and functional well-being of the patients as well as lung cancer—specific symptoms and concerns. A Trial Outcome Index (TOI) was derived to assess the physical component of QOL. A mixed-effects linear model was used to examine the effect of potential covariates (age, race, sex, response, and duration of treatment) on the outcome of QOL scores over time. A Cox regression model was used to determine the joint effect of age, race, sex, treatment duration, and baseline TOI score on the OS of the patients. ResultsEleven out of 19 patients were evaluable for this analysis. The median age was 71.8 years (range, 60.9–73.4 years). Six patients had adenocarcinoma, and 5 patients had squamous cell carcinoma, and the median treatment duration was 63.0 days (range, 35–118 days). Grade 3/4 toxicities included fatigue, rash, and diarrhea. One patient had a partial response, 7 patients had stable disease, and 3 patients progressed. The median OS was 5.3 months (range, 2.5–22.1 months), and the median progression-free survival was 3.7 months (range, 2.1–5.8 months). Baseline TOI was weak but significantly associated with OS, with a hazard ratio (HR) of 0.92 (95% CI, 0.85–0.99; P = .03). Duration of treatment was marginally associated with survival, with an HR of 0.98 (95% CI, 0.96–1.0; P = .07). As expected, the total FACT-L score and the TOI were highly correlated (r = 0.96; P < .0001). There were no significant differences in the subscale scores, FACT-General, or the FACT-L between baseline, week 5, and week 8. Notably, an increasing trend of the TOI was observed, ranging from 33.8 at baseline to 42.0 at week 5 to 45.0 at week 8, albeit this trend was not significant. Race and age were significantly associated with the TOI. TOI scores were higher in black patients compared with white patients (P = .03) and increased with age (P = .02). ConclusionSingle-agent EGFR inhibitor gefitinib could be an active and well-tolerated therapy for patients with NSCLC with poor PS, with a trend of the TOI observed for improvement in QOL. Our results suggest that increasing age and black race had higher TOI scores and thus improved QOL status.