Objectives. The relevance of febrile neutropenia (FN) to patient-reported outcomes (PROs) was examined in Japanese, East Asian (EA), and non-EA patients with stage IV non-small cell lung cancer. Materials and Methods. PROs were assessed with the Lung Cancer Symptom Scale (LCSS) and EuroQoL-5 Dimensions (EQ-5D) at baseline, every cycle, at discontinuation, and at 30-day follow-up. The time to deterioration (TtD) and mean changes (baseline to treatment completion) in the LCSS total score, average symptom burden index (ASBI), and EQ-5 D visual analog scale (VAS) scores were analyzed by the FN status, regardless of the assigned treatment. Results. For patients with and without FN, the hazard ratios (HRs; 95% confidence interval [CI]) for TtD of the LCSS total, ASBI, and EQ-5D VAS scores were 0.731 (0.469-1.141), 0.621 (0.399-0.967), and 0.802 (0.537-1.199) in Japanese patients, and 0.572 (0.250-1.313), 0.506 (0.228-1.121), and 0.792 (0.350-1.790) in EA patients, respectively, indicating a longer TtD in PROs for patients without FN than for those with FN, while no marked differences by the FN status were noted in non-EA patients. Across the three populations, the mean change in both the LCSS total and EQ-5D VAS scores demonstrated a greater deterioration at treatment completion for patients with FN than for those without FN. Conclusions. PROs deteriorated more rapidly in patients with FN than in those without FN among Japanese and EA patients but not non-EA patients. Upon treatment completion, PROs were better maintained in patients without FN than in those with FN in all three populations. These findings suggest that active prevention of FN may help maintain PROs during treatment, regardless of ethnic group (ClinicalTrials.gov registration: NCT 01703091 and NCT01168973).
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