Tumor response and health-related quality of life in clinically selected patients from Asia with advanced non-small-cell lung cancer treated with first-line gefitinib: post hoc analyses from the IPASS study.

摘要: Abstract Background In IPASS ( NCT00322452 ), progression-free survival (PFS, primary endpoint) was significantly longer with first-line gefitinib versus carboplatin/paclitaxel in never/light ex-smokers advanced pulmonary adenocarcinoma Asia, both the overall intent-to-treat (ITT) population and EGFR mutation-positive subgroup. To further characterize clinical relevance of these data, we investigated objective response rate (ORR) health-related quality life (HRQoL) patients treated gefitinib. Methods Objective assessed (RECIST) 6-weekly (previously reported). Post hoc assessments included median time to response, duration change tumor size. The analysis those who responded n  = 262 from ITT;  = 94 subgroup). percentage deterioration HRQoL (Functional Assessment Cancer Therapy-Lung [FACT-L], Trial Outcome Index [TOI]) symptoms (Lung Subscale [LCS]) at 4 months post-randomization analyzed according progression status (EFQ grouped by progressors/non-progressors treatment arms). ORR incidence skin rash/acne (evaluable-for-safety) were summarized. Results whose tumors gefitinib, 6.1 weeks ITT  = 262) 6.0 subgroup  = 94); 9.7 8.7 groups, respectively. There significant shrinkage A greater EFQ progressed experienced did not progress (FACT-L 33.7% vs 16.3%; TOI 13.2%; LCS 31.7% 15.5%). arm EFS population, rash 75.8% 68.1% -negative subgroups, respectively (with for 71.2% 1.1%, respectively). Conclusions Patients a rapid, durable response. Deterioration lung cancer found be associated progression, highlighting role patient-reported outcomes evaluation NSCLC disease. Rash supported as predictive marker