Comprehensive assessment of pretreatment sarcopenia impacts on patients with EGFR-mutated NSCLC treated with afatinib.

BACKGROUND: This study aimed to comprehensively evaluate the efficacy and toxicity of afatinib in patients with sarcopenia, an important prognostic factor for treatment efficacy and toxicity in patients with cancer. METHODS: The clinical features of patients with advanced NSCLC treated with frontline afatinib between 2014 and 2018 at a medical center in Taiwan were retrospectively reviewed. Sarcopenia was evaluated based on the total cross-sectional area of skeletal muscles assessed by computed tomography (CT) imaging at the L3 level. Baseline characteristics, response rates, survival rates, and adverse events (AEs) were compared between sarcopenic and nonsarcopenic patients. RESULTS: A total of 176 patients evaluated for sarcopenia by CT and treated with afatinib were enrolled in the current study. Sarcopenia was significantly associated with good performance status, low body mass index (BMI), low body surface area (BSA), and low total mass area (TMA). Sarcopenia did not influence the response rate (69.2% vs. 72.0%, p = 0.299), progression-free survival (median 15.9 vs. 14.9 months, p = 0.791), or overall survival (median 26.5 vs. 27.2 months, p = 0.441). However, BSA ≤ 1.7 and the 40 mg afatinib dose were associated with dose reduction. TMA was the only independent factor for afatinib discontinuation due to AEs. CONCLUSION: Sarcopenia was not associated with treatment efficacy or toxicity among patients with NSCLC harboring common mutations treated with afatinib, indicating sarcopenic patients should not be excluded from afatinib treatment. Other factors, such as BSA and TMA, were associated with dose reduction and afatinib discontinuation, respectively, which may require additional evaluations in future studies.

Cost-effectiveness of bevacizumab-based therapy versus cisplatin plus pemetrexed for the first-line treatment of advanced non-squamous NSCLC in Korea and Taiwan.

AIMS: The aim of this analysis is to investigate the mean incremental costs and life expectancy associated with two first-line treatments for advanced non-squamous non-small cell lung cancer (NSCLC) in Korea and Taiwan; bevacizumab plus cisplatin and gemcitabine (BevCG) and cisplatin plus pemetrexed (CP). METHODS: A health economic (area under curve) model with three health states was developed to assess health outcomes (life-years gained [LYG]), direct costs, and incremental cost-effectiveness ratio (ICER). Progression-free survival (PFS) and overall survival (OS) were derived from randomized clinical trials and used in an indirect comparison in order to estimate their cost effectiveness. A life-time horizon was used. Costs and outcomes were discounted yearly by 5% in Korea and by 3% in Taiwan. RESULTS: The incremental LYG for the BevCG patients compared with patients treated with CP were 1.10 (13.2 months) in Korea and 1.19 (14.3 months) in Taiwan. The incremental costs were 37,439,968 ($ 33,322) in Korea and NT$ 1,910,615 ($ 64,541) in Taiwan. The incremental cost-effectiveness ratio was 34,064,835 ($ 30,318) in Korea and NT$ 1,607,960 ($ 54,317) in Taiwan. The inputs tested in one-way sensitivity analyses had very little impact on the overall cost effectiveness. CONCLUSION: This analysis shows that BevCG is more costly but is also associated with additional life-years in Korea and Taiwan. The ICER per LYG suggests that BevCG is a cost-effective therapy when compared to CP for patients with advanced NSCLC in Korea and Taiwan.

A randomized study of gemcitabine plus cisplatin and vinorelbine plus cisplatin in patients with advanced non-small-cell lung cancer.

BACKGROUND: Gemcitabine plus cisplatin (GC) and vinorelbine plus cisplatin (VC) are active and well-tolerated regimens for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). We conducted this study to compare the safety and efficacy of these regimens as front-line chemotherapy for patients with NSCLC. METHODS: Eligible patients were randomized to receive either gemcitabine (1000 mg/m2) on days 1, 8, and 15 plus cisplatin (80 mg/m2) on day 15 (arm GC), or vinorelbine (20 mg/m2) on days 1, 8, and 15 plus cisplatin (80 mg/m2) on day 15 (arm VC). Treatments were repeated every 28 days. The costs of treatment were retrieved from the Health Care Reporting System of Chang Gung Memorial Hospital at the time of final data analysis. RESULTS: Eighty-three patients (GC, n=39; VC, n=44) were enrolled in the study. Seventy-three patients were analyzed. Response rates were 38% and 31% and median survivals were 12.9 and 9.0 months for the 34 patients in the GC arm and 39 patients in the VC arm, respectively. One-year survival was 55.9% in the GC arm and 33.3% in the VC arm. There was no difference in the response rate (p=0.622), progression free survival (p=0.443) and median survival (p = 0.4197) between the two arms. Grade 3-4 toxicities were vomiting (GC: 16.3% vs. VC: 36.3%), neutropenia (GC: 14.7% vs. VC: 20%), and thrombocytopenia (GC: 8.68% vs. VC: 5%). There was a significant increase in all-grade thrombocytopenia (p=0.002) in the GC arm. The GC arm had higher total expenses than the VC arm (p=0.020). CONCLUSIONS: Both vinorelbine plus cisplatin and gemcitabine plus cisplatin yielded similar efficacies for NSCLC.