In the third-line setting , for patients who have not received erlotinib or gefitinib , treatment with erlotinib is recommended .
There are insufficient data to recommend routine third-line cytotoxic therapy .
Purpose To provide evidence -based recommendations to up date the American Society of Clinical Oncology guideline on systemic therapy for stage IV non – small-cell lung cancer ( NSCLC ) .
Results This guideline up date reflects changes in evidence since the previous guideline .
Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: the CAPPA-2 study.
Platinum-based chemotherapy is the st and ard treatment for patients with advanced non-small cell lung cancer ( NSCLC ) , but the evidence of its efficacy among ECOG performance status (PS)2 patients is weak because these patients are usually excluded from clinical trials ; concern exists about tolerability and feasibility of st and ard chemotherapy in these patients . No prospect i ve r and omized trial has tested the addition of cisplatin to single-agent chemotherapy in patients with advanced NSCLC and PS2 . CAPPA-2 was a multicenter , r and omized phase 3 study for first-line treatment of PS2 patients with advanced NSCLC . Patients , aged 18 - 70 , were eligible if they had stage IV or IIIB with malignant pleural effusion or metastatic supraclavicular nodes ( TNM VI edition ) and adequate organ function . Patients in st and ard arm received gemcitabine 1200 mg/m(2 ) days 1 and 8 . Patients in experimental arm received cisplatin 60 mg/m(2 ) day 1 plus gemcitabine 1000 mg/m(2 ) days 1 and 8 . All treatments were repeated every 3 weeks , up to 4 cycles , unless disease progression or unacceptable toxicity . Primary endpoint was overall survival ( OS ) . To have 80 % power of detecting hazard ratio ( HR ) 0.71 , corresponding to an increase in median OS from 4.8 to 6.8 months , 285 deaths were required . The study was stopped in June 2012 after the enrolment of 57 patients , due to the slow accrual and the report of positive results from a similar study . Median OS was 3.0 months with single-agent gemcitabine and 5.9 months with cisplatin plus gemcitabine ( HR 0.52 , 95 % CI 0.28 - 0.98 , p = 0.039 ) . Combination chemotherapy produced longer PFS ( median 1.7 vs. 3.3 months , HR 0.49 , 95 % CI 0.27 - 0.89 , p = 0.017 ) and higher response rate ( 4 % vs. 18 % , p = 0.19 ) , without substantial increase in toxicity . The addition of cisplatin to single-agent gemcitabine improves survival as first-line treatment of PS2 patients with advanced NSCLC
In the third-line setting , for patients who have not received erlotinib or gefitinib , treatment with erlotinib is recommended .
There are insufficient data to recommend routine third-line cytotoxic therapy .
Purpose To provide evidence -based recommendations to up date the American Society of Clinical Oncology guideline on systemic therapy for stage IV non – small-cell lung cancer ( NSCLC ) .
Results This guideline up date reflects changes in evidence since the previous guideline .