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 .
Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial.
BACKGROUND Patients with squamous non-small-cell lung cancer that is refractory to multiple treatments have poor outcomes . We assessed the activity of nivolumab , a fully human IgG4 PD-1 immune checkpoint inhibitor antibody , for patients with advanced , refractory , squamous non-small-cell lung cancer . METHODS We did this phase 2 , single-arm trial at 27 sites ( academic , hospital , and private cancer centres ) in France , Germany , Italy , and USA . Patients who had received two or more previous treatments received intravenous nivolumab ( 3 mg/kg ) every 2 weeks until progression or unacceptable toxic effects . The primary endpoint was the proportion of patients with a confirmed objective response as assessed by an independent radiology review committee . We included all treated patients in the analyses . This study is registered with Clinical Trials.gov , number NCT01721759 . FINDINGS Between Nov 16 , 2012 , and July 22 , 2013 , we enrolled and treated 117 patients . 17 ( 14·5 % , 95 % CI 8·7 - 22·2 ) of 117 patients had an objective response as assessed by an independent radiology review committee . Median time to response was 3·3 months ( IQR 2·2 - 4·8 ) , and median duration of response was not reached ( 95 % CI 8·31-not applicable ) ; 13 ( 77 % ) of 17 of responses were ongoing at the time of analysis . 30 ( 26 % ) of 117 patients had stable disease ( median duration 6·0 months , 95 % CI 4·7 - 10·9 ) . 20 ( 17 % ) of 117 patients reported grade 3 - 4 treatment-related adverse events , including : fatigue ( five [ 4 % ] of 117 patients ) , pneumonitis ( four [ 3 % ] ) , and diarrhoea ( three [ 3 % ] ) . There were two treatment-associated deaths caused by pneumonia and ischaemic stroke that occurred in patients with multiple comorbidities in the setting of progressive disease . INTERPRETATION Nivolumab has clinical ly meaningful activity and a manageable safety profile in previously treated patients with advanced , refractory , squamous non-small cell lung cancer . These data support the assessment of nivolumab in r and omised , controlled , phase 3 studies of first-line and second-line treatment . FUNDING Bristol-Myers Squibb
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 .