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 .
Ipilimumab in combination with paclitaxel and carboplatin as first-line treatment in stage IIIB/IV non-small-cell lung cancer: results from a randomized, double-blind, multicenter phase II study.
PURPOSE Ipilimumab , which is an anti-cytotoxic T-cell lymphocyte-4 monoclonal antibody , showed a survival benefit in melanoma with adverse events ( AEs ) managed by protocol -defined guidelines . A phase II study in lung cancer assessed the activity of ipilimumab plus paclitaxel and carboplatin . PATIENTS AND METHODS Patients ( N = 204 ) with chemotherapy-naive non-small-cell lung cancer ( NSCLC ) were r and omly assigned 1:1:1 to receive paclitaxel ( 175 mg/m(2 ) ) and carboplatin ( area under the curve , 6 ) with either placebo ( control ) or ipilimumab in one of the following two regimens : concurrent ipilimumab ( four doses of ipilimumab plus paclitaxel and carboplatin followed by two doses of placebo plus paclitaxel and carboplatin ) or phased ipilimumab ( two doses of placebo plus paclitaxel and carboplatin followed by four doses of ipilimumab plus paclitaxel and carboplatin).Treatment was administered intravenously every 3 weeks for ≤ 18 weeks ( induction ) . Eligible patients continued ipilimumab or placebo every 12 weeks as maintenance therapy . Response was assessed by using immune-related response criteria and modified WHO criteria . The primary end point was immune-related progression-free survival ( irPFS ) . Other end points were progression-free survival ( PFS ) , best overall response rate ( BORR ) , immune-related BORR ( irBORR ) , overall survival ( OS ) , and safety . RESULTS The study met its primary end point of improved irPFS for phased ipilimumab versus the control ( hazard ratio [ HR ] , 0.72 ; P = .05 ) , but not for concurrent ipilimumab ( HR , 0.81 ; P = .13 ) . Phased ipilimumab also improved PFS according to modified WHO criteria ( HR , 0.69 ; P = .02 ) . Phased ipilimumab , concurrent ipilimumab , and control treatments were associated with a median irPFS of 5.7 , 5.5 , and 4.6 months , respectively , a median PFS of 5.1 , 4.1 , and 4.2 months , respectively , an irBORR of 32 % , 21 % and 18 % , respectively , a BORR of 32 % , 21 % and 14 % , respectively , and a median OS of 12.2 , 9.7 , and 8.3 months . Overall rates of grade 3 and 4 immune-related AEs were 15 % , 20 % , and 6 % for phased ipilimumab , concurrent ipilimumab , and the control , respectively . Two patients ( concurrent , one patient ; control , one patient ) died from treatment-related toxicity . CONCLUSION Phased ipilimumab plus paclitaxel and carboplatin improved irPFS and PFS , which supports additional investigation of ipilimumab in 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 .