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 .
Sunitinib plus erlotinib versus placebo plus erlotinib in patients with previously treated advanced non-small-cell lung cancer: a phase III trial.
PURPOSE Sunitinib plus erlotinib may enhance antitumor activity compared with either agent alone in non-small-cell lung cancer ( NSCLC ) , based on the importance of the signaling pathways involved in tumor growth , angiogenesis , and metastasis . This phase III trial investigated overall survival ( OS ) for sunitinib plus erlotinib versus placebo plus erlotinib in patients with refractory NSCLC . PATIENTS AND METHODS Patients previously treated with one to two chemotherapy regimens ( including one platinum-based regimen ) for recurrent NSCLC , and for whom erlotinib was indicated , were r and omly assigned ( 1:1 ) to sunitinib 37.5 mg/d plus erlotinib 150 mg/d or to placebo plus erlotinib 150 mg/d , stratified by prior bevacizumab use , smoking history , and epidermal growth factor receptor expression . The primary end point was OS . Key secondary end points included progression-free survival ( PFS ) , objective response rate ( ORR ) , and safety . RESULTS In all , 960 patients were r and omly assigned , and baseline characteristics were balanced . Median OS was 9.0 months for sunitinib plus erlotinib versus 8.5 months for erlotinib alone ( hazard ratio [ HR ] , 0.922 ; 95 % CI , 0.797 to 1.067 ; one-sided stratified log-rank P = .1388 ) . Median PFS was 3.6 months versus 2.0 months ( HR , 0.807 ; 95 % CI , 0.695 to 0.937 ; one-sided stratified log-rank P = .0023 ) , and ORR was 10.6 % versus 6.9 % ( two-sided stratified log-rank P = .0471 ) , respectively . Treatment-related toxicities of grade 3 or higher , including rash/dermatitis , diarrhea , and asthenia/fatigue were more frequent in the sunitinib plus erlotinib arm . CONCLUSION In patients with refractory NSCLC , sunitinib plus erlotinib did not improve OS compared with erlotinib alone , but the combination was associated with a statistically significantly longer PFS and greater ORR . The incidence of grade 3 or higher toxicities was greater with combination therapy
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 .