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 .
Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone.
BACKGROUND This r and omised phase III study investigated if in responsive and stable disease ( SD ) stage IV patients after two courses of cisplatin and gemcitabine , single-agent gemcitabine ( experimental arm ) was not inferior in terms of overall survival ( OS ) to cisplatin-gemcitabine ( st and ard arm ) . PATIENTS AND METHODS Noninferiority was defined as an increase in the hazard of death ( HR ) < or = 1.33 in the experimental arm . From January 2001 to February 2004 , 340 patients were registered and 250 were r and omised .  Cisplatin was administered on day 1 at 75 mg/m2 and Gemcitabine on days 1 and 8 at 1250 mg/m2 every 3 weeks . RESULTS Response rate after two courses was 29 % . The 1-year progression-free survival was 13 % in both arms . One-year survival was 52 % in the st and ard and 42 % in the experimental arm for an HR of 1.21 [ 90 % confidence interval ( CI ) 0.97 - 1.51 ] . Postprogression survival was in favour of the st and ard arm ( HR 1.30 , 95 % CI 0.99 - 1.70 , P = 0.051 ) . Grade s 3 - 4 toxicity favoured in the experimental arm . CONCLUSION In responsive and SD patients with stage IV non-small-cell lung cancer it was not possible to demonstrate that three courses of gemcitabine alone are not inferior , in terms of OS , to the st and ard approach of three courses of cisplatin-gemcitabine
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 .