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 .
Paclitaxel and gemcitabine versus paclitaxel and vinorelbine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group (HeCOG).
BACKGROUND Paclitaxel ( Taxol ) and vinorelbine have shown synergism of cytotoxic effects in vitro and clinical activity in phase I and II studies . This combination was compared prospect ively with the paclitaxel/gemcitabine regimen in non-operable non-small-cell lung cancer . PATIENTS AND METHODS Chemotherapy-naive patients , stage IIIbwet and IV with performance status ( 0 - 1 ) , were r and omized to receive paclitaxel 200 mg/m(2 ) on day 1 plus gemcitabine 1 gm/m(2 ) ( group A ) on days 1 and 8 every 3 weeks or paclitaxel 80 mg/m(2 ) plus vinorelbine 22.5 mg/m(2 ) ( group B ) on days 1 , 8 and 15 every 4 weeks . RESULTS A total of 398 out of 415 patients were eligible for analysis on intent-to-treat basis ( group A : 196 , group B : 202 ) . Progression-free survival ( PFS ) was 5.0 months [ 95 % confidence interval ( CI ) 4.3 - 5.6 ] and 4.4 months ( 95 % CI 3.7 - 5.2 ) for groups A and B respectively ( P=0.365 ) . Median survival was 11.1 months ( 95 % CI 9.2 - 13.0 ) and 8.6 months ( 95 % CI 7.0 - 10.2 ) for groups A and B respectively ( P = 0.147 ) . Grade 3/4 neutropenia and leukopenia were worse in group B ( P<0.001 , in both cases ) . Febrile neutropenia and severe infections were more prominent ( P<0.001 , P=0.029 respectively ) in group B. CONCLUSION Although response rate , PFS and survival were non-different in both groups , toxicity was significantly worse in group B and therefore further investigation of P-Vin is of no value
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 .