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 .
Chemotherapy with or without low-dose interleukin-2 in advanced non-small cell lung cancer: results from a phase III randomized multicentric trial.
Non-small cell lung cancer ( NSCLC ) is associated with IL-2-dependent cell-mediated immunodeficiency . As IL-2 is the main lymphocyte growth factor , a phase III r and omized multicenter trial was conducted to evaluate the impact of subcutaneous low-dose IL-2 added to st and ard chemotherapy ( CT ) on overall survival ( OS ) in advanced NSCLC patients . Patients ( n=241 ) with histologically confirmed stage IIIb or IV non-operable NSCLC underwent stratified r and omization on the basis of center , ECOG PS , stage of disease and percentage of weight loss . Patients received gemcitabine ( 1000 mg/m2 ) on days 1 and 8 + cisplatin ( 100 mg/m2 ) on day 2 every 21 days for a maximum of 6 cycles [ chemotherapy ( CT ) arm ] . In the CT+IL-2 arm , patients also received low-dose subcutaneous IL-2 3,000,000 IU/die on days 3 - 5 , 9 - 11 , 15 - 17 . The study had 90 % power to detect a 20 % absolute increase in 1-year OS with 118 patients /arm . An overall response ( OR ) rate of 12.8 % ( 14 % in the CT+IL-2 arm and 11.4 % in CT arm ) was observed . Stable disease was 70 and 66.7 % , and progressive disease 16 and 21.8 % in the CT+IL-2 and CT arms , respectively . No differences in response were found in any subgroup analysis . At a median follow-up of 32 months , 1-year OS was 45 % for the CT+IL-2 arm vs. 51 % for the CT arm ( p=0.456 log-rank ) . Median progression-free survival was 6.6 months in the CT+IL-2 arm vs. 6.9 months in the CT arm ( p=0.573 , log-rank ) . A higher number of grade 4 toxicities were reported with CT+IL-2 . The most common grade ≥3 adverse events were gastrointestinal toxicity ( mainly nausea and diarrhea ) and myelosuppression . No relevant differences in clinical outcome were observed from the addition of IL-2 to CT . Future studies investigating the role of T-regulators in chemoimmunotherapeutic regimens could be performed
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 .