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 .
Dabrafenib in patients with BRAF(V600E)-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial.
BACKGROUND Activating BRAF(V600E ) ( Val600Glu ) mutations are found in about 1 - 2 % of lung adenocarcinomas , which might provide an opportunity for targeted treatment in these patients . Dabrafenib is an oral selective inhibitor of BRAF kinase . We did a trial to assess the clinical activity of dabrafenib in patients with advanced non-small-cell lung cancer ( NSCLC ) positive for the BRAF(V600E ) mutation . METHODS In this phase 2 , multicentre , non-r and omised , open-label study , we enrolled previously treated and untreated patients with stage IV metastatic BRAF(V600E)-positive NSCLC . Patients received oral dabrafenib 150 mg twice daily . The primary endpoint was investigator-assessed overall response , which was assessed in patients who had received at least one dose of dabrafenib ; safety was also assessed in this population . The study is ongoing but not enrolling patients in this cohort . This trial is registered with Clinical Trials.gov , number NCT01336634 . FINDINGS Between Aug 3 , 2011 , and Feb 25 , 2014 , 84 patients were enrolled , six of whom had not previously received systemic treatment for NSCLC . 26 of the 78 previously treated patients achieved an investigator-assessed overall response ( 33 % [ 95 % CI 23 - 45 ] ) . Four of the six previously untreated patients had an objective response . One patient died from an intracranial haemorrhage that was judged by the investigator to be due to the study drug . Serious adverse events were reported in 35 ( 42 % ) of 84 patients . The most frequent grade 3 or worse adverse events were cutaneous squamous-cell carcinoma in ten ( 12 % ) , asthenia in four ( 5 % ) , and basal-cell carcinoma in four ( 5 % ) . INTERPRETATION Dabrafenib showed clinical activity in BRAF(V600E)-positive NSCLC . Our findings suggest that dabrafenib could represent a treatment option for a population of patients with limited therapeutic options . FUNDING GlaxoSmithKline
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 .