We believe that this attempt enables clinicians to choose appropriate treatment easier .
According to rapid development of chemotherapy in advanced non-small cell lung cancer ( NSCLC ) , the Japan Lung Cancer Society has been up date d its own guideline annually since 2010 .
Recently , we have had various types of chemotherapeutic drugs like kinase inhibitors or immune-checkpoint inhibitors .
Thus , the guideline proposes to categorize patients into three entities : ( 1 ) driver oncogene-positive , ( 2 ) PD-L1 ≥ 50 % , and ( 3 ) others .
Here , we report an English version of the Japan Lung Cancer Society Guidelines 2018 for NSCLC , stages IV
Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial.
BACKGROUND Dacomitinib is a second-generation , irreversible EGFR tyrosine kinase inhibitor . We compared its efficacy and safety with that of the reversible EGFR tyrosine kinase inhibitor gefitinib in the first-line treatment of patients with advanced EGFR-mutation-positive non-small-cell lung cancer ( NSCLC ) . METHODS In this international , multicentre , r and omised , open-label , phase 3 study ( ARCHER 1050 ) , we enrolled adults ( aged ≥18 years or ≥20 years in Japan and South Korea ) with newly diagnosed advanced NSCLC and one EGFR mutation ( exon 19 deletion or Leu858Arg ) at 71 academic medical centres and university hospitals in seven countries or special administrative regions . We r and omly assigned participants ( 1:1 ) to receive oral dacomitinib 45 mg/day ( in 28-day cycles ) or oral gefitinib 250 mg/day ( in 28-day cycles ) until disease progression or another discontinuation criterion was met . R and omisation , stratified by race and EGFR mutation type , was done with a computer-generated r and om code assigned by a central interactive web response system . The primary endpoint was progression-free survival assessed by masked independent review in the intention-to-treat population . Safety was assessed in all patients who received at least one dose of study treatment . This study is registered with Clinical Trials.gov , number NCT01774721 , and is ongoing but no longer recruiting patients . FINDINGS Between May 9 , 2013 , and March 20 , 2015 , 452 eligible patients were r and omly assigned to receive dacomitinib ( n=227 ) or gefitinib ( n=225 ) . Median duration of follow-up for progression-free survival was 22·1 months ( 95 % CI 20·3 - 23·9 ) . Median progression-free survival according to masked independent review was 14·7 months ( 95 % CI 11·1 - 16·6 ) in the dacomitinib group and 9·2 months ( 9·1 - 11·0 ) in the gefitinib group ( hazard ratio 0·59 , 95 % CI 0·47 - 0·74 ; p<0·0001 ) . The most common grade 3 - 4 adverse events were dermatitis acneiform ( 31 [ 14 % ] of 227 patients given dacomitinib vs none of 224 patients given gefitinib ) , diarrhoea ( 19 [ 8 % ] vs two [ 1 % ] ) , and raised alanine aminotransferase levels ( two [ 1 % ] vs 19 [ 8 % ] ) . Treatment-related serious adverse events were reported in 21 ( 9 % ) patients given dacomitinib and in ten ( 4 % ) patients given gefitinib . Two treatment-related deaths occurred in the dacomitinib group ( one related to untreated diarrhoea and one to untreated cholelithases/liver disease ) and one in the gefitinib group ( related to sigmoid colon diverticulitis/rupture complicated by pneumonia ) . INTERPRETATION Dacomitinib significantly improved progression-free survival over gefitinib in first-line treatment of patients with EGFR-mutation-positive NSCLC and should be considered as a new treatment option for this population . FUNDING SFJ Pharmaceuticals Group and Pfizer
We believe that this attempt enables clinicians to choose appropriate treatment easier .
According to rapid development of chemotherapy in advanced non-small cell lung cancer ( NSCLC ) , the Japan Lung Cancer Society has been up date d its own guideline annually since 2010 .
Recently , we have had various types of chemotherapeutic drugs like kinase inhibitors or immune-checkpoint inhibitors .
Thus , the guideline proposes to categorize patients into three entities : ( 1 ) driver oncogene-positive , ( 2 ) PD-L1 ≥ 50 % , and ( 3 ) others .
Here , we report an English version of the Japan Lung Cancer Society Guidelines 2018 for NSCLC , stages IV