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
Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial
BACKGROUND Alectinib , a potent , highly selective , CNS-active inhibitor of anaplastic lymphoma kinase ( ALK ) , showed promising efficacy and tolerability in the single-arm phase 1/2 AF-001JP trial in Japanese patients with ALK-positive non-small-cell lung cancer . Given those promising results , we did a phase 3 trial to directly compare the efficacy and safety of alectinib and crizotinib . METHODS J-ALEX was a r and omised , open-label , phase 3 trial that recruited ALK inhibitor-naive Japanese patients with ALK-positive non-small-cell lung cancer , who were chemotherapy-naive or had received one previous chemotherapy regimen , from 41 study sites in Japan . Patients were r and omly assigned ( 1:1 ) via an interactive web response system using a permuted-block method stratified by Eastern Cooperative Oncology Group performance status , treatment line , and disease stage to receive oral alectinib 300 mg twice daily or crizotinib 250 mg twice daily until progressive disease , unacceptable toxicity , death , or withdrawal . The primary endpoint was progression-free survival assessed by an independent review facility . The efficacy analysis was done in the intention-to-treat population , and safety analyses were done in all patients who received at least one dose of the study drug . The study is ongoing and patient recruitment is closed . This study is registered with the Japan Pharmaceutical Information Center ( number JapicCTI-132316 ) . FINDINGS Between Nov 18 , 2013 , and Aug 4 , 2015 , 207 patients were recruited and assigned to the alectinib ( n=103 ) or crizotinib ( n=104 ) groups . At data cutoff for the second interim analysis , 24 patients in the alectinib group had discontinued treatment compared with 61 in the crizotinib group , mostly due to lack of efficacy or adverse events . At the second interim analysis ( data cutoff date Dec 3 , 2015 ) , an independent data monitoring committee determined that the primary endpoint of the study had been met ( hazard ratio 0·34 [ 99·7 % CI 0·17 - 0·71 ] , stratified log-rank p<0·0001 ) and recommended an immediate release of the data . Median progression-free survival had not yet been reached with alectinib ( 95 % CI 20·3-not estimated ) and was 10·2 months ( 8·2 - 12·0 ) with crizotinib  . Grade 3 or 4 adverse events occurred at a greater frequency with crizotinib ( 54 [ 52 % ] of 104 ) than alectinib ( 27 [ 26 % ] of 103 ) . Dose interruptions due to adverse events were also more prevalent with crizotinib ( 77 [ 74 % ] of 104 ) than with alectinib ( 30 [ 29 % ] of 103 ) , and more patients receiving crizotinib ( 21 [ 20 % ] ) than alectinib ( nine [ 9 % ] ) discontinued the study drug because of an adverse event . No adverse events with a fatal outcome occurred in either treatment group . INTERPRETATION These results provide the first head-to-head comparison of alectinib and crizotinib and have the potential to change the st and ard of care for the first-line treatment of ALK-positive non-small-cell lung cancer . The dose of alectinib ( 300 mg twice daily ) used in this study is lower than the approved dose in countries other than Japan ; however , this limitation is being addressed in the ongoing ALEX study . FUNDING Chugai Pharmaceutical Co ,
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