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 in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial.
BACKGROUND Alectinib -- a highly selective , CNS-active , ALK inhibitor-showed promising clinical activity in crizotinib-naive and crizotinib-resistant patients with ALK-rearranged ( ALK-positive ) non-small-cell lung cancer ( NSCLC ) . We aim ed to assess the safety and efficacy of alectinib in patients with ALK-positive NSCLC who progressed on previous crizotinib . METHODS We did a phase 2 study at 27 centres in the USA and Canada . We enrolled patients aged 18 years or older with stage IIIB-IV , ALK-positive NSCLC who had progressed after crizotinib . Patients were treated with oral alectinib 600 mg twice daily until progression , death , or withdrawal . The primary endpoint was the proportion of patients achieving an objective response by an independent review committee using Response Evaluation Criteria in Solid Tumors , version 1.1 . Response endpoints were assessed in the response-evaluable population ( ie , patients with measurable disease at baseline who received at least one dose of study drug ) , and efficacy and safety analyses were done in the intention-to-treat population ( all enrolled patients ) . This study is registered with Clinical Trials.gov , number NCT01871805 . The study is ongoing and patients are still receiving treatment . FINDINGS Between Sept 4 , 2013 , and Aug 4 , 2014 , 87 patients were enrolled into the study ( intention-to-treat population ) . At the time of the primary analysis ( median follow-up 4·8 months [ IQR 3·3 - 7·1 ] ) , 33 of 69 patients with measurable disease at baseline had a confirmed partial response ; thus , the proportion of patients achieving an objective response by the independent review committee was 48 % ( 95 % CI 36 - 60 ) . Adverse events were predominantly grade 1 or 2 , most commonly constipation ( 31 [ 36 % ] ) , fatigue ( 29 [ 33 % ] ) , myalgia 21 [ 24 % ] ) , and peripheral oedema 20 [ 23 % ] ) . The most common grade 3 and 4 adverse events were changes in laboratory values , including increased blood creatine phosphokinase ( seven [ 8 % ] ) , increased alanine aminotransferase ( five [ 6 % ] ) , and increased aspartate aminotransferase ( four [ 5 % ] ) . Two patients died : one had a haemorrhage ( judged related to study treatment ) , and one had disease progression and a history of stroke ( judged unrelated to treatment ) . INTERPRETATION Alectinib showed clinical activity and was well tolerated in patients with ALK-positive NSCLC who had progressed on crizotinib . Therefore , alectinib could be a suitable treatment for patients with ALK-positive disease who have progressed on crizotinib . FUNDING F Hoffmann-La Roche
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