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
Phase I Study of Ceritinib (LDK378) in Japanese Patients with Advanced, Anaplastic Lymphoma Kinase-Rearranged Non–Small-Cell Lung Cancer or Other Tumors
Introduction : Anaplastic lymphoma kinase (ALK)-rearranged non – small-cell lung cancer ( NSCLC ) is sensitive to ALK inhibitors , but resistance develops . This study assessed the maximum-tolerated dose , safety , pharmacokinetics ( PK ) , and antitumor activity of ceritinib , a novel ALK inhibitor ( ALKi ) , in Japanese patients with ALK-rearranged malignancies . Methods : This phase I , multicenter , open-label study ( NCT01634763 ) enrolled adult patients with ALK-rearranged ( by fluorescence in situ hybridization and /or immunohistochemistry ) locally advanced/metastatic malignancy that had progressed despite st and ard therapy . The study comprised two parts : dose escalation and dose expansion . Ceritinib ( single-dose ) was administered orally in the 3-day PK run-in period , then once daily , in 21-day cycles . Adaptive dose escalations were guided by a Bayesian model . Results : Twenty patients ( 80 % with ALKi treatment history [ ALKi-pretreated ] ; 19 NSCLC ; one inflammatory myofibroblastic tumor ) received ceritinib 300 to 750 mg ( 19 during dose escalation , one in dose expansion ) . Two dose-limiting toxicities occurred : grade 3 lipase increase ( 600 mg ) ; grade 3 drug-induced liver injury ( 750 mg ) . The most common adverse events were gastrointestinal ( nausea : 95 % ; diarrhea , vomiting : 75 % ) . Ceritinib  PK profile was dose proportional across 300 to 750 mg dosages ; steady state was reached by day 15 . Overall response rate was 55 % ( 11 of 20 patients ) . Among patients with NSCLC , partial response was observed in two of four ALKi-naive patients , five of nine crizotinib-pretreated patients , two of four alectinib-pretreated patients , and one of two crizotinib and alectinib/ASP3026 pretreated patients . The ASP3026-pretreated inflammatory myofibroblastic tumor patient achieved partial response . Conclusions : Ceritinib maximum-tolerated dose was 750 mg once daily in Japanese patients .  Antitumor activity was observed irrespective of prior ALKi treatment history . Dose expansion , examining the activity of ceritinib in alectinib-resistant patients , is ongoing
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