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
Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial.
BACKGROUND The combination of nedaplatin , a cisplatin derivative , and docetaxel showed promising activity for advanced squamous cell lung carcinoma in a previous phase 1 - 2 study . We compared nedaplatin plus docetaxel with cisplatin plus docetaxel in patients with previously untreated advanced or relapsed squamous cell lung carcinoma to determine effects on overall survival . METHODS We did a r and omised , open-label , phase 3 study at 53 institutions in Japan . Eligibility criteria included pathologically proven squamous cell lung cancer with stage IIIB/IV or postoperative recurrence , age 20 - 74 years , Eastern Cooperative Oncology Group performance status of 0 - 1 , no previous chemotherapy or recurrence more than a year after previous adjuvant chemotherapy , and adequate organ function . Patients were r and omly assigned ( 1:1 ) to 100 mg/m(2 ) nedaplatin and 60 mg/m(2 ) docetaxel intravenously , or 80 mg/m(2 ) cisplatin and 60 mg/m(2 ) docetaxel , every 3 weeks for four to six cycles ( at the treating oncologist 's discretion ) . R and omisation was done central ly at the West Japan Oncology Group data centre via a computer-generated allocation sequence with dynamic minimisation that balanced stage ( IIIB/IV or postoperative recurrent ) , sex , and institution . The primary endpoint was overall survival in the modified intention-to-treat population ( ie , all patients who were r and omly assigned and met the inclusion criteria ) . Safety analyses were done in all r and omly assigned patients who received at least one dose of the study regimen . This trial is registered with the UMIN Clinical Trials Registry , number UMIN000002015 , and is closed to new participants . FINDINGS Between July 6 , 2009 , and July 26 , 2012 , 355 patients were r and omly assigned . 349 patients were included in the modified intention-to-treat analysis ( 177 in the nedaplatin group and 172 in the cisplatin group ) . Overall survival was significantly longer in the nedaplatin group ( median 13·6 months , 95 % CI 11·6 - 15·6 ) than in the cisplatin group ( 11·4 months,10·2 - 12·2 ; hazard ratio 0·81 , 95 % CI 0·65 - 1·02 ; p=0·037 , one-sided stratified log-rank test ) . Grade 3 or worse nausea ( seven of 177 patients in the nedaplatin group and 25 of 175 in the cisplatin group ) , fatigue ( six vs 20 ) , hyponatraemia ( 24 vs 53 ) , and hypokalaemia ( four vs 15 ) were more frequent in the cisplatin group than in the nedaplatin group , whereas grade 3 or worse leucopenia ( 98 vs 77 ) , neutropenia ( 146 vs 123 ) , and thrombocytopenia ( 16 vs none ) were more frequent in the nedaplatin group than in the cisplatin group . Treatment-related deaths occurred in four and three patients in nedaplatin and cisplatin groups , respectively . INTERPRETATION Overall survival was significantly longer with nedaplatin plus docetaxel than with cisplatin plus docetaxel , and the regimens had different safety profiles . Nedaplatin plus docetaxel could be a new treatment option for advanced or relapsed squamous cell lung cancer . FUNDING West Japan Oncology Group and Sanofi
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