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
Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial.
BACKGROUND Afatinib-an oral irreversible ErbB family blocker-improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer ( NSCLC ) . We compared afatinib with gemcitabine and cisplatin-a chemotherapy regimen widely used in Asia-for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC . METHODS This open-label , r and omised phase 3 trial was done at 36 centres in China , Thail and , and South Korea . After central testing for EGFR mutations , treatment-naive patients ( stage IIIB or IV cancer [ American Joint Committee on Cancer version 6 ] , performance status 0 - 1 ) were r and omly assigned ( 2:1 ) to receive either oral afatinib ( 40 mg per day ) or intravenous gemcitabine 1000 mg/m(2 ) on day 1 and day 8 plus cisplatin 75 mg/m(2 ) on day 1 of a 3-week schedule for up to six cycles . R and omisation was done central ly with a r and om number-generating system and an interactive internet and voice-response system . R and omisation was stratified by EGFR mutation ( Leu858Arg , exon 19 deletions , or other ; block size three ) . Clinicians and patients were not masked to treatment assignment , but the independent central imaging review group were . Treatment continued until disease progression , intolerable toxic effects , or withdrawal of consent . The primary endpoint was progression-free survival assessed by independent central review ( intention-to-treat population ) . This study is registered with Clinical Trials.gov , NCT01121393 . FINDINGS 910 patients were screened and 364 were r and omly assigned ( 242 to afatinib , 122 to gemcitabine and cisplatin ) . Median progression-free survival was significantly longer in the afatinib group ( 11·0 months , 95 % CI 9·7 - 13·7 ) than in the gemcitabine and cisplatin group ( 5·6 months , 5·1 - 6·7 ; hazard ratio 0·28 , 95 % CI 0·20 - 0·39 ; p<0·0001 ) . The most common treatment-related grade 3 or 4 adverse events in the afatinib group were rash or acne ( 35 [ 14·6 % ] of 239 patients ) , diarrhoea ( 13 [ 5·4 % ] ) , and stomatitis or mucositis ( 13 [ 5·4 % ] ) , compared with neutropenia ( 30 [ 26·5 % ] of 113 patients ) , vomiting ( 22 [ 19·5 % ] ) , and leucopenia ( 17 [ 15·0 % ] ) in the gemcitabine and cisplatin group . Treatment-related serious adverse events occurred in 15 ( 6·3 % ) patients in the afatinib group and nine ( 8·0 % ) patients in the gemcitabine and cisplatin group . INTERPRETATION First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC . Afatinib should be considered as a first-line treatment option for this patient population . FUNDING Boehringer Ingelheim
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