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-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials.
BACKGROUND We aim ed to assess the effect of afatinib on overall survival of patients with EGFR mutation-positive lung adenocarcinoma through an analysis of data from two open-label , r and omised , phase 3 trials . METHODS Previously untreated patients with EGFR mutation-positive stage IIIB or IV lung adenocarcinoma were enrolled in LUX-Lung 3 ( n=345 ) and LUX-Lung 6 ( n=364 ) . These patients were r and omly assigned in a 2:1 ratio to receive afatinib or chemotherapy ( pemetrexed-cisplatin [ LUX-Lung 3 ] or gemcitabine-cisplatin [ LUX-Lung 6 ] ) , stratified by EGFR mutation ( exon 19 deletion [ del19 ] , Leu858Arg , or other ) and ethnic origin ( LUX-Lung 3 only ) . We planned analyses of mature overall survival data in the intention-to-treat population after 209 ( LUX-Lung 3 ) and 237 ( LUX-Lung 6 ) deaths . These ongoing studies are registered with Clinical Trials.gov , numbers NCT00949650 and NCT01121393 . FINDINGS Median follow-up in LUX-Lung 3 was 41 months ( IQR 35 - 44 ) ; 213 ( 62 % ) of 345 patients had died . Median follow-up in LUX-Lung 6 was 33 months ( IQR 31 - 37 ) ; 246 ( 68 % ) of 364 patients had died . In LUX-Lung 3 , median overall survival was 28.2 months ( 95 % CI 24.6 - 33.6 ) in the afatinib group and 28.2 months ( 20.7 - 33.2 ) in the pemetrexed-cisplatin group ( HR 0.88 , 95 % CI 0.66 - 1.17 , p=0.39 ) . In LUX-Lung 6 , median overall survival was 23.1 months ( 95 % CI 20.4 - 27.3 ) in the afatinib group and 23.5 months ( 18.0 - 25.6 ) in the gemcitabine-cisplatin group ( HR 0.93 , 95 % CI 0.72 - 1.22 , p=0.61 ) . However , in preplanned analyses , overall survival was significantly longer for patients with del19-positive tumours in the afatinib group than in the chemotherapy group in both trials : in LUX-Lung 3 , median overall survival was 33.3 months ( 95 % CI 26.8 - 41.5 ) in the afatinib group versus 21.1 months ( 16.3 - 30.7 ) in the chemotherapy group ( HR 0.54 , 95 % CI 0.36 - 0.79 , p=0.0015 ) ; in LUX-Lung 6 , it was 31.4 months ( 95 % CI 24.2 - 35.3 ) versus 18.4 months ( 14.6 - 25.6 ) , respectively ( HR 0.64 , 95 % CI 0.44 - 0.94 , p=0.023 ) . By contrast , there were no significant differences by treatment group for patients with EGFR Leu858Arg-positive tumours in either trial : in LUX-Lung 3 , median overall survival was 27.6 months ( 19.8 - 41.7 ) in the afatinib group versus 40.3 months ( 24.3-not estimable ) in the chemotherapy group ( HR 1.30 , 95 % CI 0.80 - 2.11 , p=0.29 ) ; in LUX-Lung 6 , it was 19.6 months ( 95 % CI 17.0 - 22.1 ) versus 24.3 months ( 19.0 - 27.0 ) , respectively ( HR 1.22 , 95 % CI 0.81 - 1.83 , p=0.34 ) . In both trials , the most common afatinib-related grade 3 - 4 adverse events were rash or acne ( 37 [ 16 % ] of 229 patients in LUX-Lung 3 and 35 [ 15 % ] of 239 patients in LUX-Lung 6 ) , diarrhoea ( 33 [ 14 % ] and 13 [ 5 % ] ) , paronychia ( 26 [ 11 % ] in LUX-Lung 3 only ) , and stomatitis or mucositis ( 13 [ 5 % ] in LUX-Lung 6 only ) . In LUX-Lung 3 , neutropenia ( 20 [ 18 % ] of 111 patients ) , fatigue ( 14 [ 13 % ] ) and leucopenia ( nine [ 8 % ] ) were the most common chemotherapy-related grade 3 - 4 adverse events , while in LUX-Lung 6 , the most common chemotherapy-related grade 3 - 4 adverse events were neutropenia ( 30 [ 27 % ] of 113 patients ) , vomiting ( 22 [ 19 % ] ) , and leucopenia ( 17 [ 15 % ] ) . INTERPRETATION Although afatinib did not improve overall survival in the whole population of either trial , overall survival was improved with the drug for patients with del19 EGFR mutations . The absence of an effect in patients with Leu858Arg EGFR mutations suggests that EGFR del19-positive disease might be distinct from Leu858Arg-positive disease and that these subgroups should be analysed separately in future trials . 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