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
First-line erlotinib in patients with advanced non-small-cell lung cancer unsuitable for chemotherapy (TOPICAL): a double-blind, placebo-controlled, phase 3 trial
Summary Background Many patients with advanced non-small-cell lung cancer ( NSCLC ) receive only active supportive care because of poor performance status or presence of several comorbidities . We investigated whether erlotinib improves clinical outcome in these patients . Methods TOPICAL was a double-blind , r and omised , placebo-controlled , phase 3 trial , done at 78 centres in the UK . Eligibility criteria were newly diagnosed , pathologically confirmed NSCLC ; stage IIIb or IV ; chemotherapy naive ; no symptomatic brain metastases ; deemed unsuitable for chemotherapy because of poor ( ≥2 ) Eastern Cooperative Oncology Group performance status or presence of several comorbidities , or both ; and estimated life expectancy of at least 8 weeks . Patients were r and omly assigned ( by phone call , in a 1:1 ratio , stratified by disease stage , performance status , smoking history , and centre , block size 10 ) to receive oral placebo or erlotinib ( 150 mg per day ) until disease progression or unacceptable toxicity . Investigators , clinicians , and patients were masked to assignment . The primary endpoint was overall survival . Analyses were by intention to treat , and prespecified subgroup analyses included development of a rash due to erlotinib within 28 days of starting treatment . This study is registered , number IS RCT N 77383050 . Findings Between April 14 , 2005 , and April 1 , 2009 , we r and omly assigned 350 patients to receive erlotinib and 320 to receive placebo . We followed up patients until March 31 , 2011 . 657 patients died ; median overall survival did not differ between groups ( erlotinib , 3·7 months , 95 % CI 3·2–4·2 , vs placebo , 3·6 months , 3·2–3·9 ; unadjusted hazard ratio [ HR ] 0·94 , 95 % CI 0·81–1·10 , p=0·46 ) . 59 % ( 178 of 302 ) of patients assigned erlotinib and who were assessable at 1 month developed first-cycle rash , which was the only independent factor associated with overall survival . Patients with first-cycle rash had better overall survival ( HR 0·76 , 95 % CI 0·63–0·92 , p=0·0058 ) , compared with placebo . Compared with  placebo , overall survival seemed to be worse in the group that did not develop first-cycle rash ( 1·30 , 1·05–1·61 , p=0·017 ) . Grade 3 or 4 diarrhoea was more common with erlotinib than placebo ( 8 % [ 28 of 334 ] vs 1 % [ four of 313 ] , p=0·0001 ) , as was high- grade rash ( 23 % [ 79 of 334 ] vs 2 % [ five of 313 ] , p<0·0001 ) ; other adverse events were much the same between groups . Interpretation Patients with NSCLC who are deemed unsuitable for chemotherapy could be given erlotinib . Patients who develop a first-cycle rash should continue to receive erlotinib , whereas those who do not have a rash after 28 days should discontinue erlotinib , because of the possibility of decreased survival . Funding Cancer Research UK , 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