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In  LUX ‐Lung 3, afatinib significantly improved progression‐free survival ( PFS ) versus cisplatin/pemetrexed in   EGFR   mutation‐positive lung adenocarcinoma patients and overall survival ( OS ) in Del19 patients. Preplanned analyses in Japanese patients from  LUX ‐Lung 3 were performed. Patients were randomized 2:1 to afatinib or cisplatin/pemetrexed, stratified by mutation type (Del19/L858R/Other). Primary endpoint was  PFS  (independent review). Secondary endpoints included  OS , objective response, and safety. Median  PFS  (data cut‐off: February 2012) for afatinib versus cisplatin/pemetrexed was 13.8  vs  6.9 months (hazard ratio [ HR ], 0.38; 95% confidence interval [ CI ], 0.20–0.70;  P =  0.0014) in all Japanese patients ( N =  83), with more pronounced improvements in those with common mutations (Del19/L858R;  HR , 0.28; 95%  CI , 0.15–0.52;  P <  0.0001) and Del19 mutations ( HR , 0.16; 95%  CI , 0.06–0.39;  P <  0.0001).  PFS  was also improved in L858R patients ( HR , 0.50; 95%  CI , 0.20–1.25;  P =  0.1309). Median  OS  (data cut‐off: November 2013) with afatinib versus cisplatin/pemetrexed was 46.9  vs  35.8 months ( HR , 0.75; 95%  CI , 0.40–1.43;  P =  0.3791) in all Japanese patients, with greater benefit in patients with common mutations ( HR , 0.57; 95%  CI , 0.29–1.12;  P =  0.0966) and Del19 mutations ( HR , 0.34; 95%  CI , 0.13–0.87;  P =  0.0181);  OS  was not significantly different in L858R patients ( HR , 1.13; 95%  CI , 0.40–3.21;  P =  0.8212). Following study treatment discontinuation, most patients (93.5%) received subsequent anticancer therapy. The most common treatment‐related adverse events were diarrhea, rash/acne, nail effects and stomatitis with afatinib and nausea, decreased appetite, neutropenia, and leukopenia with cisplatin/pemetrexed. Afatinib significantly improved  PFS  versus cisplatin/pemetrexed in Japanese   EGFR   mutation‐positive lung adenocarcinoma patients and  OS  in Del19 but not L858R patients ( www.clinicaltrials.gov ;  NCT 00949650).

cancer science

Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non‐small cell lung cancer harboring activating   EGFR   mutations: Subgroup analysis of  LUX ‐Lung 3