Twenty five (26%) of 95 patients showed EGFR mutation-positive disease assessed by Scorpion ARMS. This 26% detection rate was lower than in the EURTAC study (58 [53%] of 109 serum samples) [4], and seemed to be insufficient for the screening test. However, although low detection rates were seen in serum samples, both studies showed high concordance (∼100%) between serum and tumor samples at baseline. Thus, we cannot make definitive conclusions regarding the utility of serum samples as EGFR mutation assessment specimens. This study indicates that early, local testing of EGFR mutation status is feasible and

can reliably identify patients with EGFR mutation-positive NSCLC. The reported PFS in this study of Japanese NSCLC patients was 11.8 months with first-line erlotinib treatment, which is comparable to PFS LEE011 supplier outcomes seen with this agent in other EGFR mutation-positive populations, confirming that erlotinib can provide a good PFS benefit in this subgroup. Erlotinib was generally well tolerated, although 6 (of 103) patients reported ILD/ILD-like events and 5 were confirmed by an extramural committee, confirming

that ILD remains a risk with EGFR TKI treatment Selleckchem ABT 737 in Japanese patients. Continued monitoring for symptoms of ILD and prompt action on diagnosis is recommended. Despite this, the efficacy and manageable safety profile demonstrated by erlotinib in this study confirms that erlotinib should be recommended for the first-line treatment of Japanese NSCLC patients with EGFR mutation-positive disease. This trial was designed, funded by and monitored by Chugai Pharmaceuticals Ltd. Data were collected, analyzed and interpreted by Chugai with input from the authors and investigators. The initial draft of the manuscript was reviewed and commented on by all authors and by employees else of Chugai.

The corresponding author was provided data from Chugai and took full responsibility for the final decision to submit the paper. K. Goto, M. Nishio, M. Maemondo, T. Seto, and T. Tamura have received lecture fees from Chugai Pharmaceutical Co. Ltd. N. Katakami has previously received payment from Chugai Pharmaceutical Co. Ltd. for writing or reviewing manuscripts. T. Fukuyama is an employee of Chugai Pharmaceutical Co. Ltd. All remaining authors have declared no conflicts of interest. The authors would like to thank all participating physicians, registered patients, the independent review committee members, and Joanna Salter from Gardiner-Caldwell Communications for medical writing assistance. Medical writing assistance was funded by Chugai Pharmaceutical Co. Ltd. “
“Lung cancer is the second most commonly diagnosed cancer among both men and women in the United States (US) and is the leading cause of cancer deaths in both genders [1]. Non-small cell lung cancer (NSCLC) constitutes 80–85% of all lung cancers [2].