A research group led by Professor Toshihiro Nukiwa at Tohoku University Graduate School of Medicine has verified that a new therapy for non-small-cell lung cancer using gefitinib, molecular-targeted agent called IRESSA produced by AstraZeneca, has brought greater benefits than chemotherapy using conventional anticancer agent.  This study is based on the fact that the EGFR activating mutation as a target showed high incidence in the Asian patients with NSCLC. The research result has been published in the June 24 issue of The New England Journal of Medicine.  The paper’s title is “Gefitinib or Chemotherapy for Non-Small Cell Lung Cancer with Mutated EGFR.”

 NSCLC accounts for 80% of lung cancer that is the leading cause of cancer death in Japan. Patients who can not undergo surgery have an average of about a year to survive by using conventional anticancer agents. On the basis of earlier research that a newly developed anti-lung cancer agent, EGFR kinase inhibitor called IRESSA, is especially effective among a group of NSCLC with EGFR gene mutation, North East Japan Study Group (NEJSG) led by Professor Koichi Hagiwara (Saitama University) has developed highly sensitive method to detect the mutation, and the group conducted a large-scale phase III clinical trial of 230 patients with gene mutation to compare treatment using IRESSA as first line vs conventional chemotherapy.

 The result shows that patients using IRESSA has extended a period of progression free survival twice as long as conventional treatment group and that better quality of life for the former group has been accomplished. A frequency of serious adverse events of IRESSA group is lower than chemotherapy group although a patient (1%) from IRESSA group has died of intestinal pneumonia. The overall survival of IRESSA group is an average of more than two and a half years, longer than the results using conventional chemotherapy of one year. The use of IRESSA as second line treatment has also extended the overall survival of chemotherapy treatment group to an average of two and a half years. It has been clarified that EGFR kinase inhibitor is extremely effective for lung cancer patients with EGER gene mutation. In Japan, it is especially important that two-thirds of female lung cancer patients have the mutation.

 In this study, a new standard treatment has been established as individualized treatment for NSCLC with EGFR gene mutation. In United Kingdom, National Institute for Health and Clinical Excellence (NICE）refers to clinical data that provided a basis of the research, and recommends the first line treatment using IRESSA as one of alternatives to NSCLC patients if EGFR gene mutation is positive.

 The research has been conducted with the assistance of The Tokyo Cooperative Oncology Group (TCOG), and jointly with about 50 domestic institutes including Miyagi Cancer Center, Saitama Medical University, Hokkaido University and Nippon Medical School.

More Information (Japanese)

[Contact]
Professor Toshihiro Nukiwa
Department of Respiratory Medicine, Tohoku University Graduate School of Medicine
TEL: +81-22-717-8534
E-mail: toshinkw*idac.tohoku.ac.jp (Replace * with @)

(Public Relations)
Associate professor Fuji Nagami
Tohoku University Graduate School of Medicine
Public Relations Office
TEL +81-22-717-7891, FAX: +81-22-717-8187
E-mail: f-nagami*med.tohoku.ac.jp (Replace * with @)