• Hiroya Takiuchi.
• Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.
• Gan To Kagaku Ryoho. 2009 May 1; 36 (5): 717-20.

AbstractAccording to the results of Japanese phase III trials recently reported such as JCOG 9912 and SPIRITS, there was a remarkable improvement in median survival time compared to the previous phase III study(JCOG 9205). Many newer agents were used, such as taxane and irinotecan, which were absent during JCOG 9205. Using these agents as a second- line treatment may lead to improved survival. However, there is no evidence of a randomized control trial of second-line treatment. At present, several study groups are conducting randomized control trials to establish a standard for second-line therapy. However, there are several issues regarding the study design, especially a control arm. In future trials, we should exchange information among study groups to discuss the important issues involved. On the other hand, molecular targeting agents that have shown activity in other tumor types such as trastuzumab, bevacizumab, cetuximab, and lapatinib are under investigation in global randomized control trials. In these trials, patients from Japan and Korea account for more than half of the enrollees. The number of international studies is increasing, and the role of east Asian countries will be more important in this field.

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