[Handling of Japanese Subgroup Data in Global Clinical Trials and Its Clinical Significance-In Terms of Systemic Therapies for Advanced Lung Cancer].

There has been remarkable progress in systemic therapy for advanced lung cancer in recent years. Novel molecular targeted agents directed against oncogenic driver mutations as well as combination strategies with immune checkpoint inhibitors have been continuously emerged in the clinical practice, which is driving the expansion of precision medicine. As most of these newly developed drugs and therapies were approved on the basis of global randomized studies, the robust data for the efficacy and safety focused on the Japanese patients are limited. Given that the genetic, environmental, and social backgrounds of the Japanese are different from those of Caucasians, it is questionable whether the available global data for the efficacy and safety of newly developed drugs can passively be extrapolated to the Japanese patients. In this article, we discuss the regional and racial differences of the responses or toxicity profiles of anti-cancer agents, and review the characteristics of the Japanese subgroup data in global clinical studies focusing on the following 3 different types of drugs: epidermal growth factor receptor-tyrosine kinase inhibitors, cytotoxic chemotherapeutic agents, and immune checkpoint inhibitors.