Common arm analysis: one approach to develop the basis for global standardization in clinical trials of non-small...

The global development of new anticancer treatments is desirable. However, whether results of clinical trials performed in one population can be fully extrapolated to another population remains in question. We retrospectively compared "common arms" of platinum-based doublet phase III trials among Japanese, European, and American patients with non-small cell lung cancer to develop the basis for global standardization in clinical trials. Patient demographics were very similar through all studies, indicating that extrinsic ethnic factors including socioeconomic factors, medical service background, and patient selection process for clinical trials may be consistent between geographically different oncology groups. The doses of docetaxel, gemcitabine, and vinorelbine were lower in Japanese studies. The toxicity profile was generally acceptable and similar among many studies. Thus, the dose and schedule of anticancer agents established in prior phase I and II studies conducted in each country were appropriate and applicable to large patient populations in these countries. Response rates seemed to be distributed randomly from one study to another, whereas patient survival might be better in Japanese studies. In conclusion, geographical differences in the dose of anticancer agents, response, survival and toxicity of lung cancer chemotherapy were actually observed. However, extrapolation of clinical data obtained in one country to another population and global clinical trials were considered possible with adequate dose adjustment based on dose finding studies using a carefully projected protocol.