*2.3. Toxicity and Response Evaluation*

Toxicity was evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Patients' symptoms and general condition were observed periodically. Physical examinations, complete blood counts with differential counts, serum chemistry, and urine tests were carried out at least once per week during the DLT-evaluation period. Tumor response was evaluated according to RECIST version 1.0 every month until the final tumor response was determined. Progression-free survival (PFS) was defined as the time from the date of registration to the date of the first documentation of PD or death. Patients with PFS were censored at the last date when survival was verified. Overall survival (OS) was defined as the time from the date of registration to the date of death. Surviving patients were censored at the last confirmation date of survival. This phase I/II study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board at each participating hospital. The study was monitored by an independent data and safety monitoring committee.
