*3.2. Patient Characteristics in Phase II Study*

A total of 39 patients (31 men, 8 women; median patient age, 64 years; age range, 46 to 75 years) were enrolled in the phase II study. Patient characteristics are shown in Table 1. The Eastern Cooperative Oncology Group (ECOG) performance status was 0 for 18 patients and 1 for 21 patients. Histologically, there were 24 patients with adenocarcinoma, 11 with squamous cell carcinoma, and 4 with no specified histology. Twenty-nine and 10 patients were at the clinical stages of IV and IIIb, respectively. A total of 120 cycles of therapy were administered. Treatment delay or interruption in the administration of S-1 occurred in 27 cycles (23%). The median number of cycles administered per patient was 3 (range, 1–9). The relative dose intensities were 97.7% for docetaxel and 85.7% for S-1.


**Table 1.** Characteristics of patients in the phase II study.

ECOG PS: Eastern Cooperative Oncology Group performance status.
