Statistical analysis
ONCOLOGY
Several phase III trials of docetaxel and erlotinib in patients previously treated with platinum have shown an ORR ranging from 5.5% to 12.8%. Combination therapy containing CPT‐11 administered to patients previously treated with platinum resulted in an ORR ranging from 10% to 20%. Based on these findings, we assumed that an ORR of 20% in eligible patients indicated potential usefulness, and an ORR of 5% was the lower limit of interest. Accordingly, the estimated accrual number was 28 patients, using the Southwest Oncology Group one‐arm binomial method (one‐sided alpha = 0.05; beta = 0.20). After adjusting for dropouts, the actual accrual number was 30 patients. PFS and OS were estimated until June 30, 2015 using the Kaplan–Meier method and compared using the log‐rank test. All statistical analyses were conducted using the EZR software (Saitama Medical Center, Jichi Medical University, Saitama, Japan).