Toxicity was evaluated using criteria defined by the Japan Clinical Oncology Group [29]. These criteria were based on the National Cancer Institute Common Toxicity Criteria. Toxicity was assessed on a 2 to 3-day basis during the chemoradiotherapy and subsequent hospitalization period and on every visit after the completion of chemoradiotherapy. Episodes of leucopenia, stomatitis, and cheilitis during the first 2 courses and subsequent 2 weeks (until day 70) were recorded as acute BI 2536 research buy toxicities and those of grade 3 or more as severe acute toxicities. Survival after the

chemoradiotherapy The survival period was defined as the time from the date of treatment initiation to that of death from any causes or to the last date of confirmation of survival. Survival data were updated on December 31, 2006, Torin 1 clinical trial and the 2-year survival rate was assessed using the data for 36 patients. Data analysis and statistics LOXO-101 ic50 All values reported are the mean ± standard deviation (SD). The unpaired Student’s t-test/Welch’s

test or Mann-Whitney’s U test was used for two-group comparisons of the concentrations. Fisher’s exact test was used for the analysis of contingency tables. The difference of overall survival curves was analyzed by Log-rank test. P values of less than 0.05 (two tailed) were considered to be significant. Results Demographic and clinicopathologic characteristics of the 46 ESCC patients are summarized in Table 1. The ratio of T1/T2/T3/T4 was 15/6/14/12, that of N0/N1 was 21/25, and that of M0/M1a was 39/7, resulting in a stage I/II/III/IVa ratio of 12/10/17/7. The CR rate was 47.8% (22/46), and 2-year survival rate was 50.0% (18/36). The clinical response, i.e., CR or non-CR, was predicted by T class (p = 0.002), N class (p = 0.007), M class (p = 0.001) and disease stage (p < 0.001). Episodes of severe acute leucopenia, stomatitis and cheilitis occurred in 39.1% (18/46),

13.0% (6/46) and CYTH4 15.2% (7/46) of cases, respectively and no associations were found with the demographic and clinicopathologic characteristics. Table 1 Demographic and clinicopathologic characteristics of Japanese patients with esophageal squamous cell carcinoma. Age, yr 64.6 ± 7.2 (range 48-78) Height, cm 164.2 ± 6.2 (range 152-180) Weight, kg 56.7 ± 9.6 (33-79) Male/Female 46/0 Performance status, 0/1/2/unknown 23/19/3/1 Differentiation, well/moderate/poor/unknown 7/27/6/6 T1/T2/T3/T4 15/6/14/12 N0/N1 21/25 M0/M1a 39/7 Stage I/II/III/IVa 12/10/17/7 The values are the mean ± SD. Noncervical primary tumours with positive supraclavicular lymphnodes were defined as M1a. Table 2 indicates the association of the TNFRSF1B genetic polymorphisms M196R/T587G, A1466G and C1493T with clinical response in the ESCC patients. TNFRSF1B A1466G genotype was predictive of clinical response (p = 0.040), whereas M196R/T587G and C1493T were not.