Background
Methods
Patients
Protocol
Determination of plasma concentrations of 5-FU
Clinical response
Severe acute toxicities
Survival after treatment with a 5-FU/CDDP-based CRT
Data analysis and statistics
Results
Group | Total | Survival of 5 years or more | Survival of less than 5 years | P a) |
---|---|---|---|---|
N | 49 | 21 | 28 | |
1) Demographic/clinicopathologic | ||||
Age, yr | 64.5 ± 7.4 (48 -78) b) | 67.3 ± 5.8 (60 -78) | 62.4 ± 7.9 (48 -76) | 0.020 |
Height, cm | 163.5 ± 6.6 (150-180) | 161.9 ± 6.1 (150-171) | 164.8 ± 6.8 (152-180) | 0.125 |
Weight, kg | 56.1 ± 9.6 (33-79) | 59.8 ± 9.5 (40-74) | 53.3 ± 8.9 (33-79) | 0.019 |
Male/Female | 46/3 | 20/1 | 26/2 | 1.000 |
Performance status, 0/1/2/unknown | 24/20/4/1 | 11/7/2/1 | 13/13/2/0 | 0.579 |
Differentiation, well/moderate/poor/unknown | 7/28/8/6 | 4/11/3/3 | 3/17/5/3 | 0.817 |
T1/T2/T3/T4 | 16/6/15/12 | 10/2/7/2 | 6/4/8/10 | 0.099 |
N0/N1 | 22/27 | 13/8 | 9/19 | 0.048 |
M0/M1a c) | 41/8 | 20/1 | 21/7 | 0.115 |
Stage I/II/III/IV | 12/10/19/8 | 7/7/6/1 | 5/3/13/7 | 0.048 |
2) Clinical outcome | ||||
Complete response | 23 (46.9%) | 16 (76.2%) | 7 (25.0%) | 0.0005 |
Grade 3/4 Leucopenia | 21(42.9%) | 9 (42.9%) | 12 (42.9%) | 1.000 |
Grade 3/4 Stomatitis | 7 (14.3%) | 4 (19.0%) | 3 (10.7%) | 0.443 |
Grade 3/4 Cheilitis | 8 (16.3%) | 4 (19.0%) | 4 (14.3%) | 0.710 |
Group | Total | Survival of 5 years or more | Survival of less than 5 years | P a) | |
---|---|---|---|---|---|
N | 49 | 21 | 28 | ||
1st cycle/1st course | Day 3, PM 5:00 | 0.109 ± 0.060 | 0.122 ± 0.080 | 0.100 ± 0.041 | 0.294 |
Day 4, AM 5:00 | 0.076 ± 0.040 | 0.088 ± 0.044 | 0.068 ± 0.036 | 0.097 | |
2nd cycle/1st course | Day 10, PM 5:00 | 0.150 ± 0.074 | 0.137 ± 0.071 | 0.158 ± 0.077 | 0.357 |
Day 11, AM 5:00 | 0.134 ± 0.047 | 0.132 ± 0.048 | 0.136 ± 0.047 | 0.798 | |
1st cycle/2nd course | Day 38, PM 5:00 | 0.102 ± 0.056 | 0.097 ± 0.067 | 0.105 ± 0.049 | 0.676 |
Day 39, AM 5:00 | 0.076 ± 0.041 | 0.077 ± 0.042 | 0.076 ± 0.042 | 0.897 | |
2nd cycle/2nd course | Day 45, PM 5:00 | 0.146 ± 0.080 | 0.158 ± 0.101 | 0.136 ± 0.059 | 0.364 |
Day 46, AM 5:00 | 0.119 ± 0.047 | 0.126 ± 0.036 | 0.114 ± 0.054 | 0.399 | |
Average of 8 sampling points | 0.114 ± 0.034 | 0.118 ± 0.036 | 0.112 ± 0.032 | 0.536 |
Survival of 5 years or more | Survival of less than 5 years | ||||
---|---|---|---|---|---|
CR a) | Non-CR | CR | Non-CR | P b) | |
N | 16 | 5 | 7 | 21 | |
Average of 8 sampling points | 0.122 ± 0.031 | 0.105 ± 0.051 | 0.131 ± 0.046 | 0.105 ± 0.024 | 0.226 |