Introduction
Materials and methods
Radiotherapy planning in ENI arm
Radiotherapy planning in IFRT arm
Chemotherapy regimen
Follow-up and evaluation criteria
Response and toxicity criteria
Statistical analysis
Results
Patient characteristics
ENI | IFRT | ||||
---|---|---|---|---|---|
Factor | N | % | N | % |
P value |
Total | 120 | 119 | |||
Sex | |||||
Female | 13 | 11 % | 21 | 18 % | 0.13 |
Male | 107 | 89 % | 98 | 82 % | |
Age (y.o.) | |||||
Range | 46–83 | 44–86 | 0.11 | ||
Median | 67 | 68 | |||
Location | |||||
Ce | 4 | 3 % | 6 | 5 % | 0.63 |
Ut | 19 | 16 % | 20 | 17 % | |
Mt | 56 | 47 % | 61 | 51 % | |
Lt | 41 | 34 % | 32 | 27 % | |
K-PS | |||||
-80 % | 41 | 34 % | 30 | 25 % | 0.13 |
90–100 % | 79 | 66 % | 89 | 75 % | |
Cycle number of CTx | |||||
1 | 28 | 23 % | 15 | 13 % | 0.062 |
2 | 49 | 41 % | 44 | 37 % | |
3 | 13 | 11 % | 15 | 13 % | |
4 | 30 | 25 % | 45 | 38 % | |
1–2 | 77 | 64 % | 59 | 50 % | 0.023 |
3–4 | 43 | 36 % | 60 | 50 % | |
FDG-PET scan | |||||
Conducted No. SUV-max in primary tumor | 61 | 51 % | 103 | 87 % | <0.0001 |
0–5.0 | 17 | 28 % | 25 | 21 % | 0.59 |
5.0–10.0 | 14 | 23 % | 19 | 16 % | |
10.0- | 30 | 49 % | 59 | 50 % | |
Clinical T classification | |||||
T1 | 27 | 23 % | 13 | 11 % | 0.0004 |
T2 | 19 | 16 % | 14 | 12 % | |
T3 | 51 | 43 % | 40 | 34 % | |
T4 | 23 | 19 % | 52 | 44 % | |
Clinical N classification | |||||
N0 | 46 | 39 % | 39 | 33 % | 0.37 |
N1 | 74 | 62 % | 80 | 67 % | |
Clinical M classification | |||||
M0 | 80 | 67 % | 97 | 82 % | 0.0040 |
M1 | 40 | 34 % | 20 | 17 % | |
Clinical stage | |||||
I | 21 | 18 % | 21 | 18 % | 0.24 |
II | 28 | 24 % | 19 | 16 % | |
III | 32 | 27 % | 45 | 38 % | |
IV | 39 | 33 % | 34 | 29 % | |
Histopathological type | |||||
Squamous cell carcinoma | 113 | 95 % | 109 | 92 % | 0.44 |
Others | 7 | 6 % | 10 | 8 % | |
CTx regimen | |||||
CDDP/5-FU | 40 | 34 % | % | ||
NDP/5-FU | 80 | 67 % | % | ||
NDP/TS-1 | 0 | 0 % | % | ||
Irradiated total dose | |||||
50Gy/50.4Gy | 108 | 91 % | 118 | 99 % | 0.85 |
Under 50 Gy | 3 | 3 % | 1 | 1 % | |
Over 50.4 Gy | 9 | 8 % | 0 | 0 % |
Treatment results
Locoregional failure, distant metastasis, and survival
ENI | IFRT |
p value | |||
---|---|---|---|---|---|
N | % | N | % | ||
State at analysis | |||||
Alive | 20 | 17 % | 71 | 60 % | <0.0001 |
Dead | 100 | 84 % | 48 | 40 % | |
Follow-up time of all cases | |||||
Median | 18 mo | ||||
Range | 1–169 mo | ||||
Follow-up time of alive cases | |||||
Median | 34 mo | ||||
Range | 2–154 mo | ||||
Residual (= non-CR) | 20 | 17 % | 6 | 5 % | 0.0039 |
First locoregional REC | 41 | 34 % | 30 | 25 % | 0.13 |
Primary | 30 | 23 | |||
Lymph node | 20 | 9 | |||
(Elective nodal region) | (4) | (2) | |||
Both | 9 | 2 | |||
First distant REC | 48 | 40 % | 25 | 21 % | 0.0014 |
Lymph node | 13 | 7 | |||
Lung | 20 | 8 | |||
Bone | 6 | 3 | |||
Liver | 6 | 5 | |||
Salvage surgery after REC | 11 | 9 % | 3 | 3 % | 0.029 |
Grade 3–5 non-hematological toxicities by RTOG | 19 | 16 % | 9 | 8 % | 0.047 |
Lung | 7 | 3 | |||
Heart | 5 | 0 | |||
Esophagus | 2 | 2 |
Overall survival rate | ||||
---|---|---|---|---|
Clinical stage | 1-y | 2-y | 3-y |
p value |
I | 92.5 % | 78.0 % | 67.6 % | |
II | 73.9 % | 64.5 % | 53.9 % | |
III | 63.2 % | 46.6 % | 33.3 % | |
IV | 54.8 % | 30.6 % | 23.5 % | |
Clinical T stage | <0.0001 | |||
cT1 | 87.2 % | 75.4 % | 67.5 % | |
cT2 | 77.7 % | 67.6 % | 59.1 % | |
cT3 | 65.0 % | 48.2 % | 35.7 % | |
cT4 | 52.9 % | 25.0 % | 15.1 % | |
Age (years old) | 0.049 | |||
> 70 | 60.5 % | 44.4 % | 34.6 % | |
< 70 | 72.9 % | 55.8 % | 45.4 % | |
Cycles of chemotherapy | 0.0004 | |||
One | 43.2 % | 29.3 % | 17.6 % | |
Two | 67.5 % | 51.3 % | 41.8 % | |
Three | 79.2 % | 66.7 % | 53.5 % | |
Four | 77.1 % | 56.7 % | 49.3 % |
Factors | Overall survival | Progression-free survival | ||||
---|---|---|---|---|---|---|
p - value | Odds ratio | 95 % confidence interval |
p- value | Odds ratio | 95 % confidence interval | |
Comparison 1 | ||||||
RT field | 0.31 | 0.15 | ||||
ENI | 1.21 | 0.84–1.73 | 1.32 | 0.90–1.93 | ||
IFRT | 1 | 1 | ||||
M-stage | <0.0001 | 0.0001 | ||||
M0 | 0.47 | 0.33–0.67 | 0.47 | 0.32–0.69 | ||
M1 | 1 | 1 | ||||
Comparison 2 | ||||||
RT field | 0.036 | 0.024 | ||||
ENI | 1.48 | 1.03–2.13 | 1.55 | 1.06–2.26 | ||
IFRT | 1 | 1 | ||||
Age (y.o.) | 0.092 | 0.49 | ||||
−70 | 0.74 | 0.52–1.05 | 1.15 | 0.77–1.72 | ||
71- | 1 | 1 | ||||
Comparison 3 | ||||||
RT field | 0.011 | 0.0009 | ||||
ENI | 1.60 | 1.11–2.29 | 1.90 | 1.30–2.79 | ||
IFRT | 1 | 1 | ||||
T-stage | <0.0001 | <0.0001 | ||||
T1 | <0.0001 | 0.22 | 0.13–0.39 | <0.0001 | 0.11 | 0.053–0.23 |
T2 | 0.0008 | 0.38 | 0.21–0.67 | 0.0010 | 0.36 | 0.19–0.66 |
T3 | 0.0021 | 0.53 | 0.36–0.80 | 0.013 | 0.59 | 0.39–0.89 |
T4 | 1 | 1 | ||||
Comparison 4 | ||||||
RT field | 0.017 | 0.0073 | ||||
ENI | 1.75 | 1.10–2.76 | 1.91 | 1.19–3.07 | ||
IFRT | 1 | 1 | ||||
N-stage | <0.0001 | <0.0001 | ||||
N0 | <0.0001 | 0.21 | 0.10–0.43 | <0.0001 | 0.15 | 0.070–0.33 |
N1 | 0.0090 | 0.38 | 0.19–0.79 | 0.44 | 0.21–0.91 | |
N2 | 0.13 | 0.54 | 0.24–1.21 | 0.55 | 0.24–1.24 | |
N3 | 1 | 1 | ||||
Comparison 5 | ||||||
RT field | 0.082 | 0.040 | ||||
ENI | 1.38 | 0.96–1.97 | 1.48 | 1.02–2.16 | ||
IFRT | 1 | 1 | ||||
Location | 0.53 | 0.14 | ||||
Cervix | 0.44 | 0.66 | 0.23–1.90 | 0.14 | 0.34 | 0.081–1.44 |
Upper thorax | 0.15 | 0.69 | 0.43–1.14 | 0.097 | 0.66 | 0.41–1.08 |
Middle thorax | 0.33 | 0.79 | 0.49–1.27 | 0.038 | 0.59 | 0.37–0.97 |
Lower thorax | 1 | 1 | ||||
Comparison 6 | 0.26 | 0.065 | ||||
RT field | 1.24 | 0.85–1.82 | 1.45 | 0.98–2.16 | ||
ENI | 1 | 1 | ||||
IFRT | ||||||
CTx cycle | 0.002 | 0.083 | ||||
1 | 0.0012 | 2.29 | 1.39–3.78 | 0.50 | 1.20 | 0.70–2.04 |
2 | 0.30 | 1.27 | 0.81–1.98 | 0.27 | 0.78 | 0.50–1.22 |
3 | 0.48 | 0.78 | 0.39–1.55 | 0.042 | 0.45 | 0.21–0.97 |
4 | 1 | 1 | ||||
Comparison 7 | ||||||
RT field | 0.099 | 0.017 | ||||
ENI | 1.35 | 0.94–1.93 | 1.58 | 1.09–2.30 | ||
IFRT | 1 | 1 | ||||
Stage | <0.0001 | <0.0001 | ||||
I | <0.0001 | 0.30 | 0.17–0.53 | <0.0001 | 0.12 | 0.051–0.28 |
II | 0.0009 | 0.43 | 0.26–0.71 | 0.015 | 0.53 | 0.32–0.88 |
III | 0.12 | 0.73 | 0.49–1.09 | 0.53 | 0.88 | 0.58–1.33 |
IV | 1 | 1 | ||||
Comparison 8 | ||||||
RT field | 0.16 | 0.10 | ||||
ENI | 1.30 | 0.90–1.88 | 1.38 | 0.94–2.03 | ||
IFRT | 1 | 1 | ||||
Age (y.o.) | 0.028 | 1.02 | 1.003–1.045 | 1.002 | 0.98–1.02 | |
M-stage | <0.0001 | |||||
M0 | 0.42 | 0.29–0.60 | 0.47 | 0.31–0.70 | ||
M1 | 1 | 1 | ||||
Comparison 9 | ||||||
RT field | 0.34 | 0.054 | ||||
ENI | 1.21 | 0.82–1.77 | 1.48 | 0.99–2.20 | ||
IFRT | 1 | 1 | ||||
Stage | <0.0001 | <0.0001 | ||||
I | <0.0001 | 0.22 | 0.12–0.42 | <0.0001 | 0.094 | 0.033–0.27 |
II | 0.0018 | 0.42 | 0.24–0.72 | 0.048 | 0.58 | 0.34–0.99 |
III | 0.14 | 0.74 | 0.49–1.11 | 0.75 | 0.93 | 0.60–1.44 |
IV | 1 | 1 | ||||
CTx cycle | 0.0006 | 0.066 | ||||
1 | 0.0002 | 2.62 | 1.58–4.35 | 0.12 | 1.52 | 0.89–2.59 |
2 | 0.13 | 1.42 | 0.90–2.24 | 0.95 | 0.98 | 0.62–1.55 |
3 | 0.62 | 0.84 | 0.42–1.67 | 0.078 | 0.50 | 0.24–1.08 |
4 | 1 | 1 |