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Department of Surgery, Seoul National University College of Medicine, Seoul, Korea
Copyright © 2019 The Korean Society of Coloproctology
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICT OF INTEREST
No potential conflict of interest relevant to this article was reported.
Characteristic | ypT0N0 (n = 111) | Residual disease (n = 469) | P-value |
---|---|---|---|
Age (yr) | 62.00 (34–82) | 60.00 (27–81) | 0.071 |
Sex | 0.114 | ||
Male | 66 (59.5) | 316 (67.4) | |
Female | 45 (40.5) | 153 (32.6) | |
Body mass index (kg/m2) | 23.36 (16.98–29.15) | 22.86 (16.14–33.89) | 0.107 |
ASA PS classification | 0.787 | ||
I | 48 (43.2) | 193 (41.2) | |
II | 60 (54.1) | 266 (56.7) | |
III | 3 (2.7) | 10 (2.1) | |
Diabetes mellitus | 0.983 | ||
No | 96 (86.5) | 408 (87.0) | |
Mild | 15 (13.5) | 59 (12.6) | |
Severe | 0 (0) | 2 (0.4) | |
Hypertension | 0.695 | ||
No | 76 (68.5) | 330 (70.4) | |
Yes | 35 (31.5) | 139 (29.6) | |
Heart disease | 0.561 | ||
No | 106 (95.5) | 454 (96.8) | |
Yes | 5 (4.5) | 15 (3.2) | |
Pulmonary disease | 0.239 | ||
No | 108 (97.3) | 442 (94.2) | |
Yes | 3 (2.7) | 27 (5.8) | |
Liver disease | 1.000 | ||
No | 108 (97.3) | 455 (97.0) | |
Yes | 3 (2.7) | 14 (3.0) | |
Clinical T classificationa | <0.001 | ||
cT1 | 2 (1.8) | 1 (0.2) | |
cT2 | 23 (20.9) | 55 (11.8) | |
cT3 | 82 (74.5) | 361 (77.3) | |
cT4 | 3 (2.7) | 50 (10.7) | |
Tumor location from the anal verge (cm) | 0.995 | ||
<4 | 28 (25.2) | 123 (26.2) | |
4–8 | 58 (52.3) | 235 (50.1) | |
8–12 | 23 (20.7) | 103 (22.0) | |
≥12 | 2 (1.8) | 8 (1.7) | |
Pretreatment CEA (ng/mL)b | 2.0 (0–250) | 2.5 (0–336) | 0.010 |
Post-CRT CEA (ng/mL)c | 1.6 (0–7) | 1.6 (0–45) | 0.947 |
Change in CEA (mg/mL)d | 0 (–2 to 247) | 1.0 (–2 to 326) | 0.136 |
Adjuvant chemotherapye | <0.001 | ||
Yes | 70 (63.1) | 389 (83.1) | |
No | 41 (36.9) | 79 (16.9) |
Values are presented as median (range) or number (%).
ASA PS, American Society of Anesthesiologists physical status; CEA, carcinoembryonic antigen; CRT, chemoradiotherapy.
aClinical T classification was not available in 1 patient with ypT0N0, and 2 patients with residual disease.
bData were available for 101 patients with ypT0N0, and 430 patients with residual disease.
cData were available for 107 patients with ypT0N0, and 437 patients with residual disease.
dData were available for 98 patients with ypT0N0, and 400 patients with residual disease.
eData were not available for one patient with residual disease.
Variable |
Univariable analysis |
Multivariable analysis |
||
---|---|---|---|---|
Hazard ratio (95% CI) | P-value | Hazard ratio (95% CI) | P-value | |
Overall survivala | ||||
Pathologic AJCC after preoperative CRT | ||||
Stage 0 | 1.00 (reference) | - | 1.00 (reference) | - |
Stage I | 1.97 (0.83–4.67) | 0.120 | 2.20 (0.93–5.23) | 0.070 |
Stage II | 3.62 (1.61–8.13) | 0.002 | 3.75 (1.66–8.47) | 0.001 |
Stage III | 3.77 (3.08–14.87) | <0.001 | 6.97 (3.16–15.39) | <0.001 |
Pathologic T classification | ||||
ypT0 | 1.00 (reference) | - | 1.00 (reference) | - |
ypT1 | 1.14 (0.30–4.30) | 0.850 | 1.32 (0.35–5.02) | 0.690 |
ypT2 | 2.23 (1.00–4.97) | 0.050 | 1.97 (0.88–4.43) | 0.100 |
ypT3 | 4.78 (2.31–9.87) | <0.001 | 3.61 (1.69–7.70) | 0.001 |
ypT4 | 3.03 (0.38–24.26) | 0.300 | 1.98 (0.24–16.23) | 0.520 |
Pathologic N classification | ||||
ypN0 | 1.00 (reference) | - | 1.00 (reference) | - |
ypN1 | 2.65 (1.79–3.94) | <0.001 | 1.86 (1.22–2.83) | 0.004 |
ypN2 | 3.95 (2.21–7.06) | <0.001 | 3.10 (1.69–5.70) | <0.001 |
Disease-free survivalb | ||||
Pathologic AJCC after preoperative CRT | ||||
Stage 0 | 1.00 (reference) | - | 1.00 (reference) | - |
Stage I | 2.24 (1.06–4.75) | 0.040 | 2.33 (1.09–4.94) | 0.030 |
Stage II | 4.10 (2.01–8.35) | <0.001 | 4.05 (1.98–8.28) | <0.001 |
Stage III | 7.45 (3.73–14.90) | <0.001 | 7.30 (3.63–14.67) | <0.001 |
Pathologic T classification | ||||
ypT0 | 1.00 (reference) | - | 1.00 (reference) | - |
ypT1 | 1.05 (0.33–3.35) | 0.930 | 1.07 (0.34–3.40) | 0.910 |
ypT2 | 2.21 (1.09–4.49) | 0.030 | 2.01 (1.01–4.00) | 0.050 |
ypT3 | 4.65 (2.43–8.89) | <0.001 | 3.52 (1.85–6.71) | <0.001 |
ypT4 | 8.71 (2.39–31.74) | 0.001 | 5.72 (1.41–23.25) | 0.020 |
Pathologic N classification | ||||
ypN0 | 1.00 (reference) | - | 1.00 (reference) | - |
ypN1 | 2.81 (2.01–3.93) | <0.001 | 2.01 (1.41–2.86) | <0.001 |
ypN2 | 3.26 (1.91–5.57) | <0.001 | 2.30 (1.31–4.04) | 0.004 |
Characteristic | ypT0N0 (n = 111) | Residual disease (n = 469) | P-value |
---|---|---|---|
Age (yr) | 62.00 (34–82) | 60.00 (27–81) | 0.071 |
Sex | 0.114 | ||
Male | 66 (59.5) | 316 (67.4) | |
Female | 45 (40.5) | 153 (32.6) | |
Body mass index (kg/m2) | 23.36 (16.98–29.15) | 22.86 (16.14–33.89) | 0.107 |
ASA PS classification | 0.787 | ||
I | 48 (43.2) | 193 (41.2) | |
II | 60 (54.1) | 266 (56.7) | |
III | 3 (2.7) | 10 (2.1) | |
Diabetes mellitus | 0.983 | ||
No | 96 (86.5) | 408 (87.0) | |
Mild | 15 (13.5) | 59 (12.6) | |
Severe | 0 (0) | 2 (0.4) | |
Hypertension | 0.695 | ||
No | 76 (68.5) | 330 (70.4) | |
Yes | 35 (31.5) | 139 (29.6) | |
Heart disease | 0.561 | ||
No | 106 (95.5) | 454 (96.8) | |
Yes | 5 (4.5) | 15 (3.2) | |
Pulmonary disease | 0.239 | ||
No | 108 (97.3) | 442 (94.2) | |
Yes | 3 (2.7) | 27 (5.8) | |
Liver disease | 1.000 | ||
No | 108 (97.3) | 455 (97.0) | |
Yes | 3 (2.7) | 14 (3.0) | |
Clinical T classification |
<0.001 | ||
cT1 | 2 (1.8) | 1 (0.2) | |
cT2 | 23 (20.9) | 55 (11.8) | |
cT3 | 82 (74.5) | 361 (77.3) | |
cT4 | 3 (2.7) | 50 (10.7) | |
Tumor location from the anal verge (cm) | 0.995 | ||
<4 | 28 (25.2) | 123 (26.2) | |
4–8 | 58 (52.3) | 235 (50.1) | |
8–12 | 23 (20.7) | 103 (22.0) | |
≥12 | 2 (1.8) | 8 (1.7) | |
Pretreatment CEA (ng/mL) |
2.0 (0–250) | 2.5 (0–336) | 0.010 |
Post-CRT CEA (ng/mL) |
1.6 (0–7) | 1.6 (0–45) | 0.947 |
Change in CEA (mg/mL) |
0 (–2 to 247) | 1.0 (–2 to 326) | 0.136 |
Adjuvant chemotherapy |
<0.001 | ||
Yes | 70 (63.1) | 389 (83.1) | |
No | 41 (36.9) | 79 (16.9) |
Variable | ypT0N0 (n = 111) | Residual disease (n = 469) | P-value |
---|---|---|---|
Operative name | 0.241 | ||
Low anterior resection | 64 (57.7) | 242 (51.6) | |
Ultralow anterior resection | 40 (36.0) | 189 (40.3) | |
Abdominoperineal resection | 7 (6.3) | 38 (8.1) | |
Operative time (min) | 185 (93–528) | 200 (50–740) | 0.392 |
Surgical approach | 0.260 | ||
Open | 75 (67.6) | 350 (74.6) | |
Laparoscopy | 34 (30.6) | 112 (23.9) | |
Robot | 2 (1.8) | 7 (1.5) | |
Postoperative hospital stay (day) | 9 (5–22) | 9 (1–57) | 0.624 |
Pathologic AJCC | |||
Stage 0 | 111 (100) | N/A | |
Stage I | N/A | 151 (32.2) | |
Stage II | N/A | 162 (34.5) | |
Stage III | N/A | 156 (33.3) | |
Pathologic T classification | |||
ypT0 | 111 (100) | 4 (0.9) | |
ypT1 | N/A | 36 (7.7) | |
ypT2 | N/A | 150 (32.0) | |
ypT3 | N/A | 273 (58.2) | |
ypT4 | N/A | 6 (1.3) | |
Pathologic N classification | |||
ypN0 | 111 (100) | 313 (66.7) | |
ypN1 | N/A | 124 (26.4) | |
ypN2 | N/A | 32 (6.8) | |
Median No. of harvested LNs (range) | 13 (1–34) | 13 (1–43) | 0.411 |
Circumferential resection margin | 0.144 | ||
Negative | 0 (0) | 13 (2.8) | |
Positive | 111 (100) | 456 (97.2) |
Variable | Univariable analysis |
Multivariable analysis |
||
---|---|---|---|---|
Hazard ratio (95% CI) | P-value | Hazard ratio (95% CI) | P-value | |
Overall survival | ||||
Age | 1.04 (1.02–1.05) | <0.001 | 4.18 (1.94–9.01) | <0.001 |
Sex | ||||
Male | 1.00 (reference) | - | 1.00 (reference) | - |
Female | 0.45 (0.28–0.70) | 0.001 | 0.50 (0.32–0.80) | 0.003 |
ASA PS classification | ||||
I | 1.00 (reference) | - | 1.00 (reference) | - |
II | 1.72 (1.15–2.57) | 0.008 | 1.39 (0.92–2.09) | 0.120 |
III | 6.81 (3.28–14.15) | <0.001 | 3.77 (1.70–8.36) | 0.001 |
Body mass index | 0.99 (0.93–1.06) | 0.810 | - | - |
Pretreatment CEA | 1.00 (1.00–1.00) | 0.630 | - | - |
Tumor location from the anal verge (cm) | ||||
≥12 | 1.00 (reference) | - | - | |
8–12 | 1.53 (0.21–11.27) | 0.680 | - | |
4–8 | 2.05 (0.28–14.76) | 0.480 | - | |
<4 | 1.88 (0.25–13.85) | 0.540 | - | |
Operative name | ||||
Low anterior resection | 1.00 (reference) | - | 1.00 (reference) | - |
Ultralow anterior resection | 1.56 (1.07–2.28) | 0.020 | 1.58 (1.08–2.32) | 0.020 |
Abdominoperineal resection | 1.35 (0.66–2.75) | 0.410 | 1.12 (0.54–2.30) | 0.770 |
Circumferential resection margin | ||||
Negative | 1.00 (reference) | - | - | |
Positive | 2.36 (0.87–6.40) | 0.090 | - | - |
Tumor response to preoperative CRT | ||||
pCR (ypT0N0) | 1.00 (reference) | <0.001 | 1.00 (reference) | - |
Residual disease | 3.95 (1.84–8.48) | - | 4.18 (1.94–9.01) | <0.001 |
Postoperative chemotherapy | ||||
No | 1.00 (reference) | - | - | - |
Yes | 0.82 (0.52–1.29) | 0.390 | - | - |
Disease-free survival | ||||
Age | 1.02 (1.01–1.04) | 0.003 | 1.02 (1.01–1.04) | 0.007 |
Sex | ||||
Male | 1.00 (reference) | - | 1.00 (reference) | - |
Female | 0.56 (0.39–0.81) | 0.002 | 0.65 (0.45–0.94) | 0.020 |
ASA PS classification | ||||
I | 1.00 (reference) | - | 1.00 (reference) | - |
II | 1.56 (1.11–2.18) | 0.010 | 1.26 (0.89–1.80) | 0.190 |
III | 4.10 (2.02–8.33) | <0.001 | 2.66 (1.25–5.68) | 0.010 |
Body mass index | 1.00 (0.95–1.05) | 0.930 | - | - |
Pretreatment CEA | 1.00 (1.00–1.00) | 0.130 | - | - |
Tumor location from the anal verge (cm) | ||||
≥12 | 1.00 (reference) | - | - | - |
8–12 | 1.17 (0.28–4.86) | 0.830 | - | - |
4–8 | 1.20 (0.30–4.91) | 0.790 | - | - |
<4 | 1.21 (0.29–5.02) | 0.800 | - | - |
Operative name | ||||
Low anterior resection | 1.00 (reference) | - | 1.00 (reference) | - |
Ultralow anterior resection | 1.51 (1.09–2.09) | 0.010 | 1.45 (1.04–2.03) | 0.030 |
Abdominoperineal resection | 1.62 (0.91–2.87) | 0.100 | 1.42 (0.79–2.53) | 0.240 |
Circumferential resection margin | ||||
Negative | 1.00 (reference) | - | 1.00 (reference) | - |
Positive | 3.59 (1.68–7.69) | 0.001 | 2.52 (1.15–5.53) | 0.020 |
Tumor response to preoperative CRT | ||||
pCR (ypT0N0) | 1.00 (reference) | - | 1.00 (reference) | - |
Residual disease | 4.38 (2.23–8.58) | <0.001 | 4.33 (2.20–8.51) | <0.001 |
Postoperative chemotherapy | ||||
No | 1.00 (reference) | - | - | - |
Yes | 1.05 (0.70–1.59) | 0.800 | - | - |
Variable | Univariable analysis |
Multivariable analysis |
||
---|---|---|---|---|
Hazard ratio (95% CI) | P-value | Hazard ratio (95% CI) | P-value | |
Overall survival |
||||
Pathologic AJCC after preoperative CRT | ||||
Stage 0 | 1.00 (reference) | - | 1.00 (reference) | - |
Stage I | 1.97 (0.83–4.67) | 0.120 | 2.20 (0.93–5.23) | 0.070 |
Stage II | 3.62 (1.61–8.13) | 0.002 | 3.75 (1.66–8.47) | 0.001 |
Stage III | 3.77 (3.08–14.87) | <0.001 | 6.97 (3.16–15.39) | <0.001 |
Pathologic T classification | ||||
ypT0 | 1.00 (reference) | - | 1.00 (reference) | - |
ypT1 | 1.14 (0.30–4.30) | 0.850 | 1.32 (0.35–5.02) | 0.690 |
ypT2 | 2.23 (1.00–4.97) | 0.050 | 1.97 (0.88–4.43) | 0.100 |
ypT3 | 4.78 (2.31–9.87) | <0.001 | 3.61 (1.69–7.70) | 0.001 |
ypT4 | 3.03 (0.38–24.26) | 0.300 | 1.98 (0.24–16.23) | 0.520 |
Pathologic N classification | ||||
ypN0 | 1.00 (reference) | - | 1.00 (reference) | - |
ypN1 | 2.65 (1.79–3.94) | <0.001 | 1.86 (1.22–2.83) | 0.004 |
ypN2 | 3.95 (2.21–7.06) | <0.001 | 3.10 (1.69–5.70) | <0.001 |
Disease-free survival |
||||
Pathologic AJCC after preoperative CRT | ||||
Stage 0 | 1.00 (reference) | - | 1.00 (reference) | - |
Stage I | 2.24 (1.06–4.75) | 0.040 | 2.33 (1.09–4.94) | 0.030 |
Stage II | 4.10 (2.01–8.35) | <0.001 | 4.05 (1.98–8.28) | <0.001 |
Stage III | 7.45 (3.73–14.90) | <0.001 | 7.30 (3.63–14.67) | <0.001 |
Pathologic T classification | ||||
ypT0 | 1.00 (reference) | - | 1.00 (reference) | - |
ypT1 | 1.05 (0.33–3.35) | 0.930 | 1.07 (0.34–3.40) | 0.910 |
ypT2 | 2.21 (1.09–4.49) | 0.030 | 2.01 (1.01–4.00) | 0.050 |
ypT3 | 4.65 (2.43–8.89) | <0.001 | 3.52 (1.85–6.71) | <0.001 |
ypT4 | 8.71 (2.39–31.74) | 0.001 | 5.72 (1.41–23.25) | 0.020 |
Pathologic N classification | ||||
ypN0 | 1.00 (reference) | - | 1.00 (reference) | - |
ypN1 | 2.81 (2.01–3.93) | <0.001 | 2.01 (1.41–2.86) | <0.001 |
ypN2 | 3.26 (1.91–5.57) | <0.001 | 2.30 (1.31–4.04) | 0.004 |
Values are presented as median (range) or number (%). ASA PS, American Society of Anesthesiologists physical status; CEA, carcinoembryonic antigen; CRT, chemoradiotherapy. Clinical T classification was not available in 1 patient with ypT0N0, and 2 patients with residual disease. Data were available for 101 patients with ypT0N0, and 430 patients with residual disease. Data were available for 107 patients with ypT0N0, and 437 patients with residual disease. Data were available for 98 patients with ypT0N0, and 400 patients with residual disease. Data were not available for one patient with residual disease.
Values are presented as number (%) or median (range). AJCC, American Joint Committee on Cancer; LNs, lymph nodes.
CI, confidence interval; ASA PS, American Society of Anesthesiologists physical status; CEA, carcinoembryonic antigen; CRT, chemoradiotherapy; pCR, pathologic complete response.
CI, confidence interval; AJCC, American Joint Committee on Cancer. Adjusted for age, sex, American Society of Anesthesiologists physical status (ASA PS) classification, and operative name. Adjusted for age, sex, ASA PS classification, operative name, and circumferential resection margin.