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Yong Chan Lee |
Professor of Medicine Director, Gastrointestinal Research Laboratory Veterans Affairs Medical Center, Univ. California San Francisco San Francisco, USA |
Jong Pil Im | Seoul National University College of Medicine, Seoul, Korea |
Robert S. Bresalier | University of Texas M. D. Anderson Cancer Center, Houston, USA |
Steven H. Itzkowitz | Mount Sinai Medical Center, NY, USA |
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Hyo-Joon Yang1, Young-Il Kim2, Ji Yong Ahn3, Kee Don Choi3, Sang Gyun Kim4, Seong Woo Jeon5, Jie-Hyun Kim6, Sung Kwan Shin7, Hyuk Lee8, Wan Sik Lee9, Gwang Ha Kim10, Jae Myung Park11, Woon Geon Shin12, Il Ju Choi2
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.
Gut Liver 2023;17(5):825-827. https://doi.org/10.5009/gnl220333.e
Published online September 15, 2023, Published date September 15, 2023
Copyright © Gut and Liver.
https://doi.org/10.5009/gnl220333
Gut Liver 2023;17(4):537-546.
In the article entitled “External Validation of the eCura System for Undifferentiated-Type Early Gastric Cancer with Noncurative Endoscopic Resection,”1 the statement of classification of the score was incorrectly presented.
In the Methods section, 4. eCura system outcomes for validation, the corrected statement should be:
"Patients are classified into three risk tiers based on their cumulative scores: low-risk (0–1), intermediate-risk (2–4), and high-risk (5–7)."
In Tables 1, 3, and 4, The revised statements are shown in bold in the table below.
Table 1. Baseline Characteristics of Patients in the Radical Surgery and No Additional Treatment Groups According to the Risk Categories of the eCura System*
Characteristic | Radical surgery group (n=270) | No additional treatment group (n=364) | |||||||
---|---|---|---|---|---|---|---|---|---|
Low-risk (n=151) | Intermediate-risk (n=92) | High-risk (n=27) | p-value | Low-risk (n=317) | Intermediate-risk (n=42) | High-risk (n=5) | p-value | ||
Age, yr | 57.6 (51.1–66.7) | 62.8 (55.6–70.4) | 59.8 (52.4–71.8) | 0.017 | 63.1 (53.0–72.5) | 69.9 (54.8–78.4) | 75.4 (72.2–79.6) | 0.005 | |
Male sex | 93 (61.6) | 57 (62.0) | 22 (81.5) | 0.132 | 185 (58.4) | 27 (64.3) | 1 (20.0) | 0.695 | |
ASA physical status | 0.165 | 0.035 | |||||||
I | 93 (61.6) | 48 (52.2) | 17 (63.0) | 176 (55.5) | 19 (45.2) | 3 (60.0) | |||
II | 57 (37.7) | 38 (41.3) | 8 (29.6) | 125 (39.4) | 15 (35.7) | 1 (20.0) | |||
III-IV | 1 (0.7) | 6 (6.5) | 2 (7.4) | 16 (5.1) | 8 (19.1) | 1 (20.0) | |||
Tumor location | 0.247 | 0.511 | |||||||
Upper third | 61 (40.4) | 43 (46.7) | 13 (48.2) | 119 (37.5) | 16 (38.1) | 2 (40.0) | |||
Middle third | 71 (47.0) | 42 (45.7) | 11 (40.7) | 173 (54.6) | 20 (47.6) | 2 (40.0) | |||
Lower third | 19 (12.6) | 7 (7.6) | 3 (11.1) | 25 (7.9) | 6 (14.3) | 1 (20.0) | |||
Tumor size, mm | 26.0 (20.0–35.0) | 23.0 (18.0–33.0) | 35.0 (18.0–44.0) | 0.014 | 26.0 (22.0–34.0) | 25.5 (17.5–36.0) | 24.0 (21.5–42.3) | 0.872 | |
Depth of invasion | <0.001 | <0.001 | |||||||
Mucosa | 85 (56.3) | 13 (14.1) | 0 | 233 (73.5) | 8 (19.1) | 0 | |||
Submucosa <500 µm | 27 (17.9) | 20 (21.8) | 0 | 45 (14.2) | 5 (11.9) | 0 | |||
Submucosa ≥500 µm | 39 (25.8) | 59 (64.1) | 27 (100.0) | 39 (12.3) | 29 (69.0) | 5 (100.0) | |||
Histology | 0.003† | 0.019† | |||||||
PD | 112 (74.2) | 74 (80.4) | 24 (88.9) | 195 (61.5) | 30 (71.4) | 4 (80.0) | |||
SRC | 39 (25.8) | 14 (15.2) | 1 (3.7) | 118 (37.2) | 10 (23.8) | 0 | |||
Mucinous | 0 | 4 (4.4) | 2 (7.4) | 4 (1.3) | 2 (4.8) | 1 (20.0) | |||
Lymphovascular invasion | 0 | 49 (53.3) | 27 (100.0) | <0.001 | 0 | 18 (42.9) | 5 (100.0) | <0.001 | |
Ulceration | 15 (9.9) | 10 (10.9) | 2 (7.4) | 0.856 | 32 (10.1) | 4 (9.5) | 1 (20.0) | 0.749 | |
Positive vertical margin | 4 (2.6) | 33 (35.9) | 17 (63.0) | <0.001 | 5 (1.6) | 17 (40.5) | 4 (80.0) | <0.001 |
Data are presented as median (interquartile range) or number (%).
ASA, American Society of Anesthesiologists; PD, poorly differentiated adenocarcinoma; SRC, signet ring cell carcinoma.
*The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin; †The proportion of patients with signet ring cell carcinoma was compared against the proportion of patients with poorly differentiated or mucinous adenocarcinoma.
Table 3. Adjusted Analysis* of Hazards for Mortality and Recurrence According to Risk Categories of the eCura System in the No Additional Treatment Group†
Risk category | Overall mortality | Cancer-specific mortality | Cancer recurrence | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | |||
Low-risk | 27,165 | 31 | 1 | 27,165 | 1 | 18,563 | 3 | |||||||
Intermediate-risk | 3,342 | 15 | 2.80 (1.45–5.40) | 0.002 | 3,342 | 3 | 49.39 (2.95–826.70) | 0.007 | 2,004 | 3 | 12.63 (1.91–83.31) | 0.008 | ||
High-risk | 346 | 2 | 4.61 (1.01–21.08) | 0.049 | 346 | 1 | 586.83 (6.81–50,574) | 0.005 | 195 | 1 | 57.32 (2.37–1,384) | 0.013 | ||
Overall p-value | 0.004 | 0.011 | 0.011 | |||||||||||
p for trend | 2.48 (1.46–4.21) | 0.001 | 27.45 (3.27–230.26) | 0.002 | 8.98 (2.16–37.32) | 0.003 |
HR, hazard ratio; CI, confidence interval.
*HRs were adjusted for age, sex, American Society of Anesthesiologists physical status, location, histology, and ulceration; †The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin.
Table 4. Adjusted Analysis* of Hazards for Mortality and Recurrence in the No Additional Treatment Group Compared to the Radical Surgery Group Stratified by Risk Categories of the eCura System†
Risk category | Overall mortality | Cancer-specific mortality | Cancer recurrence | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | |||
Low | ||||||||||||||
Radical surgery | 13,104 | 11 | 1 | 13,104 | 0 | 1 | 9,169 | 0 | 1 | |||||
No additional treatment | 27,165 | 31 | 0.52 (0.24–1.13) | 0.099 | 27,165 | 1 | 4,128.26 (not estimated) | 0.983 | 18,563 | 3 | 3.70×105 (not estimated) | 0.978 | ||
Intermediate-high | ||||||||||||||
Radical surgery | 1,003 | 12 | 1 | 1,003 | 3 | 1 | 6,651 | 4 | 1 | |||||
No additional treatment | 3,688 | 17 | 3.18 (1.41–7.17) | 0.005 | 3,688 | 4 | 2.60 (0.46–14.66) | 0.280 | 2,199 | 4 | 2.23 (0.41–12.18) | 0.354 |
HR, hazard ratio; CI, confidence interval.
*HRs were adjusted for age, sex, American Society of Anesthesiologists physical status, location, histology, and ulceration; †The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin.
This statement does not change the outcome of the original paper. The authors would like to apologize for any inconvenience caused.
Gut and Liver 2023; 17(5): 825-827
Published online September 15, 2023 https://doi.org/10.5009/gnl220333.e
Copyright © Gut and Liver.
Hyo-Joon Yang1, Young-Il Kim2, Ji Yong Ahn3, Kee Don Choi3, Sang Gyun Kim4, Seong Woo Jeon5, Jie-Hyun Kim6, Sung Kwan Shin7, Hyuk Lee8, Wan Sik Lee9, Gwang Ha Kim10, Jae Myung Park11, Woon Geon Shin12, Il Ju Choi2
1Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, 2Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, 3Division of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, 4Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, 5Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, 6Department of Internal Medicine, Institute of Gastroenterology, Gangnam Severance Hospital, Yonsei University College of Medicine, 7Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 8Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 9Department of Internal Medicine, Chonnam National University Medical School, Gwangju, 10Department of Internal Medicine, Pusan National University College of Medicine, Busan, 11Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, and 12Department of Internal Medicine, Institute for Liver and Digestive Diseases, Hallym University College of Medicine, Chuncheon, Korea
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.
https://doi.org/10.5009/gnl220333
Gut Liver 2023;17(4):537-546.
In the article entitled “External Validation of the eCura System for Undifferentiated-Type Early Gastric Cancer with Noncurative Endoscopic Resection,”1 the statement of classification of the score was incorrectly presented.
In the Methods section, 4. eCura system outcomes for validation, the corrected statement should be:
"Patients are classified into three risk tiers based on their cumulative scores: low-risk (0–1), intermediate-risk (2–4), and high-risk (5–7)."
In Tables 1, 3, and 4, The revised statements are shown in bold in the table below.
Table 1 . Baseline Characteristics of Patients in the Radical Surgery and No Additional Treatment Groups According to the Risk Categories of the eCura System*.
Characteristic | Radical surgery group (n=270) | No additional treatment group (n=364) | |||||||
---|---|---|---|---|---|---|---|---|---|
Low-risk (n=151) | Intermediate-risk (n=92) | High-risk (n=27) | p-value | Low-risk (n=317) | Intermediate-risk (n=42) | High-risk (n=5) | p-value | ||
Age, yr | 57.6 (51.1–66.7) | 62.8 (55.6–70.4) | 59.8 (52.4–71.8) | 0.017 | 63.1 (53.0–72.5) | 69.9 (54.8–78.4) | 75.4 (72.2–79.6) | 0.005 | |
Male sex | 93 (61.6) | 57 (62.0) | 22 (81.5) | 0.132 | 185 (58.4) | 27 (64.3) | 1 (20.0) | 0.695 | |
ASA physical status | 0.165 | 0.035 | |||||||
I | 93 (61.6) | 48 (52.2) | 17 (63.0) | 176 (55.5) | 19 (45.2) | 3 (60.0) | |||
II | 57 (37.7) | 38 (41.3) | 8 (29.6) | 125 (39.4) | 15 (35.7) | 1 (20.0) | |||
III-IV | 1 (0.7) | 6 (6.5) | 2 (7.4) | 16 (5.1) | 8 (19.1) | 1 (20.0) | |||
Tumor location | 0.247 | 0.511 | |||||||
Upper third | 61 (40.4) | 43 (46.7) | 13 (48.2) | 119 (37.5) | 16 (38.1) | 2 (40.0) | |||
Middle third | 71 (47.0) | 42 (45.7) | 11 (40.7) | 173 (54.6) | 20 (47.6) | 2 (40.0) | |||
Lower third | 19 (12.6) | 7 (7.6) | 3 (11.1) | 25 (7.9) | 6 (14.3) | 1 (20.0) | |||
Tumor size, mm | 26.0 (20.0–35.0) | 23.0 (18.0–33.0) | 35.0 (18.0–44.0) | 0.014 | 26.0 (22.0–34.0) | 25.5 (17.5–36.0) | 24.0 (21.5–42.3) | 0.872 | |
Depth of invasion | <0.001 | <0.001 | |||||||
Mucosa | 85 (56.3) | 13 (14.1) | 0 | 233 (73.5) | 8 (19.1) | 0 | |||
Submucosa <500 µm | 27 (17.9) | 20 (21.8) | 0 | 45 (14.2) | 5 (11.9) | 0 | |||
Submucosa ≥500 µm | 39 (25.8) | 59 (64.1) | 27 (100.0) | 39 (12.3) | 29 (69.0) | 5 (100.0) | |||
Histology | 0.003† | 0.019† | |||||||
PD | 112 (74.2) | 74 (80.4) | 24 (88.9) | 195 (61.5) | 30 (71.4) | 4 (80.0) | |||
SRC | 39 (25.8) | 14 (15.2) | 1 (3.7) | 118 (37.2) | 10 (23.8) | 0 | |||
Mucinous | 0 | 4 (4.4) | 2 (7.4) | 4 (1.3) | 2 (4.8) | 1 (20.0) | |||
Lymphovascular invasion | 0 | 49 (53.3) | 27 (100.0) | <0.001 | 0 | 18 (42.9) | 5 (100.0) | <0.001 | |
Ulceration | 15 (9.9) | 10 (10.9) | 2 (7.4) | 0.856 | 32 (10.1) | 4 (9.5) | 1 (20.0) | 0.749 | |
Positive vertical margin | 4 (2.6) | 33 (35.9) | 17 (63.0) | <0.001 | 5 (1.6) | 17 (40.5) | 4 (80.0) | <0.001 |
Data are presented as median (interquartile range) or number (%)..
ASA, American Society of Anesthesiologists; PD, poorly differentiated adenocarcinoma; SRC, signet ring cell carcinoma..
*The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin; †The proportion of patients with signet ring cell carcinoma was compared against the proportion of patients with poorly differentiated or mucinous adenocarcinoma..
Table 3. Adjusted Analysis* of Hazards for Mortality and Recurrence According to Risk Categories of the eCura System in the No Additional Treatment Group†.
Risk category | Overall mortality | Cancer-specific mortality | Cancer recurrence | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | |||
Low-risk | 27,165 | 31 | 1 | 27,165 | 1 | 18,563 | 3 | |||||||
Intermediate-risk | 3,342 | 15 | 2.80 (1.45–5.40) | 0.002 | 3,342 | 3 | 49.39 (2.95–826.70) | 0.007 | 2,004 | 3 | 12.63 (1.91–83.31) | 0.008 | ||
High-risk | 346 | 2 | 4.61 (1.01–21.08) | 0.049 | 346 | 1 | 586.83 (6.81–50,574) | 0.005 | 195 | 1 | 57.32 (2.37–1,384) | 0.013 | ||
Overall p-value | 0.004 | 0.011 | 0.011 | |||||||||||
p for trend | 2.48 (1.46–4.21) | 0.001 | 27.45 (3.27–230.26) | 0.002 | 8.98 (2.16–37.32) | 0.003 |
HR, hazard ratio; CI, confidence interval..
*HRs were adjusted for age, sex, American Society of Anesthesiologists physical status, location, histology, and ulceration; †The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin..
Table 4. Adjusted Analysis* of Hazards for Mortality and Recurrence in the No Additional Treatment Group Compared to the Radical Surgery Group Stratified by Risk Categories of the eCura System†.
Risk category | Overall mortality | Cancer-specific mortality | Cancer recurrence | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | |||
Low | ||||||||||||||
Radical surgery | 13,104 | 11 | 1 | 13,104 | 0 | 1 | 9,169 | 0 | 1 | |||||
No additional treatment | 27,165 | 31 | 0.52 (0.24–1.13) | 0.099 | 27,165 | 1 | 4,128.26 (not estimated) | 0.983 | 18,563 | 3 | 3.70×105 (not estimated) | 0.978 | ||
Intermediate-high | ||||||||||||||
Radical surgery | 1,003 | 12 | 1 | 1,003 | 3 | 1 | 6,651 | 4 | 1 | |||||
No additional treatment | 3,688 | 17 | 3.18 (1.41–7.17) | 0.005 | 3,688 | 4 | 2.60 (0.46–14.66) | 0.280 | 2,199 | 4 | 2.23 (0.41–12.18) | 0.354 |
HR, hazard ratio; CI, confidence interval..
*HRs were adjusted for age, sex, American Society of Anesthesiologists physical status, location, histology, and ulceration; †The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin..
This statement does not change the outcome of the original paper. The authors would like to apologize for any inconvenience caused.
Table 1 Baseline Characteristics of Patients in the Radical Surgery and No Additional Treatment Groups According to the Risk Categories of the eCura System*
Characteristic | Radical surgery group (n=270) | No additional treatment group (n=364) | |||||||
---|---|---|---|---|---|---|---|---|---|
Low-risk (n=151) | Intermediate-risk (n=92) | High-risk (n=27) | p-value | Low-risk (n=317) | Intermediate-risk (n=42) | High-risk (n=5) | p-value | ||
Age, yr | 57.6 (51.1–66.7) | 62.8 (55.6–70.4) | 59.8 (52.4–71.8) | 0.017 | 63.1 (53.0–72.5) | 69.9 (54.8–78.4) | 75.4 (72.2–79.6) | 0.005 | |
Male sex | 93 (61.6) | 57 (62.0) | 22 (81.5) | 0.132 | 185 (58.4) | 27 (64.3) | 1 (20.0) | 0.695 | |
ASA physical status | 0.165 | 0.035 | |||||||
I | 93 (61.6) | 48 (52.2) | 17 (63.0) | 176 (55.5) | 19 (45.2) | 3 (60.0) | |||
II | 57 (37.7) | 38 (41.3) | 8 (29.6) | 125 (39.4) | 15 (35.7) | 1 (20.0) | |||
III-IV | 1 (0.7) | 6 (6.5) | 2 (7.4) | 16 (5.1) | 8 (19.1) | 1 (20.0) | |||
Tumor location | 0.247 | 0.511 | |||||||
Upper third | 61 (40.4) | 43 (46.7) | 13 (48.2) | 119 (37.5) | 16 (38.1) | 2 (40.0) | |||
Middle third | 71 (47.0) | 42 (45.7) | 11 (40.7) | 173 (54.6) | 20 (47.6) | 2 (40.0) | |||
Lower third | 19 (12.6) | 7 (7.6) | 3 (11.1) | 25 (7.9) | 6 (14.3) | 1 (20.0) | |||
Tumor size, mm | 26.0 (20.0–35.0) | 23.0 (18.0–33.0) | 35.0 (18.0–44.0) | 0.014 | 26.0 (22.0–34.0) | 25.5 (17.5–36.0) | 24.0 (21.5–42.3) | 0.872 | |
Depth of invasion | <0.001 | <0.001 | |||||||
Mucosa | 85 (56.3) | 13 (14.1) | 0 | 233 (73.5) | 8 (19.1) | 0 | |||
Submucosa <500 µm | 27 (17.9) | 20 (21.8) | 0 | 45 (14.2) | 5 (11.9) | 0 | |||
Submucosa ≥500 µm | 39 (25.8) | 59 (64.1) | 27 (100.0) | 39 (12.3) | 29 (69.0) | 5 (100.0) | |||
Histology | 0.003† | 0.019† | |||||||
PD | 112 (74.2) | 74 (80.4) | 24 (88.9) | 195 (61.5) | 30 (71.4) | 4 (80.0) | |||
SRC | 39 (25.8) | 14 (15.2) | 1 (3.7) | 118 (37.2) | 10 (23.8) | 0 | |||
Mucinous | 0 | 4 (4.4) | 2 (7.4) | 4 (1.3) | 2 (4.8) | 1 (20.0) | |||
Lymphovascular invasion | 0 | 49 (53.3) | 27 (100.0) | <0.001 | 0 | 18 (42.9) | 5 (100.0) | <0.001 | |
Ulceration | 15 (9.9) | 10 (10.9) | 2 (7.4) | 0.856 | 32 (10.1) | 4 (9.5) | 1 (20.0) | 0.749 | |
Positive vertical margin | 4 (2.6) | 33 (35.9) | 17 (63.0) | <0.001 | 5 (1.6) | 17 (40.5) | 4 (80.0) | <0.001 |
Data are presented as median (interquartile range) or number (%).
ASA, American Society of Anesthesiologists; PD, poorly differentiated adenocarcinoma; SRC, signet ring cell carcinoma.
*The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin; †The proportion of patients with signet ring cell carcinoma was compared against the proportion of patients with poorly differentiated or mucinous adenocarcinoma.
Table 3 Adjusted Analysis* of Hazards for Mortality and Recurrence According to Risk Categories of the eCura System in the No Additional Treatment Group†
Risk category | Overall mortality | Cancer-specific mortality | Cancer recurrence | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | |||
Low-risk | 27,165 | 31 | 1 | 27,165 | 1 | 18,563 | 3 | |||||||
Intermediate-risk | 3,342 | 15 | 2.80 (1.45–5.40) | 0.002 | 3,342 | 3 | 49.39 (2.95–826.70) | 0.007 | 2,004 | 3 | 12.63 (1.91–83.31) | 0.008 | ||
High-risk | 346 | 2 | 4.61 (1.01–21.08) | 0.049 | 346 | 1 | 586.83 (6.81–50,574) | 0.005 | 195 | 1 | 57.32 (2.37–1,384) | 0.013 | ||
Overall p-value | 0.004 | 0.011 | 0.011 | |||||||||||
p for trend | 2.48 (1.46–4.21) | 0.001 | 27.45 (3.27–230.26) | 0.002 | 8.98 (2.16–37.32) | 0.003 |
HR, hazard ratio; CI, confidence interval.
*HRs were adjusted for age, sex, American Society of Anesthesiologists physical status, location, histology, and ulceration; †The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin.
Table 4 Adjusted Analysis* of Hazards for Mortality and Recurrence in the No Additional Treatment Group Compared to the Radical Surgery Group Stratified by Risk Categories of the eCura System†
Risk category | Overall mortality | Cancer-specific mortality | Cancer recurrence | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | Person time at risk, mo | No. of cases | HR (95% CI) | p-value | |||
Low | ||||||||||||||
Radical surgery | 13,104 | 11 | 1 | 13,104 | 0 | 1 | 9,169 | 0 | 1 | |||||
No additional treatment | 27,165 | 31 | 0.52 (0.24–1.13) | 0.099 | 27,165 | 1 | 4,128.26 (not estimated) | 0.983 | 18,563 | 3 | 3.70×105 (not estimated) | 0.978 | ||
Intermediate-high | ||||||||||||||
Radical surgery | 1,003 | 12 | 1 | 1,003 | 3 | 1 | 6,651 | 4 | 1 | |||||
No additional treatment | 3,688 | 17 | 3.18 (1.41–7.17) | 0.005 | 3,688 | 4 | 2.60 (0.46–14.66) | 0.280 | 2,199 | 4 | 2.23 (0.41–12.18) | 0.354 |
HR, hazard ratio; CI, confidence interval.
*HRs were adjusted for age, sex, American Society of Anesthesiologists physical status, location, histology, and ulceration; †The low-, intermediate-, and high-risk categories of the eCura system are assigned 0–1, 2–4, and 5–6 points, respectively, according to the sum of the following risk scores: 1 point for tumor size >30 mm, 1 point for submucosal invasion ≥500 µm from the muscularis mucosa, 3 points for lymphovascular invasion, and 1 point for positive vertical margin.