1Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
2Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
3Center of Biomedical Mass Spectrometry, Diatech Korea Co., Ltd., Seoul, Korea
4Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea
5Department of Ophthalmology, Seoul National University Boramae Medical Center, Seoul, Korea
6Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea
7Department of Ophthalmology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea
8Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
9Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
10Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Korea
Copyright © 2018 by the Korean Cancer Association
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Adjuvant chemotherapy was conducted in patients with pathologic stages II-III according to the American Joint Committee on Cancer (AJCC, 7th edition). However, two patients who had stage IB with additional risk factors (N2 lymph node metastasis according to the Japanese staging classification) were also included.
Characteristic |
Univariable analysisa) |
Multivariable analysisa) |
|||
---|---|---|---|---|---|
1-Year cumulative incidence of LDO (%) | p-value | Hazard ratio | 95% Confidence interval | p-value | |
Sex | |||||
Male | 41.4 | 0.207 | 1.00 | - | - |
Female | 29.8 | 0.88 | 0.45-1.70 | 0.697 | |
Age (yr) | |||||
< 70 | 30.4 | < 0.001 | 1.00 | - | - |
≥ 70 | 68.4 | 1.99 | 1.00-3.95 | 0.049 | |
Extent of gastrectomy | |||||
Partial gastrectomy | 34.6 | 0.201 | 1.00 | - | - |
Total gastrectomy | 46.0 | 1.17 | 0.60-2.29 | 0.641 | |
Creatinine clearance (Ccr, mL/min) | 0.018 | ||||
≥ 80 | 20.0 | < 0.001 | 1.00 | - | - |
≥ 60 and < 80 | 52.3 | 2.52 | 1.21-5.22 | 0.013 | |
< 60 | 63.7 | 3.21 | 1.35-7.65 | 0.008 | |
Plasma 5-fluorouracil concentration (median, 22.3 ng/mL)b) | |||||
< 22.3 | 22.8 | < 0.001 | 1.00 | - | - |
≥ 22.3 | 52.1 | 2.02 | 1.03-3.93 | 0.040 | |
Plasma tegafur concentration (median, 1,835.0 ng/mL)b) | |||||
<1,835.0 | 34.4 | 0.528 | 1.00 | - | - |
≥ 1,835.0 | 40.5 | 0.54 | 0.29-1.03 | 0.062 | |
Plasma CDHP concentration (median, 42.0 ng/mL)b) | |||||
< 42.0 | 30.4 | 0.032 | 1.00 | - | - |
≥ 42.0 | 45.3 | 1.22 | 0.63-2.37 | 0.559 | |
Tear tegafur concentration (median, 479.2 ng/mL)b) | |||||
< 479.2 | 26.7 | 0.006 | 1.00 | - | - |
≥ 479.2 | 50.0 | 1.85 | 0.99-3.45 | 0.055 |
Patients without LDO (n=92) | Patients with LDO (n=53) | p-valuea) | |
---|---|---|---|
Hematologic toxicity | |||
Grade 0 or 1 | 52 (56.5) | 31 (58.5) | 0.817 |
≥ Grade 2 | 40 (43.5) | 22 (41.5) | |
Non-hematologic toxicity | |||
Grade 0 or 1 | 37 (40.2) | 11 (20.8) | 0.016 |
≥ Grade 2 | 55 (59.8) | 42 (79.2) |
Clinical characteristic | No. (%) |
---|---|
Age, median (range, yr) | 59 (22-82) |
Sex | |
Male | 100 (69) |
Female | 45 (31) |
Stage | |
IB | 2 (1) |
II | 92 (63) |
III | 51 (35) |
Pathology | |
Well or moderately differentiated adenocarcinoma | 60 (41) |
Poorly differentiated adenocarcinoma | 30 (21) |
Signet ring cell carcinoma | 45 (31) |
Others | 10 (7) |
Lauren classification | |
Intestinal type | 62 (43) |
Diffuse type | 72 (50) |
Mixed or intermediate type | 11 (8) |
Primary tumor location | |
Lower third | 73 (50) |
Middle third | 21 (14) |
Upper third | 31 (21) |
≥ 2/3 of stomach | 20 (14) |
Gross morphology of primary tumor | |
Early gastric cancer | 21 (14) |
Borrmann type I | 4 (3) |
Borrmann type II | 19 (13) |
Borrmann type III | 91 (63) |
Borrmann type IV | 10 (7) |
Method of gastrectomy | |
Laparoscopic surgery | 114 (79) |
Open surgery | 31 (21) |
Extent of gastrectomy | |
Total gastrectomy | 41 (28) |
Distal gastrectomy | 99 (68) |
Proximal gastrectomy | 5 (3) |
Creatinine clearance, median (range, mL/min) | 79 (41-148) |
Characteristic | Univariable analysis |
Multivariable analysis |
|||
---|---|---|---|---|---|
1-Year cumulative incidence of LDO (%) | p-value | Hazard ratio | 95% Confidence interval | p-value | |
Sex | |||||
Male | 41.4 | 0.207 | 1.00 | - | - |
Female | 29.8 | 0.88 | 0.45-1.70 | 0.697 | |
Age (yr) | |||||
< 70 | 30.4 | < 0.001 | 1.00 | - | - |
≥ 70 | 68.4 | 1.99 | 1.00-3.95 | 0.049 | |
Extent of gastrectomy | |||||
Partial gastrectomy | 34.6 | 0.201 | 1.00 | - | - |
Total gastrectomy | 46.0 | 1.17 | 0.60-2.29 | 0.641 | |
Creatinine clearance (Ccr, mL/min) | 0.018 | ||||
≥ 80 | 20.0 | < 0.001 | 1.00 | - | - |
≥ 60 and < 80 | 52.3 | 2.52 | 1.21-5.22 | 0.013 | |
< 60 | 63.7 | 3.21 | 1.35-7.65 | 0.008 | |
Plasma 5-fluorouracil concentration (median, 22.3 ng/mL) |
|||||
< 22.3 | 22.8 | < 0.001 | 1.00 | - | - |
≥ 22.3 | 52.1 | 2.02 | 1.03-3.93 | 0.040 | |
Plasma tegafur concentration (median, 1,835.0 ng/mL) |
|||||
<1,835.0 | 34.4 | 0.528 | 1.00 | - | - |
≥ 1,835.0 | 40.5 | 0.54 | 0.29-1.03 | 0.062 | |
Plasma CDHP concentration (median, 42.0 ng/mL) |
|||||
< 42.0 | 30.4 | 0.032 | 1.00 | - | - |
≥ 42.0 | 45.3 | 1.22 | 0.63-2.37 | 0.559 | |
Tear tegafur concentration (median, 479.2 ng/mL) |
|||||
< 479.2 | 26.7 | 0.006 | 1.00 | - | - |
≥ 479.2 | 50.0 | 1.85 | 0.99-3.45 | 0.055 |
Patients without LDO (n=92) | Patients with LDO (n=53) | p-value |
|
---|---|---|---|
Hematologic toxicity | |||
Grade 0 or 1 | 52 (56.5) | 31 (58.5) | 0.817 |
≥ Grade 2 | 40 (43.5) | 22 (41.5) | |
Non-hematologic toxicity | |||
Grade 0 or 1 | 37 (40.2) | 11 (20.8) | 0.016 |
≥ Grade 2 | 55 (59.8) | 42 (79.2) |
Adjuvant chemotherapy was conducted in patients with pathologic stages II-III according to the American Joint Committee on Cancer (AJCC, 7th edition). However, two patients who had stage IB with additional risk factors (N2 lymph node metastasis according to the Japanese staging classification) were also included.
LDO, lacrimal drainage obstruction; CDHP, 5-chloro-2,4-dihydroxypyridine. In univariable analysis, a log-rank test was used. In multivariable analysis, the Cox proportional hazard model was used, Concentrations: ng/mL.
Values are presented as number (%). LDO, lacrimal drainage obstruction. Chi-square test.