Table 1 Open in new tab Patient and...

	89803	89803	89803	9581	9581
No. of patients	1,264	463	416	1,738	435
Age, years, mean (range)	59.9 (21–85)	59.8 (24–83)	60.03 (24–85)	64.1 (24–90)	64.4 (34–89)
Sex
Male	702 (55.54%)	254 (54.86%)	228 (54.81%)	901 (51.84%)	233 (53.56%)
Female	562 (44.46%)	209 (45.14%)	188 (45.19%)	837 (48.16%)	202 (46.44%)
Treatment
FU/LV or edrecolomab	629 (49.76%)	228 (49.24%)	218 (52.4%)	865 (49.77%)	234 (53.79%)
IFL or observation	635 (50.24%)	235 (50.76%)	198 (47.6%)	873 (50.23%)	201 (46.21%)
Tumor location
Proximal	715 (57.85%)	254 (55.46%)	237 (57.66%)	1048 (60.97%)	259 (59.54%)
Distal	521 (42.15%)	204 (44.54%)	174 (42.34%)	671 (39.03%)	176 (40.46%)
Tumor differentiation
Well‐differentiated	71 (5.74%)	24 (5.23%)	21 (5.1%)	146 (8.49%)	36 (8.31%)
Moderately differentiated	862 (69.68%)	331 (72.11%)	295 (71.60%)	1305 (75.92%)	325 (75.06%)
Poorly or undifferentiated	304 (24.58%)	104 (22.66%)	96 (23.30%)	268 (15.59%)	72 (16.63%)
No. of positive nodes, mean (range)	3.5 (0–29)	3.5 (1–23)	3.5 (1–24)	N/A	N/A
Nodal ratio, mean (range)	0.30 (0.30–1.33)	0.29 (0.01–1.00)	0.31 (0.01–1.00)	N/A	N/A
Nodes sampled, mean (range)	14.4 (1–99)	14.7 (1–99)	14.9 (1–68)	14.4 (0–99)	13.9 (0–59)
7‐year DFS (95% CI)	0.57 (0.54, 0.60)	0.58 (0.53, 0.62)	0.62 (0.57, 0.66)	0.74 (0.71, 0.76)	0.73 (0.69, 0.77)
7‐year OS (95% CI)	0.65 (0.62–0.67)	0.65 (0.60, 0.69)	0.69 (0.64, 0.73)	0.79 (0.77, 0.81)	0.78 (0.74, 0.82)

89803

9581

Characteristic

Entire cohort

TS by IHC

TS by AQUA

Entire cohort

TS by IHC

No. of patients

1,264

463

416

1,738

435

Age, years, mean (range)

59.9 (21–85)

59.8 (24–83)

60.03 (24–85)

64.1 (24–90)

64.4 (34–89)

Sex

Male

702 (55.54%)

254 (54.86%)

228 (54.81%)

901 (51.84%)

233 (53.56%)

Female

562 (44.46%)

209 (45.14%)

188 (45.19%)

837 (48.16%)

202 (46.44%)

Treatment

FU/LV or edrecolomab

629 (49.76%)

228 (49.24%)

218 (52.4%)

865 (49.77%)

234 (53.79%)

IFL or observation

635 (50.24%)

235 (50.76%)

198 (47.6%)

873 (50.23%)

201 (46.21%)

Tumor location

Proximal

715 (57.85%)

254 (55.46%)

237 (57.66%)

1048 (60.97%)

259 (59.54%)

Distal

521 (42.15%)

204 (44.54%)

174 (42.34%)

671 (39.03%)

176 (40.46%)

Tumor differentiation

Well‐differentiated

71 (5.74%)

24 (5.23%)

21 (5.1%)

146 (8.49%)

36 (8.31%)

Moderately differentiated

862 (69.68%)

331 (72.11%)

295 (71.60%)

1305 (75.92%)

325 (75.06%)

Poorly or undifferentiated

304 (24.58%)

104 (22.66%)

96 (23.30%)

268 (15.59%)

72 (16.63%)

No. of positive nodes, mean (range)

3.5 (0–29)

3.5 (1–23)

3.5 (1–24)

N/A

Nodal ratio, mean (range)

0.30 (0.30–1.33)

0.29 (0.01–1.00)

0.31 (0.01–1.00)

N/A

Nodes sampled, mean (range)

14.4 (1–99)

14.7 (1–99)

14.9 (1–68)

14.4 (0–99)

13.9 (0–59)

7‐year DFS (95% CI)

0.57 (0.54, 0.60)

0.58 (0.53, 0.62)

0.62 (0.57, 0.66)

0.74 (0.71, 0.76)

0.73 (0.69, 0.77)

7‐year OS (95% CI)

0.65 (0.62–0.67)

0.65 (0.60, 0.69)

0.69 (0.64, 0.73)

0.79 (0.77, 0.81)

0.78 (0.74, 0.82)

	89803	89803	89803	9581	9581
No. of patients	1,264	463	416	1,738	435
Age, years, mean (range)	59.9 (21–85)	59.8 (24–83)	60.03 (24–85)	64.1 (24–90)	64.4 (34–89)
Sex
Male	702 (55.54%)	254 (54.86%)	228 (54.81%)	901 (51.84%)	233 (53.56%)
Female	562 (44.46%)	209 (45.14%)	188 (45.19%)	837 (48.16%)	202 (46.44%)
Treatment
FU/LV or edrecolomab	629 (49.76%)	228 (49.24%)	218 (52.4%)	865 (49.77%)	234 (53.79%)
IFL or observation	635 (50.24%)	235 (50.76%)	198 (47.6%)	873 (50.23%)	201 (46.21%)
Tumor location
Proximal	715 (57.85%)	254 (55.46%)	237 (57.66%)	1048 (60.97%)	259 (59.54%)
Distal	521 (42.15%)	204 (44.54%)	174 (42.34%)	671 (39.03%)	176 (40.46%)
Tumor differentiation
Well‐differentiated	71 (5.74%)	24 (5.23%)	21 (5.1%)	146 (8.49%)	36 (8.31%)
Moderately differentiated	862 (69.68%)	331 (72.11%)	295 (71.60%)	1305 (75.92%)	325 (75.06%)
Poorly or undifferentiated	304 (24.58%)	104 (22.66%)	96 (23.30%)	268 (15.59%)	72 (16.63%)
No. of positive nodes, mean (range)	3.5 (0–29)	3.5 (1–23)	3.5 (1–24)	N/A	N/A
Nodal ratio, mean (range)	0.30 (0.30–1.33)	0.29 (0.01–1.00)	0.31 (0.01–1.00)	N/A	N/A
Nodes sampled, mean (range)	14.4 (1–99)	14.7 (1–99)	14.9 (1–68)	14.4 (0–99)	13.9 (0–59)
7‐year DFS (95% CI)	0.57 (0.54, 0.60)	0.58 (0.53, 0.62)	0.62 (0.57, 0.66)	0.74 (0.71, 0.76)	0.73 (0.69, 0.77)
7‐year OS (95% CI)	0.65 (0.62–0.67)	0.65 (0.60, 0.69)	0.69 (0.64, 0.73)	0.79 (0.77, 0.81)	0.78 (0.74, 0.82)

Table 1

Open in new tab

Patient and tumor characteristics by study

	89803	89803	89803	9581	9581
Characteristic	Entire cohort	TS by IHC	TS by AQUA	Entire cohort	TS by IHC
No. of patients	1,264	463	416	1,738	435
Age, years, mean (range)	59.9 (21–85)	59.8 (24–83)	60.03 (24–85)	64.1 (24–90)	64.4 (34–89)
Sex
Male	702 (55.54%)	254 (54.86%)	228 (54.81%)	901 (51.84%)	233 (53.56%)
Female	562 (44.46%)	209 (45.14%)	188 (45.19%)	837 (48.16%)	202 (46.44%)
Treatment
FU/LV or edrecolomab	629 (49.76%)	228 (49.24%)	218 (52.4%)	865 (49.77%)	234 (53.79%)
IFL or observation	635 (50.24%)	235 (50.76%)	198 (47.6%)	873 (50.23%)	201 (46.21%)
Tumor location
Proximal	715 (57.85%)	254 (55.46%)	237 (57.66%)	1048 (60.97%)	259 (59.54%)
Distal	521 (42.15%)	204 (44.54%)	174 (42.34%)	671 (39.03%)	176 (40.46%)
Tumor differentiation
Well‐differentiated	71 (5.74%)	24 (5.23%)	21 (5.1%)	146 (8.49%)	36 (8.31%)
Moderately differentiated	862 (69.68%)	331 (72.11%)	295 (71.60%)	1305 (75.92%)	325 (75.06%)
Poorly or undifferentiated	304 (24.58%)	104 (22.66%)	96 (23.30%)	268 (15.59%)	72 (16.63%)
No. of positive nodes, mean (range)	3.5 (0–29)	3.5 (1–23)	3.5 (1–24)	N/A	N/A
Nodal ratio, mean (range)	0.30 (0.30–1.33)	0.29 (0.01–1.00)	0.31 (0.01–1.00)	N/A	N/A
Nodes sampled, mean (range)	14.4 (1–99)	14.7 (1–99)	14.9 (1–68)	14.4 (0–99)	13.9 (0–59)
7‐year DFS (95% CI)	0.57 (0.54, 0.60)	0.58 (0.53, 0.62)	0.62 (0.57, 0.66)	0.74 (0.71, 0.76)	0.73 (0.69, 0.77)
7‐year OS (95% CI)	0.65 (0.62–0.67)	0.65 (0.60, 0.69)	0.69 (0.64, 0.73)	0.79 (0.77, 0.81)	0.78 (0.74, 0.82)

	89803	89803	89803	9581	9581
Characteristic	Entire cohort	TS by IHC	TS by AQUA	Entire cohort	TS by IHC
No. of patients	1,264	463	416	1,738	435
Age, years, mean (range)	59.9 (21–85)	59.8 (24–83)	60.03 (24–85)	64.1 (24–90)	64.4 (34–89)
Sex
Male	702 (55.54%)	254 (54.86%)	228 (54.81%)	901 (51.84%)	233 (53.56%)
Female	562 (44.46%)	209 (45.14%)	188 (45.19%)	837 (48.16%)	202 (46.44%)
Treatment
FU/LV or edrecolomab	629 (49.76%)	228 (49.24%)	218 (52.4%)	865 (49.77%)	234 (53.79%)
IFL or observation	635 (50.24%)	235 (50.76%)	198 (47.6%)	873 (50.23%)	201 (46.21%)
Tumor location
Proximal	715 (57.85%)	254 (55.46%)	237 (57.66%)	1048 (60.97%)	259 (59.54%)
Distal	521 (42.15%)	204 (44.54%)	174 (42.34%)	671 (39.03%)	176 (40.46%)
Tumor differentiation
Well‐differentiated	71 (5.74%)	24 (5.23%)	21 (5.1%)	146 (8.49%)	36 (8.31%)
Moderately differentiated	862 (69.68%)	331 (72.11%)	295 (71.60%)	1305 (75.92%)	325 (75.06%)
Poorly or undifferentiated	304 (24.58%)	104 (22.66%)	96 (23.30%)	268 (15.59%)	72 (16.63%)
No. of positive nodes, mean (range)	3.5 (0–29)	3.5 (1–23)	3.5 (1–24)	N/A	N/A
Nodal ratio, mean (range)	0.30 (0.30–1.33)	0.29 (0.01–1.00)	0.31 (0.01–1.00)	N/A	N/A
Nodes sampled, mean (range)	14.4 (1–99)	14.7 (1–99)	14.9 (1–68)	14.4 (0–99)	13.9 (0–59)
7‐year DFS (95% CI)	0.57 (0.54, 0.60)	0.58 (0.53, 0.62)	0.62 (0.57, 0.66)	0.74 (0.71, 0.76)	0.73 (0.69, 0.77)
7‐year OS (95% CI)	0.65 (0.62–0.67)	0.65 (0.60, 0.69)	0.69 (0.64, 0.73)	0.79 (0.77, 0.81)	0.78 (0.74, 0.82)

Abbreviations: AQUA, automated quantitative analysis; CI, confidence interval; DFS, disease‐free survival; FU/LV, 5‐fluorouraciland leucovorin; IFL, FU/LV and irinotecan; IHC, immunohistochemistry; OS, overall survival; TS, thymidylate synthase.

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