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Table 1 Baseline characteristics of the whole population in PRECONNECT and by duration of FTD/TPI treatment

From: Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: final results from the phase IIIb single-arm PRECONNECT study by duration of therapy

Characteristica

All

0–3 cycles

4–7 cycles

≥8 cycles

N=914

n=632

n=219

n=63

Age, years, median (min, max)

62 (24, 89)

62 (24, 89)

63 (30, 82)

65 (34, 83)

Age group

 <70 years

706 (77)

489 (77)

168 (77)

49 (78)

 ≥70 years

208 (23)

143 (23)

51 (23)

14 (22)

Gender

 Female

373 (41)

265 (42)

84 (38)

24 (38)

 Male

541 (59)

367 (58)

135 (62)

39 (62)

Body mass index, kg/m2

N=893

N=615

N=215

N=63

 <18.5

48 (5)

41 (7)

7 (3)

0 (0)

 ≥18.5

845 (95)

574 (93)

208 (97)

63 (100)

 <25

451 (51)

342 (56)

85 (40)

24 (38)

 ≥25

442 (50)

273 (44)

130 (60)

39 (62)

 <30

738 (83)

527 (86)

168 (78)

43 (68)

 ≥30

155 (17)

88 (14)

47 (22)

20 (32)

ECOG PS status

 All patientsb

887

608

216

63

 0

435 (49)

271 (45)

129 (60)

35 (56)

 1

450 (51)

335 (55)

87 (40)

28 (44)

 ≥2

2 (0)

2 (0)

  

Haematology

 Haemoglobin

N=872

N=598

N=212

N=62

  <110 g/l

162 (19)

137 (23)

21 (10)

4 (6)

  ≥110 g/l

710 (81)

461 (77)

191 (90)

58 (94)

 WBC

N=872

N=598

N=212

N=62

  <10 x 109/l

675 (77)

436 (73)

187 (88)

52 (84)

  ≥10 x 109/l

197 (23)

162 (27)

25 (12)

10 (16)

 Platelet count

N=871

N=598

N=212

N=61

  <400 x 109/l

779 (89)

524 (88)

200 (94)

55 (90)

  ≥400 x 109/l)

92 (11)

74 (12)

12 (6)

6 (10)

 NLR

N=871

N=597

N=212

N=62

  <3

325 (37)

198 (33)

95 (45)

32 (52)

  ≥3

546 (63)

399 (67)

117 (55)

30 (48)

  <5

617 (71)

383 (64)

177 (83)

57 (92)

  ≥5

254 (29)

214 (36)

35 (17)

5 (8)

Albumin

N=847

N=582

N=205

N=60

 <35 g/l

210 (25)

177 (30)

26 (13)

7 (12)

 ≥35 g/l

637 (75)

405 (70)

179 (87)

53 (88)

Total Bilirubin

N=869

N=597

N=210

N=62

 Grade 0

791 (91)

534 (89)

197 (94)

60 (97)

 Grade ≥1

78 (9)

63 (11)

13 (6)

2 (3)

AST

N=868

N=596

N=212

N=60

 Grade 0

564 (65)

344 (58)

165 (78)

55 (92)

 Grade ≥1

304 (35)

252 (42)

47 (22)

5 (8)

ALT

N=871

N=596

N=213

N=62

 Grade 0

715 (82)

471 (79)

187 (88)

57 (92)

 Grade ≥1

156 (18)

125 (21)

26 (12)

5 (8)

ALP

N=854

N=587

N=205

N=62

 Grade 0

353 (41)

201 (34)

109 (53)

43 (69)

 Grade ≥1

501 (59)

386 (66)

96 (47)

19 (31)

Primary tumour site

 Right colon

244 (27)

176 (28)

51 (23)

17 (27)

 Left colon

593 (65)

405 (64)

149 (68)

39 (62)

 Not specified

76 (8)

50 (8)

19 (9)

7 (11)

Time from first metastasis to first FTD/TPI intakec

 <18 months

161 (18)

129 (20)

28 (13)

4 (6)

 ≥18 months

752 (82)

503 (80)

190 (87)

59 (94)

No. metastatic sitesd

 1-2

734 (81)

496 (79)

184 (84)

54 (86)

 ≥3

177 (19)

134 (21)

34 (16)

9 (14)

Liver metastasis

670 (73)

486 (77)

147 (67)

37 (59)

Lung metastasis

426 (47)

280 (44)

115 (53)

31 (49)

Lymph node metastasis

208 (23)

143 (23)

49 (22)

16 (25)

RAS mutation-positivee

438 (53)

326 (56)

88 (46)

24 (42)

Previous treatment containing anti-VEGF

784 (86)

547 (87)

185 (84)

52 (83)

Previous treatment containing regorafenib

283 (31)

207 (33)

62 (28)

14 (22)

  1. an (%) unless otherwise stated. b27 patients did not have ECOG PS data available. cOne patient did not have time from first metastasis to first FTD/TPI intake measurable. dThree patients with missing data. e186 patients did not have a RAS status evaluable. ALT, alanine aminotransferase; ALP, alkaline phosphatase; AST, aspartate aminotransferase; DoT, duration of treatment. ECOG PS, Eastern Cooperative Oncology Group performance status. FTD/TPI, trifluridine/tipiracil. Min, minimum. Max, maximum, NLR, neutrophil:lymphocyte ratio; WBC, white blood cells
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BMC Cancer

ISSN: 1471-2407

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