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. 2021 Oct 22;37(1):35–46. doi: 10.1007/s00384-021-04046-x

Table 3.

Summary of the studies used for the meta-analysis

Author Year Type of study Patient details Median
follow-up
Tumour details Molecular method Tissue details
Total number of patients Male/female Age (years) Ethnicity MSI/MSS in 5-FU treated patients
Ribic (3) 2003

Retrospective MSI study of samples from patients enrolled in multicentre US/Canada phase 3 randomized controlled trials of adjuvant chemotherapy:

- 5-FU plus Leucovorin or no treatment (3 studies)

- 5-FU plus levamisole or no treatment (2 studies)

570

-326 male (57%)

-244 female (43%)

59.8 ± 11.2 No details given

MSI: 53

MSS: 230

7.4 years

Colon

Stage II-III

Grading: well to undifferentiated

Histotype: not specified

PCR

Variable number of microsatellite loci (2–11)

At least 60% tumour cells
Hong (21) 2012

Retrospective single centre case control study from Republic of Korea comparing:

-Surgery alone

-Surgery plus 5-FU

-Surgery plus 5-FU and radiotherapy

1125

-691 male (61.4%)

-434 female (38.6%)

61 (26–92) No details given

MSI: 81

MSS: 791

3.5 years

Colon-rectum

TNM stage I to IV

Grading: well to undifferentiated

Histotype: not specified

PCR

5 microsatellite loci (Bethesda panel)

Not given
Jover (24) 2009

Nested prospective follow-up multicenter study, 10 hospitals in Spain

Comparison of 5-FU adjuvant vs. surgery alone

754

-456 male

-298 female

MMR proficient: 70.0 (11.5)

MMR deficient: 68.4 (13.8)

No details given

MSI: 26

MSS: 225

4.1 years

Tumour site not specified

TNM Stage I-IV

Grading: not specified

Histotype: not specified

PCR

5 microsatellite loci (Bethesda panel)

ABI 310 Genetic Analyzer

or immunohistochemistry (MLH1 or MSH2)

Not given
Kim (18) 2007

Retrospective MSI testing of patients drawn from four US clinical trials (1983–1990):

- Surgery alone arm from 2 trials

- 5-FU and Leucovorin from 2 trials

1044 No details given No details given No details given

MSI: 61

MSS: 308

Not given

Colon

Dukes B and C

Grading: not specified

Histotype: not specified

PCR

5 microsatellite loci (Bethesda panel)

ABI 310 Genetic Analyzer

At least 50% of tumour cells
Carethers (19) 2004 Case control retrospective study of patients from two hospitals in San Diego California treated with or without 5-FU adjuvant therapy 204

-131 male

-73 female

65.73 _ 13.5

Asian 6%

Black 7%

Hispanic 10%

White 76%

Unknown 1%

MSI: 10

MSS: 56

3.6 years

Colon

Stage II and III

Grading: well to poor

Histotype:

-Mucinous 60

- Non mucinous 117

PCR

5 microsatellite loci (Bethesda panel)

Polyacrylamide

gel

Not given
Ohrling (22) 2010 Retrospective MSI testing on patients enrolled in a randomized clinical trial 1991–1996 on surgery with or without 5-FU (plus-minus levamisole). Multicentre from 59 hospitals in Sweden 1006

-559 male

-447 female

66 (24–75) No details given

MSI: 72

MSS: 274

Not given

Colon-rectum

Stage II and III

Grading: well to poorly differentiated or unknown

Histotype: not specified

MLH1 and MSH2 immunohistochemistry Not applicable
Klingbiel (8) 2015 MSI testing on patients enrolled in a randomized phase III clinical trial 2000–2002 multicentre (31 countries) on 5-FU or FOLFIRI 1254 No details given

MSI: 54 (25–75)

-MSS: 61 (21–76)

No details given

MSI: 45

MSS: 160

5.75 years

Colon

TNM stage I to IV

Grading: well to poorly differentiated

Histotype: mucinous 81%

Non mucinous 18%

Unknown 1%

PCR

5 microsatellite loci (Bethesda panel) plus

(BAT-25, BAT-26, D2S123, D5S346, TGFBR2, BAT-40, D17S787, D18S69,

D17S250, and D18S58)

Not given
Bertagnolli (20) 2009

Randomised control trial phase III randomized trial comparing FU/ Leucovorin (LV) with irinotecan, FU, and LV (IFL) for postoperative

adjuvant treatment. Two centres Canada and US

1264

-Male 702

-Female 562

61 (21–85) No details given

MSI: 46

MSS: 302

6.65 years

Colon

TNM stage III

Grading: well to poorly differentiated or unknown

Histotype: mucinous 9.9%

Non mucinous 85.1%

Unknown 5%

MLH1 and MSH2 immunohistochemistry and PCR

5 microsatellite loci (Bethesda panel) No details on analysis

At least 60% of tumour cells using microdissection when necessary
Jensen (23) 2009 Retrospective MSI on a cohort of 5FU adjuvant treated patient in a single hospital, 1996–2003, Copenhagen 311

-Male 159

-Female 152

-MSI: < 70 = 28; > 69 = 15

-MSS: < 70 = 217 > 69 = 51

No details given

MSI: 43

MSS: 268

6.1 years

Colo-rectal

TNM stage II-IV

Grading: well to poorly differentiated

Histotype: not specified

MLH1, MSH2, MSH6 and PMS2 immunohistochemistry and PCR

5 microsatellite loci (Bethesda panel) No details on analysis

At least 50% of tumour cells