Characteristics of Included Studies (Question 5)

Nazila Assasi; Gordon Blackhouse; Kaitryn Campbell; Katherine Gaebel; Robert Hopkins; Jathishinie Jegathisawaran; Alison Sinclair; Kelsey Seal; Chris Kamel; Mitchell Levine; Gordon Blackhouse; Bernice Tsoi; Kaitryn Campbell; Jathishinie Jegathisawaran; Laura Weeks; Sarah Garland; Kristen Moulton; David Kaunelis

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Assasi N, Blackhouse G, Campbell K, et al. DNA Mismatch Repair Deficiency Tumour Testing for Patients With Colorectal Cancer: A Health Technology Assessment [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Aug. (CADTH Optimal Use Report, No. 5.3b.)

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DNA Mismatch Repair Deficiency Tumour Testing for Patients With Colorectal Cancer: A Health Technology Assessment [Internet].

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Appendix 28Characteristics of Included Studies (Question 5)

Author, Year	Country	Eligibility Criteria		dMMR Testing			Chemotherapy Regimens	Reported Outcomes
Author, Year	Country	inclusion	Exclusion	MSI	IHC	Definition of MSI	Chemotherapy Regimens	Reported Outcomes
Klingbiel, 2015⁹⁶	Multinational (Europe)	- 18 to 75 years of age - Histologically proven stage II or stage III colon cancer - Available tumour specimens - Received adjuvant chemotherapy in the PETACC trial - Recruitment period: NR	NR	10 markers: BAT25, BAT26, D2S123, D5S346, TGFβRII, BAT40, D17S787, D18S69, D17S250, and D18S58)	NR	- MSI-H: instability in ≥ 3 markers - MSI-L: instability in 1 to 2 markers - MSS: instability in 0 markers - MSI-L and MSS grouped together as MSI-L/S	5-FU ± FA or FOLFIRI	DFS OS
Kim SH, 2013⁹⁹	Korea	- Pathologically proven stage III colon cancer - Available tumour specimens - Received curative surgical resection followed by adjuvant chemotherapy between January 2005 and July 2011	- Cancer other than adenocarcinoma - Signet ring cell type without extracellular mucin production - Rectal cancer - Pre-op chemotherapy - Pre-op or post-op radiotherapy - Unavailability of MSI status	5 markers: BAT25, BAT26, MFD15, D2S123 and D5S346	NR-	- MSI-H: instability in ≥ 2 markers - MSI-L: instability in 1 marker - MSS: instability in 0 markers - MSI-L and MSS grouped together as MSI-L/S	FOLFOX	DFS
Li, 2013⁹⁸	China	- Histologically proven stage III colon cancer - Available tumour specimens - Received curative surgical resection followed by adjuvant chemotherapy between January 2000 and December 2008	- < 18 years of age or > 85 years - Rectal cancer - Abdominopelvic radiotherapy - Severe complication - Changing drug regimen - Multi-primary cancer - Family history of cancer in 1st- or 2nd- degree relatives - Familial adenomatous polyposis	NR	MLH1 and MSH2	- dMMR: complete lack of expression in MLH1 and MSH2 (< 10% tumour cell staining for each protein) - pMMR: nuclear staining in ≥ 11% tumour cells	FOLFOX/XELOX or 5-FU alone	DFS OS (disease-specific)
Oh, 2013⁹⁷	Korea	- Stage III colon cancer - Underwent curative surgical resection between January 2003 and December 2010	- Treated by surgery alone - Treated with adjuvant chemotherapy other than FOLFOX	5 markers: D2S123, D17S250, D5S346, BAT25, BAT26	NR	- MSI-H: instability in ≥ 2 markers - MSI-L: instability in 1 marker - MSS: instability in 0 markers - MSI-L and MSS grouped together as MSI-L/S	FOLFOX4	DFS OS Relapse rate
Bertagnolli, 2011¹⁰⁰	USA	- Histologically proven stage III colon cancer - Underwent complete surgical resection - Received adjuvant chemotherapy in CALGB 89803 trial - Recruitment period: NR	- Metastatic disease - Rectal cancer - Positive tumour margins - Chemotherapy started too long post-operative - Labs outside limits.	10 markers: BAT25, BAT26, D17S250, D5S346, ACTC, D18S55, BAT40, D10S197, BAT34c4 and MycL	MLH1 and MSH2	- MSI - MSI-H: instability at ≥ 50% of screened loci - MSI-L: instability in at least one but ≤ 50% of the loci - MSS: all loci stable - MSI-L and MSS grouped together as MSI-L/S - IHC - dMMR: nuclear staining I < 10% tumour cells related to either MLH1 or MSH2 - pMMR: retained expression (staining in ≥ 10% of tumour cells) of both proteins	5-FU + Lev or FOLFIRI	DFS OS
Sinicrope, 2011³	USA	- Pathologically proven stage II or stage III colon cancer - Available tissue specimens - Received adjuvant chemotherapy regimens in the RCTs performed by NCCTG, FFCD, GIVIO, and NASBP - Recruitment period: variable	- NR	NCCTG 91-46-53 study: BAT26 + IHC Other NCCTG studies: 5–10 NCI panel markers that include BAT26, BAT25, D5S346, D2S123 and D17S250; NASBP studies: 5 Bethesda/NCI panel markers + TGFßRII. FFCD study: BAT25 & BAT26 GIVIO study: BAT25 & BAT26	MLH1, MSH2, and MSH6 (one study; NCCTG 91-46-53)	- MSI - MSI-H: instability in ≥ 30% of markers (GIVIO study: instability at both BAT25 & BAT26 loci) - MSI-L: instability at < 30% of loci screened - MSSL: all loci stable - MSI-L and MSS grouped together as MSI-L/S - IHC - dMMR: loss of MLH1 or MSH2 or MSH6 protein expression - pMMR: intact MMR protein expression	5-FU + FA/Lev or 5-FU + FA + Ɣ-interferon + Lev	Relapse rate
Yoon, 2011¹⁰²	Korea	- < 75 years of age - An ECOG performance status of 0 or1 - Histologically confirmed colorectal adenocarcinoma - Underwent curative surgical resection followed by adjuvant chemotherapy between August 2003 and December 2007	- HNPCC, corresponding to Amsterdam criterion I or II - FAP or attenuated FAP - Synchronous or metachronous CRC - History of pre-operative radio-chemotherapy	5 markers: BAT25, BAT26, D5S346, D2S123 and D17S250	MLH1 and MSH2	- MSI - MSI-H: instability in ≥ 2 markers - MSI-L: instability in 1 marker - MSS: instability in 0 markers - MSI-L and MSS grouped together as MSI-L/S - IHC - dMMR: nuclear staining > 10% of tumour cells for both MLH1 and MSH2	5-FU+FA / ca	DFS OS
Zaanan, 2011¹⁰¹	France	- Histologically proven stage III colon cancer - Available tumour specimens - Received curative surgical resection followed by adjuvant chemotherapy between June 2003 and December 2007	- Age < 18 years - Rectal cancer - Abdominopelvic radiotherapy - Dead within 30 days after surgery - Treated by surgery alone - Treated with chemotherapy other than FOLFOX - Chemotherapy and/or surveillance after surgery in another centre - Delay between surgery and chemotherapy > 8 weeks - Tissue samples unavailable - IHC test uninterpretable or clinical data were missing.	5 mononucleotide markers: NR21, NR24, NR27, BAT25 and BAT26	MLH1, MSH2 and MSH6	- MSI - MSI-H: instability in ≥ 3 markers - MSS: instability in < 3 markers - IHC - dMMR: loss of tumour MLH1, MSH2 or MSH6 protein expression (complete absence of tumour cell staining) - pMMR: normal tumour MLH1, MSH2 and MSH6 protein expression	FOLFOX4 or FOLFOX6	DFS OS Relapse rate
Zaanan, 2010¹⁰³	France	- Histologically proven stage III colon cancer - Underwent curative surgical resection followed by adjuvant chemotherapy between December 1997 and March 2006	NR	NR	MLH1, MSH2, and MSH6	- dMMR: the complete lack of expression (complete absence of nuclear staining of tumour cells) for MLH1, MSH2 or MSH6	5-FU + FA or FOLFOX	DFS
Dietmaier, 2006⁹²	Germany	- Primary lymph node positive stage III colon cancer reported to a clinical tumour registry centre between 1993 and 2001 - Received standard 5-FU–based adjuvant chemotherapy	NR	# markers: NR Using international microsatellite standard panel (HNPCC MSI Test kit; Roche, Mannheim, Germany)	NR	- MSI-H: instability in > 40% of markers - MSI-L: instability in < 40% of markers - MSS: instability in 0 markers	5-FU	OS
Westra, 2005¹⁰⁴	Netherlands	- Primary stage III colon cancer from CKVO 90-11 trial - Available tumour specimens - Received adjuvant chemotherapy - Recruitment period: NR	NR	9 markers (BAT25, BAT26, BAT40, MONO27, D3S2432, D7S1808, D7S3046, D7S3070, D10S1426) or 5 markers (BAT25, BAT26, D5S346, D2S123, D17S250)	NR	- MSI-H: instability in ≥ 3 of 9 markers or ≥ 2 of 5 markers - MSS: all other cases	5-FU + Lev ± FA	DFS (recurrence or disease-specific death)
Watanabe, 2001¹⁰⁵	USA	- Stage III or high-risk stage II colon cancer - Received adjuvant chemotherapy in the INT0032 and INT0089 trials, between August 1988 and July 1992	NR	10 markers (8 dinucleotides and 2 mononucleotides) (D18S69, D18S64, D18S55, D18S61, D18S58, D17S520, TGFβRII, TP53, p53VNTR, BAT26)	NR	- MSI-H: instability in ≥ 2 markers or ≥ 30% of loci	5-FU + Lev ± FA (high/low doses)	DFS OS

: 5-FU = 5 fluorouracil; ca = capecitabine; CALGB = Cancer and Leukemia Group B; CKVO = the Dutch Commissie Klinisch Vergelijkend Onderzoek group; CRC = colorectal cancer; DFS = disease-, recurrence-, and/or relapse-free survival; dMMR = deficient mismatch repair; ECOG = Eastern Cooperative Oncology Group; FA = folinic acid (leucovorin); FAP = familial adenomatous polyposis; FFCD = Federation Francophone de la Cancérologie Digestive; FOLFOX = 5-FU + leucovorin + oxaliplatin; FOLFIRI = 5-FU + leucovorin + irinotecan; GIVIO = Gruppo Italiano Valutazione Interventi in Oncologia; HNPCC = Hereditary nonpolyposis colorectal cancer; IHC = immunohistochemistry-based dMMR testing; INT = National Cancer Institute Gastrointestinal Intergroup; Lev = levamisole; MSI = PCR-based microsatellite stability (dMMR) testing; MSI-H = high microsatellite instability; MSI-L = low microsatellite instability; MSS = microsatellite stable; NASBP = the National Cancer Institute of Canada; NCCTG = North Central Cancer treatment Group; NR = not reported; OS = overall survival (all cause or disease-specific); PETACC = Pan-European Trial in Adjuvant Colon Cancer; pMMR = proficient mismatch repair; RCT = randomized controlled trial; XELOX = 5-FU (capecitabine) + oxaliplatin.

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Assasi N, Blackhouse G, Campbell K, et al. DNA Mismatch Repair Deficiency Tumour Testing for Patients With Colorectal Cancer: A Health Technology Assessment [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Aug. (CADTH Optimal Use Report, No. 5.3b.) Appendix 28, Characteristics of Included Studies (Question 5)
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Appendix 28Characteristics of Included Studies (Question 5)

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