Peri-operative chemotherapy for the treatment of resectable liver metastases from colorectal cancer: A systematic review and meta-analysis of randomized trials

Table 3 Characteristics and quality of studies

	Nordlinger, 2008	Lorenz, 2005	Portier, 2006	Langer, 2002	Kemeny, 2002	Rudroff, 1998	Lygidakis, 1995	Wagman, 1990
Therapy regimen	FOLFOX 4, systemic	5-FU/FS, HAI	5-FU/FS, systemic	5-FU/FS, systemic	FUDR, HAI + 5-FU/FS, systemic	Mitomycin C + 5FU/FS, HAI	Immuno-therapy + 5-FU/FS, HAI	FUDR, HAI
Patients analyzed (n=)	364	226	171	107	109	30 **	40	11 *
Chemotherapy	182	113	86	52	53	14	20	5
Control	182	113	85	55	56	16	20	6
Received assigned treatment (n=)	250 (68,7%)	134 (59,3%)	136 (79,5%)	83 (77,6%)	65 (59,6%)	29 (96,6%)	39 (97,5%)	n.r.
Completed chemotherapy (n=)	neoadjuvant: 143 adjuvant: 80	34	54	28	20	13	19	n.r
Underwent surgery	170	100	82	55	45	16	20	6
Randomisation	adequate	adequate (tel. periop)	adequate	n.r.	adequate (preop)	adequate (postop)	adequate	adequate (preop)
R0 - resection	303	189	171	107	unclear	30	37	11
Concealed allocation	Unclear	unclear	unclear	n.r.	unclear	unclear	adequate	unclear
Blinded evaluation	Unclear	unclear	unclear	n.r.	unclear	unclear	unclear	unclear
Analysis on ITT basis	adequate	adequate	adequate	n.r.	inadequate	adequate	adequate	adequate
Primary endpoint	PFS	OS	DFS (2 yrs)	OS	RFS (4 yrs)	OS	OS	TTF
Secondary endpoint	Toxicity	Intrahepatic recurrence	OS	DFS	OS	RFS	Intrahepatic recurrence	OS; RR
Follow-up (Months)	45	18	87.4	-	51	144	-	-
Quality	High	high	high	low	low	low	low	low

* The total number of trial patients exceeds the sum of patients in groups due to multi-arm design.
** The total number of trial patients exceeds the sum of patients in groups because 12 patients with Dukes A/B were not randomized in this trial.
Abbreviations. pre: randomisation took place pre-operatively, post: randomisation took place
Post-operatively; Peri: randomisation took place during surgery;

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