Comparison of treatment outcome in metastatic colorectal cancer patients included in a clinical trial versus daily practice in The Netherlands

Figures & data

Figure 1. Flow chart of the 4200 patients who were diagnosed with stage IV colorectal cancer during the CAIRO trial accrual period.

Table I. Patient characteristics.

		Eligible non-trial patients n = 224	Trial patients n = 394	p-Value	Non-eligible non-trial patients n = 85	p-Value
Gender	Male Female	132 (59%) 92 (41%)	256 (65%) 138 (35%)	0.14	53 (62%) 32 (38%)	0.39
Age	Median (range)	61 (29–84)	61 (27–82)	0.26	63 (31–92)	0.28
WHO PS	0–1	137 (93%)	375 (95%)	0.36	31 (60%)	< 0.0001
	2	10 (7%)	19 (5%)		9 (17%)
	3 Missing	77 (34%)			12 (23%) 33 (39%)
Number of metastatic sites	> 1	116 (52%)	224 (57%)	0.27	47 (49%)	0.27
Primary tumor resected		143 (64%)	264 (67%)	0.44	42 (51%)	0.02
location	Colon	148 (66%)	263 (67%)	0.90	51 (60%)	0.75
	Rectosigmoid	20 (9%)	38 (10%)		11 (13%)
	Rectum	56 (25%)	93 (24%)		23 (27%
Serum LDH	> ULN	91 (48%)	186 (47%)	0.74	37 (44%)	0.61
	missing	40 (18%)			16 (19%)
Serum AP	> ULN	111 (59%)	178 (56%)	0.48	43 (74%)	0.04
	missing	40 (18%)	78 (20%)		27 (31%)

AP, alkaline phosphatase; PS, performance status; ULN, upper limit of normal.

Patient baseline characteristics of stage IV colorectal cancer patients treated within the CAIRO trial (trial patients), treated outside the trial but fulfilling all trial eligibility criteria (eligible non-trial patients) and treated outside the trial but not fulfilling the trial eligibility criteria (not eligible non-trial patients).

Figure 2. Overall survival for stage IV colorectal cancer patients participating to the CAIRO trial (n = 394), and patients who were treated outside trials and did (n = 224) or did not (n = 85) meet CAIRO eligibility criteria.