CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients: promising findings from a prospective, open-label, randomized, phase III trial

Table 2 Baseline demographic and clinical characteristics of the 501 patients before the start of treatment

Characteristic^a	CMAB009 plus irinotecan (n = 337)		Irinotecan-only (n = 164)		Entire study cohort (n = 501)		P
Characteristic^a	No. of patients	%	No. of patients	%	No. of patients	%
Age, years							0.652
Median	55.0		55.0		55.0
Standard deviation	10.55		11.02		10.69
< 65	287	85.2	141	86.0	428	85.4
≥ 65	50	14.8	23	14.0	73	14.6
Sex							0.246
Male	195	57.9	104	63.4	299	59.7
Female	142	42.1	60	36.6	202	40.3
Ethnic minority							0.121
Han	334	99.1	159	97.0	493	98.4
Other	3	0.9	5	3.0	8	1.6
ECOG performance status							0.120
0	136	40.4	56	34.1	192	38.3
1	201	59.6	107	65.2	308	61.5
2	0	0	1	0.6	1	0.2
Previous therapy
Chemotherapy	337	100	163	99.4	500	99.8	0.327
Radiation therapy	92	27.3	37	22.6	129	25.7	0.277
First-line therapy							0.667
Median duration, months	6		7		7
Range, months	1–38		1–24		1–38
Reason off therapy							0.552
Disease progression	301	66.8	144	63.7	445	65.8
Adverse events	41	9.1	25	11.1	66	9.7
Other	108	24.0	57	25.2	165	24.4
Site of metastasis							0.873
Lung	142	42.1	73	44.5	215	42.9
Peritoneum	25	7.4	17	10.4	42	8.4
Liver	186	55.2	99	60.4	285	56.9
Lymph node	106	31.5	60	36.6	166	33.1
Other	105	31.2	50	30.5	155	30.9
No. of disease sites							0.199
1	98	29.1	38	23.2	136	27.1
≥ 2	239	70.9	126	76.8	365	72.9

ECOG, Eastern Cooperative Oncology Group
^aThere was no significant difference in baseline patient characteristics between the 2 groups

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