Bevacizumab plus XELOX as first-line treatment of metastatic colorectal cancer: The OBELIX study

Table 1 Baseline patient characteristics

Characteristic	n (%)1
Total recruitment	205 (100)
ITT population	197 (96.1)
Age (yr)
Median (range)	63 (34-80)
mean ± SD	62.3 ± 9.9
Gender
Males	111 (56.4)
Females	86 (43.6)
ECOG-PS
0	159 (80.7)
1	38 (19.3)
> 1	0 (0)
Site of primary tumor
Colon (any region)	141 (71.6)
Rectum	46 (23.4)
Rectum + colon (any region)	8 (4.1)
Unknown	2 (1.0)
Prior treatments (adjuvant or neo-adjuvant)
Chemotherapy	49 (24.9)
Radiotherapy	21 (10.7)
None	148 (75.1)
N of metastases for each patient
1	105 (53.3)
2	72 (36.5)
> 3	20 (10.2)
Site of metastases
Liver	150 (76.1)
Lung	70 (35.5)
Lymph nodes	27 (13.7)
Peritoneum	14 (7.1)
Other	98 (48)
Stage at first diagnosis
Local regional	75 (38.1)
Metastatic	122 (61.9)
KRAS and BRAF mutation status (34 evaluated)
Wild Type (KRAS/BRAF)	18 (52.9)
Mutated KRAS	13 (38.2)
Mutated BRAF	2 (5.9)
Mutated KRAS and BRAF	1 (2.9)

¹Values reported as number of patients and, in parentheses, percentage on total number of patients, unless specified otherwise. ECOG-PS: Eastern cooperative oncology group performance status; ITT: Intention-to-treat; SD: Standard deviation.

Table 2 Overall response rate of the intention-to-treat population

	n (%)1
CR (best overall response)	10 (5.1)
PR	87 (44.2)
SD	55 (27.9)
CB (CR + PR + SD)	152 (77.1)
PD	13 (6.6)
No tumor assessment	32 (16.2)

¹Values reported as number of patients and, in parentheses, percentage on total number of patients. CB: Clinical benefit; CR: Complete response; ITT: Intention-to-treat; PD: Progressive disease; PR: Partial response; SD: Stable disease.

Table 3 Summary of R0 resection rates

Reason for surgery	Residual disease	n (%)1
Curative
	No (radical surgery)	26 (55.8)
	Yes	7 (13.5)
	Unknown	2 (3.9)
	Not applicable	4 (7.7)
Palliative
	No (radical surgery)	2 (3.9)
	Yes	4 (7.7)
	Unknown	2 (3.9)
	Not applicable	1 (1.9)
Biopsy
	Yes	1 (1.9)
	Not applicable	1 (1.9)
Unknown
	Unknown	1 (1.9)
	Not applicable	2 (3.9)
Other
	Yes	1 (1.9)
	Not applicable	2 (3.9)

¹Values reported as number of patients and, in parentheses, percentage on total number of patients who underwent R0 resection. Patients are counted only once in each row. Each patient could have more than one surgery during the study period.