Capecitabine and irinotecan with and without bevacizumab for advanced colorectal cancer patients

Table 1 Patient characteristics

	Treatment group
	CAPIRI	CAPIRI-Bev
N (%)	17 (37%)	29 (63%)
Age (median), years (range)	66 (55-81)	60 (37-80)
Gender, M/F	9/8	22/7
Site of primary tumor, n (%)
Rectum	7 (41.2)	15 (51.7)
Colon	10 (58.8)	14 (48.2)
Site of metastases, n (%)1
Hepatic	12 (71)	24 (83)
Pulmonary	6 (35)	11 (38)
Lymphatic and nodal	4 (24)	17 (59)
Skeletal	1 (6)	4 (14)
Peritoneal	1 (6)	5 (17)
Other sites	6 (35)	5 (17)
Performance status (Karnofsky)
100%	4 (23.5)	17 (58.6)
90%	1 (5.9)	5 (17.2)
85%	1 (5.9)	0 (0)
80%	2 (11.8)	3 (10.3)
70%	4 (23.5)	0 (0)
Adjuvant chemotherapy received	8 (47%)	8 (27.6%)

¹Patients could have more than one metastatic site.

Table 2 Incidence of chemotherapy-related toxicities

	Treatment group
	CAPIRI (n = 17)		CAPIRI-Bev (n = 29)
NCI-CTC Grade	Total (1-4)	3-4	Total (1-4)	3-4
Hematologic toxicities, number (%) patients
Anemia	2 (11.8)	1 (5.9)	4 (13.8)	-
Leukopenia	4 (23.5)	2 (11.8)	6 (20.7)	1 (3.4)
Neutropenia	3 (17.6)	1 (5.9)	5 (17.2)	2 (6.9)
Non-hematologic toxicities, number (%) patients
Diarrhea	7 (41.2)	5 (29.4)	13 (44.8)	5 (17.2)
Nausea/vomiting	6 (35.3)	-	12 (41.4)	2 (6.9)
Hand-foot syndrome	6 (35.3)	1 (5.9)	9 (31.0)	-
Mucositis	3 (17.3)	2 (11.8)	5 (17.2)	-
Cholinergic syndrome	3 (17.3)	-	2 (6.9)	-
Alopecia1	2 (11.8)	-	12 (41.4)	-
Fatigue	2 (11.8)	-	10 (34.5)	-
Anorexia	1 (5.9)	1 (5.9)	2 (6.9)	1 (3.4)
Fever	1 (5.9)	-	4 (13.8)	-
Proteinuria1	-	-	7 (24.1)	1 (3.4)
Arterial hypertension	-	-	3 (10.3)	-
Cardiovascular	1 (5.9)	-	1 (3.4)	1 (3.4)
Thromboembolic event	-	-	3 (10.3)	-
GGT rise	1 (5.9)	-	4 (13.8)	4 (13.8)
Hypokalemia	1 (5.9)	1 (5.9)	3 (10.3)	-
Creatinine rise	1 (5.9)	-	1 (3.4)	-

GGT: Gamma-glutamyl transferase; NCI-CTC: National Cancer Institute-Common Toxicity Criteria (version 2),

¹Fisher’s test, P < 0.05.

Table 3 Response rates

	Treatment group
	CAPIRI (n = 17) number (%) patients	CAPIRI-Bev (n = 29) number (%) patients
Tumor control rate (CR + PR + SD)	13 (70.6)	22 (75.9)
Complete response (CR)	-	-
Partial response (PR)	5 (29.4)	10 (34.5)
Stable disease (SD)	7 (41.2)	12 (41.4)
Progressive disease (PD)	5 (29.4)	6 (20.7)
Not rated	-	1 (3.4)

Table 4 Second-line therapies

	Treatment group
	CAPIRI (n = 17) number (%) patients	CAPIRI-Bev (n = 29) number (%) patients
Folfiri + Bevacizumab	-	4 (14)
Irinotecan + Cetuximab	-	1 (3)
Capox +/-Bevacizumab	1 (6)	2 (7)
Capox + Cetuximab	-	1 (3)
Folfox +/- Cetuximab	2 (12)	2 (7)
Cetuximab alone	1 (6)	1 (3)
Capiri +/- Cetuximab	-	4 (14)
Capiri + Bevacizumab	1 (6)	-
No second line	10 (59)	14 (48)