FOLFIRI3-aflibercept in previously treated patients with metastatic colorectal cancer

Table 1 Patient characteristics n (%)

Characteristics	Irinotecan-naive cohort	Irinotecan-pre-exposed cohort	P-value
Age (yr)			0.793
< 70	21 (70.0)	23 (65.7)
≥ 70	9 (30.0)	12 (34.3)
Sex			0.623
Male	16 (53.3)	21 (60.0)
Female	14 (46.7)	14 (40.0)
ECOG PS			0.227
0	14 (46.7)	11 (31.4)
1	13 (43.3)	15 (42.9)
2	3 (10.0)	9 (25.7)
Time to metastasis			0.314
Metachronous	9 (30.0)	15 (42.9)
Synchronous	21 (70.0)	20 (57.1)
No. of metastatic sites			0.118
1	14 (46.7)	9 (25.7)
> 1	16 (53.3)	26 (74.3)
No. of prior lines for metastatic disease
			-
0	5 (16.7)	0 (0.0)
1	25 (83.3)	15 (42.9)
> 1	-	20 (57.1)
Prior drug exposure			0.699
Oxaliplatin	29 (96.7)	35 (100.0)
Bevacizumab	18 (60.0)	29 (82.9)
Anti-EGFR	2 (6.7)	4 (11.4)

ECOG PS: Eastern Cooperative Oncology Group performance status.

Table 2 Summary of the efficacy results

	Irinotecan-naïve, n = 30			Prior irinotecan, n = 35
Response rate
	n	%	%	n	%	%
		(ITT)	(evaluable)		(ITT)	(evaluable)
CR	0	0	0	1	2.8	2.9
PR	13	43.3	50	11	31.4	32.4
SD	10	33.3	38.5	9	25.7	26.5
PD	3	10	11.5	13	37.1	38.2
NE	4	13.3	-	1	2.8	-
ORR	13	43.3	50	12	34.3	35.3
DCR	23	76.7	88.5	21	60	61.8
Survivals
	median, mo	95%CI		median, mo	95%CI
PFS	11.3	6.1-29.0		5.7	3.9-10.4
OS	17.0	13.0-17.3		14.3	12.8-19.5

RR: Response rate; ITT: Intention-to-treat; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; NE: Not evaluable; ORR: Objective response rate; DCR: Disease control rate; PFS: Progression-free survival; OS: Overall survival.

Table 3 Contingency table of tumor response with FOLFIRI3-aflibercept according to prior tumor response with irinotecan [n = 35, n (%)]

		FOLFIRI3-aflibercept
		CR/PR	SD	PD	NE	All
Prior irinotecan-based regimen	CR/PR	5	3	7	0	15 (42.8)
	SD	4	4	2	0	10 (28.6)
	PD	1	2	3	1	7 (20.0)
	NE	2	0	1	0	3 (8.6)
	All	12 (34.3)	9 (25.7)	13 (37.1)	1 (2.8)	35

CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; NE: Not evaluable.

Table 4 Selected (≥ 5%) grade 3-4 adverse events (NCI CTCAE version 4.0) n (%)

SOC	PT	Irinotecan-naïve	Prior irinotecan	All
Any		17 (56.7)	15 (42.9)	32 (49.2)
Blood	Neutropenia	4 (13.3)	1 (2.9)	5 (7.7)
	Anemia	3 (10.0)	0 (0.0)	3 (4.6)
	Thrombocytopenia	0 (0.0)	0 (0.0)	0 (0.0)
Gastrointestinal	Nausea	2 (6.7)	0 (0.0)	2 (3.1)
	Vomiting	1 (3.3)	0 (0.0)	1 (1.5)
	Mucositis	3 (10.0)	3 (8.6)	6 (9.2)
	Diarrhea	11 (36.7)	9 (25.7)	20 (30.8)
Vascular	Hypertension	2 (6.7)	4 (11.4)	6 (9.2)

SOC: System Organ Class; PT: Preferred term.