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 3 Therapeutic efficacies of CMAB009 plus irinotecan treatment versus irinotecan-only treatment

Treatment response	CMAB009 plus irinotecan (n = 337)		Irinotecan-only (n =164)		P ^*
Treatment response	No. of patients	%	No. of patients	%	P ^*
CR	4	1.2	1	0.6
PR	108	32.0	20	12.2
SD	158	46.9	86	52.4
PD	47	13.9	44	26.8
Not evaluable	20	5.9	13	7.9
ORR^a	112/337	33.2	21/164	12.8	< 0.001
95% CI of ORR	28.2–38.5		8.1–8.9
DCR^b	270/337	80.1	107/164	65.2	< 0.001
95% CI of DCR	75.5–84.2		57.4–72.5
CBR^c	101/337	30.0	24/164	14.6	< 0.001
95% CI of CBR	25.1–35.2		9.6–21.0

CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; response classified by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0); ORR, overall response rate; DCR, disease control rate; CBR, clinical benefit rate
*Cochran–Mantel–Haenszel test stratified by Eastern Cooperative Oncology Group performance status (0 vs. 1) at random assignment
^aOverall response either CR or PR
^bOverall response CR PR or SD
^cOverall response CR PR or SD, ≥ 24 weeks

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