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

From: 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

Treatment response CMAB009 plus irinotecan
(n = 337)
Irinotecan-only
(n =164)
P *
No. of patients % No. of patients %
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  
ORRa 112/337 33.2 21/164 12.8 < 0.001
95% CI of ORR 28.2–38.5 8.1–8.9  
DCRb 270/337 80.1 107/164 65.2 < 0.001
95% CI of DCR 75.5–84.2 57.4–72.5  
CBRc 101/337 30.0 24/164 14.6 < 0.001
95% CI of CBR 25.1–35.2 9.6–21.0  
  1. 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
  2. *Cochran–Mantel–Haenszel test stratified by Eastern Cooperative Oncology Group performance status (0 vs. 1) at random assignment
  3. aOverall response either CR or PR
  4. bOverall response CR PR or SD
  5. cOverall response CR PR or SD, ≥ 24 weeks