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Table 2 Treatment efficacy in the phase Ib and the phase II trials

From: Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study

  Phase Ib Phase II   
  (N=42) Fruquintinib group (N=47) Placebo group (N=24) P value
Median PFS months, 95% CI 5.80, 4.01 to 7.60 4.73, 2.86 to 5.59 0.99, 0.95 to 1.58 <0.001
Median OS months, 95% CI 8.88, 7.53 to 15.53 7.72, 6.90 to 10.28 5.52, 3.61 to 11.30 0.29
CR No. (%) 0 0 0  
PR No. (%) 4 (9.5) 1 (2.1) 0  
SD No. (%) 28 (66.7) 31 (66.0) 5 (20.8)  
PD No. (%) 7 (16.7) 12 (25.5) 17 (70.8)  
Not evaluable, No. (%) 3 (7.1) 2 (4.3) 1 (4.2)  
No post-baseline assessment 0 1 (2.1) 1 (4.2)  
ORR No. (%), 95% CI 4 (9.5) 1 (2.1), 0.1 to 10.7 0, 0.0 to 12.6 0.45
DCR No. (%), 95% CI 32 (76.2) 32 (68.1), 53.6 to 80.8 5 (20.8), 8.6 to 40.6 <0.001
  1. P values are the results of stratified analyses for comparisons between the fruquintinib group and placebo group in the phase II trial. ORR = CR + PR, DCR = CR + PR + SD
  2. CI confidence interval, No. number of participants, PFS progression-free survival, OS overall survival, CR complete response, PR partial response, SD stable disease, PD progressive disease, ORR objective response rate, DCR disease control rate