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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