Table 2 Summary of efficacy: overall response and survival

From: A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin

Parameter

XELIRI (n=30)

IRI (n=30)

P-value

 

n (%)

n (%)

 

Overall response rate

 Complete response (CR)

2 (6.7)

0 (0.0)

 

 Partial response (PR)

2 (6.7)

2 (6.7)

 

 Stable disease (SD)

15 (50.0)

13 (43.3)

 

 Progressive disease (PD)

11 (36.7)

15 (50.0)

 

 Response rate (RR)

13.3%

6.7%

0.389

 Disease control rate (DCR)

63.3%

50.0%

0.297

Progression-free survival (PFS)

 Median PFS (95% CI)

3.7 months (0.3, 7.1)

2.4 months (2.0, 2.8)

0.036*

 Hazard ratio (95% CI)

0.54 (95% CI: 0.30, 0.98)

 

Overall survival (OS)

 9 months survival rate

60.9%

32.0%

0.045*

 Hazard ratio (95% CI)

0.30 (95% CI: 0.09, 0.99)

 

 Median OS (95% CI)

10.1 months (7.4, 12.8)

7.3 months (6.1, 8.5)

0.107

 Hazard ratio (95% CI)

0.63 (95% CI: 0.35, 1.12)

 
  1. XELIRI irinotecan and capecitabine, IRI irinotecan, CI confidence interval.
  2. *P < 0.05