Only patients with histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that had recurred > 6 months after platinum-based chemotherapy and who had not received chemotherapy in the recurrent setting and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents were included in the study.

A total of 484 patients with measurable disease were randomised 1:1 to either:

• Carboplatin (AUC4, Day 1) and gemcitabine (1000 mg/m2 on Days 1 and 8) and concurrent placebo every 3 weeks for 6 and up to 10 cycles followed by placebo (every 3 weeks) alone until disease progression or unacceptable toxicity

• Carboplatin (AUC4, Day 1) and gemcitabine (1000 mg/m2 on Days 1 and 8) and concurrent Avastin (15 mg/kg Day 1) every 3 weeks for 6 and up to 10 cycles followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity

The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0. Additional endpoints included objective response, duration of response, overall survival and safety. An independent review of the primary endpoint was also conducted.

The results of this study are summarised in Table 19.

Table 19 Efficacy results from study AVF4095g

Progression-free survival
 
  Investigator Assessment
 IRC Assessment
 
  Placebo+ C/G

(n=242)
 Avastin + C/G

(n=242)
 Placebo+ C/G

(n=242)
 Avastin + C/G

(n=242)
 
Not censored for NPT
  
Median PFS (months)
 8.4
 12.4
 8.6
 12.3
 
Hazard ratio

(95% CI)
 0.524 [0.425, 0.645]
 0.480 [0.377, 0.613]
 
p -value
 <0.0001
 <0.0001
 
Censored for NPT
  
Median PFS (months)
 8.4
 12.4
 8.6
 12.3
 
Hazard ratio

(95% CI)
 0.484 [0.388, 0.605]
 0.451 [0.351, 0.580]
 
p -value
 < 0.0001
 <0.0001
 
Objective response rate
 
  Investigator Assessment
 IRC Assessment
 
  Placebo+ C/G

(n = 242)
 Avastin + C/G

(n = 242)
 Placebo+ C/G

(n = 242)
 Avastin + C/G

(n = 242)
 
% pts with objective response
 57.4%
 78.5%
 53.7%
 74.8%
 
p -value
 < 0.0001
 < 0.0001
 
Overall survival
 
  Placebo+ C/G

(n = 242)
 Avastin + C/G

(n = 242)
 
Median OS (months)
 32.9
 33.6
 
Hazard Ratio

(95% CI)
 0.952 [0.771, 1.176]
 
p-value
 0.6479
 

PFS subgroup analyses depending on recurrence since last platinum therapy are summarised in Table 20.

Table 20 Progression-free survival by time from last platinum therapy to recurrence

  Investigator Assessment
 
Time from last platinum therapy to recurrence
 Placebo + C/G

(n = 242)
 Avastin + C/G

(n = 242)
 
6 - 12 months (n=202)
    
Median