(n=144)
 CT+BV

(n=142)
 
% patients with objective response
 18 (12.5%)
 40 (28.2%)
 
p -value
 0.0007
 
Overall Survival (final analysis)***
 
  CT

(n=182)
 CT+BV

(n=179)
 
Median OS (months)
 13.3
 16.6
 
Hazard Ratio

(95% CI)
 0.870 [0.678, 1.116]
 
p-value
 0.2711
 

All analyses presented in this table are stratified analyses.

* Primary analysis was performed with a data cut-off date of 14 November 2011.

**Randomized Patients with Measurable Disease at Baseline.

***The final analysis of overall survival was performed when 266 deaths, which account for 73.7 % of enrolled patients, were observed.

The trial met its primary objective of PFS improvement. Compared to patients treated with chemotherapy (paclitaxel, topotecan or PLD) alone in the recurrent platinum-resistant setting, patients who received bevacizumab at a dose of 10 mg/kg every 2 weeks (or 15 mg/kg every 3 weeks if used in combination with 1.25 mg/m2 topotecan on Days 1–5 every 3 weeks) in combination with chemotherapy and continued to receive bevacizumab until disease progression or unacceptable toxicity, had a statistically significant improvement in PFS. The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarized in Table 22.

Table 22: Exploratory PFS and OS analyses by chemotherapy cohort

 
 CT
 CT+BV
 
Paclitaxel
 n=115
 
Median PFS (months)
 3.9
 9.2
 
Hazard ratio (95% CI)
 0.47 [0.31, 0.72]
 
Median OS (months)
 13.2
 22.4
 
Hazard ratio (95% CI)
 0.64 [0.41, 0.99]
 
Topotecan
 n=120
 
Median PFS (months)
 2.1
 6.2
 
Hazard ratio (95% CI)
 0.28 [0.18, 0.44]
 
Median OS (months)
 13.3
 13.8
 
Hazard ratio (95% CI)
 1.07 [0.70, 1.63]
 
PLD
 n=126
 
Median PFS (months)
 3.5
 5.1
 
Hazard ratio (95% CI)
 0.53 [0.36, 0.77]
 
Median OS (months)
 14.1
 13.7
 
Hazard ratio (95% CI)
 0.91 [0.61, 1.35]
 

Cervical Cancer

GOG-0240

The efficacy and safety of Avastin in combination with chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in the treatment for patients with persistent, recurrent or metastatic carcinoma of the cervix was eva luated in study GOG-0240, a randomised, four-arm, open label, multi-centre phase III trial.

A total of 452 patients were randomised to receive either:

• Paclitaxel 135 mg/m2 IV over 24 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2, every 3 weeks (q3w); or

Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 (q3w); or

Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 (q3w)

• Paclitaxel 135 mg/m2 IV over 24 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 plus bevacizumab 15 mg/kg IV on Day 2 (q3w); or

Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 plus bevac