Skip to content
Bending the Curve Trial by Trial
?

AURELIA

Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial

Phase 3N = 361NCT00976911

Population
Patients with platinum-resistant (progression less than 6 months after platinum) recurrent ovarian cancer, no more than two prior regimens
Design
Open-label randomised phase III trial. Patients with measurable or assessable ovarian cancer that had progressed less than 6 months after completing platinum-based therapy (refractory disease, bowel obstruction history and more than two prior anticancer regimens excluded) had chemotherapy selected by the investigator (pegylated liposomal doxorubicin, weekly paclitaxel or topotecan) and were randomly assigned to chemotherapy alone or with bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until progression, unacceptable toxicity or consent withdrawal. Crossover to single-agent bevacizumab was permitted after progression with chemotherapy alone. 361 patients; primary end point PFS by RECIST.
Primary endpoint
PFS
Arms
  • Single-agent chemotherapy alone (control): Investigator-selected pegylated liposomal doxorubicin, weekly paclitaxel or topotecan
  • Single-agent chemotherapy plus bevacizumab (experimental): The same chemotherapy options plus bevacizumab 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks
People
Pujade-Lauraine E
PFSHR 0.48 (95% CI 0.38–0.60)Δ median PFS+3.3 monthsΔ ORR+15.5 pointsOSHR 0.85 (95% CI 0.66–1.08)Δ median OS+3.3 months
Show the numbers
Results reported for AURELIA
EndpointAnalysisSingle-agent chemotherapy plus bevacizumabSingle-agent chemotherapy aloneEffect
PFSRandomised patients (N=361); analysis population not stated in the abstractprimaryPujade-Lauraine 2014median 6.7 monthsmedian 3.4 monthsHR 0.48 (95% CI 0.38–0.60)P<0.001PFS events occurred in 301 of 361 patients. PFS by RECIST.
ORRRandomised patients (N=361); analysis population not stated in the abstractprimaryPujade-Lauraine 201427.3%11.8%P=0.001Secondary endpoint; RECIST objective response rate.
OSRandomised patients (N=361); analysis population not stated in the abstractprimaryPujade-Lauraine 2014median 16.6 monthsmedian 13.3 monthsHR 0.85 (95% CI 0.66–1.08)P<0.174Secondary endpoint; the abstract prints the p-value as 'P < .174' and describes the OS trend as not significant. Crossover to single-agent bevacizumab was permitted.
Results reported for AURELIA
EndpointAnalysisSingle-agent chemotherapy plus bevacizumabSingle-agent chemotherapy aloneEffect
PFSRandomised patients (N=361); analysis population not stated in the abstractprimaryPujade-Lauraine 2014median 6.7 monthsmedian 3.4 monthsHR 0.48 (95% CI 0.38–0.60)P<0.001PFS events occurred in 301 of 361 patients. PFS by RECIST.
ORRRandomised patients (N=361); analysis population not stated in the abstractprimaryPujade-Lauraine 201427.3%11.8%P=0.001Secondary endpoint; RECIST objective response rate.
OSRandomised patients (N=361); analysis population not stated in the abstractprimaryPujade-Lauraine 2014median 16.6 monthsmedian 13.3 monthsHR 0.85 (95% CI 0.66–1.08)P<0.174Secondary endpoint; the abstract prints the p-value as 'P < .174' and describes the OS trend as not significant. Crossover to single-agent bevacizumab was permitted.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.480.38–0.6
OS0.850.66–1.08
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Single-agent chemotherapy plus bevacizumab (experimental)
  • Single-agent chemotherapy alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSingle-agent chemotherapy plus bevacizumabSingle-agent chemotherapy alone
0100.0%100.0%
466.1%44.2%
843.7%19.6%
1326.1%7.1%
1717.2%3.1%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Single-agent chemotherapy plus bevacizumab (experimental)
  • Single-agent chemotherapy alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSingle-agent chemotherapy plus bevacizumabSingle-agent chemotherapy alone
0100.0%100.0%
1065.9%59.4%
2141.6%33.5%
3127.4%19.9%
4217.3%11.2%
Primary publication: Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014;32(13):1302-8. PubMedDOI

Appears in

Sources

  1. Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014;32(13):1302-8.

    PubMedDOI