Skip to content
Bending the Curve Trial by Trial
?

GOG-0213

Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial

Phase 3N = 674NCT00565851

Population
Women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer (bevacizumab objective)
Design
Multicentre, open-label randomised phase 3 trial in 67 centres (65 in the USA, one in Japan, one in South Korea). Women with recurrent measurable or evaluable epithelial ovarian, primary peritoneal or fallopian tube cancer, a clinical complete response to primary platinum-based chemotherapy and at least 6 months disease-free after the last platinum cycle were randomly assigned 1:1 to six 3-weekly cycles of paclitaxel 175 mg/m2 and carboplatin AUC 5, or the same plus bevacizumab 15 mg/kg every 3 weeks continued as maintenance until progression or unacceptable toxicity. This entry covers the bevacizumab objective only (674 women enrolled); the surgical objective is reported separately. Primary endpoint overall survival, by intention to treat. The abstract prints 377 for the bevacizumab group; the full text (PMC5715461) gives 337 in each group, so 377 is a typographical error in the abstract. ClinicalTrials.gov enrolment 1052 includes the surgical objective.
Primary endpoint
OS
Arms
  • Paclitaxel and carboplatin (control, n = 337): Paclitaxel 175 mg/m2 plus carboplatin AUC 5 every 3 weeks for six cycles
  • Paclitaxel and carboplatin plus bevacizumab (experimental, n = 337): The same chemotherapy plus bevacizumab 15 mg/kg every 3 weeks, continued as maintenance until progression or unacceptable toxicity
People
Coleman RL, NRG Oncology/Gynecologic Oncology Group
OSHR 0.829 (95% CI 0.683–1.005)Δ median OS+4.9 monthsOSHR 0.823 (95% CI 0.680–0.996)
Show the numbers
Results reported for GOG-0213
EndpointAnalysisPaclitaxel and carboplatin plus bevacizumabPaclitaxel and carboplatinEffect
OSprimarymedian follow-up 49.6 monthsColeman 2017median 42.2 months (37.7–46.2)median 37.3 months (32.6–39.7)HR 0.829 (95% CI 0.683–1.005)P=0.056Based on pretreatment stratification data; 415 patients had died at the end of the trial on 5 November 2014 (214 in the chemotherapy group, 201 in the bevacizumab group).
OSexploratorymedian follow-up 49.6 monthsColeman 2017——HR 0.823 (95% CI 0.680–0.996)P=0.0447Sensitivity analysis after incorrect treatment-free interval stratification data were identified for 45 (7%) patients (balanced between groups), as described in the abstract.
Results reported for GOG-0213
EndpointAnalysisPaclitaxel and carboplatin plus bevacizumabPaclitaxel and carboplatinEffect
OSprimarymedian follow-up 49.6 monthsColeman 2017median 42.2 months (37.7–46.2)median 37.3 months (32.6–39.7)HR 0.829 (95% CI 0.683–1.005)P=0.056Based on pretreatment stratification data; 415 patients had died at the end of the trial on 5 November 2014 (214 in the chemotherapy group, 201 in the bevacizumab group).
OSexploratorymedian follow-up 49.6 monthsColeman 2017——HR 0.823 (95% CI 0.680–0.996)P=0.0447Sensitivity analysis after incorrect treatment-free interval stratification data were identified for 45 (7%) patients (balanced between groups), as described in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.8290.683–1.005
OS0.8230.68–0.996
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080100Months (modelled)
  • Paclitaxel and carboplatin plus bevacizumab (experimental)
  • Paclitaxel and carboplatin (control)

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

Data table (modelled values)
MonthsPaclitaxel and carboplatin plus bevacizumabPaclitaxel and carboplatin
0100.0%100.0%
2665.2%61.7%
5341.9%37.3%
7927.3%23.0%
10617.5%13.9%
Primary publication: Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, et al. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017;18(6):779-791. PubMedDOI

Appears in

Sources

  1. Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, et al. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017;18(6):779-791.

    PubMedDOI