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Bending the Curve Trial by Trial
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GOG-0213 (surgical objective)

Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer

Phase 3N = 485NCT00565851

Population
Platinum-sensitive recurrent ovarian, primary peritoneal or fallopian-tube cancer after one previous therapy, with investigator-determined resectable disease
Design
Patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal or fallopian-tube cancer who had received one previous therapy, with a platinum-free interval of 6 months or more and investigator-determined resectable disease (to no macroscopic residual disease), were randomly assigned to secondary surgical cytoreduction then platinum-based chemotherapy, or chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the investigator's discretion. The primary end point was overall survival. The phase comes from the ClinicalTrials.gov record. The bevacizumab objective of GOG-0213 is a separate publication and is not reported here.
Primary endpoint
OS
Arms
  • Surgery plus chemotherapy (experimental, n = 240): Secondary surgical cytoreduction followed by platinum-based chemotherapy
  • Chemotherapy alone (control, n = 245): Platinum-based chemotherapy alone
People
Coleman RL
OSHR 1.29 (95% CI 0.97–1.72)Δ median OS−14.1 monthsPFSHR 0.82 (95% CI 0.66–1.01)Δ median PFS+2.7 months
Show the numbers
Results reported for GOG-0213 (surgical objective)
EndpointAnalysisSurgery plus chemotherapyChemotherapy aloneEffect
OSIntention-to-treat: all 485 randomised patients (stated in the full text of the NIH author manuscript)primarymedian follow-up 48.1 monthsColeman 2019median 50.6 monthsmedian 64.7 monthsHR 1.29 (95% CI 0.97–1.72)P=0.08Hazard ratio for death, surgery versus no surgery. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was given to 84% of patients overall, equally distributed between the groups.
PFSIntention-to-treat: all 485 randomised patients (stated in the full text of the NIH author manuscript)primarymedian follow-up 48.1 monthsColeman 2019median 18.9 monthsmedian 16.2 monthsHR 0.82 (95% CI 0.66–1.01)Hazard ratio for disease progression or death, surgery versus no surgery.
Complete resection ratePatients assigned to surgery who underwent the procedureComplete gross resection.primaryColeman 201967%——
Results reported for GOG-0213 (surgical objective)
EndpointAnalysisSurgery plus chemotherapyChemotherapy aloneEffect
OSIntention-to-treat: all 485 randomised patients (stated in the full text of the NIH author manuscript)primarymedian follow-up 48.1 monthsColeman 2019median 50.6 monthsmedian 64.7 monthsHR 1.29 (95% CI 0.97–1.72)P=0.08Hazard ratio for death, surgery versus no surgery. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was given to 84% of patients overall, equally distributed between the groups.
PFSIntention-to-treat: all 485 randomised patients (stated in the full text of the NIH author manuscript)primarymedian follow-up 48.1 monthsColeman 2019median 18.9 monthsmedian 16.2 monthsHR 0.82 (95% CI 0.66–1.01)Hazard ratio for disease progression or death, surgery versus no surgery.
Complete resection ratePatients assigned to surgery who underwent the procedureComplete gross resection.primaryColeman 201967%——
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.290.97–1.72
PFS0.820.66–1.01
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%050100150Months (modelled)
  • Surgery plus chemotherapy (experimental)
  • Chemotherapy alone (control)

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

Data table (modelled values)
MonthsSurgery plus chemotherapyChemotherapy alone
0100.0%100.0%
4057.8%65.1%
8133.0%42.0%
12119.1%27.4%
16210.9%17.6%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Surgery plus chemotherapy (experimental)
  • Chemotherapy alone (control)

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

Data table (modelled values)
MonthsSurgery plus chemotherapyChemotherapy alone
0100.0%100.0%
1264.4%59.8%
2441.5%35.8%
3527.7%22.4%
4717.8%13.4%
Primary publication: Coleman RL, Spirtos NM, Enserro D, Herzog TJ, Sabbatini P, Armstrong DK, et al. Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer. N Engl J Med. 2019;381(20):1929-1939. PubMedDOI

Appears in

Sources

  1. Coleman RL, Spirtos NM, Enserro D, Herzog TJ, Sabbatini P, Armstrong DK, et al. Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer. N Engl J Med. 2019;381(20):1929-1939.

    PubMedDOI