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OCEANS

OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer

Phase 3N = 484NCT00434642

Population
Patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer and measurable disease
Design
Randomised, multicentre, blinded, placebo-controlled phase III trial. 484 patients with platinum-sensitive recurrent disease (recurrence 6 months or more after front-line platinum-based therapy) and measurable disease were randomly assigned to gemcitabine plus carboplatin with bevacizumab or placebo for six to 10 cycles, then bevacizumab or placebo until progression. Primary end point PFS by RECIST; secondary end points objective response rate, duration of response, overall survival and safety.
Primary endpoint
PFS
Arms
  • Gemcitabine and carboplatin plus placebo (control): Gemcitabine plus carboplatin with placebo for six to 10 cycles, then placebo until progression
  • Gemcitabine and carboplatin plus bevacizumab (experimental): Gemcitabine plus carboplatin with bevacizumab for six to 10 cycles, then bevacizumab until progression
People
Aghajanian C
PFSHR 0.484 (95% CI 0.388–0.605)Δ median PFS+4 monthsΔ ORR+21.1 pointsDORHR 0.534 (95% CI 0.408–0.698)Δ median DOR+3 months
Show the numbers
Results reported for OCEANS
EndpointAnalysisGemcitabine and carboplatin plus bevacizumabGemcitabine and carboplatin plus placeboEffect
PFSRandomised patients (N=484); analysis population not stated in the abstractprimaryAghajanian 2012median 12.4 monthsmedian 8.4 monthsHR 0.484 (95% CI 0.388–0.605)P<0.0001PFS by RECIST.
ORRRandomised patients (N=484); analysis population not stated in the abstractprimaryAghajanian 201278.5%57.4%P<0.0001Secondary endpoint.
DORResponders; analysis population not stated in the abstractprimaryAghajanian 2012median 10.4 monthsmedian 7.4 monthsHR 0.534 (95% CI 0.408–0.698)Secondary endpoint.
Results reported for OCEANS
EndpointAnalysisGemcitabine and carboplatin plus bevacizumabGemcitabine and carboplatin plus placeboEffect
PFSRandomised patients (N=484); analysis population not stated in the abstractprimaryAghajanian 2012median 12.4 monthsmedian 8.4 monthsHR 0.484 (95% CI 0.388–0.605)P<0.0001PFS by RECIST.
ORRRandomised patients (N=484); analysis population not stated in the abstractprimaryAghajanian 201278.5%57.4%P<0.0001Secondary endpoint.
DORResponders; analysis population not stated in the abstractprimaryAghajanian 2012median 10.4 monthsmedian 7.4 monthsHR 0.534 (95% CI 0.408–0.698)Secondary endpoint.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSDOR0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.4840.388–0.605
DOR0.5340.408–0.698
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Gemcitabine and carboplatin plus bevacizumab (experimental)
  • Gemcitabine and carboplatin plus placebo (control)

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

Data table (modelled values)
MonthsGemcitabine and carboplatin plus bevacizumabGemcitabine and carboplatin plus placebo
0100.0%100.0%
863.9%51.7%
1640.9%26.7%
2327.6%15.0%
3117.7%7.7%
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Gemcitabine and carboplatin plus bevacizumab (experimental)
  • Gemcitabine and carboplatin plus placebo (control)

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

Data table (modelled values)
MonthsGemcitabine and carboplatin plus bevacizumabGemcitabine and carboplatin plus placebo
0100.0%100.0%
762.7%51.9%
1342.0%29.6%
2026.4%15.4%
2617.7%8.8%
Primary publication: Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012;30(17):2039-45. PubMedDOI

Appears in

Sources

  1. Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012;30(17):2039-45.

    PubMedDOI