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Bending the Curve Trial by Trial
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GOG-0262

Weekly vs. Every-3-Week Paclitaxel and Carboplatin for Ovarian Cancer

Phase 3N = 692NCT01167712

Population
Women with newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, stratified by choice of bevacizumab
Design
Randomised trial in which patients were prospectively stratified by whether they elected to receive bevacizumab, then assigned to six cycles of paclitaxel 175 mg/m2 every 3 weeks plus carboplatin AUC 6, or paclitaxel 80 mg/m2 weekly plus carboplatin AUC 6. 692 patients were enrolled, 84% of whom opted to receive bevacizumab. Primary end point progression-free survival. Eligibility (full text): incompletely resected stage III or any stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer; after the closure of GOG-0252, stage II/III disease without residual lesions larger than 1 cm was also allowed.
Primary endpoint
PFS
Arms
  • Paclitaxel every 3 weeks plus carboplatin (control): Paclitaxel 175 mg/m2 every 3 weeks plus carboplatin AUC 6, six cycles
  • Weekly paclitaxel plus carboplatin (experimental): Paclitaxel 80 mg/m2 weekly plus carboplatin AUC 6 every 3 weeks, six cycles
People
Chan JK, NRG Oncology/Gynecologic Oncology Group
PFSHR 0.89 (95% CI 0.74–1.06)Δ median PFS+0.7 monthsPFSHR 0.62 (95% CI 0.40–0.95)Δ median PFS+3.9 monthsPFSHR 0.99 (95% CI 0.83–1.20)Δ median PFS+0.2 months
Show the numbers
Results reported for GOG-0262
EndpointAnalysisWeekly paclitaxel plus carboplatinPaclitaxel every 3 weeks plus carboplatinEffect
PFSprimaryChan 2016median 14.7 monthsmedian 14 monthsHR 0.89 (95% CI 0.74–1.06)P=0.18
PFSPatients who did not receive bevacizumab (stratum chosen by the patient)exploratoryChan 2016median 14.2 monthsmedian 10.3 monthsHR 0.62 (95% CI 0.40–0.95)P=0.03Stratum defined by patient choice before randomisation; the abstract gives a difference of 3.9 months. A test for interaction between treatment and bevacizumab use gave P=0.047.
PFSPatients who received bevacizumab (stratum chosen by the patient)exploratoryChan 2016median 14.9 monthsmedian 14.7 monthsHR 0.99 (95% CI 0.83–1.20)P=0.60A test for interaction between treatment and bevacizumab use gave P=0.047.
Results reported for GOG-0262
EndpointAnalysisWeekly paclitaxel plus carboplatinPaclitaxel every 3 weeks plus carboplatinEffect
PFSprimaryChan 2016median 14.7 monthsmedian 14 monthsHR 0.89 (95% CI 0.74–1.06)P=0.18
PFSPatients who did not receive bevacizumab (stratum chosen by the patient)exploratoryChan 2016median 14.2 monthsmedian 10.3 monthsHR 0.62 (95% CI 0.40–0.95)P=0.03Stratum defined by patient choice before randomisation; the abstract gives a difference of 3.9 months. A test for interaction between treatment and bevacizumab use gave P=0.047.
PFSPatients who received bevacizumab (stratum chosen by the patient)exploratoryChan 2016median 14.9 monthsmedian 14.7 monthsHR 0.99 (95% CI 0.83–1.20)P=0.60A test for interaction between treatment and bevacizumab use gave P=0.047.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.890.74–1.06
PFS0.620.4–0.95
PFS0.990.83–1.2
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Weekly paclitaxel plus carboplatin (experimental)
  • Paclitaxel every 3 weeks plus carboplatin (control)

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

Data table (modelled values)
MonthsWeekly paclitaxel plus carboplatinPaclitaxel every 3 weeks plus carboplatin
0100.0%100.0%
965.4%64.0%
1842.8%41.0%
2826.7%25.0%
3717.5%16.0%
Illustrative — modelled from reported values, not trial data. PFS, exploratory.
0%25%50%75%100%0102030Months (modelled)
  • Weekly paclitaxel plus carboplatin (experimental)
  • Paclitaxel every 3 weeks plus carboplatin (control)

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

Data table (modelled values)
MonthsWeekly paclitaxel plus carboplatinPaclitaxel every 3 weeks plus carboplatin
0100.0%100.0%
964.4%54.6%
1841.5%29.8%
2726.8%16.3%
3617.3%8.9%
Primary publication: Chan JK, Brady MF, Penson RT, Huang H, Birrer MJ, Walker JL, et al. Weekly vs. Every-3-Week Paclitaxel and Carboplatin for Ovarian Cancer. N Engl J Med. 2016;374(8):738-48. PubMedDOI

Appears in

Sources

  1. Chan JK, Brady MF, Penson RT, Huang H, Birrer MJ, Walker JL, et al. Weekly vs. Every-3-Week Paclitaxel and Carboplatin for Ovarian Cancer. N Engl J Med. 2016;374(8):738-48.

    PubMedDOI