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Bending the Curve Trial by Trial
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GOG-107

Doxorubicin with or without cisplatin in stage III, IV or recurrent endometrial carcinoma (Gynecologic Oncology Group study)

Phase 3N = 299

Population
Stage III, IV or recurrent endometrial carcinoma
Design
Randomised phase 3 trial. Doxorubicin 60 mg/m2 intravenously, or doxorubicin 60 mg/m2 plus cisplatin 50 mg/m2, every 3 weeks until progression, unacceptable toxicity or a total doxorubicin dose of 500 mg/m2. 299 patients registered; 281 (94%) eligible.
Arms
  • Doxorubicin (control): Doxorubicin 60 mg/m2 every 3 weeks
  • Doxorubicin plus cisplatin (experimental): Doxorubicin 60 mg/m2 plus cisplatin 50 mg/m2 every 3 weeks
People
Thigpen JT, Gynecologic Oncology Group
Δ ORR+17 pointsPFSHR 0.736 (95% CI 0.577–0.939)Δ median PFS+1.9 monthsOSHR 0.928 (95% CI 0.727–1.185)Δ median OS−0.2 months
Show the numbers
Results reported for GOG-107
EndpointAnalysisDoxorubicin plus cisplatinDoxorubicinEffect
ORRAs reported in the abstract (299 registered, 281 eligible); analysis population not statedfinalThigpen 200442%25%P=0.004Complete responses 19% and partial responses 23% with the combination; complete 8% and partial 17% among 150 patients receiving doxorubicin.
PFSAs reported in the abstract (299 registered, 281 eligible); analysis population not statedfinalThigpen 2004median 5.7 monthsmedian 3.8 monthsHR 0.736 (95% CI 0.577–0.939)P=0.014
OSAs reported in the abstract (299 registered, 281 eligible); analysis population not statedfinalThigpen 2004median 9 monthsmedian 9.2 monthsHR 0.928 (95% CI 0.727–1.185)
Results reported for GOG-107
EndpointAnalysisDoxorubicin plus cisplatinDoxorubicinEffect
ORRAs reported in the abstract (299 registered, 281 eligible); analysis population not statedfinalThigpen 200442%25%P=0.004Complete responses 19% and partial responses 23% with the combination; complete 8% and partial 17% among 150 patients receiving doxorubicin.
PFSAs reported in the abstract (299 registered, 281 eligible); analysis population not statedfinalThigpen 2004median 5.7 monthsmedian 3.8 monthsHR 0.736 (95% CI 0.577–0.939)P=0.014
OSAs reported in the abstract (299 registered, 281 eligible); analysis population not statedfinalThigpen 2004median 9 monthsmedian 9.2 monthsHR 0.928 (95% CI 0.727–1.185)
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.7360.577–0.939
OS0.9280.727–1.185
Illustrative — modelled from reported values, not trial data. PFS, final.
0%25%50%75%100%02468101214Months (modelled)
  • Doxorubicin plus cisplatin (experimental)
  • Doxorubicin (control)

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

Data table (modelled values)
MonthsDoxorubicin plus cisplatinDoxorubicin
0100.0%100.0%
461.5%48.2%
742.7%27.9%
1126.2%13.4%
1418.2%7.8%
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%05101520Months (modelled)
  • Doxorubicin plus cisplatin (experimental)
  • Doxorubicin (control)

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

Data table (modelled values)
MonthsDoxorubicin plus cisplatinDoxorubicin
0100.0%100.0%
663.0%63.6%
1239.7%40.5%
1727.0%27.8%
2317.0%17.7%
Primary publication: Thigpen JT, Brady MF, Homesley HD, Malfetano J, DuBeshter B, Burger RA, et al. Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a gynecologic oncology group study. J Clin Oncol. 2004;22(19):3902-8. PubMedDOI

Appears in

Sources

  1. Thigpen JT, Brady MF, Homesley HD, Malfetano J, DuBeshter B, Burger RA, et al. Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a gynecologic oncology group study. J Clin Oncol. 2004;22(19):3902-8.

    PubMedDOI