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Bending the Curve Trial by Trial
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GOG-177

Doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced or recurrent endometrial carcinoma (Gynecologic Oncology Group study)

Phase 3N = 273NCT00003691

Population
Advanced or recurrent endometrial carcinoma
Design
Randomised phase 3 trial. Doxorubicin 60 mg/m2 and cisplatin 50 mg/m2 (AP; doxorubicin reduced to 45 mg/m2 after prior pelvic radiotherapy or above age 65), or doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 on day 1 followed by paclitaxel 160 mg/m2 on day 2 with filgrastim support (TAP). Cycles every 3 weeks to a maximum of seven. 273 women registered, 10 ineligible. ClinicalTrials.gov NCT00003691 carries the Gynecologic Oncology Group identifier GOG-0177 and the same regimen titles; its enrolment (240) is an estimate.
Primary endpoint
OS
Arms
  • Doxorubicin plus cisplatin (AP) (control): Doxorubicin 60 mg/m2 and cisplatin 50 mg/m2 every 3 weeks, maximum of seven cycles
  • Doxorubicin, cisplatin and paclitaxel (TAP) (experimental): Doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 on day 1, paclitaxel 160 mg/m2 on day 2 with filgrastim, every 3 weeks, maximum of seven cycles
People
Fleming GF, Gynecologic Oncology Group
Δ ORR+23 pointsΔ median PFS+3 monthsΔ median OS+3 months
Show the numbers
Results reported for GOG-177
EndpointAnalysisDoxorubicin, cisplatin and paclitaxel (TAP)Doxorubicin plus cisplatin (AP)Effect
ORRAs reported in the abstract (273 registered, 10 ineligible); analysis population not statedfinalFleming 200457%34%P<0.01
PFSAs reported in the abstract (273 registered, 10 ineligible); analysis population not statedfinalFleming 2004median 8.3 monthsmedian 5.3 monthsP<0.01
OSAs reported in the abstract (273 registered, 10 ineligible); analysis population not statedfinalFleming 2004median 15.3 monthsmedian 12.3 monthsP=0.037Grade 3 peripheral neuropathy 12% with TAP vs 1% with AP; grade 2 27% vs 4%.
Results reported for GOG-177
EndpointAnalysisDoxorubicin, cisplatin and paclitaxel (TAP)Doxorubicin plus cisplatin (AP)Effect
ORRAs reported in the abstract (273 registered, 10 ineligible); analysis population not statedfinalFleming 200457%34%P<0.01
PFSAs reported in the abstract (273 registered, 10 ineligible); analysis population not statedfinalFleming 2004median 8.3 monthsmedian 5.3 monthsP<0.01
OSAs reported in the abstract (273 registered, 10 ineligible); analysis population not statedfinalFleming 2004median 15.3 monthsmedian 12.3 monthsP=0.037Grade 3 peripheral neuropathy 12% with TAP vs 1% with AP; grade 2 27% vs 4%.
Illustrative — modelled from reported values, not trial data. PFS, final.
0%25%50%75%100%05101520Months (modelled)
  • Doxorubicin, cisplatin and paclitaxel (TAP) (experimental)
  • Doxorubicin plus cisplatin (AP) (control)

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

Data table (modelled values)
MonthsDoxorubicin, cisplatin and paclitaxel (TAP)Doxorubicin plus cisplatin (AP)
0100.0%100.0%
565.9%52.0%
1043.4%27.0%
1626.3%12.3%
2117.3%6.4%
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%0102030Months (modelled)
  • Doxorubicin, cisplatin and paclitaxel (TAP) (experimental)
  • Doxorubicin plus cisplatin (AP) (control)

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

Data table (modelled values)
MonthsDoxorubicin, cisplatin and paclitaxel (TAP)Doxorubicin plus cisplatin (AP)
0100.0%100.0%
1063.6%56.9%
1942.3%34.3%
2926.9%19.5%
3817.9%11.7%
Primary publication: Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, et al. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004;22(11):2159-66. PubMedDOI

Appears in

Sources

  1. Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, et al. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004;22(11):2159-66.

    PubMedDOI