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Bending the Curve Trial by Trial
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GOG-209

Carboplatin and paclitaxel versus doxorubicin, cisplatin and paclitaxel in stage III, IV or recurrent endometrial cancer (NRG Oncology/GOG0209)

Phase 3N = 1,381NCT00063999

Population
Stage III, stage IV or recurrent endometrial cancer, performance status 0-2; prior radiotherapy or hormonal therapy allowed, prior chemotherapy not allowed
Design
Randomised, open-label, noninferiority phase 3 trial. TAP: doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 on day 1, paclitaxel 160 mg/m2 on day 2 with granulocyte colony-stimulating factor; or TC: paclitaxel 175 mg/m2 and carboplatin AUC 6 on day 1; every 21 days for seven cycles. Primary endpoint overall survival in the modified intention-to-treat population; 1381 women enrolled from 2003 to 2009.
Primary endpoint
OS
Arms
  • Doxorubicin, cisplatin and paclitaxel (TAP) (control): Doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 on day 1, paclitaxel 160 mg/m2 on day 2 with G-CSF, every 21 days for seven cycles
  • Carboplatin plus paclitaxel (TC) (experimental): Paclitaxel 175 mg/m2 and carboplatin AUC 6 on day 1 every 21 days for seven cycles
People
Miller DS, NRG Oncology / Gynecologic Oncology Group
OSHR 1.002Δ median OS−4 monthsPFSHR 1.032Δ median PFS−1 months
Show the numbers
Results reported for GOG-209
EndpointAnalysisCarboplatin plus paclitaxel (TC)Doxorubicin, cisplatin and paclitaxel (TAP)Effect
OSModified intention-to-treat populationfinalMiller 2020median 37 monthsmedian 41 monthsHR 1.002Noninferiority analysis; hazard ratio of TC versus TAP with a 90% confidence interval of 0.9 to 1.12. Final overall survival analysis.
PFSNot stated in the abstract (the primary OS analysis is in the modified intention-to-treat population)finalMiller 2020median 13 monthsmedian 14 monthsHR 1.032Secondary endpoint. Hazard ratio of TC versus TAP with a 90% confidence interval of 0.93 to 1.15.
Results reported for GOG-209
EndpointAnalysisCarboplatin plus paclitaxel (TC)Doxorubicin, cisplatin and paclitaxel (TAP)Effect
OSModified intention-to-treat populationfinalMiller 2020median 37 monthsmedian 41 monthsHR 1.002Noninferiority analysis; hazard ratio of TC versus TAP with a 90% confidence interval of 0.9 to 1.12. Final overall survival analysis.
PFSNot stated in the abstract (the primary OS analysis is in the modified intention-to-treat population)finalMiller 2020median 13 monthsmedian 14 monthsHR 1.032Secondary endpoint. Hazard ratio of TC versus TAP with a 90% confidence interval of 0.93 to 1.15.
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%020406080100Months (modelled)
  • Carboplatin plus paclitaxel (TC) (experimental)
  • Doxorubicin, cisplatin and paclitaxel (TAP) (control)

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

Data table (modelled values)
MonthsCarboplatin plus paclitaxel (TC)Doxorubicin, cisplatin and paclitaxel (TAP)
0100.0%100.0%
2661.4%64.4%
5138.5%42.2%
7723.6%27.2%
10314.5%17.5%
Illustrative — modelled from reported values, not trial data. PFS, final.
0%25%50%75%100%05101520253035Months (modelled)
  • Carboplatin plus paclitaxel (TC) (experimental)
  • Doxorubicin, cisplatin and paclitaxel (TAP) (control)

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

Data table (modelled values)
MonthsCarboplatin plus paclitaxel (TC)Doxorubicin, cisplatin and paclitaxel (TAP)
0100.0%100.0%
961.9%64.0%
1838.3%41.0%
2625.0%27.6%
3515.5%17.7%
Primary publication: Miller DS, Filiaci VL, Mannel RS, Cohn DE, Matsumoto T, Tewari KS, et al. Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209). J Clin Oncol. 2020;38(33):3841-3850. PubMedDOI

Appears in

Sources

  1. Miller DS, Filiaci VL, Mannel RS, Cohn DE, Matsumoto T, Tewari KS, et al. Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209). J Clin Oncol. 2020;38(33):3841-3850.

    PubMedDOI