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Bending the Curve Trial by Trial
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GOG-179

Needs review

Cisplatin with or without topotecan in carcinoma of the uterine cervix

Phase 3N = 294

Population
Advanced cervical carcinoma; the abstract reports 294 patients enrolled onto the two analysed regimens, 146 to cisplatin and 147 to cisplatin plus topotecan (these arm sizes sum to 293)
Design
Randomised phase 3 trial of cisplatin 50 mg/m2 every 3 weeks, cisplatin 50 mg/m2 plus topotecan 0.75 mg/m2 on days 1 to 3 every 3 weeks, or MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) every 4 weeks. The MVAC arm was closed by the Data Safety Monitoring Board after four treatment-related deaths among 63 patients and is not included in the analysis. Survival was the primary endpoint.
Primary endpoint
OS
Arms
  • Cisplatin (control, n = 146): Cisplatin 50 mg/m2 every 3 weeks
  • Cisplatin plus topotecan (experimental, n = 147): Cisplatin 50 mg/m2 day 1 plus topotecan 0.75 mg/m2 days 1 to 3 every 3 weeks
People
Long HJ 3rd, senior author Gynecologic Oncology Group Study, Gynecologic Oncology Group
Δ median OS+2.9 monthsΔ median PFS+1.7 monthsΔ ORR+14 points
Show the numbers
Results reported for GOG-179
EndpointAnalysisCisplatin plus topotecanCisplatinEffect
OSPatients in the two analysed arms (cisplatin; cisplatin plus topotecan)primaryLong 2005median 9.4 monthsmedian 6.5 monthsP=0.017The abstract reports 294 patients enrolled onto the remaining regimens, 146 and 147 by arm; those arm sizes sum to 293 and the abstract does not reconcile the difference.
PFSPatients in the two analysed arms (cisplatin; cisplatin plus topotecan)primaryLong 2005median 4.6 monthsmedian 2.9 monthsP=0.014Secondary endpoint.
ORRPatients in the two analysed arms (cisplatin; cisplatin plus topotecan)primaryLong 200527%13%Secondary endpoint; the abstract gives no P value for response rate.
Results reported for GOG-179
EndpointAnalysisCisplatin plus topotecanCisplatinEffect
OSPatients in the two analysed arms (cisplatin; cisplatin plus topotecan)primaryLong 2005median 9.4 monthsmedian 6.5 monthsP=0.017The abstract reports 294 patients enrolled onto the remaining regimens, 146 and 147 by arm; those arm sizes sum to 293 and the abstract does not reconcile the difference.
PFSPatients in the two analysed arms (cisplatin; cisplatin plus topotecan)primaryLong 2005median 4.6 monthsmedian 2.9 monthsP=0.014Secondary endpoint.
ORRPatients in the two analysed arms (cisplatin; cisplatin plus topotecan)primaryLong 200527%13%Secondary endpoint; the abstract gives no P value for response rate.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Cisplatin (control)
  • Cisplatin plus topotecan (experimental)

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

Data table (modelled values)
MonthsCisplatinCisplatin plus topotecan
0100.0%100.0%
652.7%64.2%
1227.8%41.3%
1814.7%26.5%
247.7%17.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0246810Months (modelled)
  • Cisplatin (control)
  • Cisplatin plus topotecan (experimental)

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

Data table (modelled values)
MonthsCisplatinCisplatin plus topotecan
0100.0%100.0%
348.8%63.6%
623.8%40.5%
911.6%25.8%
125.7%16.4%
Primary publication: Long HJ 3rd, Bundy BN, Grendys EC Jr, Benda JA, McMeekin DS, Sorosky J, et al. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2005;23(21):4626-33. PubMedDOI

Appears in

Sources

  1. Long HJ 3rd, Bundy BN, Grendys EC Jr, Benda JA, McMeekin DS, Sorosky J, et al. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2005;23(21):4626-33.

    PubMedDOI