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Bending the Curve Trial by Trial
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GOG-169

Cisplatin with or without paclitaxel in stage IVB, recurrent or persistent squamous cell carcinoma of the cervix

Phase 3N = 280

Population
Stage IVB, recurrent or persistent squamous cell carcinoma of the cervix with measurable disease and performance status 0 to 2; 280 patients entered, 264 eligible (134 cisplatin, 130 cisplatin-paclitaxel)
Design
Randomised phase 3 trial of cisplatin 50 mg/m2 or cisplatin 50 mg/m2 plus paclitaxel 135 mg/m2 every 3 weeks for six cycles, with quality-of-life assessments.
Arms
  • Cisplatin (control, n = 134): Cisplatin 50 mg/m2 every 3 weeks for six cycles
  • Cisplatin plus paclitaxel (experimental, n = 130): Cisplatin 50 mg/m2 plus paclitaxel 135 mg/m2 every 3 weeks for six cycles
People
Moore DH, senior author Rocereto TF, Gynecologic Oncology Group
Δ median OS+0.9 monthsΔ median PFS+2 monthsΔ ORR+17 points
Show the numbers
Results reported for GOG-169
EndpointAnalysisCisplatin plus paclitaxelCisplatinEffect
OSEligible patients (n = 264)primaryMoore 2004median 9.7 monthsmedian 8.8 monthsThe abstract reports median survival (8.8 vs 9.7 months) as showing no difference, without a hazard ratio or P value.
PFSEligible patients (n = 264)primaryMoore 2004median 4.8 monthsmedian 2.8 monthsP<0.001
ORREligible patients (n = 264)primaryMoore 200436%19%P=0.002Complete plus partial responses: 6% plus 13% with cisplatin, 15% plus 21% with cisplatin-paclitaxel.
Results reported for GOG-169
EndpointAnalysisCisplatin plus paclitaxelCisplatinEffect
OSEligible patients (n = 264)primaryMoore 2004median 9.7 monthsmedian 8.8 monthsThe abstract reports median survival (8.8 vs 9.7 months) as showing no difference, without a hazard ratio or P value.
PFSEligible patients (n = 264)primaryMoore 2004median 4.8 monthsmedian 2.8 monthsP<0.001
ORREligible patients (n = 264)primaryMoore 200436%19%P=0.002Complete plus partial responses: 6% plus 13% with cisplatin, 15% plus 21% with cisplatin-paclitaxel.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Cisplatin (control)
  • Cisplatin plus paclitaxel (experimental)

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

Data table (modelled values)
MonthsCisplatinCisplatin plus paclitaxel
0100.0%100.0%
662.3%65.1%
1238.9%42.4%
1824.2%27.6%
2415.1%18.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Cisplatin (control)
  • Cisplatin plus paclitaxel (experimental)

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

Data table (modelled values)
MonthsCisplatinCisplatin plus paclitaxel
0100.0%100.0%
347.6%64.8%
622.6%42.0%
910.8%27.3%
125.1%17.7%
Primary publication: Moore DH, Blessing JA, McQuellon RP, Thaler HT, Cella D, Benda J, et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004;22(15):3113-9. PubMedDOI

Appears in

Sources

  1. Moore DH, Blessing JA, McQuellon RP, Thaler HT, Cella D, Benda J, et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004;22(15):3113-9.

    PubMedDOI