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GOG-111

Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer

Phase 3N = 410

Population
Women with stage III or stage IV ovarian cancer and residual masses larger than 1 cm after initial surgery
Design
Randomised comparison of cisplatin 75 mg/m2 with either cyclophosphamide 750 mg/m2 or paclitaxel 135 mg/m2 over 24 hours. 410 women with advanced ovarian cancer and residual masses larger than 1 cm after initial surgery were randomly assigned; 386 met all eligibility criteria (NEJM abstract). The abstract does not state which endpoint was primary; PubMed lists the publication type as phase III clinical trial.
Arms
  • Cisplatin plus cyclophosphamide (control): Cisplatin 75 mg/m2 plus cyclophosphamide 750 mg/m2
  • Cisplatin plus paclitaxel (experimental): Cisplatin 75 mg/m2 plus paclitaxel 135 mg/m2 over 24 hours
People
McGuire WP, Gynecologic Oncology Group
Δ median PFS+5 monthsΔ median OS+14 monthsΔ ORR+13 points
Show the numbers
Results reported for GOG-111
EndpointAnalysisCisplatin plus paclitaxelCisplatin plus cyclophosphamideEffect
PFSEligible women (386 of 410 randomised); analysis population not stated in the abstractprimaryMcGuire 1996median 18 monthsmedian 13 monthsP<0.001
OSEligible women (386 of 410 randomised); analysis population not stated in the abstractprimaryMcGuire 1996median 38 monthsmedian 24 monthsP<0.001
ORRWomen with measurable disease (n=216)primaryMcGuire 199673%60%P=0.01Surgically verified complete response frequency was described as similar in the two groups (no figures in the abstract).
Results reported for GOG-111
EndpointAnalysisCisplatin plus paclitaxelCisplatin plus cyclophosphamideEffect
PFSEligible women (386 of 410 randomised); analysis population not stated in the abstractprimaryMcGuire 1996median 18 monthsmedian 13 monthsP<0.001
OSEligible women (386 of 410 randomised); analysis population not stated in the abstractprimaryMcGuire 1996median 38 monthsmedian 24 monthsP<0.001
ORRWomen with measurable disease (n=216)primaryMcGuire 199673%60%P=0.01Surgically verified complete response frequency was described as similar in the two groups (no figures in the abstract).
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Cisplatin plus paclitaxel (experimental)
  • Cisplatin plus cyclophosphamide (control)

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

Data table (modelled values)
MonthsCisplatin plus paclitaxelCisplatin plus cyclophosphamide
0100.0%100.0%
1165.5%55.6%
2341.2%29.3%
3427.0%16.3%
4517.7%9.1%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080Months (modelled)
  • Cisplatin plus paclitaxel (experimental)
  • Cisplatin plus cyclophosphamide (control)

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

Data table (modelled values)
MonthsCisplatin plus paclitaxelCisplatin plus cyclophosphamide
0100.0%100.0%
2464.5%50.0%
4841.7%25.0%
7127.4%12.9%
9517.7%6.4%
Primary publication: McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med. 1996;334(1):1-6. PubMedDOI

Appears in

Sources

  1. McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med. 1996;334(1):1-6.

    PubMedDOI