Skip to content
Bending the Curve Trial by Trial
?

GOG-204

Four cisplatin-containing doublet combinations in stage IVB, recurrent or persistent cervical carcinoma

Phase 3N = 513

Population
Stage IVB, recurrent or persistent cervical carcinoma; 513 patients enrolled
Design
Randomised phase 3 trial of four cisplatin 50 mg/m2 doublets every 3 weeks: paclitaxel (reference arm, PC), vinorelbine (VC), gemcitabine (GC) or topotecan (TC). Survival was the primary endpoint, with a 33% improvement relative to PC considered important. A planned interim analysis recommended early closure for futility.
Primary endpoint
OS
Arms
  • Paclitaxel plus cisplatin (reference) (control): Paclitaxel 135 mg/m2 over 24 hours plus cisplatin 50 mg/m2 day 2 every 3 weeks
  • Vinorelbine plus cisplatin (experimental): Vinorelbine 30 mg/m2 days 1 and 8 plus cisplatin 50 mg/m2 day 1 every 3 weeks
  • Gemcitabine plus cisplatin (experimental): Gemcitabine 1,000 mg/m2 days 1 and 8 plus cisplatin 50 mg/m2 day 1 every 3 weeks
  • Topotecan plus cisplatin (experimental): Topotecan 0.75 mg/m2 days 1 to 3 plus cisplatin 50 mg/m2 day 1 every 3 weeks
People
Monk BJ, senior author Cella D, Gynecologic Oncology Group
OSHR 1.15 (95% CI 0.79–1.67)OSHR 1.32 (95% CI 0.91–1.92)OSHR 1.26 (95% CI 0.86–1.82)PFSHR 1.36 (95% CI 0.97–1.90)PFSHR 1.39 (95% CI 0.99–1.96)PFSHR 1.27 (95% CI 0.90–1.78)
Show the numbers
Results reported for GOG-204
EndpointAnalysisVinorelbine plus cisplatin / Gemcitabine plus cisplatin / Topotecan plus cisplatinPaclitaxel plus cisplatin (reference)Effect
OSEnrolled patients (N = 513)interimMonk 2009——HR 1.15 (95% CI 0.79–1.67)Planned interim analysis that recommended early closure for futility. Hazard ratio is experimental arm to PC.
OSEnrolled patients (N = 513)interimMonk 2009——HR 1.32 (95% CI 0.91–1.92)Planned interim analysis that recommended early closure for futility. Hazard ratio is experimental arm to PC.
OSEnrolled patients (N = 513)interimMonk 2009——HR 1.26 (95% CI 0.86–1.82)Planned interim analysis that recommended early closure for futility. Hazard ratio is experimental arm to PC.
PFSEnrolled patients (N = 513)interimMonk 2009——HR 1.36 (95% CI 0.97–1.90)Hazard ratio is experimental arm to PC.
PFSEnrolled patients (N = 513)interimMonk 2009——HR 1.39 (95% CI 0.99–1.96)Hazard ratio is experimental arm to PC.
PFSEnrolled patients (N = 513)interimMonk 2009——HR 1.27 (95% CI 0.90–1.78)Hazard ratio is experimental arm to PC.
ORREnrolled patients (N = 513)interimMonk 200925.9%29.1%—
Results reported for GOG-204
EndpointAnalysisVinorelbine plus cisplatin / Gemcitabine plus cisplatin / Topotecan plus cisplatinPaclitaxel plus cisplatin (reference)Effect
OSEnrolled patients (N = 513)interimMonk 2009——HR 1.15 (95% CI 0.79–1.67)Planned interim analysis that recommended early closure for futility. Hazard ratio is experimental arm to PC.
OSEnrolled patients (N = 513)interimMonk 2009——HR 1.32 (95% CI 0.91–1.92)Planned interim analysis that recommended early closure for futility. Hazard ratio is experimental arm to PC.
OSEnrolled patients (N = 513)interimMonk 2009——HR 1.26 (95% CI 0.86–1.82)Planned interim analysis that recommended early closure for futility. Hazard ratio is experimental arm to PC.
PFSEnrolled patients (N = 513)interimMonk 2009——HR 1.36 (95% CI 0.97–1.90)Hazard ratio is experimental arm to PC.
PFSEnrolled patients (N = 513)interimMonk 2009——HR 1.39 (95% CI 0.99–1.96)Hazard ratio is experimental arm to PC.
PFSEnrolled patients (N = 513)interimMonk 2009——HR 1.27 (95% CI 0.90–1.78)Hazard ratio is experimental arm to PC.
ORREnrolled patients (N = 513)interimMonk 200925.9%29.1%—
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOSOSPFSPFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.150.79–1.67
OS1.320.91–1.92
OS1.260.86–1.82
PFS1.360.97–1.9
PFS1.390.99–1.96
PFS1.270.9–1.78
Primary publication: Monk BJ, Sill MW, McMeekin DS, Cohn DE, Ramondetta LM, Boardman CH, et al. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009;27(28):4649-55. PubMedDOI

Appears in

Sources

  1. Monk BJ, Sill MW, McMeekin DS, Cohn DE, Ramondetta LM, Boardman CH, et al. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009;27(28):4649-55.

    PubMedDOI