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VANTAGE-014

Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial

Phase 3N = 661NCT00128102

Population
Adults with measurable advanced malignant pleural mesothelioma and disease progression after one or two previous systemic regimens.
Design
Double-blind, randomised (1:1), placebo-controlled phase 3 trial at 90 international centres: oral vorinostat 300 mg or matching placebo twice daily on days 1-3, 8-10 and 15-17 of a 21-day cycle. Stratified by Karnofsky performance status, histology and number of previous chemotherapy regimens. Primary endpoints overall survival and safety and tolerability; primary efficacy comparison in the ITT population. Enrolment 12 July 2005 to 14 February 2011.
Primary endpoint
OS
Arms
  • Vorinostat (experimental, n = 329): Oral vorinostat 300 mg twice daily on days 1-3, 8-10 and 15-17 of a 21-day cycle
  • Placebo (control, n = 332): Matching placebo on the same schedule
People
Krug LM
OSHR 0.98 (95% CI 0.83–1.17)
Show the numbers
Results reported for VANTAGE-014
EndpointAnalysisVorinostatPlaceboEffect
OSprimaryKrug 2015——HR 0.98 (95% CI 0.83–1.17)P=0.86Median OS is published in weeks, and the result schema holds months or years only, so the medians are given here as published rather than converted: 30.7 weeks (95% CI 26.7-36.1) with vorinostat versus 27.1 weeks (23.1-31.9) with placebo. Grade 3 or worse adverse events included fatigue or malaise in 51 (16%) patients with vorinostat versus 25 (8%) with placebo.
Results reported for VANTAGE-014
EndpointAnalysisVorinostatPlaceboEffect
OSprimaryKrug 2015——HR 0.98 (95% CI 0.83–1.17)P=0.86Median OS is published in weeks, and the result schema holds months or years only, so the medians are given here as published rather than converted: 30.7 weeks (95% CI 26.7-36.1) with vorinostat versus 27.1 weeks (23.1-31.9) with placebo. Grade 3 or worse adverse events included fatigue or malaise in 51 (16%) patients with vorinostat versus 25 (8%) with placebo.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.980.83–1.17
Primary publication: Krug LM, Kindler HL, Calvert H, Manegold C, Tsao AS, Fennell D, et al. Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Oncol. 2015;16(4):447-56. PubMedDOI

Appears in

Sources

  1. Krug LM, Kindler HL, Calvert H, Manegold C, Tsao AS, Fennell D, et al. Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Oncol. 2015;16(4):447-56.

    PubMedDOI