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De-ESCALaTE HPV

Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial

Phase 3N = 334NCT01874171

Population
HPV-positive low-risk oropharyngeal cancer (non-smokers or lifetime smokers with fewer than 10 pack-years)
Design
Open-label randomised controlled trial at 32 head and neck treatment centres in Ireland, the Netherlands and the UK: 334 patients (166 cisplatin, 168 cetuximab) with HPV-positive low-risk oropharyngeal cancer (non-smokers, or lifetime smokers with fewer than 10 pack-years) recruited between November 2012 and October 2016. Radiotherapy 70 Gy in 35 fractions plus cisplatin 100 mg per square metre on days 1, 22 and 43, or cetuximab 400 mg per square metre loading dose then seven weekly infusions of 250 mg per square metre. Primary outcome: overall severe (grade 3-5) toxicity events at 24 months, intention-to-treat and per-protocol.
Primary endpoint
Overall severe (grade 3-5) toxicity events
Arms
  • Radiotherapy plus cisplatin (control, n = 166): 70 Gy in 35 fractions plus cisplatin 100 mg per square metre on days 1, 22 and 43
  • Radiotherapy plus cetuximab (experimental, n = 168): 70 Gy in 35 fractions plus cetuximab 400 mg per square metre loading dose then seven weekly infusions of 250 mg per square metre
People
Mehanna H, De-ESCALaTE HPV Trial Group
OSHR 5.0 (95% CI 1.7–14.7)Δ 24-month OS−8.1 pointsRelapse rateHR 3.4 (95% CI 1.6–7.2)Δ 24-month Relapse rate+10.1 points
Show the numbers
Results reported for De-ESCALaTE HPV
EndpointAnalysisRadiotherapy plus cetuximabRadiotherapy plus cisplatinEffect
OSRandomised patients (334); intention-to-treat analysis is stated for all outcomes in the full textprimaryMehanna 201989.4% at 2 y97.5% at 2 yHR 5.0 (95% CI 1.7–14.7)P=0.001Secondary outcome in a trial whose primary outcome was overall severe toxicity. The abstract and full text do not label the direction of the hazard ratio; survival was higher with cisplatin.
Relapse rateRandomised patients (334); intention-to-treat analysis is stated for all outcomes in the full textprimaryMehanna 201916.1% at 2 y6% at 2 yHR 3.4 (95% CI 1.6–7.2)P=0.0007Secondary outcome (time to recurrence). The abstract does not label the direction of the hazard ratio; recurrence was higher with cetuximab.
Results reported for De-ESCALaTE HPV
EndpointAnalysisRadiotherapy plus cetuximabRadiotherapy plus cisplatinEffect
OSRandomised patients (334); intention-to-treat analysis is stated for all outcomes in the full textprimaryMehanna 201989.4% at 2 y97.5% at 2 yHR 5.0 (95% CI 1.7–14.7)P=0.001Secondary outcome in a trial whose primary outcome was overall severe toxicity. The abstract and full text do not label the direction of the hazard ratio; survival was higher with cisplatin.
Relapse rateRandomised patients (334); intention-to-treat analysis is stated for all outcomes in the full textprimaryMehanna 201916.1% at 2 y6% at 2 yHR 3.4 (95% CI 1.6–7.2)P=0.0007Secondary outcome (time to recurrence). The abstract does not label the direction of the hazard ratio; recurrence was higher with cetuximab.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSRelapse rate0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS51.7–14.7
Relapse rate3.41.6–7.2
Primary publication: Mehanna H, Robinson M, Hartley A, Kong A, Foran B, Fulton-Lieuw T, et al. Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial. Lancet. 2019;393(10166):51-60. PubMedDOI

Appears in

Sources

  1. Mehanna H, Robinson M, Hartley A, Kong A, Foran B, Fulton-Lieuw T, et al. Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial. Lancet. 2019;393(10166):51-60.

    PubMedDOI