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Bending the Curve Trial by Trial
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EORTC 22931

Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer

Phase 3N = 334NCT00002555

Population
Stage III or IV head and neck cancer after surgery with curative intent
Design
Randomised trial of adjuvant treatment for stage III or IV head and neck cancer after surgery with curative intent: 167 patients to radiotherapy alone (66 Gy over 6 1/2 weeks) and 167 to the same radiotherapy plus cisplatin 100 mg per square metre on days 1, 22 and 43. Median follow-up 60 months.
Arms
  • Postoperative radiotherapy alone (control, n = 167): 66 Gy over 6 1/2 weeks
  • Postoperative radiotherapy plus cisplatin (experimental, n = 167): Same radiotherapy plus cisplatin 100 mg per square metre on days 1, 22 and 43
People
Bernier J, European Organization for Research and Treatment of Cancer Trial 22931
PFSHR 0.75 (95% CI 0.56–0.99)Δ 60-month PFS+11 pointsOSHR 0.70 (95% CI 0.52–0.95)Δ 60-month OS+13 pointsΔ 60-month Cumulative incidence of relapse−13 pointsΔ Severe adverse events (grade 3 or higher)+20 points
Show the numbers
Results reported for EORTC 22931
EndpointAnalysisPostoperative radiotherapy plus cisplatinPostoperative radiotherapy aloneEffect
PFSRandomised patients (167 per arm); analysis population not stated in the abstractprimarymedian follow-up 60 monthsBernier 200447% at 5 y36% at 5 yHR 0.75 (95% CI 0.56–0.99)P=0.04Hazard ratio is for disease progression. Kaplan-Meier estimates.
OSRandomised patients (167 per arm); analysis population not stated in the abstractprimarymedian follow-up 60 monthsBernier 200453% at 5 y40% at 5 yHR 0.70 (95% CI 0.52–0.95)P=0.02
Cumulative incidence of relapseRandomised patients (167 per arm); local or regional relapseprimarymedian follow-up 60 monthsBernier 200418% at 5 y31% at 5 yP=0.007Local or regional relapse only; death from other causes treated as a competing risk.
Severe adverse events (grade 3 or higher)Randomised patientsprimarymedian follow-up 60 monthsBernier 200441%21%P=0.001
Results reported for EORTC 22931
EndpointAnalysisPostoperative radiotherapy plus cisplatinPostoperative radiotherapy aloneEffect
PFSRandomised patients (167 per arm); analysis population not stated in the abstractprimarymedian follow-up 60 monthsBernier 200447% at 5 y36% at 5 yHR 0.75 (95% CI 0.56–0.99)P=0.04Hazard ratio is for disease progression. Kaplan-Meier estimates.
OSRandomised patients (167 per arm); analysis population not stated in the abstractprimarymedian follow-up 60 monthsBernier 200453% at 5 y40% at 5 yHR 0.70 (95% CI 0.52–0.95)P=0.02
Cumulative incidence of relapseRandomised patients (167 per arm); local or regional relapseprimarymedian follow-up 60 monthsBernier 200418% at 5 y31% at 5 yP=0.007Local or regional relapse only; death from other causes treated as a competing risk.
Severe adverse events (grade 3 or higher)Randomised patientsprimarymedian follow-up 60 monthsBernier 200441%21%P=0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.750.56–0.99
OS0.70.52–0.95
Primary publication: Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre JL, Greiner RH, et al. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004;350(19):1945-52. PubMedDOI

Appears in

Sources

  1. Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre JL, Greiner RH, et al. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004;350(19):1945-52.

    PubMedDOI