Article Dans Une Revue Annals of Oncology Année : 2024

854MO Avelumab-cetuximab-radiotherapy (RT) versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Final analysis of randomized phase III GORTEC 2017-01 REACH trial

A. Auperin
  • Fonction : Auteur
L. Martin
  • Fonction : Auteur
C. Borel
  • Fonction : Auteur
L. Sinigaglia
  • Fonction : Auteur
E.B. Saada
  • Fonction : Auteur
J. Guigay
  • Fonction : Auteur

Résumé

Background Based on a potential synergistic effect of anti–PD-L1 avelumab plus cetuximab and RT, this combination was tested in a randomized trial against two standards of care (SOC) in LA-SCCHN. Methods The trial comprised 2 cohorts of patients (pts): fit for cisplatin (100 mg/m2, Q3W) and unfit for cisplatin. The SOC was IMRT 70 Gy / 6.5 weeks with cisplatin in fit Cohort and with cetuximab in unfit Cohort (Bonner, 2006). In both cohorts, experimental arm (Exp) was IMRT 70 Gy plus weekly cetuximab and avelumab 10 mg/kg at Day-7 and every 2 weeks during RT followed by avelumab every 2 weeks for 1 year. The primary endpoint was progression-free survival (PFS). In unfit Cohort, 115 events were needed / 277 pts to detect a HR of 0.62 (1-sided α error 0.05; power 80%). In fit Cohort, 166 events were needed / 430 pts to detect a HR of 0.64 (2-sided α error 0.05; power 80%). Results Between 2017 and 2020, 707 patients were randomized, 6 withdrew consent. Unfit Cohort: 275 pts, median age 67 years, 61% OPC including 35% p16+. The number of events was reached in 2021, the current analysis is a long-term update. With a median follow-up of 47.7 months (IQR 39.4-56.0) and 200 PFS events, HR was 0.80 (95%CI 0.60-1.06); 4-year PFS rate was 33.7% (95%CI 26.2%-42.2%) in Exp vs 18.4% (95%CI 12.5%-26.1%) in SOC-cetux. Distant metastasis rate remained lower in Exp (subHR 0.24 (95%CI 0.11-0.49)). No significant difference in OS was seen between arms (HR 1.05 (95%CI 0.76-1.44). Fit Cohort: 426 pts, median age 59 years, 70% oropharyngeal cancer (OPC) including 49% p16+. With a median follow-up of 50.8 months (IQR 45.8-57.4) and 224 PFS events, PFS was significantly lower in Exp than in SOC-cisplatin: HR 1.40 (95%CI 1.12-1.75), p=0.012; 4-year PFS rate 42.3% (95%CI 35.7%-49.2%) in Exp vs 54.7% in SOC-cisplatin (95%CI 47.8%-61.4%). OS was also lower in Exp than in SOC-cisplatin (HR=1.45, 95%CI 1.12-1.87, p=0.017). Conclusions In cisplatin-unfit pts, a favorable effect of adding avelumab to cetuximab-RT was seen on PFS and distant metastases but not on OS. In cisplatin-fit pts, the SOC cisplatin-RT was superior to combination of cetuximab-avelumab-RT.

Domaines

Cancer
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Dates et versions

hal-04704185 , version 1 (20-09-2024)

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Citer

Y. Tao, A. Auperin, X. Sun, X. Liem, C. Sire, et al.. 854MO Avelumab-cetuximab-radiotherapy (RT) versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Final analysis of randomized phase III GORTEC 2017-01 REACH trial. Annals of Oncology, 2024, 35, pp.S616. ⟨10.1016/j.annonc.2024.08.915⟩. ⟨hal-04704185⟩
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