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Poster Discussion – Head and neck cancer

4934 - Avelumab-cetuximab-radiotherapy versus standards of care (SoC) in patients (pts) with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): safety phase of randomized trial GORTEC 2017-01 (REACH)


28 Sep 2019


Poster Discussion – Head and neck cancer


Yungan Tao


Annals of Oncology (2019) 30 (suppl_5): v449-v474. 10.1093/annonc/mdz252


Y. Tao1, A. Auperin2, X. Sun3, C. Sire4, L. Martin5, A. Coutte6, C. Lafond7, J. Miroir8, X. Liem9, F. Rolland10, A. Maillard2, N. Colin-Barailhou11, C. Michel11, J. Thariat12, J. Guigay13, J. Bourhis14

Author affiliations

  • 1 Radiation Oncology, Gustave Roussy, 94805 - Villejuif/FR
  • 2 Biostatistics, Gustave Roussy, 94805 - Villejuif/FR
  • 3 Radiation Oncology, Hopital Nord Franche-Comté de Montbéliard, 25200 - Montbéliard/FR
  • 4 Radiation Oncology, Centre Hospitalier de Bretagne Sud - Hôpital du Scorff, 56322 - Lorient/FR
  • 5 Radiation Oncology, Centre Guillaume le conquérant, 76600 - Le Havre/FR
  • 6 Oncology Radiotherapy, CHU Amiens-Picardie Site Nord, 80054 - Amiens/FR
  • 7 Radiation Oncology, Centre Jean Bernard, 72000 - Le Mans/FR
  • 8 Radiation Oncology, Centre Jean Perrin, BP392 - Clermont-Ferrand/FR
  • 9 Radiation Oncology, Centre Oscar Lambret, 59000 - Lille/FR
  • 10 Medical Oncology, ICO Rene-Gauducheau, 44800 - Nantes/FR
  • 11 Clinical Research, GORTEC, 37044 - Tours/FR
  • 12 Radiation Oncology, Centre François Baclesse, 14000 - Caen/FR
  • 13 Medical Oncology, Centre Antoine Lacassagne, Université Côte d'Azur, 6100 - Nice/FR
  • 14 Radiation Oncology, Centre Hospitalier Universitaire Vaudois - CHUV, 1011 - Lausanne/CH


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Abstract 4934


Based on the hypothesis of a synergistic effect of the anti-PDL1 avelumab when combined with cetuximab (cetux) and RT, this new combination is tested in a large scale randomized trial against two well established SoC in LA-SCCHN pts.


This randomized multicenter phase III trial comprises two cohorts of pts deemed fit (Cohort 1) to receive high dose cisplatin (CDDP 100 mg/m², Q3W) or unfit (Cohort 2) to receive CDDP. The SoC is IMRT (69.96 Gy, 33 fractions) combined with CDDP in Cohort 1 (arm A) and with cetux (arm D) in Cohort 2 (400 mg/m² Day-7 and 250 mg/m² weekly). In both cohorts, experimental (exp) arms are IMRT concomitant with cetux (same schedule as in SoC) and avelumab (10 mg/kg Day-7 and every 2 weeks) followed by avelumab 10 mg/kg bi-monthly for 12 months (arms B and C). The primary objective is to test whether exp arm is superior to SoC for progression-free survival in each cohort, with 400 and 268 pts to be randomized to Cohort 1 and 2 respectively. Monitoring of grade ≥4 acute adverse events (AE) in both exp arms was planned with null and alternative hypotheses of 15% and 35%, 1-sided α error = 0.10, Lan-DeMets α spending function, power 95%. This safety phase was approved by the Independent Data and Safety Monitoring Committee (IDSMC) and planned to be run on the first 41 pts randomized in exp arms, in 3 steps, after 8 weeks follow-up of 14, 27 and 41 pts.


Between September 2017 and August 2018, 82 pts with LA-SCCHN were randomized including 41 in the exp arms. All pts of exp arms received the entire RT, except one in arm C with early stop after 55 Gy. In exp arms, 36 pts (88%) and 31 pts (76%) received the expected number of avelumab and cetux administrations during RT. In the exp arms, the most common grade ≥3 AE were radiation dermatitis, mucositis and dysphagia. Grade ≥4 AEs occurred in 5/41 (12%) pts in the exp arms (all in arm C), in 3/21 (14%) pts in arm A and 2/20 (10%) in arm D. Only one grade 5 AE occurred in arm A.


The combination of avelumab, cetuximab and RT is tolerable for pts with LA-SCCHN in the safety phase of this ongoing phase 3 trial and an approval to continue the trial was given by IDSMC.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study



Merck Serono.


Y. Tao: Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck Serono; Research grant / Funding (institution): Debiopharma; Research grant / Funding (institution): Pfizer. J. Thariat: Advisory / Consultancy: BMS; Advisory / Consultancy: Nanobiotix. J. Guigay: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Innate pharma; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck Serono. J. Bourhis: Advisory / Consultancy: Merck Serono; Advisory / Consultancy: BMS; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: MSD. All other authors have declared no conflicts of interest.

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