Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

5360 - The observational ENCORE study: cetuximab + platinum-based therapy (PBT) for first-line (1L) treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)


10 Sep 2017


Poster display session


Christophe Le Tourneau


Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374


C. Le Tourneau1, M. Ghiani2, M.C. Cau2, R. Depenni3, G. Ronzino4, L. Livi5, V. Montesarchio6, M. Bretagne7, M. Saint-Ghislain7, J. Schulten8, D. Messinger9, A. Sbrana10, M.G. Ghi11

Author affiliations

  • 1 Medical Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 2 Medical Oncology, Ospedale Oncologico Armando Businco, Cagliari/IT
  • 3 Medical Oncology, Azienda Ospedaliero - Universitaria Policlinico di Modena, 41100 - Modena/IT
  • 4 U. O. Oncologia Medica, Ospedale Vito Fazzi, Lecce/IT
  • 5 Radiation Oncology, University of Florence, Florence/IT
  • 6 Pneumo-oncology, AORN dei Colli; Monaldi Hospital, Napoli/IT
  • 7 Medical Oncology, Institut Curie, Paris/FR
  • 8 Medical Affairs, Merck KGaA, Darmstadt/DE
  • 9 Biostatistics, Prometris GmbH, 68219 - Mannheim/DE
  • 10 Medical Oncology, Azienda Ospedaliero-Universitaria Pisana; Istituto Toscano Tumori, Pisa/IT
  • 11 Medical Oncology, Ospedale SS. Giovanni e Paolo, Venice/IT


Abstract 5360


The randomized, phase 3 EXTREME study established cetuximab + platinum + 5-flurouracil (5-FU) followed by cetuximab maintenance until progressive disease (PD) as the first regimen to yield survival benefits in the 1L management of patients with R/M SCCHN. In EXTREME, the addition of cetuximab increased the overall response rate from 20% to 36%, and extended progression-free survival from 3.3 to 5.6 months and overall survival from 7.4 to 10.1 months. ENCORE is a multinational, non-interventional, prospective, open-label study, seeking to determine how treatment decisions are made, planned and executed by oncologists treating patients with 1L therapy for R/M SCCHN in the real world.


ENCORE prospectively enrolled 219 patients with R/M SCCHN from Algeria, France, Italy, Portugal and Russia. The recommended treatment for these patients is cetuximab + PBT for up to 6 cycles followed by cetuximab maintenance until PD. Patient characteristics, drugs and schedule were recorded; as the study is still ongoing, safety and efficacy will not be reported here.


ENCORE patients and the EXTREME patients who received cetuximab + platinum + 5-FU had similar performance status (PS: 13.7 and 12% with PS ≥ 2, respectively), but dissimilar median age (64 and 56 years, respectively). In ENCORE, 94.1% of patients had a planned treatment of cetuximab + PBT with cetuximab maintenance until PD. The remaining 13 (5.9%) had a fixed treatment duration of 4 to 24 weeks. 37.9% of treatment plans used cisplatin, 61.6% included carboplatin and 3.2% used a taxane. Also, only 53.4% of plans included 5-FU. When developing the treatment plan, 72.1% of all patients were discussed within the context of a multidisciplinary team (MDT). Most plans had the goal of palliative care, and 80% were formulated without a p16 or human papillomavirus status test. Updated data will be presented at congress.


The ENCORE study shows that a real-world R/M SCCHN patient population treated with the EXTREME regimen has diverse characteristics and is treated per current recommendations (e.g. in an MDT setting, with cetuximab until PD).

Clinical trial identification

EMR 62202-566

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany


Merck KGaA, Darmstadt, Germany


C. Le Tourneau: Consultancy: Novartis, MSD, Bristol-Myers Squibb, AstraZeneca; Honoraria: Merck Serono J. Schulten: Full Time Employee: Merck KGaA. D. Messinger: Employee/Consultancy: Employee of Prometris GmbH, which has a contract with Merck KGaA regarding statistical consultancy. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.