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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)

Date

10 Sep 2017

Session

Poster display session

Presenters

Christophe Le Tourneau

Citation

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

Authors

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
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Resources

Abstract 5360

Background

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.

Methods

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.

Results

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.

Conclusions

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

Funding

Merck KGaA, Darmstadt, Germany

Disclosure

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.

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