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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

2824 - TOPNIVO - A safety study of Nivolumab in Patients with Recurrent and/or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN): first results on behalf of the Unicancer Head&Neck Group and the GORTEC.


21 Oct 2018


Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology


Tumour Site

Head and Neck Cancers


Caroline Even


Annals of Oncology (2018) 29 (suppl_8): viii372-viii399. 10.1093/annonc/mdy287


C. Even1, A. Daste2, E. Saada-Bouzid3, J. Fayette4, M. Kaminsky-Forrett5, S. Zanetta6, A. Prevost7, G. Lefebvre8, C. Borel9, D. Cupissol10, F. Huguet11, J. Delord12, N. Baste Rotllan13, J. Delaye14, I. Jallut14, N. Vintonenko15, J. Bourhis16, J. Guigay17, M. Texier18, A. Auperin18

Author affiliations

  • 1 Medical Oncology, Gustave Roussy Cancer Campus, 94800 - Villejuif/FR
  • 2 Medical Oncology, CHU Bordeaux Hopital St. André, 33000 - Bordeaux/FR
  • 3 Medical Oncology, Hopital Lacassagne, 06100 - Nice/FR
  • 4 Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 5 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 6 Medical Oncology, Centre Georges-François Leclerc (Dijon), 21000 - Dijon/FR
  • 7 Medical Oncology, Institut Jean Godinot, 51726 - REIMS/FR
  • 8 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 9 Medical Oncology, Centre Paul Strauss Centre de Lutte contre le Cancer, 67065 - Strasbourg/FR
  • 10 Medical Oncology, ICM Val d'Aurelle, 34298 - Montpellier/FR
  • 11 Medical Oncology, APHP, CancerEst, Tenon University Hospital, 75020 - Paris/FR
  • 12 Medical Oncology, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 13 Medical Oncology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 14 R&d, Unicancer, 75654 - Paris/FR
  • 15 Clinical Operations, GORTEC, 37044 - TOURS/FR
  • 16 R&d, GORTEC, 37044 - TOURS/FR
  • 17 Medical Oncology, Centre Anticancer Antoine Lacassagne, 6100 - Nice/FR
  • 18 Biostatistics, Gustave Roussy Cancer Campus, 94800 - Villejuif/FR


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Abstract 2824


In the randomized phase III Study CA209141, Nivolumab (N) demonstrated significant overall survival benefit as treatment for platinum refractory R/M SCCHN and is now approved for these patients. N has demonstrated a manageable safety profile compared to chemotherapies commonly used in patients with platinum-refractory R/M SCCHN. The main objective of the study is to provide additional insight into the frequency of high-grade AEs related to N and their outcome.


Between August 2017 and October 2017, 75 patients were included in the multicenter, open-label, non-controlled phase II safety study TOPNIVO. The main inclusion criteria were patients with platinum refractory R/M SCCHN with progressive disease, ECOG 0-2. Patients received N 3mg/kg every 2 weeks intravenously over 30 minutes. We report here the safety results of the three first months of treatment.


Of 73 patients treated with N, median age was 64.0 yr, 75% were male, 23% were ECOG 0, 62% 1, 15% 2, 81% were current or former smoker. The primary site of cancer was oral cavity 27%, oropharynx 34%, larynx 19%, hypopharynx 19%. 36% had loco regional relapse, 34% had metastatic disease and 30% had both. 48% had received one prior line of chemotherapy and 32% two prior lines. 37 pts (51%) received at least 6 administrations of N during the first three months of treatment. 5% of administrations were delayed, mainly for intercurrent disease. 38 pts (52%) ended N within the first three months, 28 pts for progressive disease, 8 due to death (thrombus 1pt, progressive disease or related to cancer 7 pts), 1 for pneumonitis, 1 for pain. 35 pts experienced at least 1 AE grade 3/4/5. On the 52 AEs grade 3-4, 7 (mainly asthenia and lipase increase) were related to N. On the 7 AEs grade 5, 1 (pneumonitis) was related to N. 28 pts (38%) experienced at least 1 SAE. On the 38 SAEs, 3 were related to N. 6 patients experienced tumor bleeding (grade 1 2 pts, grade 2 1 pt, grade 3 1 pt, grade 4 1 pt, grade 5 1 pt), none were related to N.


The first results of the TOPNIVO study show an acceptable toxicity profile without additional toxicities compared to what has been described previously.

Clinical trial identification

NCT03226756; EudraCT: 2017-000424-10.

Legal entity responsible for the study



Bristol-Myers Squibb.

Editorial Acknowledgement


C. Even: MSD, Merck Serono, BMS, AstraZeneca, Innate Pharma. E. Saada-Bouzid: Advisory board and consulting: BMS, Merck Serono, AstraZeneca. C. Borel: Advisory board immunotherapy: AstraZeneca, BMS; Symposia honoraria: Merck Serono, BMS; Congress: Merck Serono. D. Cupissol: Boards: Merck, AstraZeneca, BMS. F. Huguet: Merck Serono, BMS, AstraZeneca, MSD. J. Guigay: Consulting or advisory role: Merck Serono, BMS, Innate Pharma, AstraZeneca; Research funding: BMS, GSK, Merck Serono. All other authors have declared no conflicts of interest.

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