996P - Cetuximab relative dose intensity (RDI) in recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): First observational pro...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Head and Neck Cancers
Biological Therapy
Presenter Joel Guigay
Citation Annals of Oncology (2014) 25 (suppl_4): iv340-iv356. 10.1093/annonc/mdu340
Authors J. Guigay1, F. Peyrade2, B. Petre-Lazar3, F. Mornex4, P. Ceruse5, L. Digue6, A. Berrier7, M. Degardin8, M. Alfonsi9, X. Artignan10, L. Cals11, S. Faivre12, E. Vuillemin13, F. Rolland14, A. Timochenko15, E. Babin16, A. Prevost17, O. Romano18, E. Chamorey2, C. Le Tourneau19
  • 1Medical Oncology, Institute Gustave Roussy, Villejuif at present Centre Antoine Lacassagne, 06189 - Nice/FR
  • 2Medical Oncology, Centre Antoine Lacassagne, 06189 - Nice/FR
  • 3Oncologie, Merck Serono, LYON/FR
  • 4Radiothérapie-oncologie, Centre Hospitalier Lyon-Sud, Lyon/FR
  • 5Head And Neck, Centre Hospitalier Lyon Sud, Pierre-Benite/FR
  • 6Oncology-radiotherapy, C.H.U. Bordeaux Hopital St. Andr, FR-33000 - Bordeaux/FR
  • 7Oncology, Centre Hospitalier Docteur Schaffner, Lens/FR
  • 8Département De Cancérologie Cervico-faciale, Centre Oscar Lambret, 59020 - Lille/FR
  • 9Head And Neck Radiotherapie, Institut Ste Catherine, Avignon/FR
  • 10Oncology, CH Prive Saint Gregoire, Saint Gregoire/FR
  • 11Department Of Medical Oncology, University Hospital J. Minjoz, 25000 - Besancon/FR
  • 12Cancérologie (oncology), Hôpital Beaujon, 92110 - Clichy/FR
  • 13Oncology, Centre hospitalier Bretagne Atlantique, Vannes/FR
  • 14Oncology Medical Service, Centre Rene Gauducheau, Saint-Herblain/FR
  • 15Oncology, CHU Saint-ETIENNE, St Priest en Jarez/FR
  • 16Oncology, CHU Caen, Caen/FR
  • 17Oncology, Institut Jean Godinot, Reims/FR
  • 18Oncology, Polyclinique de la Louviere, Lille/FR
  • 19Medical Oncology, Institut Curie, Paris/FR



Cetuximab combined with platinum is the standard first-line therapy in patients (pts) with R/M SCCHN. DIRECT is the first multicenter prospective observational study evaluating cetuximab RDI in this setting.


Pts were prospectively enrolled. No prior systemic therapy for R/M SCCHN was allowed. Pts received cetuximab in combination with platinum, according to the pivotal study EXTREME schedule, 5-FU if not contra-indicated and maintenance treatment with cetuximab every 2 weeks was allowed. The primary endpoint was the number of pts with cetuximab RDI >80%.


High quality of data was obtained by frequent monitoring of sites every 3 months (evaluable data in 93% of pts for baseline characteristics and in 89% of pts for cetuximab RDI). 154 pts were enrolled in 53 centres between 2012/11 and 2013/03: 86% male, median age 59 years, 81% with PS < 2, 29% oral cavity, 28% oropharynx, 23% hypopharynx, 19% larynx, 22% received previously cetuximab. Median time to relapse was 6 months. Pts received cisplatin (60%) or carboplatin (40%) with/without 5-FU (90/10%). Maintenance started in 43% pts after a median of 5 cycles, 59% pts received cetuximab every 2 weeks. Cetuximab RDI, evaluated in 130 pts with a 6 months follow-up, was >80% in 68.5%, 64.7% and 93%, during chemotherapy (CT), CT + maintenance or maintenance periods respectively. Planned doses of cetuximab were decreased in 9.7% and delayed in 36% of 154 pts, mostly during CT. 97 pts (63.0%) withdrew the study for progression (48.5%), death (31%), toxicity (6%), lost to follow-up (1%), or other reasons (13.5%). Grade > 2 skin toxicities were observed in 9 (5.8%) pts.


In unselected pts, RDI data in DIRECT study confirms the feasibility and the good tolerance of cetuximab combined with platinum previously reported in the pivotal trial. DIRECT study supports the use of cetuximab + CT as standard treatment in clinical practice.


J. Guigay: Research funding : GSK; Merck Serono; Novartis Honoraria : Merck Serono; B. Petre-Lazar: Medical advisor: Merck Serono; F. Mornex, P. Ceruse, M. Alfonsi and C. Le Tourneau: Honoraria : Merck Serono; A. Berrier: Research funding : Merck Serono; S. Faivre: membership advisory board : Merck Serono Honoraria : Merck Serono Research funding: Merck Serono; F. Rolland: Honoraria : Merck Serono Expert Testimony : Merck Serono. All other authors have declared no conflicts of interest.