971P - High incidence of cetuximab-related infusion reactions in head and neck cancer pts (real life data)

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Head and Neck Cancers
Presenter Virginia Coloma
Citation Annals of Oncology (2016) 27 (6): 328-350. 10.1093/annonc/mdw376
Authors V. Coloma, M. Annereau, N. Lezghed, C. Even, L. Mayache-Badis, M. Iacob, C. Leibu, M. Matias, P. Bravo, C. Ferte
  • Gustave Roussy, Université Paris-saclay, Villejuif, F-94805, France, Institut Gustave Roussy, 94805 - Villejuif/FR



Cetuximab is crucial in the management of squamous cell carcinoma of the head and neck (SCCHN) patients. Grade 3-4 infusion reactions (IRs) occur in 2% of colorectal cancer (ASPECCT study, ∼1000 pts). Despite the 2.7% IR rate in the EXTREME trial (NEJM 2008), higher rates were reported in small series of SCCHN (6-10%). There is an urgent need to better appraise the natural history and the predictive factors for IRs in HNSCC pts exposed to Cetuximab.


The medical records from all consecutive SCCHN patients (n = 451) treated by cetuximab at Gustave Roussy (Cancer Campus Grand Paris) from January 2013 to December 2015 were reviewed. IR severity was defined as per the NCI-CTCAE v4.0. The impact of potential risk factors was analyzed (history of allergy, biological and clinicopathological variables).


All patients analyzed received pre-medication including corticosteroids and antihistamines. Out of 441 patients, 34 patients (7.5%) presented grade 3-4 IR, nearly all of them requiring intensive care unit referral. Most of the IRs occurred during the first cycle (range: 1-3). The occurrence of grade 3-4 IR was associated with prior allergy history (P 


In real life, grade 3-4 IR consecutive to cetuximab appears far more common (7.5%) than reported in prospective trials. This is the largest series of patients ever focusing on the risk of IR induced by cetuximab in SCCHN pts. History of prior allergy is a strong predictor of IR and could be used to better allocate treatment and supervise pts. Further prospective data are however required to confirm this.

Clinical trial identification

Gustave Roussy, Université Paris-Saclay, Villejuif, F-94805, France

Legal entity responsible for the study

Gustave Roussy, Université Paris-Saclay, Villejuif, France


Gustave Roussy, Université Paris-Saclay, Villejuif, France


All authors have declared no conflicts of interest.