1036P - Induction therapy with cetuximab, docetaxel, cisplatin, and fluorouracil in patients with resectable non metastatic stage III or IV squamous cell ca...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anticancer agents
Head and Neck Cancers
Therapy
Biological Therapy
Presenter Benoist Chibaudel
Authors B. Chibaudel1, R. Lacave2, J. Belloc3, A. Banal4, S. Albert5, F. Chabolle6, M. Lefevre7, P. Soussan8, R. Moukoko9, J. Lacau Saint Guily10
  • 1Department Of Medical Oncology, Hôpital Saint Antoine, FR-75012 - Paris/FR
  • 2Laboratoire D'histologie Et Biologie Tumorale, Hôpital Tenon, 75020 - PARIS/FR
  • 3Oto-rhino-laryngologie, Hôpital Simone Veil, EAUBONNE/FR
  • 4Chirurgie De La Face Et Du Cou, Centre rené Huguenin, 92210 - Saint-Cloud/FR
  • 5Oto-rhino-laryngologie Et Chirurgie Cervico-faciale, Hôpital Bichat Claude Bernard, 75018 - Paris/FR
  • 6Oto-rhino-laryngologie Et Chirurgie Cervico-faciale, Hôpital Foch, Suresnes/FR
  • 7Anatomie Et Cyto Pathologie, Hôpital Tenon, paris/FR
  • 8Virologie, Hôpital Tenon, paris/FR
  • 9Groupe Coopérateur Multidisciplinaire En Oncologie, GERCOR, paris/FR
  • 10Oto-rhino-laryngologie Et Chirurgie Cervico-faciale, Hôpital Tenon, Paris/FR

Abstract

Background

Docetaxel/cisplatin/5-FU (TPF) has been reported to be more active than cisplatin/5-FU in Squamous Cell Carcinoma (SCC) of the head and neck (HN). A clinical Complete Response (CR) rate of 8.5% was achieved after TPF induction therapy (IT) in patients (pts) with unresectable pharyngolaryngeal SCC (Vermorken et al, NEJM 2007). EGFR is overexpressed in up to 90% of HN cancers. Cetuximab (Cet) was active in combination with radiotherapy and with cisplatin. The aim of this multicenter single-arm phase II study was to evaluate Cet with TPF as IT in oropharyngeal SCC.

Methods

Main inclusion criteria were: previously untreated histologically proven oropharyngeal SCC, non-metastatic stage III or IV disease (UICC 2002), surgically resectable, age 18-75 years, ECOG Performance Status (PS) 0-1. Pts received Cet iv /1-2h (400 mg/m2 loading dose, then weekly 250 mg/m2) followed by docetaxel iv 75mg/m2 /1h and cisplatin iv 75mg/m2 /1h (day 1); and 5-FU iv 750mg/m2/day continuously (days 1-5), every 3 weeks for 3 courses. After completion of IT, the treatment of the primitive tumor was at the investigator's discretion. The primary endpoint was the clinical and radiological CR of primitive tumor at 3 months. Correlative studies investigated several EGFR-related biomarkers and HPV analyses in tumor and blood samples.

Results

Among 42 pts enrolled from 07/2008 to 11/2011 in 9 centers, 41 pts were treated. The main pts characteristics were: male 81%, mean age 56y, PS0 79%, tonsil area 88%, stage III/IV 76%/24%. The planned 9 infusions were given in 31 (76%) pts. A clinical and radiological CR of the primitive tumor at 3 months was achieved in 9 (22%) pts, and a clinical CR in 17 (41%) pts. The most frequent G3-4 toxicities were: neutropenia (39%), febrile neutropenia (20%), diarrhea (10%), and mucositis (12%). Any grade acnea-like syndrome was observed in 18 (44%) pts. One toxic death occurred secondary to chemo-induced colitis with colonic perforation.

Conclusions

The combination of cetuximab with TPF is highly active. A systematic therapy with granulocyte colony-stimulating factor is necessary to prevent febrile neutropenia.

Disclosure

All authors have declared no conflicts of interest.