1035P - Induction chemotherapy (ICT) with docetaxel/cisplatin/5-fluorouracil (T/P/F) followed by chemoradiotherapy with Cisplatin (CRTP) vs bioradiotherapy...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cytotoxic agents
Head and Neck Cancers
Surgical oncology
Therapy
Biological therapy
Radiation oncology
Presenter Ricardo Hitt
Citation Annals of Oncology (2014) 25 (suppl_4): iv340-iv356. 10.1093/annonc/mdu340
Authors R. Hitt1, R. Mesia2, J.J. Grau3, J. Rubio4, J. Martinez-Trufero5, E. Del Barco Morillo6, C. Almodóvar Alvarez7, M. Taberna-Sanz8, C. García_girón9, S. Vazquez10, B. Cirauqui11, M. Pastor Borgoñón12, E. Galve Calvo13, O. Juan-Vidal14, R. Lopez15, J. Martinez-Galan16, R. Bastus17, A. Berrocal18, J.C. Adansa Klain6, J.J. Cruz Hernandez6
  • 1Servicio De Oncologia Medica, University Hosptial 12 De Octubre, ES-28041 - Madrid/ES
  • 2Medical Oncology Department. Idibell. Head And Neck Cancer Unit., Institut Català d'Oncologia (ICO)-Hospitalet, 08098 - Hospitalet de Llobregat, Barcelona/ES
  • 3Medical Oncology, Hospital Clinic i Provincial, 08036 - Barcelona/ES
  • 4Oncology, Hospital Josep Trueta - ICO Girona, Girona/ES
  • 5Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 6Medical Oncology, Hospital Universitario de Salamanca - IBSAL, 30007 - Salamanca/ES
  • 7Head And Neck Surgery, University Hosptial 12 De Octubre, ES-28041 - Madrid/ES
  • 8Medical Oncology, Institut Català d'Oncologia, 08907 - L'Hospitalet , Barcelona/ES
  • 9Servicio De Oncología Médica, Hospital General Yagüe, 09005 - Burgos/ES
  • 10Medical Oncology, Hospital Xeral-Calde, 27004 - Lugo/ES
  • 11Medical Oncology, ICO Hospital Universitario Germans Trias i Pujol, 08916 - Badalona/ES
  • 12Medical Oncology, Hospital La Fe, 46026 - valencia/ES
  • 13Medical Oncology, Hospital de Basurto, 48013 - Bilbao/ES
  • 14Medical Oncology, Hospital Universitario Arnau de Vilanova, 46015 - Valencia/ES
  • 15Medical Oncology, Complejo Hospitalario Universitario de Santiago de Compostela SERGAS, 15706 - Santiago de Compostela/ES
  • 16Medical Oncology, Hospital Universitario Virgen de las Nieves, 18014 - Granada/ES
  • 17Medical Oncology, Hospital Mutua Terrassa, 08221 - Terrassa/ES
  • 18Medical Oncology, Hospital General Universitario Valencia, 46014 - Valencia/ES

Abstract

Background

ICT with taxanes regimens has been demonstrate increase overall survival (OS) in the recent metaanalysis (Blanchard JCO 2013) in patients (pts) with LAHNC. However CRTP or RTCx hasńt be compared as consolidation treatment. This randomized phase III trial (TTCC-2007-01, NCT00716391) compared OS and not inferiority of RTCx respect to CRTP. Now, we report preliminary results of toxicity in both regimen.

Trial design

Methods: Eligible pts: unresectable tumors, measurable disease, adequate organ function, ECOG 0–1. Treatment: T 75 mg/m2 d1, P 75 mg/m2 d1, F 750 mg/m2 CI d 1–5 q 21 d + G-CSF & ciprofloxacin, by 3 cycles; then, they were randomized to: conventional radiotherapy (RT) up to 70 Gy + P 100 mg/m2 d 1–22-43 vs conventional RT up to 70 Gy + cetuximab 400/250 mg/m2 weekly until the completion of RT, and they were stratified by primary tumor site (TS). Surgery after RT (neck dissection) was allowed.

Results: By July 2008, 516 pts over 531 were evaluable for toxicity; 89% male, 99,8% caucasian, median age: 57y (29–73), PS: 0=25.7%, 1=70.5%. Disease stage: III: 8,1% - IV: 90,5%. TS: oropharynx: 37.2%, hypopharynx: 20.7%, larynx: 14,3% and oral cavity: 12.8%. Median follow-up: 8,9 months, 197 deaths occurred. G3-4 toxicity: TPF neutropenia: 9,1%, febrile neutropenia (FN): 12,6%, non-hematological toxicity (NHT): 15,9%, toxic death: 2,13%. CRTP: anemia 1,4%, neutropenia 4,9%, FN 1,4%, NHT: 11,2%, mucosal and gastrointestinal toxicity were the most common, toxic death: 0,78%. RTCx: anemia 0,2%,neutropenia 0%, FN: 0,2%, NHT: 19,2% , cutaneous and mucosal toxicity were the most common disorders, toxic death: 0,78%. SAEs: CRTP 8,3%, RTCx: 4,5%.

Conclusions: Interim data suggest that ICT is tolerable in ULAHNC. RTCx seems to have less haematological side effects than CRTP, and decreases the rate of SAEs. There's a trend of less gastrointestinal and renal toxicity with RTCx, and less dermatological toxicity and radiation-induced skin injury with CRTP. Currently ongoing to further evaluate efficacy and OS.

Disclosure

R. Hitt, R. Mesia and J.J. Cruz Hernandez: This trial was funded by Sanofi Aventis and Merck. Consultant, advisory board and expert testimony compensated by Sanofi Aventis and Merck; J.J. Grau, J. Rubió, J. Martínez-Trufero, E. Del Barco Morillo, C. García-Girón, S. Vazquez, B. Cirauqui, M. Pastor Borgoñón, E. Galve Calvo, O. Juan-Vidal, R. Lopez, J. Martinez-Galan, R. Bastus and A. Berrocal: This trial was funded by Sanofi Aventis and Merck.All other authors have declared no conflicts of interest.