1020PD - Concomitant chemoradiotherapy (CT/RT) or cetuximab/RT (CET/RT) with or without induction docetaxel/cisplatin/5-fluorouracil (tpf) in locally advance...

Date 30 September 2012
Event ESMO Congress 2012
Session Head and neck cancer
Topics Anti-Cancer Agents & Biologic Therapy
Head and Neck Cancers
Surgery and/or Radiotherapy of Cancer
Presenter maria grazia Ghi
Authors M.G. Ghi1, A. Paccagnella2, D. Ferrari3, M. Cossu Rocca4, E. Verri4, F. Morelli5, G. Azzarello6, C. D'Ambrosio7, C. Casanova8, I.C. Floriani9
  • 1Medical Oncology Department, Ospedale SS Giovanni e Paolo e Ospedale dell'Angelo, 30173 - Venezia/IT
  • 2Div. Di Oncologia Medica, Ospedale SS Giovanni e Paolo e Ospedale dell'Angelo, 30173 - Venezia/IT
  • 3Madical Oncology, Polo Universitario San Paolo Hospital, 30100 - Milano/IT
  • 4Unit For Medical Care, European Institute of Oncology, 30100 - Milano/IT
  • 5Oncohaematology, IRCCS Casa Sollievo della Sofferenza, 30100 - San Giovanni rotondo/IT
  • 6Oncology Unit, Department of Internal Medical Sciences,ASL 13, 30100 - Milano/IT
  • 7Oncology Department, Azienda Ospedaliera Policlinico, 30100 - Modena/IT
  • 8Oncology Hematology, Ospedale Sta Maria delle Croci, 30100 - Ravenna/IT
  • 9Department Of Oncology, Mario Negri Institute, 20156 - Milano/IT

 

Abstract

Background

CT/RT or CET/RT are standard treatment options for LASCCHN. Strategies to improve the efficacy with the integration of induction chemotherapy are being investigated. Primary endpoints of this study were to compare: 1) the 3 y overall survival (OS) of induction vs. no induction arms; 2) the Grade(G)3-4 in-field toxicity of CT/RT vs. CET/RT.

Methods

Patients (pts) with unresectable LASCCHN, stage III-IV, ECOG PS 0–1 were randomized to a 2x2 factorial design: Arm A1: CT/RT (2 cycles of ciplatin/5fluorouracil); Arm A2: CET/RT; Arm B1: 3 cycles of induction TPF followed by the same CT/RT; Arm B2: 3 cycles of induction TPF followed by CET/RT. A total of 204 deaths (420 ptsincluding the 101 randomized in the phase II part of the study comparing CT/RT with or w/o induction TPF) were required to detect a HR of death of 0.675 (A1 + A2 vs. B1 + B2; 2-sided a = 0.05; b = 0.20) and a 10% difference in G3-4 in-field mucosal toxicity (A1 + B1 vs. A2 + B2).

Results

Accrual was completed (421 pts) in April 2012. By May 2012, 348 patients were evaluable for toxicity during the planned concomitant treatments. 82% of pts were male; median age was 60y; PS of 0 (77.8%) or 1 (22.2%). Stage was III (31%) or IV (69%). Sites of disease were: oral cavity: 21.7%, oropharynx: 54.8%, hypopharynx: 23.5%. Data on G3-4 in-field toxicity (primary endpoint) and compliance to CT/RT vs CET/RT are shown in table 1.

CT/RT N 215 CET/RT N 133 p
In-field mucositis Grade 3 Grade 4 37% 4% 35% 2% 0.79 0.45
In-field skin reaction Grade 3 Grade 4 13% 1% 20% 1% 0.07 0.58
RT median dose, Gy (range) 70 (8-70) 70 (14-70) 0.32
RT median duration, weeks (range) 7 (1-13) 8 (1-14) <0.01
Pts with RT interruption >3days 32% 38% 0.22
RT modification due to acute toxicity 37% 40% 0.58

Conclusions

No advantage for CET/RT over CT/RT were observed regarding G3-4 in-field toxicities and feasibility. Pts are still being followed-up to assess OS. Table 1:

Disclosure

All authors have declared no conflicts of interest.