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 Cytotoxic agents
Head and Neck Cancers
Surgical oncology
Therapy
Biological therapy
Radiation oncology
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.