- Email: [email protected]
M) Squamous Cell Carcinoma of the Head and Neck (Scchn): First Observational Prospective Study in Unselected Patients (Direct Trial)
Annals of Oncology 25 (Supplement 4): iv340–iv356, 2014 doi:10.1093/annonc/mdu340.11
head and neck cancer 996P
abstracts
J. Guigay1, F. Peyrade2, B. Petre-Lazar3, F. Mornex4, P. Ceruse5, L. Digue6, A. Berrier7, M. Degardin8, M. Alfonsi9, X. Artignan10, L. Cals11, S. Faivre12, E. Vuillemin13, F. Rolland14, A. Timochenko15, E. Babin16, A. Prevost17, O. Romano18, E. Chamorey2, C. Le Tourneau19 1 Medical Oncology, Institute Gustave Roussy, Villejuif at present Centre Antoine Lacassagne, Nice, FRANCE 2 Medical Oncology, Centre Antoine Lacassagne, Nice, FRANCE 3 Oncologie, Merck Serono, Lyon, FRANCE 4 Radiothérapie-oncologie, Centre Hospitalier Lyon-Sud, Lyon, FRANCE 5 Head and Neck, Centre Hospitalier Lyon Sud, Pierre-Benite, FRANCE 6 Oncology-radiotherapy, C.H.U. Bordeaux Hopital St. Andr, Bordeaux, FRANCE 7 Oncology, Centre Hospitalier Docteur Schaffner, Lens, FRANCE 8 Département de Cancérologie Cervico-faciale, Centre Oscar Lambret, Lille, FRANCE 9 Head and Neck Radiotherapie, Institut Ste Catherine, Avignon, FRANCE 10 Oncology, CH Prive Saint Gregoire, Saint Gregoire, FRANCE 11 Department of Medical Oncology, University Hospital J. Minjoz, Besancon, FRANCE 12 Cancérologie (oncology), Hôpital Beaujon, Clichy, FRANCE 13 Oncology, Centre hospitalier Bretagne Atlantique, Vannes, FRANCE 14 Oncology Medical Service, Centre Rene Gauducheau, Saint-Herblain, FRANCE 15 Oncology, CHU Saint-Etienne, St Priest en Jarez, FRANCE 16 Oncology, CHU Caen, Caen, FRANCE 17 Oncology, Institut Jean Godinot, Reims, FRANCE 18 Oncology, Polyclinique de la Louviere, Lille, FRANCE 19 Medical Oncology, Institut Curie, Paris, FRANCE
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv344/2241707 by guest on 24 October 2019
CETUXIMAB RELATIVE DOSE INTENSITY (RDI) IN RECURRENT/METASTATIC (R/M) SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN): FIRST OBSERVATIONAL PROSPECTIVE STUDY IN UNSELECTED PATIENTS (DIRECT TRIAL)
Aim: Cetuximab combined with platinum is the standard first-line therapy in patients ( pts) with R/M SCCHN. DIRECT is the first multicenter prospective observational study evaluating cetuximab RDI in this setting. Methods: Pts were prospectively enrolled. No prior systemic therapy for R/M SCCHN was allowed. Pts received cetuximab in combination with platinum, according to the pivotal study EXTREME schedule, 5-FU if not contra-indicated and maintenance treatment with cetuximab every 2 weeks was allowed. The primary endpoint was the number of pts with cetuximab RDI >80%. Results: High quality of data was obtained by frequent monitoring of sites every 3 months (evaluable data in 93% of pts for baseline characteristics and in 89% of pts for cetuximab RDI). 154 pts were enrolled in 53 centres between 2012/11 and 2013/03: 86% male, median age 59 years, 81% with PS < 2, 29% oral cavity, 28% oropharynx, 23% hypopharynx, 19% larynx, 22% received previously cetuximab. Median time to relapse was 6 months. Pts received cisplatin (60%) or carboplatin (40%) with/without 5-FU (90/ 10%). Maintenance started in 43% pts after a median of 5 cycles, 59% pts received cetuximab every 2 weeks. Cetuximab RDI, evaluated in 130 pts with a 6 months follow-up, was >80% in 68.5%, 64.7% and 93%, during chemotherapy (CT), CT + maintenance or maintenance periods respectively. Planned doses of cetuximab were decreased in 9.7% and delayed in 36% of 154 pts, mostly during CT. 97 pts (63.0%) withdrew the study for progression (48.5%), death (31%), toxicity (6%), lost to follow-up (1%), or other reasons (13.5%). Grade > 2 skin toxicities were observed in 9 (5.8%) pts. Conclusions: In unselected pts, RDI data in DIRECT study confirms the feasibility and the good tolerance of cetuximab combined with platinum previously reported in the pivotal trial. DIRECT study supports the use of cetuximab + CT as standard treatment in clinical practice. Disclosure: J. Guigay: Research funding : GSK; Merck Serono; Novartis Honoraria : Merck Serono; B. Petre-Lazar: Medical advisor: Merck Serono; F. Mornex, P. Ceruse, M. Alfonsi and C. Le Tourneau: Honoraria : Merck Serono; A. Berrier: Research funding : Merck Serono; S. Faivre: membership advisory board : Merck Serono Honoraria : Merck Serono Research funding: Merck Serono; F. Rolland: Honoraria : Merck Serono Expert Testimony : Merck Serono. All other authors have declared no conflicts of interest.
head and neck cancer 996P
abstracts
J. Guigay1, F. Peyrade2, B. Petre-Lazar3, F. Mornex4, P. Ceruse5, L. Digue6, A. Berrier7, M. Degardin8, M. Alfonsi9, X. Artignan10, L. Cals11, S. Faivre12, E. Vuillemin13, F. Rolland14, A. Timochenko15, E. Babin16, A. Prevost17, O. Romano18, E. Chamorey2, C. Le Tourneau19 1 Medical Oncology, Institute Gustave Roussy, Villejuif at present Centre Antoine Lacassagne, Nice, FRANCE 2 Medical Oncology, Centre Antoine Lacassagne, Nice, FRANCE 3 Oncologie, Merck Serono, Lyon, FRANCE 4 Radiothérapie-oncologie, Centre Hospitalier Lyon-Sud, Lyon, FRANCE 5 Head and Neck, Centre Hospitalier Lyon Sud, Pierre-Benite, FRANCE 6 Oncology-radiotherapy, C.H.U. Bordeaux Hopital St. Andr, Bordeaux, FRANCE 7 Oncology, Centre Hospitalier Docteur Schaffner, Lens, FRANCE 8 Département de Cancérologie Cervico-faciale, Centre Oscar Lambret, Lille, FRANCE 9 Head and Neck Radiotherapie, Institut Ste Catherine, Avignon, FRANCE 10 Oncology, CH Prive Saint Gregoire, Saint Gregoire, FRANCE 11 Department of Medical Oncology, University Hospital J. Minjoz, Besancon, FRANCE 12 Cancérologie (oncology), Hôpital Beaujon, Clichy, FRANCE 13 Oncology, Centre hospitalier Bretagne Atlantique, Vannes, FRANCE 14 Oncology Medical Service, Centre Rene Gauducheau, Saint-Herblain, FRANCE 15 Oncology, CHU Saint-Etienne, St Priest en Jarez, FRANCE 16 Oncology, CHU Caen, Caen, FRANCE 17 Oncology, Institut Jean Godinot, Reims, FRANCE 18 Oncology, Polyclinique de la Louviere, Lille, FRANCE 19 Medical Oncology, Institut Curie, Paris, FRANCE
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv344/2241707 by guest on 24 October 2019
CETUXIMAB RELATIVE DOSE INTENSITY (RDI) IN RECURRENT/METASTATIC (R/M) SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN): FIRST OBSERVATIONAL PROSPECTIVE STUDY IN UNSELECTED PATIENTS (DIRECT TRIAL)
Aim: Cetuximab combined with platinum is the standard first-line therapy in patients ( pts) with R/M SCCHN. DIRECT is the first multicenter prospective observational study evaluating cetuximab RDI in this setting. Methods: Pts were prospectively enrolled. No prior systemic therapy for R/M SCCHN was allowed. Pts received cetuximab in combination with platinum, according to the pivotal study EXTREME schedule, 5-FU if not contra-indicated and maintenance treatment with cetuximab every 2 weeks was allowed. The primary endpoint was the number of pts with cetuximab RDI >80%. Results: High quality of data was obtained by frequent monitoring of sites every 3 months (evaluable data in 93% of pts for baseline characteristics and in 89% of pts for cetuximab RDI). 154 pts were enrolled in 53 centres between 2012/11 and 2013/03: 86% male, median age 59 years, 81% with PS < 2, 29% oral cavity, 28% oropharynx, 23% hypopharynx, 19% larynx, 22% received previously cetuximab. Median time to relapse was 6 months. Pts received cisplatin (60%) or carboplatin (40%) with/without 5-FU (90/ 10%). Maintenance started in 43% pts after a median of 5 cycles, 59% pts received cetuximab every 2 weeks. Cetuximab RDI, evaluated in 130 pts with a 6 months follow-up, was >80% in 68.5%, 64.7% and 93%, during chemotherapy (CT), CT + maintenance or maintenance periods respectively. Planned doses of cetuximab were decreased in 9.7% and delayed in 36% of 154 pts, mostly during CT. 97 pts (63.0%) withdrew the study for progression (48.5%), death (31%), toxicity (6%), lost to follow-up (1%), or other reasons (13.5%). Grade > 2 skin toxicities were observed in 9 (5.8%) pts. Conclusions: In unselected pts, RDI data in DIRECT study confirms the feasibility and the good tolerance of cetuximab combined with platinum previously reported in the pivotal trial. DIRECT study supports the use of cetuximab + CT as standard treatment in clinical practice. Disclosure: J. Guigay: Research funding : GSK; Merck Serono; Novartis Honoraria : Merck Serono; B. Petre-Lazar: Medical advisor: Merck Serono; F. Mornex, P. Ceruse, M. Alfonsi and C. Le Tourneau: Honoraria : Merck Serono; A. Berrier: Research funding : Merck Serono; S. Faivre: membership advisory board : Merck Serono Honoraria : Merck Serono Research funding: Merck Serono; F. Rolland: Honoraria : Merck Serono Expert Testimony : Merck Serono. All other authors have declared no conflicts of interest.