Lionnel Geoffrois1, Laurent Martin1, Dominique De Raucourt1, Xu Shan Sun1, Yungan Tao1, Philippe Maingon1, Joëlle Buffet1, Yoann Pointreau1, Christian Sire1, Claude Tuchais1, Emmanuel Babin1, Alexandre Coutte1, Frédéric Rolland1, Marie-Christine Kaminsky1, Marc Alfonsi1, Michel Lapeyre1, Marie Saliou1, Cédric Lafond1, Eric Jadaud1, Bernard Gery1, Ayman Zawadi1, Jean-Marc Tourani1, Cédric Khoury1, Anne Rose Henry1, Ali Hasbini1, François Guichard1, Christian Borel1, Nicolas Meert1, Pierre Guillet1, Marie-Hélène Calais1, Pascal Garaud1, Jean Bourhis1. 1. Lionnel Geoffrois, Marie-Christine Kaminsky, Institut de Cancérologie de Lorraine, Vandoeuvre Lès Nancy; Laurent Martin, Centre Guillaume le Conquérant; Dominique De Raucourt, Bernard Gery, Centre François Baclesse; Emmanuel Babin, Hopital Universitaire, Caen; Xu Shan Sun, Joëlle Buffet, Centre Hospitalier Universitaire de Besançon, Besançon; Hôpital de Mulhouse, Mulhouse; Yungan Tao, Gustave-Roussy Institute, Villejuif; Philippe Maingon, Centre François Leclercq, Leclercq; Yoann Pointreau, Cédric Lafond, Marie-Hélène Calais, Pascal Garaud, Centre Jean Bernard, Le Mans; Centre Hospitalier Universitaire de Tours, Tours; Christian Sire, Centre Hospitalier de Lorient, Lorient; Claude Tuchais, Eric Jadaud, Centre Paul Papin, Angers; Alexandre Coutte, Centre Hospitalier Universitaire Amiens, Amiens; Frédéric Rolland, Centre René Gauducheau, Saint Herblain; Marc Alfonsi, Clinique Sainte Catherine, Avignon; Michel Lapeyre, Centre Jean Perrin, Clermont; Marie Saliou, Clinique Mutualiste, Saint Nazaire; Ayman Zawadi, Centre Hospitalier de La Roche-sur-Yon, La Roche-sur-Yon; Jean-Marc Tourani, Centre Hospitalier Universitaire, Poitiers, Poitiers; Cédric Khoury, Centre Saint Louis; Pierre Guillet, Hôpital Font-Pré, Toulon, Toulon; Ali Hasbini, Hopital de Saint Brieuc, Saint Brieuc; François Guichard, Polyclinique de Bordeaux-Nord, Bordeaux; Christian Borel, Centre Paul Strauss, Strasbourg, France; Anne Rose Henry, Hôpital Montigny le Tilleul, Montigny-le-Tilleul; Nicolas Meert, Centre Hospitalier de Charlebois, Charlebois, Belgium; and Jean Bourhis, Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne, Switzerland.
Abstract
PURPOSE: Both concurrent chemoradiotherapy (CT-RT) and cetuximab radiotherapy (cetux-RT) have been established as the standard of care for the treatment of locally advanced squamous cell carcinoma of the head and neck. It was not known whether the addition of induction chemotherapy before cetux-RT could improve outcomes compared with standard of care CT-RT. PATIENTS AND METHODS: The current trial was restricted to patients with nonmetastatic N2b, N2c, or N3 squamous cell carcinoma of the head and neck and fit fortaxotere, cisplatin, fluorouracil (TPF). Patients were randomly assigned to receive three cycles of TPF followed by cetux-RT versus concurrent carboplatin fluorouracil and RT as recommended in National Comprehensive Cancer Network guidelines. The trial was powered to detect a hazard ratio (HR) of 0.66 in favor of TPF plus cetux-RT for progression-free survival at 2 years. The inclusion of 180 patients per arm was needed to achieve 80% power at a two-sided significance level of .05. RESULTS:Between 2009 and 2013, 370 patients were included. All patients and tumors characteristics were well balanced between arms. There were more cases of grade 3 and 4 neutropenia in the induction arm, and the induction TPF was associated with 6.6% treatment-related deaths. With a median follow-up of 2.8 years, 2-year progression-free survival was not different between both arms (CT-RT, 0.38 v TPF + cetux-RT, 0.36; HR, 0.93 [95% CI, 0.73 to 1.20]; P = .58). HR was 0.98 (95% CI, 0.74 to 1.3; P = .90) for locoregional control and 1.12 (95% CI, 0.86 to 1.46; P = .39) for overall survival. These effects were observed regardless of p16 status. The rate of distant metastases was lower in the TPF arm (HR, 0.54 [95% CI, 0.30 to 0.99]; P = .05). CONCLUSION:Induction TPF followed by cetux-RT did not improve outcomes compared with CT-RT in a population of patients with advanced cervical lymphadenopathy.
RCT Entities:
PURPOSE: Both concurrent chemoradiotherapy (CT-RT) and cetuximab radiotherapy (cetux-RT) have been established as the standard of care for the treatment of locally advanced squamous cell carcinoma of the head and neck. It was not known whether the addition of induction chemotherapy before cetux-RT could improve outcomes compared with standard of care CT-RT. PATIENTS AND METHODS: The current trial was restricted to patients with nonmetastatic N2b, N2c, or N3 squamous cell carcinoma of the head and neck and fit for taxotere, cisplatin, fluorouracil (TPF). Patients were randomly assigned to receive three cycles of TPF followed by cetux-RT versus concurrent carboplatin fluorouracil and RT as recommended in National Comprehensive Cancer Network guidelines. The trial was powered to detect a hazard ratio (HR) of 0.66 in favor of TPF plus cetux-RT for progression-free survival at 2 years. The inclusion of 180 patients per arm was needed to achieve 80% power at a two-sided significance level of .05. RESULTS: Between 2009 and 2013, 370 patients were included. All patients and tumors characteristics were well balanced between arms. There were more cases of grade 3 and 4 neutropenia in the induction arm, and the induction TPF was associated with 6.6% treatment-related deaths. With a median follow-up of 2.8 years, 2-year progression-free survival was not different between both arms (CT-RT, 0.38 v TPF + cetux-RT, 0.36; HR, 0.93 [95% CI, 0.73 to 1.20]; P = .58). HR was 0.98 (95% CI, 0.74 to 1.3; P = .90) for locoregional control and 1.12 (95% CI, 0.86 to 1.46; P = .39) for overall survival. These effects were observed regardless of p16 status. The rate of distant metastases was lower in the TPF arm (HR, 0.54 [95% CI, 0.30 to 0.99]; P = .05). CONCLUSION: Induction TPF followed by cetux-RT did not improve outcomes compared with CT-RT in a population of patients with advanced cervical lymphadenopathy.
Authors: Benjamin Lacas; Alexandra Carmel; Cécile Landais; Stuart J Wong; Lisa Licitra; Jeffrey S Tobias; Barbara Burtness; Maria Grazia Ghi; Ezra E W Cohen; Cai Grau; Gregory Wolf; Ricardo Hitt; Renzo Corvò; Volker Budach; Shaleen Kumar; Sarbani Ghosh Laskar; Jean-Jacques Mazeron; Lai-Ping Zhong; Werner Dobrowsky; Pirus Ghadjar; Carlo Fallai; Branko Zakotnik; Atul Sharma; René-Jean Bensadoun; Maria Grazia Ruo Redda; Séverine Racadot; George Fountzilas; David Brizel; Paolo Rovea; Athanassios Argiris; Zoltán Takácsi Nagy; Ju-Whei Lee; Catherine Fortpied; Jonathan Harris; Jean Bourhis; Anne Aupérin; Pierre Blanchard; Jean-Pierre Pignon Journal: Radiother Oncol Date: 2021-01-27 Impact factor: 6.280
Authors: Michael J Jelinek; Nathan R Foster; Alex J Zoroufy; Gary K Schwartz; Pamela N Munster; Tanguy Y Seiwert; Jonas A de Souza; Everett E Vokes Journal: Oral Oncol Date: 2021-01-26 Impact factor: 5.337
Authors: Leila T Tchelebi; Emma Batchelder; Ming Wang; Eric J Lehrer; Joseph J Drabick; Navesh Sharma; Mitchell Machtay; Daniel M Trifiletti; Nicholas G Zaorsky Journal: JNCI Cancer Spectr Date: 2021-05-19