INDUCTION CHEMOTHERAPY FOR LARYNX PRESERVATION

J Clin Oncol. 2013 Jan 22. [Epub ahead of print]

Induction Chemotherapy Followed by Either Chemoradiotherapy or Bioradiotherapy for Larynx Preservation: The TREMPLIN Randomized Phase II Study.

Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM,Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E.

Source

Jean Louis Lefebvre and Marian Degardin, Centre Oscar Lambret; Dominique Chevalier, Centre Hospitalier Universitaire Claude Huriez, Lille; Yoann Pointreau, Gilles Calais, and Pascal Garaud, Centre Hospitalier Universitaire Pierre Bretonneau, Tours; Frederic Rolland and Etienne Bardet, Institut de Cancerologie de l'Ouest Rene Gauducheau; Olivier Malard, Centre Hospitalier Universitaire Hotel Dieu, Nantes; Marc Alfonsi, Institut Sainte Catherine, Avignon; Christian Sire, Centre Hospitalier Bretagne Sud, Lorient; Dominique de Raucourt, Centre Francois Baclesse; Emmanuel Babin, Centre Hospitalier Universitaire Cote de Nacre, Caen; Claude Tuchais, Centre de Cancerologie de l'Ouest, Paul Papin, Angers; Emmanuel Blot, Centre Henri Becquerel, Rouen; Michel Rives, Centre Claudius Regaud, Toulouse; Emile Reyt, Centre Hospitalier Albert Michallon, Grenoble; Jean Marc Tourani, Centre Hospitalier Universitaire Jean Bernard, Poitiers; Lionel Geoffrois, Centre Alexis Vautrin, Nancy; Frederic Peyrade, Institut Universitaire de la Face et du Cou, Nice; Francois Guichard, Polyclinique de Bordeaux Nord, Bordeaux; Philippe Lang, Centre Hospitalier Universitaire Pitie Salpetriere, Paris; Francois Janot, Institut Gustave Roussy, Villejuif, France; and Alain Baudoux, Centre Medical Sainte Elisabeth, Namur, Belgium.

Abstract

PURPOSETo compare the efficacy and safety of induction chemotherapy (ICT) followed by chemoradiotherapy (CRT) or bioradiotherapy (BRT) for larynx preservation (LP). PATIENTS AND METHODSPreviously untreated patients with stage III to IV larynx/hypopharynx squamous cell carcinoma received three cycles of ICT-docetaxel and cisplatin 75 mg/m(2) each on day 1 and fluorouracil 750 mg/m(2) per day on days 1 through 5. Poor responders (< 50% response) underwent salvage surgery. Responders (≥ 50% response) were randomly assigned to conventional radiotherapy (RT; 70 Gy) with concurrent cisplatin 100 mg/m(2) per day on days 1, 22, and 43 of RT (arm A) or concurrent cetuximab 400 mg/m(2) loading dose and 250 mg/m(2) per week during RT (arm B). Primary end point was LP at 3 months. Secondary end points were larynx function preservation (LFP) and overall survival (OS) at 18 months.ResultsOf the 153 enrolled patients, 116 were randomly assigned after ICT (60, arm A; 56, arm B). Overall toxicity of both CRT and BRT was substantial following ICT. However, treatment compliance was higher in the BRT arm. In an intent-to-treat analysis, there was no significant difference in LP at 3 months between arms A and B (95% and 93%, respectively), LFP (87% and 82%, respectively), and OS at 18 months (92% and 89%, respectively). There were fewer local treatment failures in arm A than in arm B; salvage surgery was feasible in arm B only. CONCLUSIONThere is no evidence that one treatment was superior to the other or could improve the outcome reported with ICT followed by RT alone (French Groupe Oncologie Radiothérapie Tête et Cou [GORTEC] 2000-01 trial [Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma]). The protocol that can best compare with RT alone after ICT is still to be determined.