title: Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study.
abstract: OBJECTIVE
  To compare the efficacy and safety of induction chemotherapy (ICT) followed by chemoradiotherapy (CRT) or bioradiotherapy (BRT) for larynx preservation (LP).
  
  
  METHODS
  Previously 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.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  There 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.
authors: Head and Neck Department, Centre Oscar Lambret, 3 rue Combemale, Lille, France 59020. jl-lefebvre@o-lambret.fr
authors: Jean Louis
authors: JL
authors: Lefebvre
authors: Yoann
authors: Y
authors: Pointreau
authors: Frederic
authors: F
authors: Rolland
authors: Marc
authors: M
authors: Alfonsi
authors: Alain
authors: A
authors: Baudoux
authors: Christian
authors: C
authors: Sire
authors: Dominique
authors: D
authors: de Raucourt
authors: Olivier
authors: O
authors: Malard
authors: Marian
authors: M
authors: Degardin
authors: Claude
authors: C
authors: Tuchais
authors: Emmanuel
authors: E
authors: Blot
authors: Michel
authors: M
authors: Rives
authors: Emile
authors: E
authors: Reyt
authors: Jean Marc
authors: JM
authors: Tourani
authors: Lionel
authors: L
authors: Geoffrois
authors: Frederic
authors: F
authors: Peyrade
authors: Francois
authors: F
authors: Guichard
authors: Dominique
authors: D
authors: Chevalier
authors: Emmanuel
authors: E
authors: Babin
authors: Philippe
authors: P
authors: Lang
authors: Francois
authors: F
authors: Janot
authors: Gilles
authors: G
authors: Calais
authors: Pascal
authors: P
authors: Garaud
authors: Etienne
authors: E
authors: Bardet
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000503:physiopathology / Q000532:radiotherapy*; D000068818:Cetuximab; D059186:Chemoradiotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy; D060828:Induction Chemotherapy / Q000009:adverse effects; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000503:physiopathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D059351:Organ Sparing Treatments / Q000379:methods*; D011159:Population Surveillance; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068818:Cetuximab; D002945:Cisplatin