Guillaume Janoray1, Yoann Pointreau2, Pascal Garaud2, Sophie Chapet2, Marc Alfonsi2, Christian Sire2, Eric Jadaud2, Gilles Calais2. 1. Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ). guillaume.janoray@yahoo.fr. 2. Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ).
Abstract
BACKGROUND: The purpose of GORTEC 2000-01 was to compare the long-term efficacy and safety of induction chemotherapy with cisplatin (P) and 5-fluorouracil (F) with or without docetaxel (T) for larynx preservation. METHODS:Operable patients with untreated stage III or IV larynx or hypopharynx invasive squamous cell carcinoma who required total laryngectomy were randomly assigned to three cycles of induction chemotherapy with either TPF or PF, followed by radiation therapy for responders. The primary endpoint was three-year larynx preservation rate. Secondary endpoints included larynx dysfunction-free survival (LDFFS), overall survival (OS), disease-free survival (DFS), loco-regional control rate (LCR), cause of death, and later toxicity rates. Survival and other data were analyzed by Kaplan-Meier methods. All statistical tests were two-sided. RESULTS:Two hundred thirteen patients were treated with median follow-up of 105 months. The five- and 10-year larynx preservation rates were 74.0% (95% CI = 0.64 to 0.82) vs 58.1% (95% CI = 0.47 to 0.68) and 70.3% (95% CI = 0.58 to 0.8) vs 46.5% (95% CI = 0.31 to 0.63, P = .01) in the TPF vs PF arm, respectively. The five- and 10-year LDFFS rates were 67.2% (95% CI = 0.57 to 0.76) vs 46.5% (95% CI = 0.36 to 0.57) and 63.7% (95% CI = 0.52 to 0.74) vs 37.2% (95% CI = 0.24 to 0.52, P = .001), respectively. OS, DFS, and LCR were not statistically improved in the TPF vs the PF arm. Statistically fewer grade 3-4 late toxicities of the larynx occurred with the TPF regimen compared with the PF arm (9.3% vs 17.1%, G-test, P = .038). CONCLUSION: Long-term follow-up confirms that induction chemotherapy with TPF increased larynx preservation and larynx dysfunction-free survival. In this larynx preservation approach using induction chemotherapy, TPF should be recommended, followed by radiation therapy.
RCT Entities:
BACKGROUND: The purpose of GORTEC 2000-01 was to compare the long-term efficacy and safety of induction chemotherapy with cisplatin (P) and 5-fluorouracil (F) with or without docetaxel (T) for larynx preservation. METHODS: Operable patients with untreated stage III or IV larynx or hypopharynx invasive squamous cell carcinoma who required total laryngectomy were randomly assigned to three cycles of induction chemotherapy with either TPF or PF, followed by radiation therapy for responders. The primary endpoint was three-year larynx preservation rate. Secondary endpoints included larynx dysfunction-free survival (LDFFS), overall survival (OS), disease-free survival (DFS), loco-regional control rate (LCR), cause of death, and later toxicity rates. Survival and other data were analyzed by Kaplan-Meier methods. All statistical tests were two-sided. RESULTS: Two hundred thirteen patients were treated with median follow-up of 105 months. The five- and 10-year larynx preservation rates were 74.0% (95% CI = 0.64 to 0.82) vs 58.1% (95% CI = 0.47 to 0.68) and 70.3% (95% CI = 0.58 to 0.8) vs 46.5% (95% CI = 0.31 to 0.63, P = .01) in the TPF vs PF arm, respectively. The five- and 10-year LDFFS rates were 67.2% (95% CI = 0.57 to 0.76) vs 46.5% (95% CI = 0.36 to 0.57) and 63.7% (95% CI = 0.52 to 0.74) vs 37.2% (95% CI = 0.24 to 0.52, P = .001), respectively. OS, DFS, and LCR were not statistically improved in the TPF vs the PF arm. Statistically fewer grade 3-4 late toxicities of the larynx occurred with the TPF regimen compared with the PF arm (9.3% vs 17.1%, G-test, P = .038). CONCLUSION: Long-term follow-up confirms that induction chemotherapy with TPF increased larynx preservation and larynx dysfunction-free survival. In this larynx preservation approach using induction chemotherapy, TPF should be recommended, followed by radiation therapy.
Authors: Adam R Burr; Paul M Harari; Alyx M Haasl; Aaron M Wieland; Justine Y Bruce; Randall J Kimple; Gregory K Hartig; Timothy M McCulloch; Matthew E Witek Journal: Head Neck Date: 2020-02-14 Impact factor: 3.147
Authors: D Alterio; M Cossu Rocca; W Russell-Edu; S Dicuonzo; G Fanetti; G Marvaso; L Preda; S Zorzi; E Verri; F Nole'; B A Jereczek-Fossa Journal: Med Oncol Date: 2017-04-08 Impact factor: 3.064
Authors: Allen S Ho; Sungjin Kim; Mourad Tighiouart; Cynthia Gudino; Alain Mita; Kevin S Scher; Anna Laury; Ravi Prasad; Stephen L Shiao; Nabilah Ali; Chrysanta Patio; Jon Mallen-St Clair; Jennifer E Van Eyk; Zachary S Zumsteg Journal: JAMA Oncol Date: 2018-07-01 Impact factor: 31.777