title: Acute toxicity profile and compliance to accelerated radiotherapy plus carbogen and nicotinamide for clinical stage T2-4 laryngeal cancer: results of a phase III randomized trial.
abstract: OBJECTIVE
  To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer.
  
  
  METHODS
  From April 2001 to February 2008, 345 patients with cT2-4 squamous cell laryngeal cancer were randomized to AR (n = 174) and ARCON (n = 171). Acute toxicity was scored weekly until Week 8 and every 2-4 weeks thereafter. Compliance to carbogen and nicotinamide was reported.
  
  
  RESULTS
  Between both treatment arms (AR vs. ARCON) no statistically significant difference was observed for incidence of acute skin reactions (moist desquamation: 56% vs. 58%, p = 0.80), acute mucosal reactions (confluent mucositis: 79% vs. 85%, p = 0.14), and symptoms related to acute mucositis (severe pain on swallowing: 53% vs. 58%, p = 0.37; nasogastric tube feeding: 28% vs. 28%, p = 0.98; narcotic medicines required: 58% vs. 58%, p = 0.97). There was a statistically significant difference in median duration of confluent mucositis in favor of AR (2.0 vs 3.0 weeks, p = 0.01). There was full compliance with carbogen breathing and nicotinamide in 86% and 80% of the patients, with discontinuation in 6% and 12%, respectively. Adjustment of antiemesis prophylaxis was needed in 42% of patients.
  
  
  CONCLUSIONS
  With the exception of a slight increase in median duration of acute confluent mucositis, the present data reveal a similar acute toxicity profile between both regimens and a good compliance with ARCON for clinical stage T2-4 laryngeal cancers. Treatment outcome and late morbidity will determine the real therapeutic benefit.
authors.affiliation: Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. g.janssens@rther.umcn.nl
authors.forename: Geert O
authors.initials: GO
authors.lastname: Janssens
authors.forename: Chris H
authors.initials: CH
authors.lastname: Terhaard
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Doornaert
authors.forename: Hendrik P
authors.initials: HP
authors.lastname: Bijl
authors.forename: Piet
authors.initials: P
authors.lastname: van den Ende
authors.forename: Alim
authors.initials: A
authors.lastname: Chin
authors.forename: Lucas A
authors.initials: LA
authors.lastname: Pop
authors.forename: Johannes H
authors.initials: JH
authors.lastname: Kaanders
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000627:therapeutic use; D002245:Carbon Dioxide / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D003680:Deglutition Disorders / Q000209:etiology; D005260:Female; D006801:Humans; D007441:Intubation, Gastrointestinal; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009426:Netherlands; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects; D010100:Oxygen / Q000008:administration & dosage / Q000009:adverse effects; D010349:Patient Compliance; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011855:Radiodermatitis / Q000473:pathology; D013280:Stomatitis / Q000209:etiology / Q000473:pathology; D014803:Vitamin B Complex / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000701:Analgesics, Opioid; D011838:Radiation-Sensitizing Agents; D014803:Vitamin B Complex; D002245:Carbon Dioxide; D009536:Niacinamide; C011700:carbogen; D010100:Oxygen