title: Physical examination during chemoradiation predicts outcome of locally advanced head and neck cancer. Secondary results of a randomized phase III trial (SAKK 10/94).
abstract: OBJECTIVE
  To analyze the prognostic value of clinical tumor response during chemoradiation for locally advanced head and neck cancer.
  
  
  METHODS
  The locoregional response at 50.4Gy was assessed by physical examination (PE) in patients treated within the randomized trial SAKK 10/94 using hyperfractionated radiotherapy (RT), median total dose 74.4Gy with or without cisplatin 20mg/m(2) chemotherapy on 5 consecutive days during weeks 1 and 5 or 6 of RT. Response was classified as a complete response (CR), complete response with uncertainty (Cru), partial response (PR), stable disease (SD), or progressive disease (PD). The primary endpoint was time to treatment failure (TTF) due to any cause. Secondary endpoints included locoregional-recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS) and overall survival (OS). Univariate and multivariate Cox proportional hazards (PH) models were applied to analyze the associations between survival endpoints and clinical tumor response.
  
  
  RESULTS
  A total of 136, 131 and 97 patients were evaluable for response at the primary tumor, lymph nodes and both sites combined, respectively. At 50.4Gy 57/136 (42%), 46/131 (35%) and 21/97 (22%) patients had a good response (CR/Cru vs. PR/SD) at the primary tumor, the lymph nodes, and both sites combined, respectively. The median follow-up times were 11.4, 9.6 and 11.4years for the three groups. Good responses were all significantly associated with improved TTF, LRRFS, DMFS and OS in univariate analysis whereas good response at the primary tumor and lymph nodes remained significantly associated with TTF and OS after multivariate Cox PH models.
  
  
  CONCLUSIONS
  Locoregional response at 50.4Gy was identified as predictor of oncologic outcome. PE during treatment should not be underestimated in clinical practice.
authors.affiliation: Departments of Radiation Oncology, Charité University Medicine, Germany; Inselspital, Bern University Hospital, Switzerland. Electronic address: pirus.ghadjar@charite.de.
authors.forename: Pirus
authors.initials: P
authors.lastname: Ghadjar
authors.forename: Hong
authors.initials: H
authors.lastname: Sun
authors.forename: Frank
authors.initials: F
authors.lastname: Zimmermann
authors.forename: Stephan
authors.initials: S
authors.lastname: Bodis
authors.forename: Jacques
authors.initials: J
authors.lastname: Bernier
authors.forename: Gabriela
authors.initials: G
authors.lastname: Studer
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Aebersold
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy / Q000556:secondary / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D007822:Laryngeal Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D008198:Lymph Nodes; D008297:Male; D009062:Mouth Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D009364:Neoplasm Recurrence, Local / Q000556:secondary; D010610:Pharyngeal Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D010808:Physical Examination; D011379:Prognosis; D016016:Proportional Hazards Models
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin
keywords: Chemoradiation; Head and neck cancer; Outcome; Physical examination; Radiotherapy