title: Primary chemotherapy in resectable oral cavity squamous cell cancer: a randomized controlled trial.
abstract: OBJECTIVE
  Prognosis of patients with advanced oral cavity cancer is worth improving. Chemotherapy has been reported to be especially active in oral cavity tumors. Here we repeat the results of a randomized, multicenter trial enrolling patients with a resectable, stage T2-T4 (> 3 cm), N0-N2, M0 untreated, squamous cell carcinoma of the oral cavity.
  
  
  METHODS
  Patients were randomly assigned to three cycles of cisplatin and fluorouracil followed by surgery (chemotherapy arm) or surgery alone (control arm). In both arms, postoperative radiotherapy was reserved to high-risk patients, and surgery was modulated depending on the tumor's closeness to the mandible. Patients' accrual was opened in 1989 and closed in 1999. It included 195 patients.
  
  
  RESULTS
  In the chemotherapy arm, three toxic deaths were recorded. No significant difference in overall survival was found. Five-year overall survival was, for both arms, 55%. Postoperative radiotherapy was administered in 33% of patients in the chemotherapy arm, versus 46% in the control arm. A mandible resection was performed in 52% of patients in the control arm, versus 31% in the chemotherapy arm.
  
  
  CONCLUSIONS
  The addition of primary chemotherapy to standard surgery was unable to improve survival. However, in this study, primary chemotherapy seemed to play a role in reducing the number of patients who needed to undergo mandibulectomy and/or radiation therapy. Variations in the criteria used to select patients for these treatment options may make it difficult to generalize these results, but there appears to be room for using preoperative chemotherapy to spare destructive surgery or radiation therapy in patients with advanced, resectable oral cavity cancer.
authors.affiliation: Istituto Nazionale Tumori, Milan, Italy. lisa.licitra@istitutotumori.mi.it
authors.forename: Lisa
authors.initials: L
authors.lastname: Licitra
authors.forename: Cesare
authors.initials: C
authors.lastname: Grandi
authors.forename: Marco
authors.initials: M
authors.lastname: Guzzo
authors.forename: Luigi
authors.initials: L
authors.lastname: Mariani
authors.forename: Salvatore
authors.initials: S
authors.lastname: Lo Vullo
authors.forename: Francesca
authors.initials: F
authors.lastname: Valvo
authors.forename: Pasquale
authors.initials: P
authors.lastname: Quattrone
authors.forename: Pinuccia
authors.initials: P
authors.lastname: Valagussa
authors.forename: Gianni
authors.initials: G
authors.lastname: Bonadonna
authors.forename: Roberto
authors.initials: R
authors.lastname: Molinari
authors.forename: Giulio
authors.initials: G
authors.lastname: Cantù
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D009367:Neoplasm Staging; D015996:Survival Rate; D014062:Tongue Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin; D005472:Fluorouracil