title: Biweekly paclitaxel, cisplatin, tegafur, and leucovorin as neoadjuvant chemotherapy for unresectable squamous cell carcinoma of the head and neck.
abstract: BACKGROUND
  The goal of the current study was to evaluate the efficacy and toxicity of paclitaxel, cisplatin (P), tegafur (T), and leucovorin (L) as a neoadjuvant chemotherapy (CT) for patients with advanced, unresectable squamous cell carcinoma of the head and neck.
  
  
  METHODS
  From November 1999 to January 2001, 21 consecutive patients (Stage IV, 100%; T4, 86%; and N3, 41%) were treated with paclitaxel-PTL (Day 1: paclitaxel, 120 mg/m(2) intravenous infusion for 3 hours; Day 1: P, 50 mg/m(2); T, 800 mg; and L, 60 mg orally daily over a 14-day cycle). Evaluation after three cycles led to CT termination if primary tumor responses were less than partial responses. Otherwise, paclitaxel-PTL was continued for up to six cycles before commencement of locoregional therapy.
  
  
  RESULTS
  CT responses were analyzed on an intent-to-treat basis. Response rates (RR) for the primary tumors were 81% (17 of 21), with 28.6% (6 of 21) showing a complete response (CR). RR and CR rates for the neck lymph nodes were 85.3% (15 of 18) and 22% (4 of 18), respectively. The combined RR for primary tumors and neck lymph nodes was 81% (95% confidence interval, 62.9-99.3%) with a CR rate of 19%. Grade 3/4 toxicities according to World Health Organization criteria included leukopenia, 19.0%; emesis, 9.5%; asthenia, 9.5%; mucositis, 4.8%; and neuropathy, 4.8%. Both the overall and disease-free survival rates were 14.3% (3 of 21), with a median follow-up of 41 months.
  
  
  CONCLUSIONS
  The relatively low toxicities and encouraging response rates demonstrated in the current study suggested that paclitaxel-PTL merits future trials in the setting of resectable tumors with more favorable characteristics.
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan, Republic of China. whm526@ms12.hinet.net
authors.forename: Hung-Ming
authors.initials: HM
authors.lastname: Wang
authors.forename: Chun-Ta
authors.initials: CT
authors.lastname: Liao
authors.forename: Tung-Chieh Joseph
authors.initials: TC
authors.lastname: Chang
authors.forename: Jen-Shi
authors.initials: JS
authors.lastname: Chen
authors.forename: Cuang-Chi
authors.initials: CC
authors.lastname: Liaw
authors.forename: I-How
authors.initials: IH
authors.lastname: Chen
authors.forename: Ngan-Ming
authors.initials: NM
authors.lastname: Tsang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D016879:Salvage Therapy; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D005641:Tegafur; D017239:Paclitaxel; D002945:Cisplatin; D002955:Leucovorin