title: A prospective study to assess the efficacy and toxicity of 5-flurouracil and cisplatin versus taxane and cisplatin as induction chemotherapy in locally advanced head and neck squamous cell cancer in a regional cancer center in India.
abstract: OBJECTIVE
  The aim of this study is to assess the efficacy and toxicity of 5-flurouracil (5-FU) and cisplatin (PF) versus taxane and cisplatin (TP) as induction chemotherapy in locally advanced head and neck squamous cell cancer.
  
  
  METHODS
  There were 50 patients in each arm, matched for age, performance state, site and stage of disease. PF arm (cisplatin - 100 mg/m2 D1, 5-FU - 1000 mg/m2 D1-D5) TP arm (docetaxel - 75 mg/m2 or paclitaxel - 175 mg/m2 on D1, cisplatin 75 mg/m2 on D2), received once in 3 weeks for 3 cycles. Patients without progressive disease underwent either surgery or chemoradiation. The primary end point was overall response rate (ORR) and secondary endpoint was toxicity.
  
  
  RESULTS
  In a total of 100 patients in our study, 44 in PF and 47 in TP arm were evaluable. ORR was 86.6% in PF arm and 82.9% in TP arm (P = 0.71).There were more Grade 3 or 4 events of neutropenia, mucositis (P ≤ 0.05) and myelosuppression diarrhea, febrile neutropenia (P ≥ 0.05) in PF arm compared with TP arm. Post-chemotherapy hospital admissions due to toxicity were more frequent in PF arm (38.6% vs. 19%), dropout rate due to toxicity (9% vs. 0%) and deaths (6.8% vs. 2.1%) were more common in PF arm compared with TP arm.
  
  
  CONCLUSIONS
  TP induction chemotherapy better tolerated than PF, which has similar efficacy, further multicenter randomized controlled studies; involving a large sample size is needed to confirm our data.
authors.forename: K C
authors.initials: KC
authors.lastname: Lakshmaiah
authors.affiliation: Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore, Karnataka, India.
authors.forename: A H
authors.initials: AH
authors.lastname: Rudresha
authors.forename: T M
authors.initials: TM
authors.lastname: Suresh
authors.forename: D
authors.initials: D
authors.lastname: Lokanatha
authors.forename: G K
authors.initials: GK
authors.lastname: Babu
authors.forename: L A
authors.initials: LA
authors.lastname: Jacob
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D007194:India; D060828:Induction Chemotherapy / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D043823:Taxoids; D002945:Cisplatin; D005472:Fluorouracil