title: Docetaxel, cisplatin, and fluorouracil for patients with inoperable recurrent or metastatic head and neck squamous cell carcinoma.
abstract: OBJECTIVE
  The first-line treatment for inoperable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) has long been the combination of cisplatin and fluorouracil (PF). Recently, cetuximab has been shown to provide an additional survival benefit to PF. It remains unknown whether docetaxel adds additional benefits to PF. Therefore, we sought to evaluate the efficacy and toxicity of docetaxel, cisplatin, and fluorouracil (TPF) for inoperable recurrent or metastatic HNSCC.
  
  
  METHODS
  A retrospective chart review from January 2005 to March 2013 identified patients who were treated with docetaxel 60 mg/m(2) on day 1, followed by cisplatin 60 mg/m(2) on day 1, and fluorouracil 600 mg/m(2)/day on days 1-5 (modified TPF) every 4 weeks for inoperable recurrent or metastatic HNSCC.
  
  
  RESULTS
  Twenty-four patients were identified; seven and five patients had locoregional disease only and distant metastasis only, respectively, while 12 patients had locoregional disease and distant metastasis simultaneously. Of the 17 patients with distant metastasis, multiple organs were affected in 9 patients, with the most frequently affected organ being the lung (n=11). Three patients had no prior treatment, whereas 21 patients underwent intensive prior treatment. In 17 of 21 patients who had received prior treatment, the treatment included chemoradiotherapy and/or chemotherapy. The median number of cycles of modified TPF was two (range, 1-5). One patient showed complete response, four patients showed partial response, two patients had stable disease, and 17 patients had progressive disease. Overall, the rate of objective response was 21%, with a 95% confidence interval (CI) of 9-40%. Median overall survival was 8.0 months (95%CI, 4.4-10.6 months). The treatment efficacy differed significantly according to extent of disease. Objective response in patients with distant metastasis alone was better than in patients with locoregional disease with or without distant metastasis (60% vs. 11%, respectively; P=0.02). Median overall survival in the former patients was longer than in the latter patients (not reached vs. 7.0 months, respectively; P=0.02). Fifteen patients (63%) had Grades 3-4 neutropenia, and seven patients (29%) developed Grade 3 febrile neutropenia. There were no toxic deaths.
  
  
  CONCLUSIONS
  The efficacy of modified TPF in the setting of first-line treatment for recurrent or metastatic HNSCC is not very high, while the toxicity is acceptable with extensive care. The development of more efficacious chemotherapeutic regimen is required.
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Hironori
authors.initials: H
authors.lastname: Cho
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Suetaka
authors.initials: S
authors.lastname: Nishiike
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Takenaka
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Nakahara
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Toshimichi
authors.initials: T
authors.lastname: Yasui
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hanamoto
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan. Electronic address: hinohara@ent.med.osaka-u.ac.jp.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Inohara
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D015331:Cohort Studies; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D012189:Retrospective Studies; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: Chemotherapy; Cisplatin; Docetaxel; Fluorouracil; Recurrent or metastatic head and neck squamous cell carcinoma; TPF