title: Phase 2 study of docetaxel, cisplatin, and concurrent radiation for technically resectable stage III-IV squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  We investigated the efficacy and safety of weekly low-dose docetaxel and cisplatin therapy concurrent with conventionally fractionated radiation in patients with technically resectable stage III-IV squamous cell carcinoma of the head and neck.
  
  
  METHODS
  Between March 2004 and October 2011, we enrolled 117 patients, of whom 116 were analyzable (43 had oropharyngeal cancer, 54 had hypopharyngeal cancer, and 19 had laryngeal cancer), and 85 (73%) had stage IV disease. Radiation consisted of 66 Gy in 33 fractions. Docetaxel, 10 mg/m(2), followed by cisplatin, 20 mg/m(2), administered on the same day were given once a week for 6 cycles. The primary endpoint was overall complete response (CR) rate after chemoradiation therapy. Human papillomavirus (HPV) DNA in oropharyngeal cancer was examined by PCR.
  
  
  RESULTS
  Of 116 patients, 82 (71%) completed treatment per protocol; 102 (88%) received the full radiation therapy dose; and 90 (78%) and 12 (10%) patients received 6 and 5 chemotherapy cycles, respectively. Overall CR rate was 71%. After median follow-up of 50.9 months (range: 15.6-113.9 months for surviving patients), 2-year and 4-year overall survival rates were 82% and 68%, respectively. Cumulative 2-year and 4-year local failure rates were 27% and 28%, respectively, whereas distant metastasis rates were 15% and 22%, respectively. HPV status in oropharyngeal cancer was not associated with treatment efficacy. Acute toxicity included grade 3 and 4 in-field mucositis in 73% and 5% of patients, respectively, whereas myelosuppression and renal injury were minimal. No patients died of toxicity. Feeding tube dependence in 8% and tracheostomy in 1% of patients were evident at 2 years postchemoradiation therapy in patients who survived without local treatment failure.
  
  
  CONCLUSIONS
  Local control and survival with this regimen were satisfactory. Although acute toxicity, such as mucositis, was common, late toxicity, such as laryngoesophageal dysfunction, was minimal. Therapy using weekly low-dose docetaxel and cisplatin concurrent with radiation warrants further evaluation.
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
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: Tadashi
authors.initials: T
authors.lastname: Yoshii
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: 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: Yoichiro
authors.initials: Y
authors.lastname: Tomiyama
authors.affiliation: Department of Radiation Oncology, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Seo
authors.affiliation: Department of Radiation Oncology, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Isohashi
authors.affiliation: Department of Radiation Oncology, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Suzuki
authors.affiliation: Department of Radiation Oncology, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Yoshioka
authors.affiliation: Department of Radiation Oncology, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Iori
authors.initials: I
authors.lastname: Sumida
authors.affiliation: Department of Radiation Oncology, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Ogawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy* / Q000821:virology; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D004279:DNA, Viral / Q000302:isolation & purification; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy* / Q000821:virology; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy; D007822:Laryngeal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D059351:Organ Sparing Treatments / Q000379:methods; D009959:Oropharyngeal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy / Q000821:virology; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification; D016879:Salvage Therapy; D000077195:Squamous Cell Carcinoma of Head and Neck; D013280:Stomatitis / Q000209:etiology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage*
chemical_list: D004279:DNA, Viral; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin