title: Phase II study of preoperative concurrent chemoradiation therapy with S-1 in patients with T4 oral squamous cell carcinoma.
abstract: OBJECTIVE
  To determine the feasibility and efficacy of preoperative concurrent chemoradiation therapy (CCRT) with S-1, an oral fluoropyrimidine derivative, in patients with T4 oral squamous cell carcinoma (SCC).
  
  
  METHODS
  Only patients with histologically proven T4 oral SCC were included. Radiotherapy (total dose, 30 Gy) was delivered in 2-Gy daily fractions over a period of 3 weeks. Concurrently, S-1 (80 mg/m(2)/day) was administered orally twice daily for 14 consecutive days.
  
  
  RESULTS
  We enrolled 46 patients. All underwent radiotherapy as planned; however, oral S-1 was discontinued in 3 patients who manifested acute toxicity. Grade 3 toxicities were mucositis (20%), anorexia (9%), and neutropenia (4%). We encountered no Grade 4 adverse events or serious postoperative morbidity requiring surgical intervention. After CCRT, 32 of the 46 patients underwent radical resection; in 17 (53%) of the operated patients, the pathologic response was complete. During follow-up ranging from 7 to 58 months (median, 22 months), tumor control failed in 5 (16%) of the 32 operated patients; there were 3 local and 2 regional failures. Of the 14 non-operated patients, 8 (57%) manifested local (n = 7) or regional failure (n = 1). The 3-year overall survival rate for all 46 patients was 69%; it was significantly higher for operated than for non-operated patients (82% vs. 48%; p = 0.0288).
  
  
  CONCLUSIONS
  Preoperative CCRT with S-1 is feasible and effective in patients with T4 oral SCC. Even in inoperable cases, CCRT with S-1 provides adequate tumor control.
authors.affiliation: Department of Oral and Maxillofacial Surgery, Kumamoto University Hospital, Honjo, Kumamoto, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Nomura
authors.forename: Ryuji
authors.initials: R
authors.lastname: Murakami
authors.forename: Ryo
authors.initials: R
authors.lastname: Toya
authors.forename: Keiko
authors.initials: K
authors.lastname: Teshima
authors.forename: Aya
authors.initials: A
authors.lastname: Nakahara
authors.forename: Toshinori
authors.initials: T
authors.lastname: Hirai
authors.forename: Akimitsu
authors.initials: A
authors.lastname: Hiraki
authors.forename: Hideki
authors.initials: H
authors.lastname: Nakayama
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Yoshitake
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Ota
authors.forename: Takehisa
authors.initials: T
authors.lastname: Obayashi
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Yamashita
authors.forename: Natsuo
authors.initials: N
authors.lastname: Oya
authors.forename: Masanori
authors.initials: M
authors.lastname: Shinohara
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy / Q000379:methods; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D011300:Preoperative Care; D011446:Prospective Studies; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011879:Radiotherapy Dosage; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D004338:Drug Combinations; D011838:Radiation-Sensitizing Agents; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid