title: Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma.
abstract: OBJECTIVE
  To evaluate induction chemotherapy with docetaxel, cisplatin, and fluorouracil (TPF) followed by surgery and postoperative radiotherapy versus up-front surgery and postoperative radiotherapy in patients with locally advanced resectable oral squamous cell carcinoma (OSCC).
  
  
  METHODS
  A prospective open-label phase III trial was conducted. Eligibility criteria included untreated stage III or IVA locally advanced resectable OSCC. Patients received two cycles of TPF induction chemotherapy (docetaxel 75 mg/m(2) on day 1, cisplatin 75 mg/m(2) on day 1, and fluorouracil 750 mg/m(2) on days 1 to 5) followed by radical surgery and postoperative radiotherapy (54 to 66 Gy) versus up-front radical surgery and postoperative radiotherapy. The primary end point was overall survival (OS). Secondary end points included local control and safety.
  
  
  RESULTS
  Of the 256 patients enrolled onto this trial, 222 completed the full treatment protocol. There were no unexpected toxicities, and induction chemotherapy did not increase perioperative morbidity. The clinical response rate to induction chemotherapy was 80.6%. After a median follow-up of 30 months, there was no significant difference in OS (hazard ratio [HR], 0.977; 95% CI, 0.634 to 1.507; P = .918) or disease-free survival (HR, 0.974; 95% CI, 0.654 to 1.45; P = .897) between patients treated with and without TPF induction. Patients in the induction chemotherapy arm with a clinical response or favorable pathologic response (≤ 10% viable tumor cells) had superior OS and locoregional and distant control.
  
  
  CONCLUSIONS
  Our study failed to demonstrate that TPF induction chemotherapy improves survival compared with up-front surgery in patients with resectable stage III or IVA OSCC.
authors.affiliation: Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Lai-ping
authors.initials: LP
authors.lastname: Zhong
authors.forename: Chen-ping
authors.initials: CP
authors.lastname: Zhang
authors.forename: Guo-xin
authors.initials: GX
authors.lastname: Ren
authors.forename: Wei
authors.initials: W
authors.lastname: Guo
authors.forename: William N
authors.initials: WN
authors.lastname: William
authors.forename: Jian
authors.initials: J
authors.lastname: Sun
authors.forename: Han-guang
authors.initials: HG
authors.lastname: Zhu
authors.forename: Wen-yong
authors.initials: WY
authors.lastname: Tu
authors.forename: Jiang
authors.initials: J
authors.lastname: Li
authors.forename: Yi-li
authors.initials: YL
authors.lastname: Cai
authors.forename: Li-zhen
authors.initials: LZ
authors.lastname: Wang
authors.forename: Xin-dong
authors.initials: XD
authors.lastname: Fan
authors.forename: Zhong-he
authors.initials: ZH
authors.lastname: Wang
authors.forename: Yong-jie
authors.initials: YJ
authors.lastname: Hu
authors.forename: Tong
authors.initials: T
authors.lastname: Ji
authors.forename: Wen-jun
authors.initials: WJ
authors.lastname: Yang
authors.forename: Wei-min
authors.initials: WM
authors.lastname: Ye
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.forename: Yue
authors.initials: Y
authors.lastname: He
authors.forename: Yan-an
authors.initials: YA
authors.lastname: Wang
authors.forename: Li-qun
authors.initials: LQ
authors.lastname: Xu
authors.forename: Bo-song
authors.initials: BS
authors.lastname: Wang
authors.forename: Merrill S
authors.initials: MS
authors.lastname: Kies
authors.forename: J Jack
authors.initials: JJ
authors.lastname: Lee
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Myers
authors.forename: Zhi-yuan
authors.initials: ZY
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000601:surgery*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects / Q000379:methods; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery*; D052016:Mucositis / Q000209:etiology; D009325:Nausea / Q000139:chemically induced; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil