title: Phase II study of sorafenib in combination with cisplatin and 5-fluorouracil to treat recurrent or metastatic nasopharyngeal carcinoma.
abstract: BACKGROUND
  We aimed to investigate the efficacy and tolerability of sorafenib combined with cisplatin and 5-fluorouracil (5-FU) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).
  
  
  METHODS
  It was a Simon two-stage designed trial. Chemotherapy-naive patients with recurrent or metastatic disease were enrolled. The regimen was sorafenib 400 mg orally b.i.d., cisplatin 80 mg/m(2) i.v. day 1, and 5-FU 1000 mg/m(2)/day CIV for 4 days, repeated every 21 days. After a maximum of six cycles of chemotherapy, patients received maintenance of sorafenib.
  
  
  RESULTS
  In total, 54 patients were enrolled. The objective response rate reached 77.8%, including 1 complete response and 41 partial responses. The median progression-free survival was 7.2 months (95% CI 6.8-8.4 months), and the median overall survival was 11.8 months (95% CI 10.6-18.7 months). Major toxic effects included hand-foot skin reaction, myelosuppression, and gastrointestinal (GI) reaction. The incidence of hemorrhage was 22.2%, and one patient with liver metastases died of GI bleeding. Contrast-enhanced ultrasonography was carried out in a subset of patients with liver metastases.
  
  
  CONCLUSIONS
  Combination of sorafenib, cisplatin (80 mg/m(2)) and 5-FU (3000 mg/m(2)) was tolerable and feasible in recurrent or metastatic NPC. Further randomized trials to compare sorafenib plus cisplatin and 5-FU with standard dose of cisplatin plus 5-FU in NPC are warranted.
authors.affiliation: State Key Laboratory of Oncology in South China.
authors.forename: C
authors.initials: C
authors.lastname: Xue
authors.forename: Y
authors.initials: Y
authors.lastname: Huang
authors.forename: P Y
authors.initials: PY
authors.lastname: Huang
authors.forename: Q T
authors.initials: QT
authors.lastname: Yu
authors.forename: J J
authors.initials: JJ
authors.lastname: Pan
authors.forename: L Z
authors.initials: LZ
authors.lastname: Liu
authors.forename: X Q
authors.initials: XQ
authors.lastname: Song
authors.forename: S J
authors.initials: SJ
authors.lastname: Lin
authors.forename: J X
authors.initials: JX
authors.lastname: Wu
authors.forename: J W
authors.initials: JW
authors.lastname: Zhang
authors.forename: H Y
authors.initials: HY
authors.lastname: Zhao
authors.forename: F
authors.initials: F
authors.lastname: Xu
authors.forename: J L
authors.initials: JL
authors.lastname: Liu
authors.forename: Z H
authors.initials: ZH
authors.lastname: Hu
authors.forename: L P
authors.initials: LP
authors.lastname: Zhao
authors.forename: Y Y
authors.initials: YY
authors.lastname: Zhao
authors.forename: X
authors.initials: X
authors.lastname: Wu
authors.forename: J
authors.initials: J
authors.lastname: Zhang
authors.forename: Y X
authors.initials: YX
authors.lastname: Ma
authors.forename: L
authors.initials: L
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D002277:Carcinoma; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000556:secondary; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy*; D009362:Neoplasm Metastasis / Q000188:drug therapy / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077157:Sorafenib; D014463:Ultrasonography
chemical_list: D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib; D002945:Cisplatin; D005472:Fluorouracil