title: [Clinical analysis of nimotuzumab plus cisplatin and fluorouracil regimen as induction treatment in resectable head and neck squamous cell carcinoma].
abstract: OBJECTIVE
  A phase II study was conducted to test the efficacy and toxicity of the combination of cisplatin, 5-Fu and nimotuzumab, as induction treatment of resectable head and neck squamous cell carcinoma (HNSCC).
  
  
  METHODS
  Forty cases of resectable HNSCC were treated with nimotuzumab (400 mg on day 1) combined with PF regimens (cisplatin 75 mg/m² on days 1 and 5-Fu 750 mg/m² on days 1-5 q3wks). After 2 cycles, an organ-preservation local therapy (surgery or radiotherapy) was recommended. The primary endpoints of this study were overall response rate, pathologic complete response and safety of the induction treatment. Mean age of 40 patients was 54 years old, of them 9 patients with oropharyngeal cancer (22.5%), 16 hypopharyngeal cancer (40.0%), 10 laryngeal cancer (25.0%), and 5 oral cancer (12.5%).
  
  
  RESULTS
  With a 2-cycle induction treatment, 34 (85.0%) patients achieved complete or partial response. Twenty-four patients (60.0%) got downstage, with T downstage in 21 (52.5%) patients and N downstage in 8 (20.0%) patients. Totally 27 patients got surgery after the induction treatment, of them 20 patients (74.1%) preserved organ functions. Four patients' primary tumors (10.0% in all 40 patients and 14.8% in operated 27 patients) showed pathologically complete responses. The toxicity was mild and manageable. The most common grade 3/4 toxicities were neutropenia (5.0%), nausea/vomiting (2.5%), stomatitis (2.5%) and thrombocytopenia (2.5%). One patient got grade 2 renal insufficiency and one patient got grade 1 skin rash.
  
  
  CONCLUSIONS
  For resectable HNSCC, nimotuzumab plus PF regimen as induction treatment is highly effective for preserving the organ function and the toxicities are well tolerable.
authors.affiliation: Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai Medical School, Fudan University, China.
authors.forename: Xiao-ying
authors.initials: XY
authors.lastname: Zhao
authors.forename: Ye
authors.initials: Y
authors.lastname: Guo
authors.forename: Yong-xue
authors.initials: YX
authors.lastname: Zhu
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
authors.forename: Guo-pei
authors.initials: GP
authors.lastname: Zhu
authors.forename: Chao-su
authors.initials: CS
authors.lastname: Hu
authors.forename: Qing-hai
authors.initials: QH
authors.lastname: Ji
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077195:Squamous Cell Carcinoma of Head and Neck; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C501466:nimotuzumab; D002945:Cisplatin; D005472:Fluorouracil