title: Cisplatin-based chemoradiation plus cetuximab in locally advanced head and neck cancer: a phase II clinical study.
abstract: BACKGROUND
  Intensification of chemoradiation for advanced head and neck squamous cell carcinoma (HNSCC) is unlikely due to toxicity. Cetuximab combined either with radiotherapy or with chemotherapy showed favourable toxic profile with positive results in both combinations. Therefore, cetuximab could intensify chemoradiation without worsening toxicity. We conducted a phase II study of chemoradiation and cetuximab.
  
  
  METHODS
  Eligible patients had stage III-IV M0 HNSCC. Treatment consisted of three cycles of cisplatin (20 mg/m(2)/day × 5 days) and fluorouracil (200 mg/m(2)/day × 5 days) rapidly alternated to three split courses of radiotherapy up to 70 Gy and concurrent weekly cetuximab. The primary end point of the study was complete response (CR) rate. Secondary end points were toxicity, progression-free survival (PFS) and overall survival (OS).
  
  
  RESULTS
  Fourty-five patients were enrolled: median age was 56 years, 38 had stage IV disease and 40 nodal involvement. CR occurred in 32 patients (71%). PFS and OS was 21+ months and 32.6+, respectively. Acute grade 3-4 toxic effects were in the expected range, but grade 3 radiodermatitis occurred in 33 patients.
  
  
  CONCLUSIONS
  The combination of cetuximab, cisplatin, fluorouracil and radiotherapy leads to a very high proportion of CR and it is feasible with toxic effects similar to those expected by radiochemotherapy. The only unexpected toxicity was skin toxicity: grade 3 radiodermatitis occurred in 73% of the patients.
authors.affiliation: Department of Medical Oncology. Electronic address: mcmerlano@tiscali.it.
authors.forename: M
authors.initials: M
authors.lastname: Merlano
authors.affiliation: Department of Radiation Therapy, S. Croce General Hospital, Cuneo.
authors.forename: E
authors.initials: E
authors.lastname: Russi
authors.affiliation: Department of Medical Oncology, La Spezia General Hospital, La Spezia.
authors.forename: M
authors.initials: M
authors.lastname: Benasso
authors.affiliation: Department of Radiation Therapy, National Institute for Cancer Research, Genoa.
authors.forename: R
authors.initials: R
authors.lastname: Corvò
authors.affiliation: Department of Medical Oncology.
authors.forename: I
authors.initials: I
authors.lastname: Colantonio
authors.affiliation: Department of Radiation Therapy, S. Croce General Hospital, Cuneo.
authors.forename: R
authors.initials: R
authors.lastname: Vigna-Taglianti
authors.affiliation: Department of Medical Oncology, La Spezia General Hospital, La Spezia.
authors.forename: V
authors.initials: V
authors.lastname: Vigo
authors.affiliation: Department of Radiation Therapy, National Institute for Cancer Research, Genoa.
authors.forename: A
authors.initials: A
authors.lastname: Bacigalupo
authors.affiliation: Department of Medical Oncology, Aosta General Hospital, Aosta.
authors.forename: G
authors.initials: G
authors.lastname: Numico
authors.affiliation: Department of Medical Oncology.
authors.forename: N
authors.initials: N
authors.lastname: Crosetto
authors.affiliation: Department of Medical Oncology.
authors.forename: M
authors.initials: M
authors.lastname: Gasco
authors.affiliation: Department of Medical Oncology.
authors.forename: C
authors.initials: C
authors.lastname: Lo Nigro
authors.affiliation: Department of Otorhinolaryngology.
authors.forename: R
authors.initials: R
authors.lastname: Vitiello
authors.affiliation: Clinical Trials Office, Department of Medical Oncology, S. Croce General Hospital, Cuneo, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Violante
authors.affiliation: Department of Medical Oncology.
authors.forename: O
authors.initials: O
authors.lastname: Garrone
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D000068818:Cetuximab; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011855:Radiodermatitis / Q000139:chemically induced; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068818:Cetuximab; D002945:Cisplatin