title: Cetuximab plus platinum-based chemotherapy in head and neck squamous cell carcinoma: a retrospective study in a single comprehensive European cancer institution.
abstract: BACKGROUND
  The use of cetuximab in combination with platinum (P) plus 5-fluorouracil (F) has previously been demonstrated to be effective in the treatment of metastatic squamous cell cancer of head and neck (SCCHN). We investigated the efficacy and outcome of this protocol as a first-line treatment for patients with recurrent or metastatic disease. We evaluated overall-survival (OS), progression-free-survival (PFS), overall response rate (ORR) and the treatment toxicity profile in a retrospective cohort.
  
  
  METHODS
  This study enrolled 121 patients with untreated recurrent or metastatic SCCHN. The patients received PF+ cetuximab every 3 weeks for a maximum of 6 cycles. Patients with stable disease who received PF+ cetuximab continued to receive cetuximab until disease progressed or unacceptable toxic effects were experienced, whichever occurred first.
  
  
  RESULTS
  The median patient age was 53 (37-78) years. The patient cohort was 86.8% male. The addition of cetuximab to PF in the recurrent or metastatic setting provided an OS of 11 months (Confidential Interval, CI, 95%, 8.684-13.316) and PFS of 8 months (CI 95%, 6.051-9.949). The disease control rate was 48.9%, and the ORR was 23.91%. The most common grade 3 or 4 adverse events in the PF+ cetuximab regimen were febrile neutropenia (5.7%), skin rash (3.8%) and mucosistis (3.8%).
  
  
  CONCLUSIONS
  The results of this study suggest that cetuximab plus platinum-fluorouracil chemotherapy is a good option for systemic treatment in advanced SSCHN patients. This regimen has a well-tolerated toxicity profile.
authors: Department of Medical Oncology, Head and Neck Unit, Portuguese Oncology Institute, Porto, Portugal ; Department of Medicine and Biomedical Sciences, School of Medicine, University of Algarve, Faro, Portugal ; Department of Medicine, Faculty of Medicine, University of Porto, Porto, Portugal.
authors: Ramon Andrade
authors: RA
authors: de Mello
authors: Service of Otorhinolaryngology, Head and Neck Unit, Portuguese Oncology Institute, Porto, Portugal ; Department of Otorhinolaryngology and Cervical Facial Surgery, Centro Hospitalar de Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal.
authors: Sandra
authors: S
authors: Gerós
authors: Department of Medical Oncology, Head and Neck Unit, Portuguese Oncology Institute, Porto, Portugal.
authors: Marcos Pantarotto
authors: MP
authors: Alves
authors: Department of Medicine, Faculty of Medicine, University of Porto, Porto, Portugal.
authors: Filipa
authors: F
authors: Moreira
authors: Department of Medical Oncology, Head and Neck Unit, Portuguese Oncology Institute, Porto, Portugal.
authors: Isabel
authors: I
authors: Avezedo
authors: Department of Medical Oncology, Head and Neck Unit, Portuguese Oncology Institute, Porto, Portugal.
authors: José
authors: J
authors: Dinis
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D000068818:Cetuximab; D018572:Disease-Free Survival; D005060:Europe; D005260:Female; D005472:Fluorouracil / Q000494:pharmacology / Q000627:therapeutic use; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D010984:Platinum / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077195:Squamous Cell Carcinoma of Head and Neck; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D010984:Platinum; D000068818:Cetuximab; D005472:Fluorouracil