title: Efficacy and safety of weekly paclitaxel combined with cetuximab in the treatment of pretreated recurrent/metastatic head and neck cancer patients.
abstract: BACKGROUND
  The addition of cetuximab to weekly paclitaxel has demonstrated high efficacy in the first-line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN). However, this combination has been widely extended to patients who present resistance to first line chemotherapy (CT) or those who are not candidates for platinum-based CT.
  
  
  METHODS
  We have retrospectively analyzed the efficacy and safety of cetuximab in combination with weekly paclitaxel in patients with R/M-SCCHN who present disease progression after platinum schedules or those who were not candidates for platinum-based CT. Patients received weekly paclitaxel 80mg/m(2) and cetuximab 250mg/m(2) (initial dose of 400mg/m(2)) until progression or unacceptable toxicity.
  
  
  RESULTS
  Twenty-two patients were included. Median age was 58 (43-68), ECOG PS (0/1/2): 6/10/4, 19 patients had received prior platinum-based treatment (nine patients were platinum-sensitive and nine were platinum-refractory). With a median follow-up of 6.18months (range 1.3-29.7), overall response rate (ORR) was 55% (95% CI 31-76%):1 (5%) complete response and 9 (50%) partial responses. Median duration of response was 10.23months. Median progression free survival (PFS) and overall survival (OS) were 5.4 and 9.1months, respectively. There were no differences in response rate according to platinum sensitivity (66% sensitive vs 44% refractory; P=0.61). The main toxicity consisted of rash in 70% of patients (5% grade 3), with an association between rash severity and ORR (grade 0-1: 33% vs grade 2-3: 64%; P=0.03) and a trend for better PFS and OS.
  
  
  CONCLUSIONS
  Weekly paclitaxel in combination with cetuximab is a well tolerated and highly active second-line treatment in patients with R/MSCCHN who experience disease progression after platinum-based CT, including those who present resistant disease. Our results suggest that the efficacy of this combination is apparently superior than the published data on single agent cetuximab in this setting.
authors.affiliation: Hospital Universitario Virgen de la Victoria, Department of Medical Oncology, Málaga, Spain. begojrodriguez@gmail.com
authors.forename: Begoña
authors.initials: B
authors.lastname: Jiménez
authors.forename: José M
authors.initials: JM
authors.lastname: Trigo
authors.forename: Bella I
authors.initials: BI
authors.lastname: Pajares
authors.forename: Maria I
authors.initials: MI
authors.lastname: Sáez
authors.forename: Cristina
authors.initials: C
authors.lastname: Quero
authors.forename: Victor
authors.initials: V
authors.lastname: Navarro
authors.forename: Casilda
authors.initials: C
authors.lastname: Llácer
authors.forename: Laura
authors.initials: L
authors.lastname: Medina
authors.forename: Antonio
authors.initials: A
authors.lastname: Rueda
authors.forename: Emilio
authors.initials: E
authors.lastname: Alba
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068818:Cetuximab; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage; D012008:Recurrence
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D017239:Paclitaxel; D000068818:Cetuximab