title: Activity of weekly paclitaxel-cetuximab chemotherapy in unselected patients with recurrent/metastatic head and neck squamous cell carcinoma: prognostic factors.
abstract: BACKGROUND
  Standard treatment for recurrent/metastatic head and neck squamous cell carcinoma (RM-SCCHN) is based in on platinum and cetuximab combination therapy. Unfortunately, not all patients are candidates to receive platinum-based treatment, because of different conditions as comorbidity and poor performance status. Weekly paclitaxel and cetuximab (WPC) is an active therapeutic alternative, based on a phase II study, with less toxicity. Our main objective is to confirm its activity in unselected patients, mostly unfit for aggressive therapies, analysing also some clinically relevant prognostic factors (PFs).
  
  
  METHODS
  Retrospective data was collected for RM-SCCHN patients, treated at our institution between January 2008 and July 2014 with weekly paclitaxel (80 mg/m2) and cetuximab (400/250 mg/m2).
  
  
  RESULTS
  148 patients were treated. The objective response rate (OR) was as follows: 13 patients (8.78%) complete response (CR); 57 patients (38.51%) partial response (PR) and 30 patients (20.3%) stable disease (SD). Median overall survival (OS) was 10 months (95% CI 8.31-11.69) and median progression free survival (PFS) was 7 months (95% CI 5.88-8.12). Response to treatment showed independent prognosis relevance as PF in multivariate analysis for PFS and OS. Furthermore, decline in serum magnesium during the treatment was also an independent PF for OS.
  
  
  CONCLUSIONS
  WPC activity was confirmed as a useful therapy on real-life unselected RM-SCCHN patients, with similar benefit to that obtained in the phase II study, and comparable to platinum and cetuximab based treatment, confirming its value in unfit patients. In addition to treatment response, a change in serum magnesium values during treatment was proved as independent PF on OS.
authors.affiliation: Medical Oncology Department, Miguel Servet University Hospital, 1-3 Isabel la Catolica Avenue, 50009, Saragossa, Spain. ispaber@hotmail.com.
authors.forename: I Pajares
authors.identifier: http://orcid.org/0000-0003-4825-4977
authors.initials: IP
authors.lastname: Bernad
authors.affiliation: Medical Oncology Department, Miguel Servet University Hospital, 1-3 Isabel la Catolica Avenue, 50009, Saragossa, Spain.
authors.forename: J Martínez
authors.initials: JM
authors.lastname: Trufero
authors.affiliation: Medical Oncology Department, Miguel Servet University Hospital, 1-3 Isabel la Catolica Avenue, 50009, Saragossa, Spain.
authors.forename: L Calera
authors.initials: LC
authors.lastname: Urquizu
authors.affiliation: Medical Oncology Department, Miguel Servet University Hospital, 1-3 Isabel la Catolica Avenue, 50009, Saragossa, Spain.
authors.forename: R A
authors.initials: RA
authors.lastname: Pazo Cid
authors.affiliation: Medical Oncology Department, Miguel Servet University Hospital, 1-3 Isabel la Catolica Avenue, 50009, Saragossa, Spain.
authors.forename: A Cebollero
authors.initials: AC
authors.lastname: de Miguel
authors.affiliation: Pharmacy Department, Miguel Servet University Hospital, Saragossa, Spain.
authors.forename: M J
authors.initials: MJ
authors.lastname: Agustin
authors.affiliation: Radiotherapy Department, Miguel Servet University Hospital, Saragossa, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Lanzuela
authors.affiliation: Medical Oncology Department, Miguel Servet University Hospital, 1-3 Isabel la Catolica Avenue, 50009, Saragossa, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Antón
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality; D000068818:Cetuximab / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D000077195:Squamous Cell Carcinoma of Head and Neck; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D000068818:Cetuximab
keywords: Head and neck squamous cell carcinoma; Prognostic factors; Recurrent metastatic; Serum magnesium; Weekly paclitaxel cetuximab