991P - Retrospective study of weekly paclitaxel-cetuximab (WPC) in unselected patients (p) with recurrent/metastatic head and neck squamous cell carcinoma...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Head and Neck Cancers
Presenter Isabel Pajares Bernad
Citation Annals of Oncology (2016) 27 (6): 328-350. 10.1093/annonc/mdw376
Authors I. Pajares Bernad1, J. Mártinez Trufero2, L. Calera Urquizu2, A. Cebolleo de Miguel2, R. Pazo Cid2, M. Lanzuela Valero3, M.J. Agsustín4, E. Millastre2, C. Santander Lobera2, M. Alvarez Alejandro2, N. Gimeno5, M. Malo Yague6, Y. Llorente7, A. Antón Torres2
  • 1Department Of Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 2Department Of Medical Oncology, Hospital Miguel Servet, Zaragoza/ES
  • 3Department Of Radiotherapy, Hospital Miguel Servet, Zaragoza/ES
  • 4Department Of Pharmacy, Hospital Miguel Servet, Zaragoza/ES
  • 5Department Of Medical Oncology, Hospital Royo Villanova, Zaragoza/ES
  • 6Hematology Department, Hospital Ernest Lluch, Calatayud/ES
  • 7Supportive Care, Arrabal centre, Zaragoza/ES

Abstract

Background

WPC is an active treatment in RM-SCCHN, specially for unfit p not candidates to platinum. There are limited data so far about pronostic factors (PFs) in real-life practice.

Methods

Outcome data (Response and survival) along with PFs analysis of RM-SCCHN p treated in our centre with weekly paclitaxel (80 mg/m2) and Cetuximab (400/250 mg/m2) were retrospectively reviewed.

Results

148p were treated with WPC between January 2008 and July 2014. Female 15p (10,3%).Median age 62 years (38-87). Location: larynx 44p (29,7%), oral cavity 44p (29,7%), oropharynx 26p (17,6%), hipopharynx 11p (7,4%) and other 25p (15,6). Previous platinum-based therapy: 103p (69,6%) as initial treatment for localized stage, 31p (20,9%) for recurrent/metastatic disease. Stage: 101p (68,2%) unresectable/advanced disease, 9p(6,1%) metastatic disease and 38p (25,7%) both . Median number cycles: 9(1-27). 64p (43,2%) received cetuximab maintenance. Response rate (RR): 70p (47.3%) objetive response (OR)(complete + partial), 30p (20.3%) stable disease (SD), 48p (32.4%) progressive disease (PD). Median overall survival (OS) was 10 months(m) (95%CI;8.31-11.69) and progression free survival (PFS) was 7 m (95%CI;5.88-8.12). Analyzed PFs: Age, Sex, ECOG, Comorbidity index (CI)(ACE27 and Charslton CI), location, RR, stage, and albumin (Al), hemoglobin(Hb) and magnesium (Mg) serum levels were analyzed at baseline and monthly during therapy until PD or death. PD, basalAl level 1, Charslton CI >3, ECOG >1, previous disease free interval ≤ 20 m, Al basal level< 3gr/dl, Hb and Mg decrease. In MA, both PD and a 10% or less decrease in serum Mg levels were the only independent PFs for poor OS.

Conclusions

OS and PFS of a non-selected population of RM-SCCHN p treated with WPC was similar to that reported in a previous phase II trial, and comparable to platinum based treatment.Decrease of Mg levels during WPC therapy might be a prognostic biomarker that could be tested in prospective trials.

Clinical trial identification

Legal entity responsible for the study

Isabel Pajares Bernad

Funding

Department of Medical Oncology. Miguel Servet University Hospital

Disclosure

All authors have declared no conflicts of interest.