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
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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.