Lay Summary: Xeloda is a reasonable palliative option in metastatic head and neck cancer.
Xeloda for palliatve use in head and neck cancer is supported by 2 phase II studies. Xeloda is active in head and neck cancer as it its close relative 5FU and there are a number of studies of Xeloda in combination with platin drugs that confirm its effectiveness. Xeloda is NOT NCCN CHEM-A, 2 recommended as a single agent or in combination for palliation and ,as a large tablet, it is sometimes difficult for patients to swallow it. It is not FDA approved for this indication and would be considered off-label.
Most recently, Peron (2012) studied Xeloda as a single agent in 25 heavily pre-trerated patients. Twenty-five patients (86%) had received at least three previous lines of chemotherapy. The disease control rate was 48% (95% CI: 29-67%). The median progression-free survival was 2.0 months (95% CI: 0.1-3.9 months) and the median overall survival was 7.0 months (95% CI: 4.1-9.9 months). Hand-foot syndrome, fatigue, and mucositis were the most frequent severe side effects. No patient died, and only three patients discontinued treatment because of side effects. Capecitabine seemed to be an active and well-tolerated regimen, even in heavily pretreated, frail patients.
Arnedos M, Carbonell X, et al. Phase I Study of Capecitabine in Combination With Platinol in Patients (pts) With Advanced and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN). Annals of Oncology. 2002. 13(Suppl. 5): p. A#567.
J. Martínez-Trufero, D. Isla, J. C. Adansa, R. Hitt, J. J. Cruz, Phase II study of capecitabine (X) as palliative treatment for patients (p) with squamous head and neck cancer (HNC) with locoregional and/or metastatic relapse after previous platinum-based treatment (PBT): An interim analysis. Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 6074
J. Martinez-Trufero, D. Isla, J. C. Adansa, A. Irigoyen, R. Hitt, J. Lambea, J. J. Cruz; Hospital Miguel Servet, Zaragoza, Spain; Hospital Clinico Lozano Blesa, Zaragoza, Spain; Hospital Clinico Universitario, Salamanca, Spain; Hospital Virgen de las Nieves, Granada, Spain; Hospital Doce de Octubre, Madrid, Spain Phase II study of capecitabine as palliative treatment for patients (p) with squamous head and neck cancer (HNC) with locoregional and/or metastatic relapse after previous platinum-based treatment (PBT): Final results of Spanish Head and Neck Cancer Group (TTCC).
J Clin Oncol 27:15s, 2009 (suppl; abstr 6047)
Péron J, Poupart M, Ceruse P, Ramade A, Girodet D, Zrounba P, Fayette J Efficacy and safety of capecitabine in heavily pretreated recurrent/metastatic head and neck squamous cell carcinoma.Anticancer Drugs. 2012 Nov;23(10):1107-11.