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Temodar and Xeloda for neuroendocrine cacner

Posted Nov 20 2009 10:02pm

CVS/Caremark policy considers Temodar unapproved for lack of efficacy or of harm. Most of the available information is in abstract form. A retrospective review suggest that a combination of T + C is active, well tolerated and may prolong survival and palliate symptoms in pts with neuroendocrine tumors, a malignancy closely relatd to islet cell (NET).

InN 2008 abstract, 17 patients received this combination as front-line chemotherapy. There were three gastrinomas (17%), two insulinomas (12%), two glucagonomas (12%), and ten nonfunctioning tumors (59%). Twelve patients (71%) had a partial response and five patients (29%) had stable disease. With a median follow-up of 12 months, there were no cases of disease progression. Only 1 patient (6%) experienced a grade 3/4 toxicity (idiosyncratic immune thrombocytopenia secondary to capecitabine).

There is an ongogin study: Phase II Study of Capecitabine and Temozolomide for Progressive, Differentiated, Metastatic Neuroendocrine Cancers. This phase II study is designed to assess whether treatment with capecitabine/temozolomide ('CAP/TEM') is safe and effective in treating subjects with progressive, differentiated, metastatic neuroendocrine tumors (NET).The primary objective of the study is to determine the radiologic response rate to this regimen in progressive, metastatic, differentiated neuroendocrine cancers. Secondary objectives include determining the overall and one year survival rates to this regimen, to determine progression free survival, to assess toxicities, improvement of quality of life, biochemical responses of tumor markers, and relief from NET symptoms.

J. R. Strosberg, J. Choi, N. Gardner, L. Kvols, First-line treatment of metastatic pancreatic endocrine carcinomas with capecitabine and temozolomide. J Clin Oncol 26: 2008 (May 20 suppl; abstr 4612)

Isacoff, W. H., Moss, R. A., Pecora, A. L., Fine, R. L.
Temozolomide/capecitabine therapy for metastatic neuroendocrine tumors of the pancreas. A retrospective review
J Clin Oncol (Meeting Abstracts) 2006 24: 14023

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