Safety and Efficacy of Sorafenib in Patients With Advanced Thyroid Cancer: a Phase II Clinical Study
Status:
Completed
Trial end date:
2019-11-01
Target enrollment:
Participant gender:
Summary
Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and
C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a
rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in
Colombia, 2010).
Although this disease has a low rate of attributable mortality, the costs arising from
treatment, monitoring, and disabilities among affected patients and their families are high
for the health system.
The therapeutic approach to differentiated thyroid cancer once it starts progressing is
limited; there are no truly favorable treatment options for patients with advanced thyroid
cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.
Molecular biology now allows the identification of the effects of mutations and alterations
in the proteins that participate in cell signaling which account for dedifferentiation,
invasiveness, and the progression of neoplastic cells.
VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be
addressed by targeted molecular therapy. Its increased expression in differentiated thyroid
cancer has been demonstrated and has been associated with increased growth, invasiveness, and
shorter recurrence-free survival.
Different agents are effective against this tyrosine kinase receptor; nevertheless, taking
into account that it is not solely responsible for tumor progression, according to clinical
study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as
sorafenib and motesanib. These inhibitors have already been tested in phase II studies.
Results from recent phase II research studies using these emerging treatment options have
shown important effects in the therapeutic approach to other solid neoplasms.
Information about the safety of this type of treatment is limited; a need for information
regarding the use of new therapeutic approaches in Colombia is one of the contributions that
the National Institute of Cancer can make to the country through this study.