Differentiated Thyroid Cancer Clinical Trial
Official title:
Impact of BRAFV600E Intratumor Heterogeneity on the Efficacy of Tyrosine Kinase Inhibitors in the Treatment of Radioiodine-resistant Thyroid Cancer
- Background: BRAFV600E is the most frequent oncogene in differentiated thyroid cancer
(DTC) occurring in about 50% of cases. Clinical trials with tyrosine kinase inhibitors
(TKI) with specific activity against BRAF in metastatic radioiodine-resistant DTC
(MRR-DTC) are ongoing. Very recently it has been demonstrated that DTC often consists
of a mixture of tumor cells with wild-type and mutant BRAF. The subclonal occurrence of
BRAFV600E in MRR-DTC could disable the therapy with BRAF targeted TKI and be
responsible of the frequent defeats of this treatment. A therapeutic strategy based
upon BRAF inhibitors in tumors bearing subclonal BRAFV600E could be initially
successful hitting the tumor cells expressing the oncogene, and after the initial tumor
growth arrest and/or shrinkage, the oncogene negative cells insensitive or less
sensitive to the treatment, could restart the growth of the tumor causing the
progression of the disease and the escape from the clinical response.
- Aims: To determine the impact of subclonal BRAFV600E on the efficacy of BRAF inhibitors
in the treatment of MRR-DTC.
- Study design: Primary tumor tissues will be analyzed for the presence of BRAFV600E by
pyrosequencing or other quantitative assay. If available, synchronous metastases and
post-therapy metachronous metastases will be analyzed as well. The clinical response
will be determined according to RECIST, and the association with the percentage of
BRAFV600E alleles will be evaluated. Attention will be paid to the possible difference
of BRAFwild-type/BRAFV600E ratio between primary tumors and synchronous metastases,
primary tumors and post-therapy metachronous metastases, and between responsive and
resistant synchronous tumor lesions.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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