Cancer Treatment Today » Thyroid cancer

Afirma test for thyroid nodules: ACEG – pro

M Levin, MD — Thu, 03 Oct 2013 02:28:37 +0000

The majority of FNAs of tyroid nodules show benign histological findings but some are indeterminate or non-diagnostic. In an attempt to separate out patients with a worse prognosis, Afirma has develoiped a proprietory tests, Benign Gene Expression Classifier. In 2010, two modest-sized validation studies showed that the AGEC test could identify a benign gene expression signature in indeterminate cytology thyroid FNA samples with a negative predictive value >95%.

Independent evaluations of the test have been positive. Palmetto Government Benefits Administrators (Palmetto GBA), the CMS Medicare Administrative Contractor with oversight for the Afirma GEC, has published its assessment of the test as an update to its local coverage article on molecular diagnostics. This review determined that the test meets criteria for analytical and clinical validity, and clinical utility as a reasonable and necessary Medicare benefit, effective January 1, 2012.25. As part of the CLIA Laboratory licensure process, the analytical and clinical validation data for the Afirma GEC were independently assessed by reviewers from the California Department of Public Health and the New York State Department of Health.26,27 Both of these reviews resulted in a favorable licensure outcome.

The National Comprehensive Cancer Network (NCCN) thyroid carcinoma guidelines were updated in December, 2012 to state “Molecular diagnostics may be useful to allow reclassification of follicular lesions (follicular neoplasm or follicular lesion of undetermined significance) as more likely to be benign or more likely to be malignant…If molecular testing predicts a risk of malignancy comparable to the risk of malignancy seen with a benign FNA cytology (approximately 5% or less), consider observation.” The NCCN guidelines for abnormal gene/gene expression profile testing are associated with Level of Evidence 2A (lower level evidence, uniform NCCN consensus that the intervention is appropriate)

Daniel S. Duick et al, The Impact of Benign Gene Expression Classifier Test Results on the Endocrinologist–Patient Decision to Operate on Patients with Thyroid Nodules with Indeterminate Fine-Needle Aspiration Cytopathology, Thyroid. 2012 October; 22(10): 996–1001.

Syed Z. Ali, etal, Use of the Afirma® Gene Expression Classifier for Preoperative Identification of Benign Thyroid Nodules with Indeterminate Fine Needle Aspiration Cytopathology, PLoS Curr. 2013 February 11; 5

Axitinib and sorafenib for thyroid cancer

M Levin, MD — Fri, 26 Oct 2012 14:07:43 +0000

Medullary and papillary thyroid carcinoma (MTC and PTC) are two types of thyroid cancer that can originate from activating mutations or rearrangements in the RET gene. Axitinib has been studied for thyroid cancer. Two phase II studies were reported in the Journal of Clinical Oncology evaluating different axitinib and sorafenib therapies in patients with advanced thyroid cancer have special significance. Eligible patients in both studies included a full spectrum of thyroid cancer histologic subtypes—from differentiated to anaplastic, with both medullary and nonmedullary cancers allowed—but papillary and follicular histologies predominated. Although no complete responses were reported, a significant minority of patients had a major response to therapy by Response Evaluation Criteria in Solid Tumors (RECIST): 30% and 23%, respectively, for axitinib and sorafenib. Stable disease for no less than 3 months was also common, reported in 38% and 53%, respectively. Median progression-free survival rates were similar in both studies at approximately 18 months. The oral route of administration and noncytotoxic, targeted mechanism of action did not mean a lack of side effects. Grade 3 or 4 toxicities with both agents were not rare: 32% of patients treated with axitinib had at least one treatment-related adverse that was grade 3 or worse, and 47% of patients treated with sorafenib required dose reductions to control toxicities. Discontinuation of treatment occurred in 13% and 20% of patients treated with axitinib or sorafenib, respectively, because of toxicity.

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Alcohol injection for small thyroid cancers

M Levin, MD — Thu, 04 Oct 2012 22:02:45 +0000

Recurrent thyroid cancer can present as isolated localized nodules, which may persist for a long time, and may conceivably not require systemic treatment. Alcohol ablation involves injecting small recurrent thyroid cancers with alcohol using imaging such as ultrasound for placement. This procedure was pioneered at Mayo clinic and is not universally available. The concept is that this procedure can produce long term control or cure of such isolated recurrences. The Thyroid Associations guideline of 2009 says: “Data supporting the safety and efficacy of such techniques come largely from outside the United States). Long-term follow-up exists to 5 years, showing that PEI is effective and safe. In a large series of 125 patients, Tarantino et al. demonstrated an overall cure rate (absent uptake in the nodule) of 93%, and a major complication rate of 3%. These included transient laryngeal nerve damage, abscess, and hematoma. All patients remained euthyroid (low/normal TSH and normal free T₃ and free T₄ estimates) during follow-up. The average reduction in the volume of nodules after PEI was 66%. Given the relative lack of experience with these alternative techniques, ¹³¹I therapy and surgery remain the mainstay of treatment. PEI or alternative treatments should be employed only in the very rare situation when standard therapies have failed, or are contraindicated or refused.”

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