Updated Eligibility Criterion Warranted in Clinical Trials of Patients With ATC

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Having a prior malignancy did not significantly impact overall survival (OS) in patients with anaplastic thyroid cancer (ATC), according to findings from a retrospective cohort study.¹

These findings warrant revisions to the eligibility criteria for the enrollment of patients with ATC into clinical trials.

"We found that 14% and 23% of ATC patients had a history of clinically-documented thyroid and non-thyroid malignancies prior to ATC diagnosis, respectively. Since ATC is a rare cancer, enrollment in clinical trials is a key determinant of patient outcomes as well as progress in the field. A history of prior malignancies has traditionally been an exclusion criterion in ATC patients seeking to enroll in clinical trials. In this study, we found that prior thyroid and non-thyroid malignancy do not significantly impact survival outcomes in patients with ATC," Jennifer Rui Wang, MD, PhD, assistant professor of Head and Neck Surgery at The University of Texas MD Anderson Cancer Center told Targeted Oncology^TM.

Traditionally, the presence of thyroid and nonthyroid malignancies has been an exclusion criterion for patients with ATC when looking to enroll in a clinical trial. To further assess the impact of prior malignancies on OS in this patient population, experts at MD Anderson Cancer Center evaluated 451 patients with ATC in a retrospective cohort study.

Patients included in the study were treated between 2000 and 2019, and clinical and pathological information was obtained through chart review. Investigators assessed survival analyses which were conducted using the Kaplan–Meier method and multivariable Cox proportional hazard models.

In 62 of the patients enrolled (14%), there was a history of clinically documented differentiated thyroid cancer (DTC) reported. Most commonly, this DTC was papillary thyroid cancer, as it was aseen in 50 of the patients (81%). The median time from diagnosis of prior DTC to ATC diagnosis was 3.5 years (range, 6 months-35 years). Additionally, 234 (52%) patients had concomitant DTC, and 102 patients (23%) had a history of nonthyroid cancer. Of those 102 patients with nonthyroid cancer, 19% (n = 87) had 1, 2% (n = 10) had 2, and 1% (n = 5) had 3 prior cancers.

The median time from diagnosis of prior nonthyroid cancer to the diagnosis of ATC was 8 years (range, 3 months-53 years). Prior nonthyroid cancers that were most common in patients included nonmelanoma skin (28.4%), prostate (19.6%), and breast cancers (16.7%).

"The cohort of patients included in the study include all patients that were treated at MD Anderson Cancer Center, a tertiary care cancer center within a 9 year time frame between 2000-2019. Average age at ATC diagnosis was 66 years of age. The majority of patients had stage IVC disease at presentation [with distant metastases]. Median overall survival as 8.4 months, reflective of the aggressive disease biology of ATC," added Wang.

A subgroup analysis was then performed in patients with available tumor mutation information (n = 183). Researchers found that the frequency of detected tumor driver mutations, including BRAF, RAS, TP53, was not significantly different between patients with ATC who either had or did not have a history of nonthyroid cancer.

After adjusting for age and overall stage on the multivariate analysis, prior DTC, concomitant DTC, and prior nonthyroid cancers each showed there to be no significant impact on OS.

These findings support the need to revise the eligibility criteria for patients with ATC wanting to enroll into clinical trials as data showed that the presence of a prior malignancy did not significantly impact OS among patients with ATC.

REFERENCE:

Chen YH, Cabanillas M, Sperling J, et al. Prior thyroid and nonthyroid cancer history do not significantly alter overall survival in patients diagnosed with anaplastic thyroid cancer. Thyroid. 2023;33(3):321-329. doi:10.1089/thy.2022.0350