Updated Eligibility Criteria Confirmed in Clinical Trials in ATC Patients

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According to the results of a retrospective cohort study, the history of malignancy had no significant effect on overall survival (OS) in patients with anaplastic thyroid carcinoma (ATC).¹

These findings warrant revision of eligibility criteria for enrollment of ATC patients in clinical trials.

“We found that 14% and 23% of patients with ATC had clinically documented histories of thyroid and non-thyroid malignancies, respectively, prior to ATC diagnosis. Enrollment in clinical trials is an important determinant of patient outcome.A history of previous malignancy has traditionally been an exclusion criterion for ATC patients seeking enrollment in clinical trials. and non-thyroid malignancies did not significantly affect survival in patients with ATC,” said Jennifer Rui Wang, MD, PhD, assistant professor of head and neck surgery at the University of Texas MD Anderson Cancer Center. told Targeted Oncology.^TMs.

Traditionally, the presence of thyroid and non-thyroid malignancies has been an exclusion criterion for ATC patients when considering enrollment in clinical trials. To further evaluate the impact of previous malignancies on OS in this patient population, MD Anderson Cancer Center experts retrospectively evaluated 451 of her ATC patients in her cohort study.

Patients included in the study were treated between 2000 and 2019, and clinical and pathological information was obtained through chart review. Investigators evaluated survival analyzes performed using the Kaplan-Meier method and the multivariable Cox proportional hazards model.

A clinically documented history of differentiated thyroid cancer (DTC) was reported in 62 (14%) of the enrolled patients. Most commonly, this DTC is papillary thyroid carcinoma and was seen in 50 patients (81%). The median time from previous DTC diagnosis to ATC diagnosis was 3.5 years (range, 6 months–35 years). In addition, 234 (52%) patients had his DTC, and 102 patients (23%) had a history of non-thyroid cancer. Of the 102 patients with nonthyroid cancer, 19% (n = 87) had one, 2% (n = 10) had two, and 1% (n = 5) had three cancers. was

The median time from diagnosis of nonthyroid cancer to diagnosis of ATC was 8 years (range 3 months to 53 years). The most common previous non-thyroid cancers in patients included non-melanoma skin (28.4%), prostate (19.6%), and breast cancer (16.7%).

“The cohort of patients included in this study included all patients treated at MD Anderson Cancer Center, a tertiary care cancer center, within the nine-year time frame from 2000 to 2019. The mean age at ATC diagnosis was 66. The majority had stage IVC disease at the time of patient presentation. [with distant metastases]Median overall survival was 8.4 months, reflecting the aggressive disease biology of ATC,” Wang added.

Subgroup analyzes were then performed in patients with available tumor mutational information (n = 183). Researchers found that the frequency of detected tumor driver mutations was Bluff, Russ, TP53there was no significant difference between ATC patients with or without a history of non-thyroid cancer.

After adjusting for age and overall stage in multivariate analysis, history of DTC, concurrent DTC, and history of nonthyroid cancer, respectively, were shown to have no significant effect on OS.

These findings highlight the need to revise the eligibility criteria for ATC patients wishing to enroll in clinical trials, as the data showed that the presence of previous malignancies had no significant impact on OS in ATC patients. I back it up.

reference:

Cheng YH, Kavanillas M, Sperling J, et al In patients diagnosed with anaplastic thyroid cancer, history of thyroid and nonthyroid cancer has no significant impact on overall survival . thyroid2023;33(3):321-329. doi:10.1089/thy.2022.0350