Integrating next-generation sequencing (NGS) into clinical workflows proved feasible and provided information that could guide treatment decisions for patients with uterine cancer, according to research published in Gynecologic Oncology.
NGS provided “actionable information for targetable mutations and/or clinical trial enrollment in most patients,” according to researchers. However, there were racial disparities in targeted therapy initiation and clinical trial enrollment.
For this study, the researchers evaluated a workflow and infrastructure to implement NGS testing to help guide treatment decisions in 159 patients with uterine cancer. The patients had recurrent/progressive disease or newly diagnosed disease that was advanced and/or a high-risk histology.
The patients’ median age was 63 years (range, 33-86 years), 67.3% were Caucasian, 31.4% were African American, and 0.6% each were Asian and Hispanic. Histologic subtypes included endometrioid (42.1%), serous (21.4%), carcinosarcoma (12.6%), mixed histology (8.8%), leiomyosarcoma (7.5%), and “other” (7.5%).
For NGS, tumor samples were sent to Foundation Medicine, and the FoundationOne® CDx panel was used. NGS results were communicated to physicians via electronic medical records. The results were reported in a median of 13 days (range, 5-65 days).
The median number of mutations detected was 5 (range, 1-19). The median number of targetable mutations — defined as mutations for which there is an approved therapy — was 2 (range, 0-6).
The most common targetable mutations were TP53, PIK3CA, PTEN, and ARID1A. Compared with Caucasian patients, African-American patients had a significantly higher percentage of TP53 mutations (P <.05) and a significantly lower percentage of ARID1A mutations (P <.05).
In all, 85.5% of patients (n=136) had targetable mutations, and 34.5% (n=47) of these patients were started on targeted therapy. African-American patients were less likely to be started on targeted therapy (28.2%) compared with Caucasian patients (38.2%).
About half of patients (45.9%, n=73) were eligible for clinical trial enrollment based on mutations identified by NGS, and 20.5% (n=15) of those patients were ultimately enrolled. The proportion of patients enrolled in clinical trials was lower among African Americans (15%) than among Caucasians (22.6%).
“This initiative demonstrates the feasibility and potential impact of the integration of NGS testing into the management of uterine malignancies, illustrating how these results can provide physicians with prognostic information and targeted therapeutic options,” the researchers wrote.
“The potential to provide individualized treatment based on the molecular profile of the tumor increases available therapy options for patients beyond the standard of chemotherapy or radiation.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Arend RC, Goel N, Roane BM, et al. Systematic next generation sequencing is feasible in clinical practice and identifies opportunities for targeted therapy in women with uterine cancer: Results from a prospective cohort study. Gynecol Oncol. Published August 6, 2021. doi:10.1016/j.ygyno.2021.07.017