Heloisa Soares, MD, Ph.D., Associate Professor at Huntsman Cancer Institute. In this video, she speaks about the ASCO GI 2022 Abstract – Randomized phase II trial of postoperative adjuvant capecitabine and temozolomide versus observation in high-risk pancreatic neuroendocrine tumors: SWOG S2104. This study was led by SWOG, and is Co-Chair with Dr. Syed A. Ahmad, University of Cincinnati.
Origins:
Resection is the sole curative purpose method for pancreatic neuroendocrine tumors (pNETS), which account for roughly 1-2 percent of all pancreatic tumors; however, many patients will have recurrence after surgery. Recurrence is prognosticated by tumor size, positive lymph nodes, and a higher grade. The United States Neuroendocrine Tumor Study Group released a prediction score (Zaidi score, see table) that showed tumors with a score of 6 had a 33 percent chance of recurrence within 24 months. Patients with metastatic disease who receive curative intent resection also face a high chance of recurrence, according to research. Despite these known risk factors for recurrence, no prospective study investigating the role of adjuvant cytotoxic chemotherapy in this population has yet been conducted. S2104 explores the role of capecitabine and temozolomide (CAPTEM) in the adjuvant setting, based on the findings of E2211 employing capecitabine and temozolomide (CAPTEM) in the metastatic setting.
Methodologies:
S2104 is a randomized phase II trial evaluating recurrence-free survival (RFS) in people with resected pNETs who were randomly assigned to either CAPTEM or observation on a 2:1 basis. Patients who have resected well-differentiated grade 2 or 3 (ki-67 up to 55%) pNETS with a Zaidi score of 3 are suitable. At the time of well-differentiated pNET resection, patients may have had a liver oligo-metastatic illness (up to 5 liver metastases) resection/ablation. Age of 18 years, Zubrod performance status of 0-2, and appropriate organ and marrow function are the main requirements. 1) Disease status before resection (metastatic vs. non-metastatic disease) and 2) Zaidi score (6 vs. 6) are two stratification criteria. Imaging will be used to track participants for the next five years. Grants U10CA180888, U10CA180819, U10CA180821, and U10CA180868 from the National Institutes of Health/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National Cancer Institute/National NCT05040360 is the number for the clinical trial.