Efficacy and safety of the CAPTEM regimen in patients with advanced adrenocortical carcinoma.

PURPOSE: The purpose of this study was to evaluate the activity and tolerability of the CAPTEM regimen (capecitabine + temozolomide) in patients with advanced, heavily pretreated adrenocortical carcinoma (ACC). METHODS: A retrospective analysis of 15 patients with metastatic ACC who received at least two lines of systemic therapy, including the CAPTEM regimen, between 2017 and 2022. Clinical characteristics, treatment outcomes (PFS, OS), and toxicities were collected and analysed. Treatment response was assessed using RECIST 1.1 criteria. Survival outcomes were estimated using the Kaplan-Meier method. RESULTS: Among the 15 patients, CAPTEM was administered in the first line therapy in three patients (20%), in the second-line therapy in 53.3%, and in further lines in the remaining cases. The overall disease control rate was 26.6% (all stable disease). Median progression-free survival (PFS) was 3 months (95% CI: 2-6), and median overall survival (OS) was 8 months (95% CI: 6-13). Patients who achieved disease stabilization had improved outcomes (mPFS 9.5 months, mOS 16.5 months) compared to those with progression (mPFS 2 months, mOS 7 months). Treatment-related adverse events occurred in 86.7% of patients, mostly mild; grade 3 toxicity was observed in one patient. CONCLUSION: The CAPTEM regimen demonstrated modest activity and acceptable toxicity in a heavily pretreated ACC population. While not recommended as a standard treatment, CAPTEM may be considered in select patients, particularly those who achieve disease stabilization. Further prospective studies are needed to better define its role and identify predictive biomarkers.