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

Abstract

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: This is 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 and OS), and toxicities were collected and analysed. Treatment response was assessed using the 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 eight patients (53.3%), and in further lines in the remaining cases. The overall disease control rate was 26.6% (all stable disease). The median progression-free survival (PFS) was 3 months (95% CI: 2-6), and the 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 with 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.