Cardiovascular complications of cancer treatment: update CACOCA trial

Rationale. Oncological treatment, applying chemotherapy or new targeted drugs has already shown to induce cardiotoxicity. Present knowledge is primarily based on patients, who were treated in prospective clinical trials and is focused on acute toxicities. In contrast, there is a lack of data concerning the long-term cardiotoxic effects of systemic cancer therapies. The present trial aims to prove the risk and the consequences of long-term cardiotoxicity experienced after different cancer treatments in an unselected cohort of patients.

Methods. In this prospective, non-interventional, multicenter trial 1000 patients suffering from breast cancer, colorectal cancer, non-small cell lung cancer or lymphoma will be included. Curative intervention (operation and/or radiotherapy) has to be completed and patients must qualify for adjuvant systemic treatment. In case of lymphoma, stage and histology must offer the option of a long term remission after systemic therapy. Patients will be evaluated in regard to their cardiovascular status, risk factors and quality of life over a time period of 60 months.

Objectives. Primary objective is to evaluate the incidence of major cardiac events defined as cardiac related death, severe cardiac symptoms or cardiac disorders which require invasive interventions. Secondary objectives are the incidence of patients with minor cardiac events, PFS, OS, QOL, physical performance status and biomarker assessment.

Current Status. The first patient was enrolled in October 2013. In March 2015, 10 centers have been initiated and 142 patients were included in the study. Further centers will be invited to participate.