In patients with cardio-kidney-metabolic (CKM) syndrome, comorbid cancer was frequent and independently associated with worse outcomes but did not affect the treatment benefit of finerenone, according to a post-hoc analysis of the FINE-HEART pooled analysis published Aug. 18 in EHJ.

The FINE-HEART pooled participant-level analysis included the FIDELIO-DKD, FIGARO-DKD and FINEARTS-HF trials and investigated the treatment effect of finerenone in participants with type 2 diabetes, chronic kidney disease and heart failure (HF) with mildly reduced or preserved LVEF.

In their analysis, Mihály Ruppert, PhD, et al., assessed the risks of clinical outcomes according to history of cancer and randomization to finerenone using Cox proportional hazard models and Fine-Gray subdistribution hazard models. The primary outcome was time to cardiovascular death, excluding undetermined causes of death.

Among the nearly 19,000 participants, 7% had a history of cancer, with the most common types being gastrointestinal, male reproductive, renal/urinary tract and hematologic. Patients with a history of cancer were older, more frequently White, less often Asian and more often originated from North America, Western Europe or Oceania.

Over a median follow-up of 2.9 years, among those with no history of cancer, 5% were reported to newly develop cancer.

Results showed that patients with comorbid cancer more frequently had advanced CKM stages and a greater burden of CKM conditions. History of cancer was also associated with higher risks of all-cause hospitalization and all-cause mortality.

Finerenone consistently reduced all-cause death, HF and all-cause hospitalization, as well as a composite kidney outcome, major adverse cardiovascular events and new-onset atrial fibrillation, regardless of cancer history. Notably, finerenone's safety profile was consistent despite adverse events occurring more frequently in patients with a history of cancer.

Ruppert and colleagues believe their findings "...are relevant as many clinicians may be hesitant to initiate disease-modifying therapies in patients with CKM syndrome and a history of cancer," and write that "...further studies are needed to determine whether these findings extend to typical oncology populations, including higher-risk patients."