Phase 3 study of systemic treatmens versus primary tumor resection and systemic treatment for mCRC: 60-day mortality

The role of primary tumor resection (PTR) in synchronous patients with metastatic colorectal cancer who have unresectable metastases and few or absent symptoms of their primary tumor is unclear. The phase 3 CAIRO4 study in The Netherlands and Denmark randomized mCRC patients with unresectable metastases to systemic treatment only versus PTR followed by systemic treatment. The 60-day mortality was 3% in the systemic treatment group versus 11% in the PTR followed by systemic treatment group (p=0.03). Risk factors for higher 60-day mortality in the PTR group were elevated LDH, elevated aminotransferases, and elevated neutrophils. Final OS results of the study have to be awaited.