Preliminary results of a randomized phase II trial comparing standard bi-therapy versus three intensified chemotherapy regimens as treatment for patients with non resectable liver metastases from colorectal cancer (LMCRC). (METHEP)

Abstract

4075 Background: LVFU combinations with irinotecan (FOLFIRI) or oxaliplatin (FOLFOX) have shown to improve outcome of advanced colorectal cancer. However, the standard doses of these regimens applied to patients with initially unresectable LMCRC have shown poor rates of resectability. The aim of this randomized trial was to select the most efficacious experimental intensified chemotherapy arm among high dose (HD) FOLFIRI (Iri 260mg/m²), FOLFOX-7 (Ox 130mg/m²) and FOLFIRINOX (Iri 180mg/m² + Ox 85mg/m²) in patients (pts) with initially unresectable or potentially resectable LMCRC. Methods: Main inclusion criteria: non pretreated potentially resectable LM (class II) or unresectable LM without extra-hepatic metastases except 1 to 3 resectable lung metastases. Pts were randomized to either standard (A/B) or intensified chemotherapy (C/D/E): FOLFIRI (A), FOLFOX-4 (B), FOLFIRI-HD (C), FOLFOX-7 (D), or FOLFIRINOX (E). In arms C/D/E, prophylactic G-CSF was given. Primary endpoint was objective response rate (RR) (...