(CHICAGO, IL) – Dose-dense oxaliplatin therapy followed by an irinotecan-based regimen does not improve outcomes over standard FOLFOX4 chemotherapy for metastatic colorectal cancer patients, according to results of a phase 3 study presented at the 2012 American Society of Clinical Oncology Annual Meeting.
“FOLFOX7 followed by FOLFIRI is not superior to the standard FOLFOX4 chemotherapy in patients with resectable metastatic colorectal cancer,” said lead author Mohamed Hebbar, MD, Medical Oncology Unit – Hôpital Huriez, Lille, France.
Perioperative FOLFOX4 (leucovorin, 5-fluorouacil, oxaliplatin) is the standard chemotherapy regimen for patients with resectable metastases from colorectal cancer, but it is associated with severe neuropathy. To increase cure rates and reduce neuropathy rates, Dr. Hebbar and colleagues assessed sequential administration of a dose-dense oxaliplatin-based regimen followed by irinotecan-based FOLFIRI (leucovorin, 5-fluorouracil, irinotecan).
Patients with initially resectable or resected colorectal cancer metastases were randomized to a control arm of FOLFOX4 (n=142) receiving 12 cycles; oxaliplatin 85mg/m²) or an investigational arm of FOLFOX7 (n=142) receiving six cycles; oxaliplatin 130mg/m²) followed by FOLFIRI (six cycles; irinotecan 180mg/m²). The liver was the main site of metastatic disease.
After a median follow-up period of 50.4 months, the difference in median disease-free survival rates between groups was not statistically significant (22.4 months in control-arm patients vs. 23.0 months in investigational-arm patients; HR=0.97;P=0.856). No difference in OS was observed. Neutropenia was the most common grade 3/4 adverse event and was comparable in both arms.
Dr. Hebbar and colleagues concluded that administering FOLFIRI after FOLFOX7 shows no superiority over the standard FOLFOX4 chemotherapy regimen in patients with resectable metastatic colorectal cancer.