TY - JOUR T1 - Intra-arterial Infusion of Irinotecan-loaded Drug-eluting Beads (DEBIRI) <em>versus</em> Intravenous Therapy (FOLFIRI) for Hepatic Metastases from Colorectal Cancer: Final Results of a Phase III Study JF - Anticancer Research JO - Anticancer Res SP - 1387 LP - 1395 VL - 32 IS - 4 AU - GIAMMARIA FIORENTINI AU - CAMILLO ALIBERTI AU - MASSIMO TILLI AU - LUCA MULAZZANI AU - FRANCESCO GRAZIANO AU - PAOLO GIORDANI AU - ANDREA MAMBRINI AU - FRANCESCO MONTAGNANI AU - PAOLO ALESSANDRONI AU - VINCENZO CATALANO AU - PAOLO COSCHIERA Y1 - 2012/04/01 UR - http://ar.iiarjournals.org/content/32/4/1387.abstract N2 - Background: Metastases to the liver receive most of their blood supply from the arterial route, therefore for patients with hepatic metastases from large bowel cancer, hepatic arterial infusion adopting drug-eluting beads preloaded with irinotecan (DEBIRI) may offer a chance of cure. Patients and Methods: In a multi-institutional study, 74 patients were randomly assigned to receive DEBIRI (36) versus systemic irinotecan, fluorouracil and leucovorin (FOLFIRI, 38). The primary end-point was survival; secondary end points were response, recurrence, toxicity, quality of life, cost and influence of molecular markers. Results: At 50 months, overall survival was significantly longer for patients treated with DEBIRI than for those treated with FOLFIRI (p=0.031, log-rank). Median survival was 22 (95% Confidence Interval CI=21-23) months, for DEBIRI and 15 (95% CI=12-18) months for FOLFIRI. Progression-free survival was 7 (95% CI=3-11) months in the DEBIRI group compared to 4 (95% CI=3-5) months in the FOLFIRI group and the difference between groups was statistically significant (p=0.006, log-rank). Extrahepatic progression had occurred in all patients by the end of the study, at a median time of 13 (95% CI=10-16) months in the DEBIRI group compared to 9 (95% CI 5-13) months in the FOLFIRI group. A statistically significant difference between groups was not observed (p=0.064, log-rank).The median time for duration of improvement to quality of life was 8 (95% CI=3-13) months in the DEBIRI group and 3 (95% CI=2-4) months in the FOLFIRI group. The difference in duration of improvement was statistically significant (p=0.00002, log-rank). Conclusion: This study showed a statistically significant difference between DEBIRI and FOLFIRI for overall survival (7 months), progression-free survival (3 months) and quality of life (5 months). In addition, a clinically significant improvement in time to extrahepatic progression (4 months) was observed for DEBIRI, a reversal of the expectation for a regional treatment. This suggests a benefit of DEBIRI treatment over standard chemotherapy and serves to establish the expected difference between these two treatment options for planning future large randomized studies. ER -