Objective/Background: The GONO-FOLFOXIRI regimen improved the rate of R0 secondary resection of metastases in initially unresectable metastatic colorectal cancer. The objective of this study was to evaluate the long-term outcome of resected patients and the impact of FOLFOXIRI on perioperative morbidities, mortality, and chemotherapy induced hepatotoxicity. Patients and Methods: Overall, 196 patients with initially unresectable metastatic colorectal cancer were treated with FOLFOXIRI in 2 phase II and I phase III trial. This regimen was associated with an elevated response rate (70.4%) and 37 patients (19%) could undergo a secondary R0 surgery on metastases. This study was registered with the Australian New Zealand Clinical Trials Registry Database at http://www.anzctr.org.au/Statistics.aspx and has ID number ACTRN12608000615381. Results: Main characteristics of the 37 radically resected patients were: median age 64 years (45-73), Eastern Cooperative Oncology Group Performance Status (ECOG) PS >= 1 in 30%, synchronous metastases in 65%, multiple sites of disease in 22%, and metastases confined to the liver in 68%. Preoperative FOLFOXIRI was administered for a median of 5.5 months. There was no perioperative mortality and all morbidities (27% of patients) resolved without sequelae. After a median follow up of 67 months, 5-year and 8-year survival are 42% and 33% respectively. At 5 years, 29% of patients are free of disease. The analysis of treatment-induced liver injury showed neither G3 vascular toxicity nor G4 steatosis, and steato-hepatitis in only 5% of patients. Conclusions: The GONO-FOLFOXIRI regimen allow an R0 Surgery in approximately I out of 5 unselected patients with initially unresectable metastatic colorectal cancer, and the long-term survival of resected patients is considerable. Neoadjuvant FOLFOXIRI for 3-6 months is safe and not associated with severe liver injury.

Long-Term Outcome of Initially Unresectable Metastatic Colorectal Cancer Patients Treated with 5-Fluorouracil/Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Followed by Radical Surgery of Metastases / Gianluca, Masi; Fotios, Loupakis; Luca, Pollina; Enrico, Vasile; Samanta, Cupini; Sergio, Ricci; Isa Maura, Brunetti; Roberta, Ferraldeschi; Naso, Giuseppe; Franco, Filipponi; Andrea, Pietrabissa; Orlando, Goletti; Giacomo, Baldi; Lorenzo, Fornaro; Michele, Andreuccetti; Alfredo, Falcone. - In: ANNALS OF SURGERY. - ISSN 0003-4932. - STAMPA. - 249:3(2009), pp. 420-425. [10.1097/sla.0b013e31819a0486]

Long-Term Outcome of Initially Unresectable Metastatic Colorectal Cancer Patients Treated with 5-Fluorouracil/Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Followed by Radical Surgery of Metastases

NASO, Giuseppe;
2009

Abstract

Objective/Background: The GONO-FOLFOXIRI regimen improved the rate of R0 secondary resection of metastases in initially unresectable metastatic colorectal cancer. The objective of this study was to evaluate the long-term outcome of resected patients and the impact of FOLFOXIRI on perioperative morbidities, mortality, and chemotherapy induced hepatotoxicity. Patients and Methods: Overall, 196 patients with initially unresectable metastatic colorectal cancer were treated with FOLFOXIRI in 2 phase II and I phase III trial. This regimen was associated with an elevated response rate (70.4%) and 37 patients (19%) could undergo a secondary R0 surgery on metastases. This study was registered with the Australian New Zealand Clinical Trials Registry Database at http://www.anzctr.org.au/Statistics.aspx and has ID number ACTRN12608000615381. Results: Main characteristics of the 37 radically resected patients were: median age 64 years (45-73), Eastern Cooperative Oncology Group Performance Status (ECOG) PS >= 1 in 30%, synchronous metastases in 65%, multiple sites of disease in 22%, and metastases confined to the liver in 68%. Preoperative FOLFOXIRI was administered for a median of 5.5 months. There was no perioperative mortality and all morbidities (27% of patients) resolved without sequelae. After a median follow up of 67 months, 5-year and 8-year survival are 42% and 33% respectively. At 5 years, 29% of patients are free of disease. The analysis of treatment-induced liver injury showed neither G3 vascular toxicity nor G4 steatosis, and steato-hepatitis in only 5% of patients. Conclusions: The GONO-FOLFOXIRI regimen allow an R0 Surgery in approximately I out of 5 unselected patients with initially unresectable metastatic colorectal cancer, and the long-term survival of resected patients is considerable. Neoadjuvant FOLFOXIRI for 3-6 months is safe and not associated with severe liver injury.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11573/104506
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