Abstract
Purpose
To assess the rate of R0 resection of liver metastases achieved after chemotherapy with FOLFIRINOX.
Patients and methods
Patients with histologically proven primary colorectal cancer and bidimensionally measurable liver metastasis, not fully resectable based on technical inability to achieve R0 resection, but potentially resectable after tumor reduction, were given FOLFIRINOX: oxaliplatin 85 mg/m², irinotecan 180 mg/m², leucovorin 400 mg/m², bolus fluorouracil 400 mg/m² and fluorouracil 46-h continuous IV infusion 2,400 mg/m², every 2 weeks for a maximum of 12 cycles.
Results
Thirty-four patients were enrolled. Response rate before surgery was 70.6% (95%CI: 52.5–84.9). Twenty-eight patients (82.4%) underwent hepatic resection and nine achieved R0 resection [26.5% (95% CI: 12.9–44.4%)]. The rate of clinical complete remission after surgery was 79.4%. Two-year overall survival was 83%.
The most frequent grade 3 or 4 toxicities were neutropenia (64.8%), diarrhea (29.4%), fatigue (23.5%), abdominal cramps (14.7%), neuropathy and nausea (11.8% each), and AST/ALT elevation (14.7/11.8%). Only one patient experienced febrile neutropenia, four patients withdrew due to toxicity and no toxic death was observed.
Conclusion
FOLFIRINOX, with an acceptable toxicity profile, shows a high response rate in liver metastases from colorectal cancer. The rate of hepatic resection in patients initially not resectable, is attractive and warrants further assessment of this regimen in randomized studies compared to standard regimens.
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Acknowledgments
We thank Dr. Patrice Herait for expert assistance in preparation of this manuscript and Sophie Gourgou for help in statistical analyses.
Conflict of interest statement
Marc Ychou has received honoraria from PFIZER (amount < 10,000 USD) and has no other conflict of interest. Emmanuel Mitry has received honoraria from PFIZER (amount < 10,000 USD) and has no other conflict of interest.
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Supported by grants from Aventis and Pfizer, Paris, France.
This full manuscript is original. Preliminary data were presented at the annual meetings of the American Society of Clinical Oncology, New Orleans, LA, 2004, the European Society for Medical Oncology, Vienna, Austria, 2004 and WCIG, Barcelona, Spain, 2004. In addition, a second manuscript focused on surgical issues is sent simultaneously to Annals of Surgical Oncology.
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Ychou, M., Viret, F., Kramar, A. et al. Tritherapy with fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in colorectal cancer patients with non-resectable liver metastases. Cancer Chemother Pharmacol 62, 195–201 (2008). https://doi.org/10.1007/s00280-007-0588-3
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DOI: https://doi.org/10.1007/s00280-007-0588-3