Originally published as JCO Early Release 10.1200/JCO.2005.07.740 on October 17 2005

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Oxaliplatin, Fluorouracil, and Leucovorin for Patients With Unresectable Liver-Only Metastases From Colorectal Cancer: A North Central Cancer Treatment Group Phase II Study

From the Mayo Clinic and Mayo Foundation, Rochester, MN; Toledo Community Hospital Oncology Program Community Clinical Oncology Program (CCOP), Toledo, OH; Wichita CCOP, Wichita, KS; Meritcare Hospital CCOP, Fargo, ND; Carle Cancer Center CCOP, Urbana, IL; and Geisinger Medical Center, Danville, PA.

Address reprint requests to Steven R. Alberts, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: alberts.steven{at}mayo.edu

PURPOSE: Surgical resection of liver-only metastases from colorectal cancer has undergone extensive evaluation and review. The use of neoadjuvant chemotherapy to improve the likelihood of resection in disease that is not optimally resectable has not been as well studied.

PATIENTS AND METHODS: Patients with liver-only metastases from colorectal cancer deemed not optimally resectable by a surgeon with expertise in liver surgery received fluorouracil, leucovorin, and oxaliplatin (FOLFOX4). Patients were periodically reassessed for resectability. Surgical response was classified as completely resectable (S-CR), partially resectable (S-PR), or unresectable (S-UR). Study design specified the accrual of 39 patients, with two or more S-CRs considered evidence of promising activity with respect to increasing the S-CR rate.

RESULTS: Forty-two of 44 patients were assessable for this analysis. Twenty-five patients (60%) had tumor reduction by serial imaging. Seventeen patients (40%) underwent surgery (S-CR, n = 14; S-PR, n = 1; and S-UR, n = 2) after a median of 6 months of chemotherapy. With a median postsurgical follow-up of 22 months (range, 13 to 32 months), 11 recurrences have occurred in the 15 S-CR and S-PR patients. Median survival time was 26 months.

CONCLUSION: Our data suggest that FOLFOX4 has a high response rate (complete response, partial response, or reduction) in patients with liver-only metastases from colorectal cancer, allowing for successful resection of disease in a portion of patients initially not judged to be optimally resectable. However, a high recurrence rate after surgery was observed, which, in 73% of patients, involved the liver. Further trials are indicated based on the promising results observed in this trial.

Supported in part by Public Health Service Grant Nos. CA-25224, CA-37404, CA-35269, CA-60276, and CA-37417.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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