Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 3670
© 2005 American Society of Clinical Oncology

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Abstract

Definitive results of hybrid chemotherapy with intravenous (iv) oxaliplatin (OXA) and folinic acid (FA), and intra-hepatic infusion (HAI) of 5-fluorouracil (5-FU) in patients with colorectal liver metastases

Inst Clinico Humanitas, Rozzano, Milano, Italy

3670

Background: Liver is the dominant site of metastases in patients (pts) with colorectal cancer (CRC). Intrahepatic arterial chemotherapy should deliver higher doses of drugs to the liver, but extrahepatic disease progression are frequent. Methods: We started a phase II study with concomitant HAI of 5-FU and iv OXA and FA in pts with colorectal liver metastases. From March 2000 to May 2004 39 pts have been recruited. The majority (74%) of the catheters were implanted by laparotomy. The regimen consisted of iv OXA 85 mg/m² d 1 and FA 75 mg/m² d 1,2, followed by bolus HAI of 5-FU 300 mg/m² d 1,2 and 22-hour HAI of FU 1200 mg/m² d 1,2. The cycles were repeated every 2 weeks for a maximum of 16 cycles. The median age of pts was 59 yrs (range, 37–73), 30 pts (77%) had synchronous liver metastases, 11 pts (28%) had minimal extra-hepatic disease and 49% of the pts were chemonaive. The median follow-up time for living pts is 15 months (range, 2–51). Results: Three-hundred and thirteen courses of therapy have been administered, and the median number of cycles was 8 (range 2–16). Although the treatment was generally well tolerated, the high incidence (42%) of NCI-CTC grade 3–4 neutropenia required frequent dose reduction (45% of cycles) or treatment delay (27%). Early discontinuation of therapy was necessary in 11 pts (28%) due to problems related to the catheter. Thirty-four pts (87%) were assessable for response, there were 3 CR (9%), 11 PR (32%), for an overall response rate of 41%. Nineteen pts (56%) achieved a SD. The overall response rate was 53% and 29% for chemonaive and pretreated pts respectively. Six pts (15%) underwent radical surgery on the liver. The median reduction of the CEA level was 91%. The median time to progression was 9 months (range, 2–43) and the median overall survival was 22 months (range, 2–51+). Better results were obtained in chemonaive pts and in pts without extra-hepatic disease. Conclusions: These results suggest that this regimen is feasible and active. The relatively low response rate observed could be partially explained by the marked necrosis and peri-lesional edema, being the survival data very promising.

No significant financial relationships to disclose.