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01 February 2010

Neoadjuvant treatment with weekly high-dose 5-fluorouracil as a 24h-infusion, folinic acid and biweekly oxaliplatin in patients with primary resectable liver metastases of colorectal cancer: long-term results of a phase II trial

Frank BoxbergerABCDEF, Heinz AlbrechtE, Peter C. KonturekE, Udo ReulbachCD, Gudrun MaennleinE, Thomas MeyerE, Werner HohenbergerE, Eckhart G. HahnE, Axel WeinABCDEF

Med Sci Monit 2010; 16(2): CR49-55 :: ID: 878350

Abstract

Background
In 2003 Wein et al. published data after a short median follow up (23 months). Here we report on the long-term results.
Material and Method
The patients (n=20) received a neoadjuvant treatment regimen comprising biweekly 85 mg/m2 oxaliplatin (L-OHP) (2h-infusion, d 1, 15, 29 qd 57) and 500 mg/m2 calcium folinic acid (FA) (1-2h-infusion, d 1, 8, 15, 22, 29, 36 qd 57) followed by 2600 mg/m2 5-Fluorouracil (5-FU) (24h-infusion, d 1, 8, 15, 22, 29, 36 qd 57). Two cycles of chemotherapy were administered, with a third being added when the treatment was well tolerated. Thereafter, curative resection of the liver metastases was attempted.
Results
After neoadjuvant therapy, imaging procedures revealed complete remission in 2 patients (10%) and partial remission in 18 patients (90%). Diarrhea (Common Toxicity Criteria toxicity grade 3) was observed in 6 patients (30%) as main symptom of toxicity, followed by vomiting in 3 patients (15%). Higher grade sensomotoric neuropathy did not present. The curative resectability rate (R0) was 80%. In 9 out of 18 patients (50%) undergoing surgical intervention minor postoperative complications occurred. No postoperative mortality was observed. Over a median follow up of 45,5 months the median survival of all patients is 3.0 years and the 5-year overall survival rate is 40%. The 5-year disease-free survival rate is 25%.
Conclusions
Neoadjuvant treatment with 5-FU combined with FA and L-OHP proved to be highly effective and well tolerated. Disease-free survival rates and median overall survival rates are promising.

Keywords: Organoplatinum Compounds - therapeutic use, Neoplasm Recurrence, Local - drug therapy, Neoadjuvant Therapy, Liver Neoplasms - surgery, Leucovorin - therapeutic use, Infusion Pumps, Implantable, Kaplan-Meier Estimate, Fluorouracil - therapeutic use, Drug Administration Schedule, Dose-Response Relationship, Drug, Colorectal Neoplasms - pathology, Antineoplastic Combined Chemotherapy Protocols - therapeutic use, Antineoplastic Agents - therapeutic use, Patient Compliance, Time Factors

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750