[Interim analysis of a prospective, randomized multi-center study by the "Liver Metastases" Study Group: adjuvant intra-arterial chemotherapy after curative liver resection of colorectal metastases].
Recurrence after resection of colorectal liver metastases occurs after 9-12 months in up to 80% of patients. Half of the relapses is isolated to the liver. An intraarterial chemotherapy with 5-FU and folinic acid was compared to only resection. Main objective of the trial was survival. Within 14 days after resection followed the 6-month therapy with 5-FU 1000 mg/m2 continuously over 5d/28d and Folinic Acid 200 mg/m2 over 15 minutes 5d/28d. The first interim-analysis with 226 randomised patients showed in the intention-to-treat-analysis a median survival of 34.5 months (m.) with therapy versus 40.8 months (p = 0.1519 with a negative trend. (95%-Confidence interval for hazard ratio: [0.5; 1.15]) and time to progression of 14.2 m. with therapy versus 13.7 m. Severe toxicities (WHO grade III/IV) occurred in 25.6% of cycles and 62.9% of patients. Mainly registered were stomatitis (57.6%) and nausea (55.4%). The recruitment of patients for study was terminated, because in best case the risk to die could be lowered only by 15% and therefore clinical relevant prolongation of survival is not to achieve with this type of adjuvant therapy.
D000328:Adult; D000368:Aged; D017024:Chemotherapy, Adjuvant; D003082:Colectomy; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D006498:Hepatectomy; D006801:Humans; D007261:Infusions, Intra-Arterial; D002955:Leucovorin / Q000008:administration & dosage* / Q000009:adverse effects; D008113:Liver Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000556:secondary* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality; D015996:Survival Rate
D002955:Leucovorin; D005472:Fluorouracil