Prospective randomised trial on adjuvant hepatic-artery infusion chemotherapy after R0 resection of colorectal liver metastases.
OBJECTIVE
The liver represents the predominant site of cancer relapse after curative resection of hepatic metastases from colorectal carcinoma. Adjuvant intra-arterial chemotherapy was therefore considered a promising therapeutic approach in high-risk patients.


METHODS
From July 1984 to December 1985, a total of 42 consecutive patients underwent R0 resection of colorectal liver metastases. Thirty patients with mesenteric lymph-node metastases (Dukes C) were randomised into two groups. In 14 group-A patients, a hepatic artery port catheter was placed during liver resection. Four courses of adjuvant chemotherapy were administered at 4-week intervals, consisting of mitomycin C (8 mg/m2, day 1) and 5-fluorouracil (800 mg/m2, days 1-5). Sixteen group-B patients served as controls. The 12 patients with no mesenteric lymph-node metastases (Dukes A/B) were included in the follow-up program.


RESULTS
After 5 years, 64% of Dukes A/B patients and 29% of Dukes C patients were alive (P<0.01). The probability of remaining free of recurrent disease after 5 years and 10 years was 55% and 18%, respectively (P<0.01). No significant difference in either 5-year survival (25% vs 31%) or long-term disease-free status (15% vs 23%) was detected between groups A and B. The initial tumour relapse was shifted towards extrahepatic sites in group-A patients, but no difference was obtained regarding the definite distribution of recurrent disease.


CONCLUSIONS
Routine application of adjuvant regional chemotherapy after R0 liver resection is not warranted.
Rudroff
C
C
Department of Surgery, Friedrich-Schiller-University, Jena, Germany.
Altendorf-Hoffmann
A
A
Stangl
R
R
Scheele
J
J
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; 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; D008113:Liver Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000556:secondary* / Q000601:surgery; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009367:Neoplasm Staging; D015996:Survival Rate
D016685:Mitomycin; D005472:Fluorouracil