Adjuvant therapy of poor prognosis colon cancer with levamisole: results of an EORTC double-blind randomized clinical trial.
From 1978 to 1985, 297 patients were entered in a double-blind randomized trial comparing levamisole to placebo as adjuvant therapy of Dukes' C carcinoma of the colon. Therapy consisted of from two to five tablets of 50 mg levamisole (or placebo) twice a week, depending on bodyweight for 1 year. Levamisole was generally well tolerated, with only four reversible cases of agranulocytosis reported among 129 patients. The trial failed to show a benefit of levamisole on disease-free survival (P = 0.53) or on survival (P = 0.35). There was no difference between the two treatment groups in terms of number of disease relapses, sites of relapse, or time to relapse. The proportion of patients still alive at 5 years was 51 per cent (standard error, 5.5 per cent) in the levamisole group versus 39 per cent (standard error, 5.4 per cent) in the placebo group.
Arnaud
J P
JP
C.M.C.O., Strasbourg, France.
Buyse
M
M
Nordlinger
B
B
Martin
F
F
Pector
J C
JC
Zeitoun
P
P
Adloff
A
A
Duez
N
N
D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003110:Colonic Neoplasms / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007978:Levamisole / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011184:Postoperative Period; D011379:Prognosis; D011897:Random Allocation
D000276:Adjuvants, Immunologic; D007978:Levamisole