LEVAMISOLE MAY INCREASE BREAST CANCER RECURRENCE RATES

A negative report from the Danish Breast Cancer Cooperative Group Although previous studies have shown the immunostimulant, levamisole, to have potential usefulness in tumor t.tlerapy, a preliminary report from the Danish Breast Cancer Cooperative Group now suggests that the drug could cause more harm than good. Postmastectomy breast cancer patients with histologically positive lymph nodes but no distant metastases (N + , MJ were randomly allocated either to 48 weeks' of radiotherapy alone (384 patients) or radiotherapy plus levamisole 2.5 mg / kg / day for 2 days each week (336 patients). A significantly higher recurrence rate of breast cancer occurred by I year in levamisole-treated patients (12-28 %) than in the radiotherapy-only group(ll-t4%). Levamisole was associated with an incidence of side effects much higher than previously reported, causing 50 % of premenopausal women and 6 t .4 % of postmenopausal women to withdraw from therapy before 48 weeks. These side effects include fever (18-28 %) leukopenia (t 5-20 %), exanthema (10-13 %), GI symptoms (8-1 0 %) and agranulocytosis 0-4 %). It is suggested that as levamisole could immunologically enhance tumor growth, it should not be used in patients with N + , Mo breast cancer. Brincker. H. et aI.: Lancet 2: 824 (Oct 18. 1980)

10 INPHARMA 1 Nov 1980 0156-2703/80/1101-0010 $00.50/0 ©ADIS Press