Adjuvant chemoimmunotherapy with LMF plus BCG in node-negative and node-positive breast cancer - intermediate report at 4 years.
A randomized surgical adjuvant trial in 242 evaluable patients with T1-3a, N0-1, and M0 breast cancer was initiated 4 years ago. The well-tolerated, oral combination chemotherapy with six cycles of Leukeran plus methotrexate plus fluorouracil (LMF) plus repeated BCG skin scarifications was used. After 4 years, the following results were seen: (1) significant increase of relapse-free (RFS) and also overall survival (S) in both pre- and postmenopausal node-negative patients versus surgical controls (RFS 91.1 vs. 701%, P = 0.003; S 96 vs. 88%, P = 0.03); (2) no significant increase of RFS or S in pre- and postmenopausal node-positive patients versus surgical controls (RFS 50.1 versus 44%, P = 0.49; S 70 versus 68 %, P = 0.9, respectively); (3) Patients receiving greater than 90% of the planned LMF dose showed significantly better survival after 4 years; and (4) Nonrandomized comparison with concurrent Swiss adjuvant studies with LMF alone indicate no beneficial or harmful effect of BCG skin scarifications in addition to the six-cycle LMF.
D001943:Breast Neoplasms / Q000601:surgery / Q000628:therapy*; D002699:Chlorambucil / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy; D008207:Lymphatic Metastasis; D008593:Menopause; D008727:Methotrexate / Q000627:therapeutic use*; D009163:Mycobacterium bovis / Q000276:immunology
D002699:Chlorambucil; D005472:Fluorouracil; D008727:Methotrexate