Adjuvant Chemoimmunotherapy with LMF Plus BCG in Node-Negative and Node-Positive Breast Cancer — Intermediate Report at 4 Years

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Abstract
A randomized surgical adjuvant trial in 242 évaluable 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. 70.1%, 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.