Adjuvant chemoimmunotherapy with LMF plus BCG in node-negative and node-positive breast cancer - intermediate report at 4 years

Recent Results Cancer Res. 1982;80:177-84. doi: 10.1007/978-3-642-81685-7_29.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Breast Neoplasms / surgery
  • Breast Neoplasms / therapy*
  • Chlorambucil / therapeutic use*
  • Clinical Trials as Topic
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Immunotherapy
  • Lymphatic Metastasis
  • Menopause
  • Methotrexate / therapeutic use*
  • Mycobacterium bovis / immunology

Substances

  • Chlorambucil
  • Fluorouracil
  • Methotrexate