Immunochemotherapies versus chemotherapy as adjuvant treatment after curative resection of operable breast cancer

Anticancer Res. 1995 Nov-Dec;15(6B):2907-11.


In our previous study, oral adjuvant combination chemotherapy of 5-fluorouracil, cyclophosphamide, mitomycin C, and predonisolone (FEMP) after curative resection of operable breast cancer with vascular invasion in the tumor and/or in the metastatic lymph node was found to be more effective than one course of mitomycin C or cyclic course of mitomycin C. In the present study, we have assessed the efficacy of protein-bound polysaccharide (PSK) or levamisole (LMS) in addition to FEMP. Between January 1980 and December 1990, 227 operable breast cancer patients with vascular invasion in the tumor and/or in the metastatic lymph node were randomized into FEMP, FEMP + LMS, or FEMP + PSK. The risk ratio was lower in the FEMP + PSK group compared to the FEMP group. In disease-free survival or overall survival, there was no significant difference between the three groups, however, the survival curve of the FEMP + PSK group tended to be better than that of the FEMP group(logrank, P = 0.0706; generalized Wilcoxon, P = 0.0739). Side effects were observed at a low incidence, but they were mild and tolerable. Immunochemotherapy using PSK improved the prognosis of patients with operable breast cancer with vascular invasion.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic / therapeutic use*
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / blood supply
  • Breast Neoplasms / drug therapy
  • Breast Neoplasms / mortality
  • Breast Neoplasms / surgery
  • Breast Neoplasms / therapy*
  • Chemotherapy, Adjuvant
  • Combined Modality Therapy
  • Cyclophosphamide / administration & dosage
  • Disease-Free Survival
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Levamisole / therapeutic use*
  • Life Tables
  • Mastectomy
  • Middle Aged
  • Mitomycin / administration & dosage
  • Neoplasm Invasiveness
  • Prednisolone / administration & dosage
  • Proteoglycans / therapeutic use*
  • Risk
  • Survival Analysis
  • Treatment Outcome


  • Adjuvants, Immunologic
  • Proteoglycans
  • Levamisole
  • polysaccharide-K
  • Mitomycin
  • Cyclophosphamide
  • Prednisolone
  • Fluorouracil

Supplementary concepts

  • FEMP protocol