title: Adjuvant chemoimmunotherapy with LMF + BCG in node-negative and node-positive breast cancer patients: 10 year results.
abstract: A total of 254 patients with stages T1-3a/N0-1/M0 operable breast cancer were randomized to either surgery alone or surgery plus adjuvant chemoimmunotherapy (LMF + BCG). Ten-year results are presented for RFS (relapse-free survival) and OAS (overall survival) in the whole patient population as well as in the most important menopausal and nodal subgroups. LMF + BCG significantly increased RFS in the whole patient population as well as in node-positive women. The earlier impressive RFS and OAS gains for node-negative patients were fading after 5 and 8 years respectively, leaving marginal trends in favour of the LMF + BCG treated women. Node-positive patients treated with LMF + BCG continue to demonstrate a marginal gain in RFS up to 10 years. This gain is nearly exclusively expressed in postmenopausal node-positive women, an observation which can be made in the node-negative patient group as well. Despite the still continuing increase in RFS,' no OAS benefit was observed for node-positive women with LMF + BCG at any time of the study. Dose still remains a critical factor in cancer therapy. However, at 10 years of follow-up, a full dose of LMF (greater than or equal to 90%) during the six cycles no longer affects OAS favourably. There was no indication of any adverse long-term toxicity of LMF + BCG in our study after a median follow-up of 10 years, especially no increase of second tumours. In the node-negative patient population, the presence or absence of intramammary lymphatic infiltration seems to be a significant prognostic factor within this nodal subgroup.
authors.affiliation: Department of Medicine C (Oncology-Hematology), Kantonsspital, St. Gallen, Switzerland.
authors.forename: H J
authors.initials: HJ
authors.lastname: Senn
authors.forename: A R
authors.initials: AR
authors.lastname: Barett-Mahler
authors.forename: W F
authors.initials: WF
authors.lastname: Jungi
authors.lastname: Osako
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D002699:Chlorambucil / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis / Q000628:therapy; D015411:Mastectomy, Modified Radical; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged
chemical_list: D001500:BCG Vaccine; D002699:Chlorambucil; D005472:Fluorouracil; D008727:Methotrexate