title: Vinorelbine + mitomycin C as second-line treatment of metastatic breast cancer: a two-stage phase 2 study.
abstract: Second-line treatment of patients with metastatic breast cancer resistant to anthracyclines is an important clinical issue. The aim of the present two-stage phase II study was to evaluate activity and toxicity of vinorelbine + mitomycin C (VM) in such patients. Fifty-five patients were entered and received vinorelbine 30 mg/m(2) on days 1 and 8 + mitomycin C 10 mg/m(2) on day 1, every 4 weeks, up to 9 cycles. Two complete and 23 partial responses were observed for an overall response rate of 45.4% (95% CI 32.0-59.4). Median survival was 13 months and probability of surviving after a 1-year follow-up was 58%. Toxicity was never life-threatening, but G-CSF was used in 45% of cycles to contrast neutropenia that was the most frequent side effect. These results are consistent with previous studies and strongly support VM being considered among the optimal polychemotherapy regimens for second-line treatment of metastatic breast cancer in clinical practice; for clinical research aims, VM should be used as control arm for randomized trials evaluating the activity of new drugs against breast cancer.
authors.affiliation: Division of Medical Oncology, University of Naples Federico II, Naples, Italy. deplacid@unina.it
authors.forename: S
authors.initials: S
authors.lastname: De Placido
authors.forename: R
authors.initials: R
authors.lastname: Lauria
authors.forename: F
authors.initials: F
authors.lastname: Perrone
authors.forename: A
authors.initials: A
authors.lastname: Vernaglia Lombardi
authors.forename: C
authors.initials: C
authors.lastname: Carlomagno
authors.forename: E
authors.initials: E
authors.lastname: Varriale
authors.forename: R
authors.initials: R
authors.lastname: Costanzo
authors.forename: L
authors.initials: L
authors.lastname: Leo
authors.forename: M
authors.initials: M
authors.lastname: De Laurentiis
authors.forename: A R
authors.initials: AR
authors.lastname: Bianco
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000903:Antibiotics, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D016179:Granulocyte Colony-Stimulating Factor; D016685:Mitomycin; D014747:Vinblastine; D000077235:Vinorelbine