title: Phase II study of gemcitabine plus cisplatin in metastatic breast cancer.
abstract: Our objectives were to assess the efficacy and toxicity of gemcitabine plus cisplatin as first-line therapy in metastatic breast cancer (MBC). Patients with stage IV MBC and no prior chemotherapy for metastatic disease were treated with gemcitabine 1200 mg/m on days 1 and 8, and cisplatin 75 mg/m on day 1 every 21 days. Up to 6 cycles were given. A total of 46 patients with a median age of 49 years (range 24-77) and Karnofsky performance status of 80 or above were enrolled. In total, 238 cycles were administered. Of the 42 patients evaluable for response, seven (17%) achieved a complete response and 27 (64%) a partial response, for an overall response rate of 81% [95% confidence interval (CI) 69-93%]. Median time to progression was 14.9 months (95% CI 0-30.2 months). Median duration of response was 24.2 months (95% CI 11.2-37.3 months). The median survival was 27.9 months (95% CI 23.1-32.7 months), and the 1- and 2-year survival probabilities were 71.4 and 61.4%, respectively. All patients were evaluable for toxicity, and grade 3/4 WHO toxicities included neutropenia (41.3%), anemia (8.7%), thrombocytopenia (8.7%), alopecia (26.1%) and nausea/vomiting (32.6%). We conclude that gemcitabine plus cisplatin is a highly effective and safe first-line treatment for patients with MBC. The time to progression of 14.9 months compares favorably with other standard treatments (anthracyclines, taxanes). A randomized study is required to further investigate the role of this combination as first-line treatment for MBC.
authors.affiliation: ISSSTE, Tijuana, Mexico. doctorhomerofuentes@hotmail.com
authors.forename: Homero
authors.initials: H
authors.lastname: Fuentes
authors.forename: German
authors.initials: G
authors.lastname: Calderillo
authors.forename: Francisco
authors.initials: F
authors.lastname: Alexander
authors.forename: Marcelino
authors.initials: M
authors.lastname: Ramirez
authors.forename: Enrique
authors.initials: E
authors.lastname: Avila
authors.forename: Leonel
authors.initials: L
authors.lastname: Perez
authors.forename: Guillermo
authors.initials: G
authors.lastname: Aguirre
authors.forename: Luis F
authors.initials: LF
authors.lastname: Oñate-Ocaña
authors.forename: Dolores
authors.initials: D
authors.lastname: Gallardo
authors.forename: Jorge
authors.initials: J
authors.lastname: Otero
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine