title: Gemcitabine/paclitaxel as first-line treatment of advanced breast cancer.
abstract: Gemcitabine (Gemzar) and paclitaxel exhibit good activity and good safety profiles when used alone and together in the treatment of advanced breast cancer. In a phase II trial, 45 patients with metastatic breast cancer received gemcitabine at 1,200 mg/m2 on days 1 and 8 and paclitaxel at 175 mg/m2 on day 1 every 21 days. Twenty-seven patients (60.0%) had prior adjuvant therapy. Objective response was observed in 30 patients (objective response rate 66.7%, 95% confidence interval [CI] = 52%-71%), including complete response in 10 (22.2%) and partial response in 20 (44.4%). Median duration of response was 18 months (95% CI = 11-26.7 months), median time to tumor progression for the entire population was 11 months (95% CI = 7.1-18.7 months), median overall survival was 19 months (95% CI = 17.3-21.7 months), and the 1-year survival rate was 69%. Treatment was well tolerated, with grade 3/4 toxicities being infrequent. Grade 3/4 leukopenia, neutropenia, and thrombocytopenia were each observed in six patients (13.3%). No patient was discontinued from the study due to hematologic or nonhematologic toxicity. Thus, the gemcitabine/paclitaxel combination shows promising activity and tolerability when used as first-line treatment in advanced disease. The combination recently has been shown to be superior to paclitaxel alone as first-line treatment in anthracycline-pretreated advanced disease according to interim results of a phase III trial and it should be further evaluated in comparative trials in breast cancer.
authors.affiliation: Hospital Privado de Comunidad, Mar del Plata, Argentina.
authors.forename: Carlos
authors.initials: C
authors.lastname: Delfino
authors.forename: Graciela
authors.initials: G
authors.lastname: Caccia
authors.forename: Luis
authors.initials: L
authors.lastname: Riva Gonzáles
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mickiewicz
authors.forename: Jeannette
authors.initials: J
authors.lastname: Rodger
authors.forename: Luis
authors.initials: L
authors.lastname: Balbiani
authors.forename: Daniel
authors.initials: D
authors.lastname: Flores Morales
authors.forename: Alberto
authors.initials: A
authors.lastname: Zori Comba
authors.forename: Celia
authors.initials: C
authors.lastname: Brosio
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016001:Confidence Intervals; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D018579:Patient Selection; D015996:Survival Rate; D016896:Treatment Outcome; D014944:World Health Organization; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine