title: Paclitaxel/5-fluorouracil/leucovorin in metastatic breast cancer: a Vanderbilt Cancer Center phase II trial.
abstract: Fifty-five women with metastatic breast cancer were treated with a regimen consisting of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) 175 mg/m2 administered intravenously over 3 hours on day 1 only plus leucovorin given intravenously over 30 to 60 minutes followed by 5-fluorouracil 350 mg/m2 via intravenous push on days 1 to 3 every 28 days for six cycles. Eight patients were chemotherapy naive. Of 47 previously treated women, 30 had received anthracyclines. Fifty-two patients were evaluable for response. Three (6%) experienced a complete response and 24 (46%) had a partial response, for an overall response rate of 52%. Patients previously exposed to doxorubicin had a response rate similar to those with no prior doxorubicin exposure (50% v 54%, respectively). The median duration of response was 8.6 months and median survival was 17.7 months. Toxicity was modest, with grade 3 or 4 neutropenia observed in only 5.5% (15 of 274) of cycles. Preliminary results indicate that paclitaxel/5-fluorouracillleucovorin is an active, well-tolerated regimen for treating metastatic breast cancer.
authors.affiliation: Vanderbilt University Medical School, The Vanderbilt Clinic, Nashville, TN 37232-5536, USA.
authors.forename: B
authors.initials: B
authors.lastname: Nicholson
authors.forename: D
authors.initials: D
authors.lastname: Paul
authors.forename: Y
authors.initials: Y
authors.lastname: Shyr
authors.forename: M
authors.initials: M
authors.lastname: Garrett
authors.forename: K R
authors.initials: KR
authors.lastname: Hande
authors.forename: D H
authors.initials: DH
authors.lastname: Johnson
mesh_terms: D000328:Adult; D000368:Aged; D000931:Antidotes / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate
chemical_list: D000931:Antidotes; D017239:Paclitaxel; D002955:Leucovorin; D005472:Fluorouracil