title: First-line, single-agent Herceptin(trastuzumab) in metastatic breast cancer: a preliminary report.
abstract: Following confirmation of the appropriate dosage, safety and potential efficacy of Herceptin(trastuzumab) in small-scale phase I and II trials involving patients with refractory disease, a large trial was conducted in 222 patients with breast cancer who had relapsed after one or two chemotherapy regimens for their metastatic disease. The results showed a positive and durable overall response rate (15% according to a response evaluation committee (REC) assessment) using trastuzumab monotherapy (initial dose 4 mg/kg intravenously (i.v.) followed by 2 mg/kg i.v. weekly). In another recently completed phase II trial, 113 patients were randomised to two dose levels (initial dose of 4 mg/kg i.v. dose followed by 2 mg/kg i.v. weekly, or initial dose of 8 mg/kg followed by 4 mg/kg i.v. weekly) of single-agent trastuzumab as first-line therapy for metastatic disease. The preliminary overall response rate was 23% based on investigator assessment, and tolerability was excellent as in previous trials; efficacy was similar in both dose groups, but the side-effects tended to be more frequent in the higher dose group. The preferred dosage is therefore the same as that currently recommended, i.e. an initial dose of 4 mg/kg i.v. followed by 2 mg/kg weekly i.v. until disease progression.
authors.affiliation: University of Miami School of Medicine, Miami, FL, USA. drcvogel@aol.com
authors.forename: C
authors.initials: C
authors.lastname: Vogel
authors.forename: M A
authors.initials: MA
authors.lastname: Cobleigh
authors.forename: D
authors.initials: D
authors.lastname: Tripathy
authors.forename: J C
authors.initials: JC
authors.lastname: Gutheil
authors.forename: L N
authors.initials: LN
authors.lastname: Harris
authors.forename: L
authors.initials: L
authors.lastname: Fehrenbacher
authors.forename: D J
authors.initials: DJ
authors.lastname: Slamon
authors.forename: M
authors.initials: M
authors.lastname: Murphy
authors.forename: W F
authors.initials: WF
authors.lastname: Novotny
authors.forename: M
authors.initials: M
authors.lastname: Burchmore
authors.forename: S
authors.initials: S
authors.lastname: Shak
authors.forename: S J
authors.initials: SJ
authors.lastname: Stewart
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068878:Trastuzumab