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.
Original language | English (US) |
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Pages (from-to) | 25-29 |
Number of pages | 5 |
Journal | European Journal of Cancer |
Volume | 37 |
DOIs | |
State | Published - 2001 |
Keywords
- Clinical trial
- Efficacy
- First-line
- Herceptin® (trastuzumab)
- Metastatic breast cancer
ASJC Scopus subject areas
- Cancer Research
- Hematology
- Oncology