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- Title
First-Line Herceptin[sup ®] Monotherapy in Metastatic Breast Cancer.
- Authors
Vogel, Charles L.; Cobleigh, Melody A.; Tripathy, Debu; Gutheil, John C.; Harris, Lyndsay N.; Fehrenbacher, Louis; Slamon, Dennis J.; Murphy, Maureen; Novotny, William F.; Burchmore, Michael; Shak, Steven; Stewart, Stanford J.
- Abstract
The pivotal phase II and III Herceptin[sup ®] trials proved the efficacy and safety of second- or third-line single-agent Herceptin and first-line Herceptin in combination with chemotherapy, respectively. In the current trial, 114 patients were randomized to one of two dose groups of first-line Herceptin monotherapy: standard dose of 4 mg/ kg initial dose followed by 2 mg/kg intravenous (i.v.) weekly; or high dose of 8 mg/kg initial dose followed by 4 mg/kg i.v. weekly. The regimen was generally well tolerated. A similar incidence of adverse events was demonstrated in the two dose groups with the possible exception of acute infusion-related events such as fever and chills as well as rash and dyspnea, which appear to be more prevalent in the higher dose group. The overall response rate was 26% and response rates were similar between the two dose groups (24% for the standard Herceptin dose group and 28% for the high Herceptin dose group). Subgroup analysis determined a higher response rate in IHC 3+ patients (35%) and FISH-positive patients (41%). When women with stable disease for ≥6 months were included with responders, the clinical benefit rate in IHC 3+ patients was 47%. Median survival was 24.4 months, which is comparable with the survival rate seen in the pivotal phase III combination trial (25 months). Therefore, single-agent Herceptin is an important new option for the first-line treatment of HER2-positive metastatic breast cancer patients.Copyright © 2001 S. Karger AG, Basel
- Subjects
HER2 gene; TRASTUZUMAB; MONOCLONAL antibodies; ANTINEOPLASTIC agents; BREAST cancer; THERAPEUTICS
- Publication
Oncology, 2001, Vol 61, p37
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000055400