Autor: |
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. |
Předmět: |
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Zdroj: |
Oncology; 2001 Supplement 2, Vol. 61, p37-42, 6p |
Abstrakt: |
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 [ABSTRACT FROM AUTHOR] |
Databáze: |
Complementary Index |
Externí odkaz: |
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