• DOI:10.1159/000055400
• Corpus ID: 24924864

First-Line Herceptin® Monotherapy in Metastatic Breast Cancer

@article{Vogel2001FirstLineHM,
  title={First-Line Herceptin{\textregistered} Monotherapy in Metastatic Breast Cancer},
  author={Charles L. Vogel and Melody A Cobleigh and Debu Tripathy and John C. Gutheil and Lyndsay N. Harris and Louis Fehrenbacher and Dennis J Slamon and Maureen Murphy and William F. Novotny and Michael Burchmore and Steven Shak and Stanford J. Stewart},
  journal={Oncology},
  year={2001},
  volume={61},
  pages={37 - 42}
}

• C. Vogel, M. Cobleigh, +9 authors S. Stewart
• Published 26 October 2001
• Medicine
• Oncology

The pivotal phase II and III Herceptin® 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.