First-line herceptin® monotherapy in metastatic breast cancer

Charles L. Vogel, Melody A. Cobleigh, Debu Tripathy, John C. Gutheil, Lyndsay N. Harris, Louis Fehrenbacher, Dennis J. Slamon, Maureen Murphy, William F. Novotny, Michael Burchmore, Steven Shak, Stanford J. Stewart

Research output: Contribution to journalArticlepeer-review

161 Scopus citations


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 Her-ceptin 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 ≥ 66 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.

Original languageEnglish (US)
Pages (from-to)37-42
Number of pages6
Issue numberSUPPL. 2
StatePublished - Nov 15 2001


  • First-line therapy
  • FISH
  • HER2 positive
  • Herceptin®
  • IHC 3+
  • Metastatic breast cancer
  • Monotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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