The Pharmaceutical Journal
Vol 269 No 7217 p431
28 September 2002

This article
Reprint
Photocopy

News summary

Related websites
Drug and Therapeutics Bulletin (more)
National Institute for Clinical Excellence (www.nice.org.uk)

NICE trastuzumab guidance questioned

The place of trastuzumab (Herceptin) monotherapy as a third-line treatment for patients with metastatic breast cancer is unclear, according to the Drug and Therapeutics Bulletin (2002;40:65).

Six months ago, the National Institute for Clinical Excellence recommended trastuzumab monotherapy as a third-line option for women who have advanced breast cancer that greatly over-expresses human epidermal growth factor receptor 2 (HER2), where treatment with an anthracycline, a taxane and hormonal therapy has failed.

The DTB review has criticised this recommendation. It argues that there has only been one, uncontrolled trial that has used trastuzumab monotherapy to treat women with this form of breast cancer that was resistant or refractory to chemotherapy regimens. The DTB says NICE's recommendation of trastuzumab monotherapy was based on this trial and states: "Before we can recommend this, we would wish to see evidence of the advantages from randomised controlled trials."

However, the DTB agrees with NICE's recommendation that trastuzumab be used in combination with paclitaxel (Taxol) as a first line treatment for these breast cancer patients, since it has been shown to delay disease progression by three to four months in this setting.