Authors' objectives:

To provide guidance on the use of taxanes for breast cancer.

Authors' recommendations: Guidance 1.1 Both docetaxel (Taxotere) and paclitaxel (Taxol) should be available for the treatment of advanced breast cancer where initial cytotoxic chemotherapy (including anthracycline) has failed or is inappropriate. 1.2 The decision as to which product should be used in individual cases should be taken by the responsible clinician in discussion with the patient, taking account of the evidence set out below: 1.2.1 - Currently available Randomised Controlled Trial (RCT) evidence for the use of the taxanes in advanced breast cancer shows improved initial response and progression free survival: For docetaxel, there are four RCTs (based on approximately 1000 patients), which show significantly longer progression free survival versus controls. The median progression free survival is approximately six months and the gain over controls ranges from 5 to 16 weeks. These four RCTs used different comparator drugs. For paclitaxel, there are two RCTs, (with a total of approximately 500 patients), one of which is a comparison against mitomycin and the other is a dose ranging study. Compared to mitomycin, patients on paclitaxel have a median progression free survival of approximately 3.5 months and a gain over control of about 9 weeks and this result is supported by the dose ranging study. 1.2.2 The adverse effects (for example, hair loss and mouth ulcers) of the taxanes are well documented but the side effect profile in individual patients may differ between the two products available. However, no significant difference in overall quality of life has been demonstrated between the taxanes and the comparator agents used in the trials. 1.2.3 The taxanes are not currently licensed in the UK for adjuvant treatment of early breast cancer or for the first-line treatment of advanced breast cancer. However, the Institute is aware that randomised trials evaluating their use in these indications have been conducted or are in the process of being completed. These trials have not yet been fully reported. The Institute recommends that the use of the taxanes for these indications should be limited to a clinical trials setting.The Institute has been advised that license applications for the use of paclitaxel and docetaxel in the first-line and adjuvant settings have been submitted or are likely to be submitted.

Authors' methods: Guidance

Project Status: Completed

URL for project: http://www.nice.org.uk/page.aspx?o=TA006

Year Published: 2000

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: National Institute for Clinical Excellence

Contact Address: MidCity Place, 71 High Holborn, London WC1V 6NA, UK. Tel: +44 020 7067 5800; Fax: +44 020 7067 5801

Contact Name: nice@nice.nhs.uk

Contact Email: nice@nice.nhs.uk

Copyright: National Institute for Clinical Excellence (NICE)