The effectiveness of prophylactic chemotherapy for women who are at a high risk of breast cancer may remain unclear unless more UK women are recruited to chemotherapy trials, conclude authors of a research letter in this week’s issue of THE LANCET.
Appropriate management of women at high lifetime risk of familial breast cancer is hampered because of limited data of various treatment options. Over the past 8 years, women at very high (greater than 40%) lifetime risk of breast cancer in north-west England have had the option of entering two chemoprevention (prophylactic chemotherapy) trials, a magnetic resonance imaging (MRI) breast-screening study, or a risk-reducing mastectomy (RRM) study.
Since 1987, Gareth Evans and colleagues from St Marys Hospital, Manchester, UK, have studied 4475 women who were at a high risk of breast cancer (identified by epidemiological data and genetic assessment). They comment how entry into the MRI screening study is the preferred option for high-risk women (60%), with only 10% opting for prophylactic mastectomy or entry into chemoprevention trials.
Gareth Evans comments: “While further evidence is necessary to prove the level of risk reduction with mastectomy in BRCA1/2 carriers, it may prove very difficult to involve sufficient numbers of women at high risk in chemoprevention studies until randomisation does not involve a placebo, and the treatment arm does not involve significant chances of unpleasant symptoms. Design of the next definitive prevention study for women at high risk of developing breast cancer may need to consider randomisation without a placebo arm and inclusion of tamoxifen, which is generally well tolerated.”
This week’s Lancet Editorial (p 853) comments that there is a wider problem of recruiting women to randomised trials. It concludes: “…to ensure that women benefit fully from research being done, all effort should be made to recruit them in adequate numbers into any study of disorders affecting women.”
Contact: Professor D Gareth R Evans, Central Manchester Health NHS trust, Regional Clinical Genetic Service, St Mary's Hospital, Hathersage Road, MANCHESTER M13 OJH, UK; T) (Thursday 13 September onwards) +44 (0)161 276 6322; F) +44 (0)161 276 6145; E) gevans@central.cmht.nwest.nhs.uk
Journal
The Lancet