While many news organizations will undoubtedly report on positive news for the drugs known as aromatase inhibitors for breast cancer because of a study in this week's New England Journal of Medicine, few will probably pick up on a letter to the editor of the Annals of Oncology raising questions about aromatase inhibitor recommendations.
Päivi Hietanen of the Finnish Medical Journal wrote the letter. Hietanen asks if an expert panel provided an unbiased opinion about aromatase inhibitors in the management of women with early breast cancer.
The 11th International Conference on primary therapy for early breast cancer took place in St Gallen from 11 to 14 March 2009. About 4500 delegates from 96 nations attended the meeting, which was designed to review recent results of clinical trials for early breast cancer. The final day of the meeting was reserved to update the International Consensus on treatment recommendations for the primary therapy for early breast cancer, which traditionally ends the biannual conference. An international panel of 41 experts under the leadership of two cochairs tried to reach consensus by voting on several aspects of treatment of women with early breast cancer. These recommendations will be published, and publications from previous meetings have been influential in guiding the treatment of women with breast cancer worldwide.
Aromatase inhibitors provide a recent example of aggressively marketed products, which have a similar clinical efficacy and safety profile. Three companies are trying to increase their share of the market by convincing doctors and patients of the superiority of their own product compared with another, and with the much cheaper tamoxifen, which is the older adjuvant treatment of breast cancer with a well-known safety profile.
Aromatase inhibitors have been shown to lead to a small increase in disease-free survival compared with tamoxifen when evaluated as adjuvant therapy for postmenopausal women with hormone-responsive breast cancer in large clinical trials. They are useful as alternatives for women who have contraindications to the use of tamoxifen and might lead to a small improvement in survival when used after initial tamoxifen. However, there is no evidence for superiority of overall survival or quality of life compared with tamoxifen when they are used as initial adjuvant treatment of postmenopausal women with hormone-responsive breast cancer, which should be the key end point for a clinician when considering replacement of a well-established agent with a newer and more expensive alternative.
Some members of the expert panel with open long-standing relationships with companies that market aromatase inhibitors encouraged the panel to vote on the question "should aromatase inhibitors or tamoxifen be used first?" Other members of the panel stated: "we do not have enough data to address this", but the decision to vote was made by the chair, after some hesitation. The result was 69% in favor of the initial use of aromatase inhibitors--some were against, some were undecided.
... Eleven of the 41 panel members did not have possible conflicts of interests or relevant publications. Twenty-four of the panel, including both chairs, had reported financial relationships with companies that market aromatase inhibitors, and as many had relationships with other companies that market other therapeutic agents used in the treatment of breast cancer. The search results may provide an underestimate of potential conflicts of interest because many journals do not demand disclosure, the reporting was sometimes inconsistent and some articles may have been missed.
Thanks to Marilyn Mann for the tip.