Standards, Options and Recommendations (SOR) for endocrine therapy in patients with non metastatic breast cancer

Context: The "Standards, Options and Recommendations" (SOR) project, starte d in 1993, is a collaboration between the Federation of the French Cancer C entres (FNCLCC), the 20 French Cancer Centres and specialists from French P ublic Universities, General Hospitals and Private Clinics. The main objecti ve is the development of clinical practice guidelines to improve the qualit y of health care and outcome for cancer patients. The methodology is based on literature systematic review and critical appraisal by a multidisciplina ry group of experts, with feedback from specialists in cancer care delivery . Objectives: To develop clinical practice guidelines according to the defi nitions of Standards, Options and Recommendations for endocrine therapy in patients with non metastatic breast cancer. Methods: Data have been identif ied by literature search using Medline(R), Embase(R), Cancerlit(R) and Coch rane(R) databases - until July 1999 - and the personal reference lists of t he expert group. Once the guidelines were defined, the document was submitt ed for review to 125 independent reviewers. Results: The main recommendatio ns for the endocrine therapy of patients with non metastatic breast cancer are: 1) Endocrine therapy modalities depend on menopausal status or age of women: ovarian suppression for premenopausal women, antiestrogen drug thera py for postmenopausal women (standard). 2) Tamoxifen (20 mg/d - 5 years) is beneficial to women with positive estrogen receptor tumor (standard, level of evidence A). There is no indication of tamoxifen treatment for women wi th negative estrogen receptor tumor (standard, level of evidence A). 3) For postmenopausal women with positive estrogen receptor tumor, tamoxifen is t he standard adjuvant treatment (level of evidence A). For postmenopausal wo men with negative estrogen receptor, adjuvant chemotherapy has to be consid ered (option, level of evidence A). No adjuvant treatment has to be conside red for women with poor health condition (option). 4) For premenopausal wom en with estrogen receptor tumor, results of clinical trails of chemotherapy versus endocrine therapy, suggest a benefit for endocrine therapy. However , there is no sufficient evidence to consider endocrine therapy alone as a standard adjuvant treatment. 5) For premenopausal women, chemotherapy + ova rian suppression or chemotherapy + tamoxifen are not better than chemothera py alone (level of evidence A). 6) For postmenopausal women, administration of chemotherapy plus adjuvant tamoxifen versus the same tamoxifen alone, i s of additional benefit in reducing recurrences but not in prolonging overa ll survival (standard, level of evidence A). 7) Balance of known benefits ( delay to recurrence and death) and risks (side-effects of therapy) for adju vant chemoendocrine therapy has to be taken into consideration before decis ion making. Chemoendocrine therapy can be indicated for women at high risk of developing metastatic disease (recommendation, experts agreement).