Standards, Options and Recommendations (SOR) for tumor markers in 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 Pu blic Universities, General Hospital; and Private Clinics. The main objectiv e is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based o n literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. Objectives : To define, according to the definitions of the Standards, Options and Rec ommendations project, the characteristics of various tumour markers in brea st cancer and the potential role of these markers in the management of pati ents with this malignancy Methods: Data were identified by searching Medlin e and the personal reference lists of members of the expert groups. Once th e guidelines were defined, the document tons submitted for review to 43 ind ependent reviewers, and to the medical committees of the 20 French Cancer C entres. Results: The main recommendations are: 1) CA 153 and CEA are the se rum tumour markers most often used in breast cancer (standard). 2) if the C A 15.3 is raised at presentation, there is no place for the measurement of other tumour markers (standard, expert agreement). 3) All analyses for each patient must be performed in the same laboratory using the same technique (standard expert agreement). 4) CA 15.3 should not be used for screening or diagnosis. 5) The level of CIA 15.3 before treatment is a recognised progn ostic factor, the independent value of which has not been proven (standard, level of evidence C). 6) If the initial value of CA 15.3 is greater than 5 0 kU.L-1 disseminated disease should be actively sought before any treatmen t decisions are made (standard, expert agreement). 7) An initial elevation of CIA 15.3 that does not return to normal reflects a lack of response to t reatment and is a strong adverse prognostic factor (standard, level of evid ence C). 8) The accuracy of tumours markers (especially CA 15.3) as early i ndicators of metastatic disease is well recognised (standard) but the clini cal benefit has not been established. 9) There is a correlation between tum our markers and clinical response in the treatment of metastatic disease (l evel of evidence C). The level of CA 15.3 in metastatic disease does not pr edict response to treatment.