STANDARDS, OPTIONS AND RECOMMENDATIONS (S OR) FOR THE CLINICAL USE OFERYTHROPOIETIN IN ONCOLOGY

The ''Standards, Options and Recommendations'' (SOR), started in 1993, are a collaborative project between the Federation of the French Canc er Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. Th e main objective is the development of clinical practice guidelines to improve the quality of health care and outcomes for cancer patients. The methodology is based on literature review and critical appraisal b y a multidisciplinary experts group, with feedback from specialists in cancer care delivery. Objectives: To develop a clinical practice guid eline with definitions of Standards, Options and Recommendations for t he use of recombinant human erythropoietin (rHuEPO) in oncology. Metho ds: Data have been identified by literature search using Medline (up t o march 1996) and Current Contents (up to october 1996) and personal r eferences lists. The main end points considered were hemoglobin level, haematocrit, qualify of life, transfusion requirements, incidence and length of hospital stays, efficacy of cancer treatment, safety and co sts. Once the guideline was defined, the document was submitted to 39 reviewers for peer review and agreement. Results: The key recommendati ons are: 1) the use of recombinant human erythropoietin in oncology is validated for chemotherapy-induced anemia when the chemotherapeutic r egimen contains platinum. In other cases, we recommend to suggest pati ents participating in prospective clinical trials; 2) for chemotherapy (platinum based)-induced anemia, the benefits/risks ratio for anemia therapy (i.e. transfusion or erythropoietin therapy) must be analysed for each individual patient; 3) we recommend participation in studies to identify predictive factors for non-response to erythropoietin ther apy to select non-responding patients; 4) to investigate the clinical benefit of erythropoietin therapy for anemia due to intensive cytotoxi c chemotherapy and radiation therapy, we recommend to suggest patients participating in large multicentre phase III trials; 5) at the presen t time, there is insufficient evidence to recommend the use of erythro poietin therapy in children.