John Libbey Eurotext

Bulletin du Cancer

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Standards, Options and Recommendations (SOR) for the clinical use of erythropoeitin in oncology Volume 85, issue 4, Avril 1998

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The “Standards, Options and Recommendations” (SOR), started in 1993, are a collaborative project between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The 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 by a multidisciplinary experts group, with feedback from specialists in cancer care delivery. Objectives: To develop a clinical practice guideline with definitions of Standards, Options and Recommendations for the use of recombinant human erythropoietin (rHuEPO) in oncology. Methods: Data have been identified by literature search using Medline (up to march 1996) and Current Contents (up to october 1996) and personal references lists. The main end points considered were hemoglobin level, haematocrit, qualify of life, transfusion requirements, incidence and lenght of hospital stays, efficacy of cancer treatment, safety and costs. Once the guideline was defined, the document was submitted to 39 reviewers for peer review, and to the medical committees of the 20 French Cancer Centres for review and agreement. Results: The key recommendations are: 1) the use of recombinant human erythropoietin in oncology is validated for chemotherapy-induced anemia when the chemotherapeutic regimen contains platinum. In other cases, we recommend to suggest patients 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 therapy to select non-responding patients; 4) to investigate the clinical benefit of erythropoietin therapy for anemia due to intensive cytotoxic chemotherapy and radiation therapy, we recommend to suggest patients participating in large multicentre phase III trials; 5) at the present time, there is insufficient evidence to recommend the use of erythropoietin therapy in children.