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6/22/2004 - "This is the first clinical evidence of an association between any erythropoietin product and cognitive function in haematological malignancies, and it is of vital significance to cancer patients. " - Preliminary results from a prospective, international, multi-centre trial (EPOLYM) indicate haemoglobin (Hb) increases achieved with EPREX® /ERYPO® (epoetin alfa) are associated with improved cognitive function in cancer patients with chemotherapy-related anaemia. These findings, presented at the 9th European Haematology Association (EHA) congress, suggest that benefits of EPREX may be greater than previously recognised. Professor Hans Tesch (Bethanien-Krankenhaus, Frankfurt, Germany), lead author of the study, says, "This is the first clinical evidence of an association between any erythropoietin product and cognitive function in haematological malignancies, and it is of vital significance to cancer patients. Chemotherapy-associated cognitive dysfunction can impact social, educational and professional activities, and reduce overall quality of life (QoL). So far it has received relatively little attention, but now that may change." EPREX has been shown in clinical trials to have a positive impact on cognitive function in cancer patients with chemotherapy-associated anaemia. Cognitive function is impaired in patients with haematological malignancies. Preliminary data analysis shows substantial improvement (8 per cent) in combined speed of memory scores (numeric, word recognition, picture recognition) as Hb increases from 10.5 g/dl to around 12 g/dl at Weeks 8-12, with improvements sustained for up to 24 weeks. Preliminary findings also show cancer patients improve in QoL parameters as they attain an optimal Hb level of 12 g/dl. Quality of life was evaluated from baseline to Week 12 by the Linear Analog Scale Assessment (LASA) and the Functional Assessment of Cancer Therapy-Anaemia (FACT-An). Mean baseline LASA scores ranged from 44.5-49.1 mm (normal is 70-100 mm) indicating that all patients had large QoL deficits at study initiation. At Week 12, clinically significant changes were observed for energy level (mean 12.7 mm), daily activities (mean 10.1 mm) and overall QoL (mean 14.3 mm). Other randomised, placebo controlled studies, and community based trials in thousands of patients also have proven epoetin alfa to be a well-tolerated, effective treatment for cancer-related anaemia with a significant positive impact on QoL. Professor Tesch concludes, "Whilst the findings around cognitive function are based on preliminary results and will need to be confirmed by data from the full study cohort, they are promising for the future of epoetin alfa treatment. A predictable benefit to cognitive function is highly desirable to optimise cancer patient care." Interim data analyses from the EPOLYM trial focus on 383 anaemic patients receiving chemotherapy for non-Hodgkin's lymphoma (NHL, n=165), multiple myeloma (MM, n=106), Hodgkin's disease (HD, n=58) and chronic lymphocytic leukaemia (CLL, n=53). Patients received epoetin alfa subcutaneously to a target Hb of 11.5-13.0 g/dl. Changes in cognitive function and mood were assessed from baseline to Week 24 with the Cognitive Drug Research (CDR) Computerised Cognitive Assessment System. This system includes tasks of attention (simple reaction time, choice reaction time, digit vigilance), working memory (numeric working memory) and secondary memory (immediate and delayed word recognition, picture recognition). Mean Hb increased 1.02 g/dl at Weeks 3-5 and 2.02 g/dl at Weeks 15-16. The greatest Hb increase was seen in MM patients (2.5 g/dl), who also had the lowest baseline Hb (10.0 g/dl). There is a strong positive correlation between high Hb levels and high QoL scores, with a maximal gain in QoL seen at an Hb level of 12 g/dl (range 11-13 g/dl). Now, for the first time, in haematological malignancies an improvement in cognitive function also has been shown for Hb levels of 12 g/dl. An unrestricted educational grant from Ortho Biotech, Biopharmaceutical division of JanssenCilag, supported this study. Ortho Biotech markets EPREX® /ERYPO® (epoetin alfa) in Europe. For more details please contact: Daniel De Schryver Global Pharmaceutical Communications Johnson & Johnson Lenneke Marelaan 6 1930 St Stevens Woluwe +32 2 749 2770 1. J O'Shaughnessy, S. Vukelja, et al. Impact of epoetin alfa on cognitive function, asthenia, and quality of life in women with breast cancer receiving adjuvant or neoadjuvant chemotherapy: analysis of 6-month follow-up data. Breast Cancer Res Treat 2002; 76: S138. 2. Littlewood TJ, Bajetta E, Nortier JWR, et al. Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: results of a randomized, double-blind, placebo-controlled trial. J Clin Oncol 2001;19:2865-2874. 3. Patrick DL, Gagnon DD, Zagari MJ, et al. Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. Eur J Cancer 2003;39:335-345 4. JL Gabrilove, CS Cleeland, RB Livingston, B Sarokhan, E Winer, LH Einhorn. Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: improvements in hemoglobin and quality of life are similar to three-times-weekly dosing. J Clin Oncol. 2001 Jun 1;19(11):2875-82. 5. G Curt & PG Johnston. Cancer fatigue: the way forward. The Oncologist 2003; 8 (Suppl 1): 2730. 6. D Shasha, MJ George, LB Harrison. Once-weekly dosing of epoetin-alpha increases haemoglobin and improves quality of life in anaemic cancer patients receiving radiation therapy either concomitantly or sequentially with chemotherapy. Cancer 2003 Sep 1;98(5):1072-9. 7. S Pecorelli, P Wilkinson. Improvement of quality of life with epoetin alfa in anaemic patients with ovarian cancer. Presented at the International Congress on Anti-Cancer Treatment (ICACT) in Paris, France, 9-12 February 2004. 8. JA Glaspy. The potential for anemia treatment to improve survival in cancer patients. Oncology 2002; 16 (Suppl 10): 35-40. 9. GD Demetri, M Kris, J Wade, L Degos, D Cella. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol. 1998 Oct;16(10):341225. 10. K Hassan, W Simri, I Rubenchik, J Manelis, B Gross, S Shasha, B Kristal. Effect of erythropoietin therapy on polyneuropathy in predialytic patients. J Nephrol. 2003 JanFeb;16(1):121-5. 11. J Crawford. Relationship between changes in hemoglobin level and quality of life during chemotherapy in anaemic cancer patients receiving epoetin alfa therapy. Cancer 2002; 95: 888-895. http://www.janssencilag.com/news/avscontent.jhtml?topic=news&id=41600066&itemname=eprex_cognitivefunction