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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
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