12th Congress of the European Hematology ... - Haematologica

Results. A total of 396 patients were randomized and received ≥1 dose
of DA (IV iron arm =200; oral iron/no iron arm = 196). Patients had a
mean (SD) age of 61.0 (11.5) years; most (61%) were women. As presented
elsewhere, at the end of the study, significantly more patients
receiving IV iron and DA exhibited a haematopoietic response than did
those receiving oral/no iron and DA (Kaplan-Meier estimates [95%CI],
86% [79-92] vs 73% [66-80], respectively; difference, 13% [3-23],
p=0.011). The LS mean (SE) changes from baseline to EOTP in FACT-F
score were 2.4 (0.79) and 2.17 (0.77), respectively, for the IV iron and
oral/no-iron arms. Changes in FACT-F score from baseline to EOTP by
efficacy responder status are presented in the Table 1. Summary and conclusions
In this study, within each treatment arm, QOL improvements
were better for patients who demonstrate an efficacy response than
those who do not. Most groups of efficacy responders exhibited an
adjusted mean change in FACT-F score that was close to or exceeded the
3-point threshold identified as clinically significant (Cella et al., J Pain
Symptom Manage 2002;24(6): 547-61). These data provide further evidence,
suggesting a link between quality of life improvements and clinical
responses.
0769
QUALITY OF LIFE ASSESSMENT IN HAEMOPHILIC PATIENTS WITH INHIBITORS: RESULTS
OF THE COHIBA STUDY
S. von Mackensen, 1 A. Gringeri, 2 L. Scalone, 3 F. Borghetti, 3
L. Mantovani3
1 2 Institute of Medical Psychology HAMBURG Germany; Haemophilia &
Thrombosis Centre, MILAN, Italy; 3Center of Pharmacoeconomics, MILAN,
Italy
Background. Haemophilia with inhibitors is a rare condition, with a
prevalence of 1 of 100,000 inhabitants. The development of inhibitors
requires a substantial amount of economical and human resources and
represents one of the most challenging complications of haemophilia
treatment in terms of life-threatening bleeding, severe arthropathy and
physical disability. Quality of life and self-management abilities of
patients are affected by this complication. Health-Related Quality-of-Life
(HRQoL) and treatment satisfaction are so-called patient-rated outcomes
(PROs), which provide an opportunity for patients to report their own
experience of functioning, well-being and treatment. In the frame of the
Italian COHIBA Study haemophilia patients with inhibitors were asked
about their treatment preferences, HRQoL and treatment satisfaction.
Aims. Description of HRQoL and treatment satisfaction in adult and paediatric
haemophilic patients with inhibitors across age groups and clinical
conditions. Methods. HRQoL and treatment satisfaction was assessed
in 30 patients from 9 Italian Haemophilia Centers. HRQoL was evaluated
with the Core Instrument of the haemophilia-specific Haem-A-
QoL consisting of 25 items (allowing the comparison between children
and adults), treatment satisfaction was assessed with the Hemo-Sat questionnaire
(for adults and parents of haemophilic children) consisting of
34 items pertaining to 6 dimensions (ease & convenience, efficacy, burden,
specialist/nurses, centre/hospital, general satisfaction). Results. In
total 23 adult and 7 paediatric inhibitor patients, severely affected by
haemophilia A, were enrolled in the COHIBA Study. 56% received ondemand
treatment, 22% prophylaxis and 22% ITI. The median age in
adults was 40 years (17-60), in children 10 years (4-16). Patients as well
as parents of haemophilic children were mainly unsatisfied with
haemophilia treatment in terms of efficacy (MA=56.25, SDA=18.7;
Mp=72.22, SD p=11.7) and ease (MA=53.38, SDA=10.42; Mp=61.21,
SDp=8.6), even though parents seemed to be more unsatisfied than adult
patients. Adult patients showed main impairments in their HRQoL in the
dimensions sport, physical health and future; most of them (87%) had to
refrain often or always from sports like soccer, pain in the joints was
reported often or always by 65% and concerning their future 43% thought
seldom or never that things get better in the future. Whereas children were
less impaired in their HRQoL than adult patients; areas of main impairments
were sport (100% could seldom or never do as much sports as others),
dealing (33% were seldom or never able to tell whether they were
bleeding) and view (33% found seldom or never that their life was more
difficult because of haemophilia). Conclusions. Adult haemophilic patients
were more impaired in their HRQoL than paediatric patients, even
though both were mainly limited in sports activities. Assessment of
PROs is important to understand specific problems of haemophilic
patients and to improve their individual treatment.
12 th Congress of the European Hematology Association
0770
EFFECTIVENESS OF EPOETIN B 30,000 UI ONCE WEEKLY FOR TREATMENT OF ANEMIA
IN PATIENTS WITH HEMATOLOGICAL MALIGNANCIES TREATED WITH CHEMOTHERAPY
P. Rodon, 1 T. Facon, 2 G. Salles, 3 R. Garidi, 4 C. Hennequin, 5
L. Bergougnoux, 6 P. Bleuzen, 6 A. Jenabian, 6 D. Spaeth7 1 Centre Hospitalier de Blois, BLOIS CEDEX; 2 Hôpital Claude Huriez, LILLE;
3 Centre Hospitalier Lyon Sud, LYON; 4 Centre Hospitalier, SAINT QUENTIN;
5 Hôpital Saint-Louis, PARIS; 6 F. Hoffmann-La Roche, NEUILLY-SUR-SEINE;
7 Centre dOncologie de Gentilly, NANCY, France
Background. Anemia is the most frequent hematological complication
of chemotherapy in cancer patients with a profound impact on their
quality of life. Furthermore, hematological malignancies (HM) by themselves
are frequently a cause of anemia. Epoetin β (E) is an effective treatment
of chemotherapy-induced anemia in patients (pts) with non
myeloid HM. Aims. To evaluate the efficacy and safety of E 30 000 IU
once weekly (QW) in pts with non-myeloid HM and more specifically
in subgroups of lymphomas (L) and multiple myelomas (MM). Methods.
This was a multicenter, single-arm trial. Eligibility criteria were: informed
consent, age ≥18 yrs, WHO performance status 0-2, malignant nonmyeloid
malignancies, on-going chemotherapy and anemia: hemoglobin
(Hb)