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

12 th Congress of the European Hematology Association
Anemia and PNH - Clinical trials
0376
RITUXIMAB THERAPY FOR IMMUNE ANEMIA AND THROMBOCYTOPENIA:
A BELGIAN REGISTRY RUN BY THE RED CELL SUBCOMITTEE OF THE BELGIAN SOCIETY
FOR HEMATOLOGY
D. Dierickx, 1 A. Triffet, 2 P. Mineur, 3 A. Kentos, 4 A. Ferster, 5 D. Boulet, 6
C. Vermylen, 7 B. Deprijk, 6 Y. Beguin, 2 M.F. Dresse, 6 K. Kargar, 6
G. Verhoef, 1 A. Delannoy8 1 Gasthuisberg, LEUVEN; 2 CHU, CHARLEROI; 3 CH Gilly, CHARLEROI;
4 CHU Erasme, BRUSSELS; 5 HUDERF, BRUSSELS; 6 CHR, MONS; 7 UCL
St Luc, BRUSSELS; 8 CHJolimont and UCL St Luc, LA LOUVIÈRE, Belgium
Background. Immune thrombocytopenic purpura (ITP) and autoimmune
hemolytic anemia (AHA) may respond to the chimeric anti-CD20
monoclonal antibody rituximab, even when refractory to conventional
therapy. Aims. To collect data on Belgian patients given rituximab in the
setting of ITP or AHA in order to assess the response rate and the factors
predictive for response in a multicenter study. Method. Belgian
hematology centers were invited to fill a questionnaire specifying the
major characteristics and quality of response of ITP and AHA patients
given rituximab. For ITP, complete response (CR) was defined as a
platelet count >100,000/µL without immunosuppressive therapy, and a
partial response as a platelet count 50-100,000/µL without immunosuppressive
drugs. For AHA, CR was defined as a normal hemoglobin in the
absence of hemolysis, and a PR as a 2g increase of the hemoglobin concentration.
Results. Patient characteristics and response to therapy are
presented in the attached Table 1. In practically all the patients reported
here, rituximab was given at the dose of 375 mg/m 2 weekly for 4
weeks. In both ITP and AHA patients we could find no significant correlation
between response and sex, age, prior splenectomy, platelet count
or hemoglobin concentration when rituximab was started. Conclusions.
In this still open registry, we could confirm that rituximab induces
responses in a majority of previously treated patients with ITP or AHA.
Responses could not be predicted from pre-treatment patient characteristics.
As data are accumulating in the registry, more information on the
duration of response will be made available.
Table 1.
136 | haematologica/the hematology journal | 2007; 92(s1)
0377
RESULTS FROM A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED
STUDY OF DARBEPOETIN ALFA FOR THE TREATMENT OF ANEMIA IN CANCER PATIENTS
NOT RECEIVING CHEMOTHERAPY OR RADIOTHERAPY
J.A. Glaspy, 1 R.E. Smith, 2 M. Aapro, 3 H. Ludwig, 4 T. Pintér, 5
M. Smakal, 6 T. Ciuleanu, 7 L. Chen8 1 UCLA Medical Center, LOS ANGELES, USA; 2 South Carolina Oncology
Associates, COLUMBIA, USA; 3 Clinique de Genolier, GENOLIER, Switzerland;
4 Wilhelminenspital, VIENNA, Austria; 5 Petz Aladar County Teaching
Hospital, GYOR, Hungary; 6 Ustav Onkologie a Pneumologie Na Plesi, PLEαI,
Czech Republic; 7 Institutul Oncologic Ion Chiricuta Onc, CLUJ-NAPOCA,
Romania; 8 Amgen Inc., THOUSAND OAKS, USA
Background. Patients with cancer, not receiving chemotherapy or radiation,
often develop anemia as a result of the disease itself. Aims. This phase
3 study was designed to evaluate the efficacy and safety of darbepoetin
alfa (DA) 6.75 mcg/kg administered every 4 weeks (Q4W) for the treatment
of anemia of cancer (AoC). Methods. Pt eligibility included: ≥18 years,
non-myeloid malignancy (with active disease), hemoglobin ″11 g/dL,
ECOG status score of 0-2, receiving neither chemotherapy nor radiotherapy
within 4 weeks of screening or during the study, and providing
informed consent. Patients (n=985) were randomized to DA 6.75 mcg/kg
or placebo Q4W for 16 weeks, with an end of study visit at week 19, and
2 years of follow up to evaluate survival. Patients were stratified by screening
hemoglobin (13 g/dL and reinstated at 25% dose reduction once hemoglobin