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

G-CSF can be used in neutropenic patients. In case of neutrophils
500/µL neutrophils. If neutrophils fall 500/∝L. Similarly, if platelets fall 2.5 ng/dL had
not been included in clinical trials. Response to Len/Dex was superior to
Dex alone, independently of the type of prior therapy (bortezomib,
thalidomide, or prior transplant). It is important to note that patients
refractory to thalidomide still respond to Len/Dex, although the overall
response might be less than in patients not refractory to thalidomide
(not significant). Patients with only 1 previous line of therapy had a
greater survival advantage than patients with more than 1 previous line
of therapy. There is some evidence that a lower dose of Dex may result
in less toxicity (Rajkumar et al., Blood 2006; 108:799), but efficacy data
are not yet available. However, the dexamethasone dose may be adjusted
in elderly, fragile patients >75 years. Also, as lenalidomide is mainly
renally excreted, dose reduction of lenalidomide depending on the severity
of renal impairment will be provided. Adjustments for mild to moderate
hepatic dysfunction or potential drug-interactions are not required.
Conclusions. Len/Dex is recommended for patients with relapsed/refractory
MM regardless of baseline factors.
0268
EARLY BORTEZOMIB TREATMENT IMPROVES RESULTS IN RELAPSED MYELOMA
PATIENTS. BETTER SECOND THAN FURTHER LINES
L.F. Casado Montero, 1 I. Cano, 2 C. Calle, 2 M.I. Gómez-Roncero, 2
F. Solano, 2 M.A. Foncillas, 2 D. De Miguel, 2 M.J. Bustos-Medina, 2
A.R. López-Quiñones, 2 J.R. Romero2 1 Hospital Virgen de la salud, TOLEDO, Spain; 2 Grupo Clínico de la SCMHH,
CASTILLA LA MANCHA, Spain
Background. Proteasome inhibition with bortezomib (VELCADE ) is
the standard of care in patients with relapsed/refractory multiple myeloma
(MM) who have received at least one prior therapy. The phase II
SUMMIT trial of patients with relapsed and refractory MM showed that
bortezomib is active, with a response rate of 27% (CR/PR) as a single
agent, median TTP of 7 months, and median OS of 17 months. The
phase 3 APEX trial in pts with relapsed MM following 1 3 prior therapies
showed btz to be superior to high-dose dexamethasone (dex) in
terms of response rate, TTP, and OS. Updated APEX data show a CR/PR
rate of 43%, median TTP of 6.2 months, and median OS of 29.8 months.
Preliminary data from the APEX trial showed that earlier treatment (second
vs further lines of therapy) resulted in better RR,TtPD and OS. Aims.
To compare patients receiving bortezomib as second line therapy vs
those receiving it as third or subsequent lines of treatment. Methods. 63
patients with relapsed or refractory MM were treated with bortezomib
at a dose of 1.3 mg/m 2 on days 1, 4, 8, and 11 in a 21-day cycle. 80% of
patients received dexamethasone at a dose of 20 mg on days 1, 2, 4, 5,
8, 9, 11 and 12. Median age was 68.9 years old (range 43-87). Twentyfour
patients received only one line of therapy with melphalan-prednisone,
and 39 of them received previously 2 or more lines of therapy;
haematologica/the hematology journal | 2007; 92(s1) | 97