Haematologica 2003 - Supplements

cost of SRE-related care was $10,247 per patient (95% CI
$7,921-$12,573); 74% of these costs were incurred within 6
months of the first SRE-related claim. Conclusions: The
economic burden of SREs in multiple myeloma patients is
substantial. Coupled with evidence from randomized trials
demonstrating the benefits of potent intravenous bisphosphonates
in reducing the incidence of SREs, our findings suggest that early
intervention with these agents may play an important role in
improving outcomes in multiple myeloma patients.
1Groot MT et al. Costs of prostate cancer, metastatic to bone, in
The Netherlands. Eur Urol 2003;43:226-32.
248
Safety and efficacy of pamidronate and zoledronic acid
in multiple myeloma patients are comparable
Maria Kraj, Ryszard Pogłód, Stanisław Maj, Jan
Pawlikowski, Urszula Sokołowska, Janusz Szczepanik
Institute of Haematology and Blood Transfusion, Warsaw, Poland
Randomized, double-blind study was conducted to compare the
efficacy and safety of zoledronic acid and pamidronate for
treating myeloma bone disease. Since March 1999 the efficacy
and safety of pamidronate and zoledronic acid is evaluated in
MM patients all receiving anti-myeloma chemotherapy acc. to
VMCP/VBAP regimen. Nine patients with stage III myeloma and
osteolytic lesions (3 female, 6 male, median age 57 years, range
52-67), were randomly assigned (1:1:1 ratio) to treatment with
either 4 or 8 mg of zoledronic acid via 15-minute intravenous
infusion or 90mg of pamidronate via 2-hour intravenous infusion
every 3 to 4 weeks for 12 months . In extension phase of the
study (June 2000 – February 2003) patients did not received
bisphosphonates. Results. In 7 patients 18 cycles of assessed
treatment was administered to each of them and one patient
received 16 cycles. One patient died after receiving 12
pamidronate therapy cycles at 11 month of the trial duration. The
patient’s death occurred during the progression of plasma cell
proliferation due to acute left ventricle cardiac failure. During the
12-month-period of bisphosphonate treatment and in extension
phase skeletal related events (SRE) and progression of osteolysis
occurred with the same frequency in 3 treatment groups. One
patient experienced spinal cord compression and received
radiation to bone and 2 patients experienced vertebral fracture.
Time from study entry to the first SRE was 304 days in
pamidronate and 366 and 392 days in 4 and 8 mg zoledronic acid
group, respectively. The skeletal morbidity rate was identical in
all treatment groups. Adverse events: single hypocalcemic events
occurred in 2 patients, mild hypertransaminasemia was observed
in 3, worsening of renal function parameters in 2 patients.
Muscular pain and fever up to 39 ˚C occurred in 6 patients after
several or some dozens of hours from study drug administration.
Adverse events were similar in nature and frequency with
zoledronic acid and pamidronate. Median time of patient’s
observation duration after completing of administered treatment
with zoledronic acid and pamidronate amounts 24 months. At
present actual median survival time of analysed patients since
MM diagnosis is 46 months, since the beginning of treatment
with pamidronate and zoledronic acid – 34 months, and is similar
in 3 treatment groups. Two patients in the pamidronate group
died as did 3 and 1 in 4 mg and 8 mg zoledronic acid group,
respectively. Conclusions. As was shown in our single center
study in MM patients the safety and efficacy of pamidronate 90
mg and zoledronic acid 4 mg and 8 mg in monthly i.v. infusion
are comparable. Thus the recommended dosage of zoledronic
acid is 4 mg administered as a 15 minute i.v. infusion at intervals
of 3 to 4 weeks.
Core phase of this study is part of an international, multicenter
trial (Rosen et al. Cancer J 2001; 7: 377).
249
Maintenance with intravenous Pamidronate in multiple
myeloma patients in complete remission after tandem
autologous stem cell transplantation (ASCT).
R. Cairoli, G. D’avanzo L. Barbarano, , A. Cafro, G. Grillo,
E. Tresoldi, M. Valentini, E. Morra
Department of Hematology, Niguarda Hospital, Milano, Italy.
The aim of the study was to evaluate the impact of a maintenance
with Pamidronate in patients with Multiple Myeloma in CR after
tandem ASCT. The conditioning regimen was L-PAM 200
mg/m2 for each transplant procedure. Between 1997 and 2001,
19 patients in CR after ASCT were enrolled in this study. Five
patients (study group) received a monthly-4 hours infusion of
Pamidronate at a dose of 90 mg, starting 3 months after the 2nd
ASCT to the relapse. Fourteen patients received no treatment
(control group). The characteristics of the patients are
summarized in the table.
Study Group (n° 5)
Control Group
(n° 14)
Age median (range) 55 (41-56) 51 (38-60)
Male to Female ratio 3:2 3:11
Stage (number) III/A (5) III/A (7), II/A(3),
I/A(4)
Ig subtype (number) IgA(3), IgG(2) IgA(5), IgG(7),
Light chain (2)
β2 microglobulin at 1.55 (1-2.2) 1.9 (1-5.4)
ASCT
median (range)
C-reactive protein at 0.4 (0.1-0.4) 0.35 (0.1-2.1)
ASCT
median (range)
Serum Creatinine 0.9 (0.7-1.08) 0.9 (0.4-1.71)
median (range)
We recorded, for the study group and the control group,
respectively, a CR incidence of 80% (4/5 patients) vs 57%
(8/14) (p=0.3) at 12 months after ASCT; 80% (4/5 patients) vs
21.5% (3/14 patients) (p=0.04) at 24 months after ASCT and 40%
(2/5 patients ) vs 21% (3/14 patients) (p=0.11) at 36 months from
transplant. At a median follow-up of 24 months (range 12-63)
from the 2nd ASCT the study group and the control group
showed an OS of 100% vs 79% (p=NS) and a median CR
duration of 52 months (range 12-60) vs 15 (range 2-30 ) (p= NS)
respectively. In conclusion this preliminary observation on a
substantial benefit of Pamidronate after 2 years post ASCT needs
to be confirmed on a large number of patients.
250
Kyphoplasty enhances function and structural
alignment in multiple myeloma
Joseph M. Lane, Richard Hong, David Siegel, Roger N
Pearse, Tamara Kiechle, Morton Coleman, and Ruben
Niesvizky
The Center for Lymphoma and Myeloma, Weill Medical College of
Cornell University, New York Presbyterian HospitalHospital for
Special Surgery
Multiple myeloma is associated with vertebral compression
fractures and secondary kyphosis. These pathological fractures
result in pain and functional disability. Kyphoplasty that utilizes
minimal invasive balloon tamps to reduce osteoporotic vertebral
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