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Blood, 1 September 2001, Vol. 98, No. 5, pp. 1614-1615
BRIEF REPORT
Increased risk of deep-vein thrombosis in patients with multiple
myeloma receiving thalidomide and chemotherapy
Maurizio Zangari,
Elias Anaissie,
Bart Barlogie,
Ashraf Badros,
Raman Desikan,
A. Viju Gopal,
Christopher Morris,
Amir Toor,
Eric Siegel,
Louis Fink, and
Guido Tricot
From the Central Arkansas Veterans Healthcare System
and the University of Arkansas for Medical Sciences, Little Rock, AR.
 |
Abstract |
The occurrence of deep-vein thrombosis (DVT) in patients with newly
diagnosed multiple myeloma, who were randomly assigned to receive
identical induction chemotherapy with or without thalidomide, are
reported in this study. The 2 study arms were comparable with respect to key myeloma prognostic factors and known risk factors for
DVT. One hundred patients received induction chemotherapy including 4 cycles of continuous infusion of combinations of dexamethasone, vincristine, doxorubicin, cyclophosphamide, etoposide, and cisplatin, and each patient completed at least one induction cycle. DVT developed in 14 of 50 patients (28%) randomly assigned to receive thalidomide but in only 2 of 50 patients (4%) not given the agent
(P = .002). All episodes of DVT occurred during the first
3 cycles of induction. Administration of thalidomide was
resumed safely in 75% of patients receiving anticoagulation therapy.
Thus, thalidomide given in combination with multiagent chemotherapy and
dexamethasone is associated with a significantly increased risk of DVT,
which appears to be safely treated with anticoagulation and does not
necessarily warrant discontinuation of thalidomide.
(Blood. 2001;98:1614-1615)
© 2001 by The American Society of Hematology.
| |
Introduction |
Although approximately 20% of patients with
symptomatic deep-vein thrombosis (DVT) have a known malignant disease,
only a few thrombotic episodes occur as the first manifestation of an occult neoplastic process.1 This phenomenon is
multifactorial, and several concomitant factors are necessary to
trigger a thrombotic event.
Hypercoagulability has been observed in patients with dysproteinemias,
and multiple myeloma (MM) has been associated with DVT in 10% of
treated patients.2 We previously showed that thalidomide
is an active agent in patients with MM refractory to combination
chemotherapy and autotransplantation.3 In a study of 169 patients treated with thalidomide as a single agent, DVT occurred in
1%.4 We here describe a significantly increased rate of
DVT in patients with newly diagnosed MM who were randomly assigned to
receive thalidomide and repeated cycles of combination chemotherapy as
part of an ongoing phase III trial. Informed consent approved by the
Institutional Review Board of the University of Arkansas for Medical
Sciences was obtained from each patient.
| |
Study design |
Patients with newly diagnosed MM (untreated or with one cycle of
preceding chemotherapy) were randomly assigned in our Total Therapy II
phase III study to receive combination chemotherapy with or without
thalidomide at a dose of 400 mg daily. The treatment regimen consisted
of an induction phase with 4 cycles of multiagent chemotherapy, with
peripheral blood stem cell (PBSC) collection after the third cycle,
followed by 2 cycles of high-dose melphalan (200 mg/m2 of
body-surface area) with autologous PBSC rescue.
The induction phase included one cycle of vincristine (0.5 mg/day by
continuous infusion [CI] on days 1-4), doxorubicin (10 mg/m2 per day by CI on days 1-4), and dexamethasone (40 mg/day orally on days 1-4, 9-12, and 17-20; then one cycle of
dexamethasone (40 mg orally on days 1-4), cyclophosphamide (400 mg/m2 by CI on days 1-4), etoposide (40 mg/m2
by CI on days 1-4), and cisplatin (15 mg/m2 by CI on days
1-4) (DCEP); one cycle of cyclophosphamide (750 mg/m2 by CI
on days 1-4), doxorubicin (15 mg/m2 by CI on days 1-4), and
dexamethasone (40 mg orally on days 1-4); and another cycle of DCEP.
| |
Results and discussion |
At the time of the analysis described here, 100 patients had
completed at least one cycle of induction chemotherapy. The patients' median age was 56 years (range, 32 to 71 years), and 67% of them were
men. Six patients had a previous history of DVT and were not receiving
anticoagulation therapy at enrollment. The 2 study arms were comparable
with respect to key baseline myeloma prognostic factors, including
immunoglobulin subtype, cytogenetic findings, histopathological
features, Durie-Salmon stage, bone marrow plasmacytosis, and levels of
serum  2 microglobulin, C-reactive protein, lactic dehydrogenase,
albumin, and paraprotein. A slightly higher proportion of patients in
the thalidomide arm than in the nonthalidomide (control) arm had an
IgA-subtype myeloma (34% versus 22%; P = .18). Known
risk factors for DVT, such as the presence of central venous catheters
(CVCs), which all patients had in place at the time of their first
cycle of chemotherapy; age; and performance status were not different
in the 2 study groups.
Baseline serologic and plasma risk factors for thrombosis, including
protein C and S activity antiphospholipid antibodies and activated
protein C resistance (analysis obtained for 20 patients, 13 of whom
were taking thalidomide), were not significantly different in the 2 study arms. However, the patients receiving thalidomide had less
antithrombin III activity (0.90 versus 1.04;
P = .18) and a lower fibrinogen level (2.8 versus 3.6 g/L;
P = .11) but a higher proportion of von Willebrand factor
antigen (2.55 versus 1.12; P = .09). One patient taking
thalidomide was found to be heterozygous for factor V Leiden but has
not had any thrombotic complications. None of the patients tested had
prothrombin gene abnormalities (G20210A).
Patients were evaluated regularly by medical staff members and
underwent additional studies if signs or symptoms suggestive of DVT
were observed. Patients with such manifestations were assessed with use
of Doppler ultrasonography followed by venography, if indicated. DVT
developed in 14 of 50 patients (28%) receiving thalidomide but in only
2 of 50 patients (4%) in the nonthalidomide arm
(P = .002). All episodes of DVT occurred during the first 3 cycles of induction: 7 during cycle 1, 3 during cycle 2, and 6 during
cycle 3. Although the response rate in each treatment arm had not been
disclosed at the time this report was prepared, within the thalidomide
arm, the time from start of treatment to 50% reduction in paraprotein
was computed for evaluable patients and compared in the patients with
and without DVT in that arm. No significant difference was observed
(P = .7).
All patients received 400 mg of oral thalidomide daily, except for one,
who received 300 mg daily. The median time from start of thalidomide
therapy to diagnosis of DVT was 42.5 days (range, 7 to 93 days).
Thrombosis developed at the site of the CVC in 4 patients (3 in the
thalidomide arm and 1 in the control arm) and at distant sites in 12 patients (11 receiving thalidomide and 1 control). DVT not related to a
CVC developed in 12 patients, 5 of whom were affected bilaterally. In
all 5 patients, calf veins were involved. Seven patients had unilateral
occlusion, which was limited to deep veins below the knee in 2 patients.
In most patients (75%), administration of thalidomide was resumed
safely after appropriate anticoagulation therapy was initiated. The
most extensive thrombosis involved femoral-popliteal and calf veins in
both legs. Anticoagulation therapy consisted of low-molecular-weight heparin followed by warfarin, with the target being the international normalized ratio of 2.5 to 3. This therapy was continued as long as it
was clinically indicated and the patient was receiving thalidomide. At
the time of analysis, no patient had clinical evidence of progression of DVT. One episode of pulmonary embolism was observed in one patient
taking thalidomide. The embolism responded to appropriate therapy, and
thalidomide administration was subsequently reinstituted, without
further complications.
Our data show that thalidomide given in combination with chemotherapy
including dexamethasone is associated with an increased risk of DVT,
the progression of which can be controlled by full anticoagulation. In
support of our findings is a report by Flageul et al,5 who
described occurrence of thrombotic events shortly after low-dose
(50-100 mg/day) thalidomide therapy was begun in 5 patients with lupus
erythematosus. All 5 patients were known to have hypercoagulability
related to either antiphospholipid antibodies or recent trauma. An
increased rate of DVT was not observed in patients with relapsed MM who
were treated with thalidomide as a single agent.4
In conclusion, close monitoring for DVT should be done in patients with
MM who are receiving thalidomide concomitantly with glucocorticosteroids and cytotoxic agents. Studies aimed at
preventing DVT in patients with myeloma and other patients with
hypercoagulability receiving thalidomide are needed. Our preliminary
experience suggests that administration of thalidomide can be resumed
safely after successful anticoagulation therapy. Prophylactic
anticoagulation should be strongly considered in patients receiving
thalidomide in combination with chemotherapy. Occurrence of DVT is not
an absolute contraindication to continuing thalidomide treatment.
| |
Footnotes |
Submitted January 3, 2001; accepted April 16, 2001.
Supported in part by a grant from the National Cancer Institute (CA
55819) to M.Z., E.A., B.B., A.B., R.D., C.M., A.T., E.S., and G.T. and
a grant provided by Dr J. Zeldis, Celgene, to L.F.
The publication costs of this
article were defrayed in part by
page charge payment. Therefore,
and solely to indicate this fact,
this article is hereby marked
"advertisement"
in accordance with 18 U.S.C.
section 1734.
Reprints: Maurizio Zangari, 4301 West Markham, Slot 776, Little Rock, AR 72205; e-mail: zangarimaurizio{at}uams.edu.
| |
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Thromboembolic events during treatment with thalidomide
- Eleonora Urbauer, Hannes Kaufmann, Thomas Nösslinger, Markus Raderer, and Johannes Drach
Blood 2002 99: 4247-4248.
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Top
Abstract
Introduction