VIENNA-Mantle cell lymphoma
(MCL) is often refractory to
standard chemotherapy, and there are
few alternative therapeutic opportunities
or strategies. Thalidomide
(Thalomid) has demonstrated antitumor
activity in multiple myeloma
and is being investigated for several
other malignancies, including prostate
cancer, glioma, and mantle cell
lymphoma. Johannes Drach, MD,
and colleagues at University Hospital
in Vienna, Austria, presented data
from a phase II trial evaluating the
efficacy and safety of rituximab (Rituxan)
combined with thalidomide in
patients with mantle cell lymphoma
that did not respond to or relapsed
after treatment with standard CHOP
vincristine (Oncovin), and prednisone)
or CHOP-like chemothera
py (ASH abstract 606).
Patients received rituximab 375
mg/m2/day on days 1, 8, 15, and 22.
Thalidomide was administered orally
at 200 mg/day on day 1, followed by a
dose escalation to 400 mg/day on day
15, and continued daily as maintenance
therapy until disease progression,
disease relapse, or unacceptable
Eleven patients were evaluable:
one with primary mantle cell lymphoma
resistant to CHOP, seven enrolled
at first relapse, and three enrolled
at second or further relapse.
The median time from diagnosis was
21 months (range, 6 to 53 months).
No Unexpected Side Effects
This treatment regimen was safe
and well tolerated, and no unexpected
side effects were encountered with
the addition of thalidomide to rituximab
therapy. Because of its antian
effects, thalidomide can increase
the risk for thromboembolic
events, particularly when adminis-
tered in combination with chemotherapy.[
3] In this study using thali-
domide in combination with rituximab,
thromboembolic events were
observed in two patients. One patient
discontinued therapy because
of severe neutropenia associated with
the administration of thalidomide.
The objective response rate was
91%, with three complete and seven
partial responses observed. Notably,
one of the complete responses was in
the patient resistant to CHOP chemotherapy.
Remissions were durable
(see Table 1). The time to progression
for patients with a complete response
was improved relative to their
previous chemotherapy regimens.
Overall, these results suggest that
rituximab plus thalidomide has a favorable
toxicity profile and marked
antitumor activity in patients with
relapsed or CHOP-resistant mantle
cell lymphoma. Further study in a
prospectively defined, homogenous
patient population is warranted.
1. Richardson P, Hideshima T,
Anderson K: Thalidomide: emerging
role in cancer medicine. Annu Rev
Med 53: 629-657, 2002.
2. Drach J, Kaufmann H, Puespoek
A, et al: Marked anti-tumor activity
of rituximab plus thalidomide
in patients with relapsed/resistant
mantle cell lymphoma (abstract 606).
Blood 100:162a, 2002.
3. Clark TE, Edom N, Larson J,
Lindsey LJ: Thalomid (thalidomide)
capsules: a review of the first 18
months of spontaneous postmarketing
adverse event surveillance, including
off-label prescribing. Drug Saf