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Blood, Vol. 94 No. 7 (October 1), 1999:
pp. 2217-2224
Cytokine-Release Syndrome in Patients With B-Cell Chronic Lymphocytic
Leukemia and High Lymphocyte Counts After Treatment With an Anti-CD20
Monoclonal Antibody (Rituximab, IDEC-C2B8)
U. Winkler,
M. Jensen,
O. Manzke,
H. Schulz,
V. Diehl, and
A. Engert
From the Department I of Internal Medicine, University of Cologne,
Cologne, Germany.
Eleven patients with relapsed fludarabine-resistant B-cell chronic
lymphocytic leukemia (CLL) or leukemic variants of low-grade B-cell
non-Hodgkin's lymphoma (NHL) were treated with the chimeric monoclonal
anti-CD20 antibody rituximab (IDEC-C2B8). Peripheral lymphocyte counts
at baseline varied from 0.2 to 294.3 × 109/L. During the
first rituximab infusion, patients with lymphocyte counts exceeding
50.0 × 109/L experienced a severe cytokine-release
syndrome. Ninety minutes after onset of the infusion, serum levels of
tumor necrosis factor- (TNF-) and interleukin-6 (IL-6) peaked in
all patients. Elevated cytokine levels during treatment were associated
with clinical symptoms, including fever, chills, nausea, vomiting,
hypotension, and dyspnea. Lymphocyte and platelet counts dropped to
50% to 75% of baseline values within 12 hours after the onset of the infusion. Simultaneously, there was a 5-fold to 10-fold increase of
liver enzymes, d-dimers, and lactate dehydrogenase (LDH),
as well as a prolongation of the prothrombin time. Frequency and severity of first-dose adverse events were dependent on the number of
circulating tumor cells at baseline: patients with lymphocyte counts
greater than 50.0 × 109/L experienced
significantly more adverse events of National Cancer Institute
(NCI) grade III/IV toxicity than patients with less than
50.0 × 109/L peripheral tumor cells (P
= .0017). Due to massive side effects in the first patient
treated with 375 mg/m2 in 1 day, a fractionated dosing
schedule was used in all subsequent patients with application of 50 mg
rituximab on day 1, 150 mg on day 2, and the rest of the 375 mg/m2 dose on day 3. While the patient with the leukemic
variant of the mantle-cell NHL achieved a complete remission (9 months+) after treatment with 4 × 375 mg/m2 rituximab,
efficacy in patients with relapsed fludarabine-resistant B-CLL was
poor: 1 partial remission, 7 cases of stable disease, and 1 progressive
disease were observed in 9 evaluable patients with CLL. On the basis of
these data, different infusion schedules and/or combination regimens
with chemotherapeutic drugs to reduce tumor burden before treatment
with rituximab will have to be evaluated.
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