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Rituximab/Fludarabine Combination Feasible in CLL

Rituximab/Fludarabine Combination Feasible in CLL

COLOGNE, Germany—Combining rituximab (Rituxan) with fludarabine
(Fludara) is a feasible, effective strategy in treating chronic lymphocytic
leukemia (CLL), as it produces a 90% response rate and does not increase
infection risk beyond that seen with fludarabine alone, Holger Schulz, MD,
reported in a poster presentation at the 43rd Annual Meeting of the American
Society of Hematology. Dr. Schulz is in the Department of
Hematology/Oncology at the University of Cologne, Germany.

Rationale and Study Design

"Fludarabine is generally considered standard first-line therapy for
CLL, producing response rates up to 71%. However, most of these patients
will relapse, and a significant proportion of CLL patients will not respond
to fludarabine at all," Dr. Schulz said. "The rationale for
combining rituximab with fludarabine includes single-agent efficacy of both
drugs, possible synergism of rituximab and chemotherapy, and no apparent
overlapping toxicities."

The report included 29 patients treated with fludarabine at 25 mg/m²/d
(on days 1-5, 29-33, 57-61, 85-89). The first two infusions of
rituximab were given together with fludarabine on days 57 and 85, while the
following doses (375 mg/m²) were given on days 113 and 151. Eighteen
patients were previously untreated, and 11 had previous
chlorambucil/prednisone. Twenty-one patients had stage B disease, and 8 had
stage C.

The overall response rate in 29 evaluable patients was 90% (see Table 1),
including 7 complete responses (24%), 3 unconfirmed complete responses
(10%), and 16 partial responses (53%). In previously untreated patients, 16
of 18 responded (89%). The median time to progression has not been reached
after a median follow-up of 6 months.

Toxicity Is Tolerable

Grade 3 or 4 adverse events included infections in four patients (13%)
and fever in one (3%). The most common side effects—fever, chills, and
exanthema of the skin—were mild. Fever and chills were mainly related to
the first rituximab infusion. Hematologic toxicity included neutropenia
grade 1/2 in 30%, grade 3/4 in 37% and thrombocytopenia grade 1/2 in 20%,
grade 3/4 in 10%. Dr. Schulz told Oncology News International that the
neutropenias typically resolved in 3 to 4 days without intervention. One
patient died after the second cycle of fludarabine during prolonged
thrombocytopenia due to cerebral bleeding. No hemolytic anemia has been
noted.

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