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Fludarabine/Mitoxantrone/Rituximab Effective in NHL

Fludarabine/Mitoxantrone/Rituximab Effective in NHL

ORLANDO—In advanced-stage low-grade non-Hodgkin’s lymphoma (NHL),
a regimen of fludarabine (Fludara) plus mitoxantrone (Novantrone) followed by
rituximab (Rituxan) is highly effective and well tolerated, according to study
results presented at the 43rd Annual Meeting of the American Society of
Hematology (ASH abstract 2534).

There is no known cure for the low-grade non-Hodgkin’s lymphomas, a group
of lymphoproliferative malignancies with a survival of 6 to 8 years. The
rationale for the three-agent approach, said Stephanie Gregory, MD,
Rush-Presbyterian-St. Lukes Medical Center, Chicago, is that the combination of
fludarabine and mitoxantrone has previously been shown to be effective in the
disease, both as frontline therapy and for patients who have failed prior
therapy.

The strategy aims to induce remission with the combination and then to
consolidate response by eradicating residual disease with the anti-CD20
monoclonal antibody rituximab.

Dr. Gregory undertook a phase II study to evaluate the safety and efficacy
of the combination. Twenty-nine previously untreated low-grade NHL patients (Karnofsky
performance status greater than 70%) have completed treatment. They received
mitoxantrone 12 mg/m² on the first day of each 28-day cycle plus fludarabine 25
mg/m² on days 1 to 3.

After four cycles, those with a complete response received 375 mg/m² of
rituximab weekly for 4 weeks. Partial responders received two further cycles of
fludarabine and mitoxantrone, followed by rituximab for 4 weeks.

Shorter Regimen

To reduce toxicity, the study chemotherapy regimen was shorter than has been
conventionally given, Dr. Gregory told ONI. "Instead of the standard 5
days of fludarabine at 25 mg/m², we have been able to cut it down to 3 days per
week. Also, instead of treating these patients for 8 to 10 cycles, we have
tried to get a quick response with 4 to 6 months of treatment, rather than 9
months plus a maintenance regimen," she said.

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