ORLANDOIn advanced-stage low-grade non-Hodgkin’s lymphoma (NHL), a regimen of fludarabine (Fludara) plus mitoxantrone(Drug information on mitoxantrone) (Novantrone) followed by rituximab(Drug information on 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.
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.