Treatment of indolent lymphoma with fludarabine/mitoxantrone combination: a phase II trial

In an effort to reduce the risk of opportunistic infections, 25 patients with advanced indolent lymphoma (age range: 30-77 years) were treated, using a combination of fludarabine and mitoxantrone, without corticosteroids. Fludarabine was given at 25 mg/m2 for three daily doses, and mitoxantrone at 10 mg/m2. Cycles were repeated every four weeks for up to maximum response, and for no more than six months. Eight patients had follicular lymphoma, and 11 had CLL/SLL. Objective response was observed in 11 of 12 previously untreated patients, including five complete remissions, and in 10 of 13 previously treated patients, including three complete remissions. Only two relapsed patients failed to respond, whereas two patients were not evaluable. Hence, the overall response rate based on the intention-to-treat analysis was 84 per cent (95 per cent CI: 70-98 per cent). The median survival has not been reached after a 22-month follow-up. Median time to progression was 15 months. One patient on corticosteroids developed pneumocystis carinii pneumonia, and an elderly patient succumbed to neutropenic sepsis. Apart from granulocytopenia, the treatment was well tolerated. Omission of corticosteroids reduces the risk of opportunistic infections, while the activity of the combination against indolent lymphoma and CLL is maintained.