Combination rituximab in FL urged

Tuesday 22nd May 2007

Rituximab plus MCP (melphalan, chlorambucil and prednisone) should become a new standard treatment for patients with previously untreated advanced follicular lymphoma (FL) needing therapeutic intervention, researchers have recommended.

The recommendation is based on a multicentre phase III trial aiming to assess whether adding rituximab to an MCP regimen conferred any benefit in first-line treatment of advanced FL.

A total of 358 previously untreated patients with stage III or IV CD20+ indolent or mantle-cell lymphoma and an ECOG performance status of two or below were randomised to receive up to eight cycles of MCP plus rituximab (R-MCP; n=181) or MCP alone (n=177).

All patients had at least one of the following criteria present, indicating the need for treatment: "B" symptoms or extranodal manifestation; haematopoietic insufficiency (haemoglobin <10g/dl and/or platelets <100,000/µl); rapid tumour growth; bulky disease; or immunohaematological phenomena (eg haemolytic anaemia or immune thrombocytopenia). All patients who achieved complete or partial remission (CR or PR respectively) were treated with interferon alfa-2a (4.5MU three times a week) until relapse.

The primary analysis population was defined as the population of FL patients, constituting the majority of patients (n=201; 56%) recruited to the trial (R-MCP, n=105; MCP, n=96). Primary endpoint was overall remission rate (ORR), defined as the rate of CR (complete resolution of all disease symptoms) and PR (at least 50% decrease in all measurable/assessable lymphoma manifestations and normalisation of blood counts for at least four weeks). Secondary efficacy parameters included progression-free survival (PFS), overall survival, duration of response and toxicity.

After median follow-up of 47 months, patients randomised to the R-MCP arm had higher rates of overall response (92% vs 75% respectively; p=0.0009) and complete response (50% vs 25% respectively; p=0.004). The R-MCP arm was also associated with significantly improved responses in several secondary endpoints, including median PFS (not reached vs 28.8 months, respectively; p<0.0001) and OS (four-year OS rate, 87% vs 74%, respectively; p=0.0096).

J Clin Oncol 2007;25(15):1986-92