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Rituximab plus MCP (melphalan, chlorambucil and prednisone) shouldbecome a new standard treatment for patients with previously untreatedadvanced follicular lymphoma (FL) needing therapeutic intervention,researchers have recommended.
The recommendation is based ona multicentre phase III trial aiming to assess whether adding rituximabto an MCP regimen conferred any benefit in first-line treatment ofadvanced FL.
A total of 358 previously untreated patientswith stage III or IV CD20+ indolent or mantle-cell lymphoma and an ECOGperformance status of two or below were randomised to receive up toeight cycles of MCP plus rituximab (R-MCP; n=181) or MCP alone (n=177).
All patients had at least one of the following criteriapresent, indicating the need for treatment: “B” symptoms or extranodalmanifestation; haematopoietic insufficiency (haemoglobin <10g/dland/or platelets <100,000/µl); rapid tumour growth; bulky disease;or immunohaematological phenomena (eg haemolytic anaemia or immunethrombocytopenia). All patients who achieved complete or partialremission (CR or PR respectively) were treated with interferon alfa-2a(4.5MU three times a week) until relapse.
The primaryanalysis population was defined as the population of FL patients,constituting the majority of patients (n=201; 56%) recruited to thetrial (R-MCP, n=105; MCP, n=96). Primary endpoint was overall remissionrate (ORR), defined as the rate of CR (complete resolution of alldisease symptoms) and PR (at least 50% decrease in allmeasurable/assessable lymphoma manifestations and normalisation ofblood counts for at least four weeks). Secondary efficacy parametersincluded progression-free survival (PFS), overall survival, duration ofresponse and toxicity.
After median follow-up of 47 months,patients randomised to the R-MCP arm had higher rates of overallresponse (92% vs 75% respectively; p=0.0009) and complete response (50%vs 25% respectively; p=0.004). The R-MCP arm was also associated withsignificantly 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