Prospective subgroup analyses of the randomized <scp>MCL</scp>‐002 (<scp>SPRINT</scp>) study: lenalidomide <i>versus</i> investigator's choice in relapsed or refractory mantle cell lymphoma

Abstract

<jats:title>Summary</jats:title><jats:p>In the mantle cell lymphoma (<jats:styled-content style="fixed-case">MCL</jats:styled-content>)‐002 study, lenalidomide demonstrated significantly improved median progression‐free survival (<jats:styled-content style="fixed-case">PFS</jats:styled-content>) compared with investigator's choice (<jats:styled-content style="fixed-case">IC</jats:styled-content>) in patients with relapsed/refractory <jats:styled-content style="fixed-case">MCL</jats:styled-content>. Here we present the long‐term follow‐up data and results of preplanned subgroup exploratory analyses from <jats:styled-content style="fixed-case">MCL</jats:styled-content>‐002 to evaluate the potential impact of demographic factors, baseline clinical characteristics and prior therapies on <jats:styled-content style="fixed-case">PFS</jats:styled-content>. In <jats:styled-content style="fixed-case">MCL</jats:styled-content>‐002, patients with relapsed/refractory <jats:styled-content style="fixed-case">MCL</jats:styled-content> were randomized 2:1 to receive lenalidomide (25 mg/day orally on days 1–21; 28‐day cycles) or single‐agent <jats:styled-content style="fixed-case">IC</jats:styled-content> therapy (rituximab, gemcitabine, fludarabine, chlorambucil or cytarabine). The intent‐to‐treat population comprised 254 patients (lenalidomide, <jats:italic>n</jats:italic> = 170; <jats:styled-content style="fixed-case">IC</jats:styled-content>,<jats:italic> n</jats:italic> = 84). Subgroup analyses of <jats:styled-content style="fixed-case">PFS</jats:styled-content> favoured lenalidomide over <jats:styled-content style="fixed-case">IC</jats:styled-content> across most characteristics, including risk factors, such as high <jats:styled-content style="fixed-case">MCL</jats:styled-content> International Prognostic Index score, age ≥65 years, high lactate dehydrogenase (<jats:styled-content style="fixed-case">LDH</jats:styled-content>), stage <jats:styled-content style="fixed-case">III</jats:styled-content>/<jats:styled-content style="fixed-case">IV</jats:styled-content> disease, high tumour burden, and refractoriness to last prior therapy. By multivariate Cox regression analysis, factors associated with significantly longer <jats:styled-content style="fixed-case">PFS</jats:styled-content> (other than lenalidomide treatment) included normal <jats:styled-content style="fixed-case">LDH</jats:styled-content> levels (<jats:italic>P </jats:italic>&lt;<jats:italic> </jats:italic>0·001), nonbulky disease (<jats:italic>P </jats:italic>=<jats:italic> </jats:italic>0·045), &lt;3 prior antilymphoma treatments (<jats:italic>P </jats:italic>=<jats:italic> </jats:italic>0·005), and ≥6 months since last prior treatment (<jats:italic>P </jats:italic>=<jats:italic> </jats:italic>0·032). Overall, lenalidomide improved <jats:styled-content style="fixed-case">PFS </jats:styled-content><jats:italic>versus</jats:italic> single‐agent <jats:styled-content style="fixed-case">IC</jats:styled-content> therapy in patients with relapsed/refractory <jats:styled-content style="fixed-case">MCL</jats:styled-content>, irrespective of many demographic factors, disease characteristics and prior treatment history.</jats:p>