Research in context
Evidence before this study
We did a literature search on Jan 27, 2016, for data available before the finalisation of the protocol of this trial in October, 2009, using the terms “rituximab”, “maintenance”, and “CLL” or “chronic lymphocytic leuk(a)emia”. Searches in PubMed (all publications until Oct 31, 2009) retrieved nine hits, searches in abstracts of the annual meetings of the American Society of Hematology (Jan 1, 2004, to Oct 31, 2009) retrieved 19 hits, and searches in the abstracts of the annual meetings of the American Society of Clinical Onoclogy (Jan 1, 2004, to Oct 31, 2009) retrieved four hits. The complete Cochrane Library (Cochrane Central Register of Controlled Trials) was also searched, but yielded no results. No evidence was found of published data from phase 3 randomised clinical trials of rituximab maintenance therapy.
Added value of this study
To the best of our knowledge, this is the first randomised trial to investigate rituximab maintenance in patients with chronic lymphocytic leukaemia sensitive to rituximab-containing chemoimmunotherapy. Our findings of this final analysis demonstrate that rituximab maintenance significantly increases tumour control as shown by prolongation of progression-free survival, increased conversion rate to complete response (with or without complete bone marrow recovery) and minimal residual disease negativity, time to next treatment, and event-free survival compared with observation across a broad spectrum of clinical covariates and induction regimens. This increase in progression-free survival is accompanied by an increase in mostly moderate infections.
Implications of all the available evidence
Our findings support a role for inclusion of anti-CD20 antibodies in maintenance treatments for patients with chronic lymphocytic leukaemia who respond to induction with chemoimmunotherapy.