By Reuters Staff
NEW YORK (Reuters Health) - Two-years of rituximab maintenance therapy can prolong remission in selected elderly patients with chronic lymphocytic leukemia (CLL) in first remission after an abbreviated front-line course of fludarabine, cyclophosphamide and rituximab (FCR), according to a study from France.
Chemoimmunotherapy with FCR is the standard front-line treatment for fit patients with CLL without the del(17p) mutation. However, most patients who receive FCR relapse and require further treatment, Dr. Caroline Dartigeas from Hopital Bretonneau, CHU Tours, and colleagues note in Lancet Hematology, online December 20.
In an open-label randomized phase 3 study, they evaluated the efficacy and safety of rituximab maintenance treatment (500 mg/m2 intravenously) every eight weeks for up to two years versus observation in patients age 65 or older in remission after front-line abbreviated FCR induction. There were 202 patients in the rituximab arm and 207 in the observation arm.
After a median follow-up of 47.7 months, median progression-free survival (the primary endpoint) was better with rituximab maintenance than observation (59.3 months vs. 49.0 months; hazard ratio, 0.55; P=0.0002).
The benefit of rituximab maintenance on PFS was evident “even in patients with poor prognostic features such as del(11q), unmutated IGHV status, or partial response, translating into a delayed need for second-line therapy,” the investigators say.
Rituximab maintenance therapy showed an “acceptable safety profile,” but was associated with an increased incidence of adverse events such as grade 3-4 neutropenia and infections in this elderly population.
Dr. Dartigeas and colleagues say to their knowledge this is the first study to demonstrate a benefit of rituximab maintenance on PFS in elderly patients treated with uniform first-line modern chemoimmunotherapy and who are in an age range close to that seen at diagnosis.
Based on the findings, they say two-year maintenance rituximab in selected elderly CLL patients is a “relevant option.”
The study was funded by the French National Cancer Institute, Roche and Chugai. Several authors disclosed financial relationships with Roche, Chugai and other pharmaceutical companies.
Lancet Haematol 2017.
(c) Copyright Thomson Reuters 2018. Click For Restrictions - http://about.reuters.com/fulllegal.asp