Ibrutinib Plus Rituximab Could Become New Treatment Standard against Leukemia


Patients with chronic lymphocytic leukemia (CLL) are generally treated to a six-month course of chemotherapy with FCR (intravenous Fludarabine and Cyclophosphamide plus Rituximab [Rituxan]). The latest edition of the annual meeting of the American Society of Hematology, however, brought to attention a new possible alternative approach.

CLL is a common form of adult leukemia with slow development. Often times, patients don’t show any symptom for years, but the cancerous cells grow and spread to other parts of the body, including the lymph nodes, liver, and spleen. The United States report approximately 60,000 new cases each year, according to the American Cancer Society.


Results from a head-to-head phase III trial comparing FCR against a more targeted Ibrutinib (Imbruvica)-based therapy showed that patients receiving Ibrutinib plus rituximab had a two-thirds reduction in the risk of disease progression relative to those getting standard care.

We found ibrutinib-based therapy is both more effective and less toxic than our previous best therapy for [patients with] CLL”, said lead author Tait D. Shanafelt, MD, from Stanford University School of Medicine. “These findings have immediate practice-changing implications. They establish the combination of ibrutinib plus rituximab as the most effective first-line treatment for [patients with] CLL aged 70 and younger”.

The study enrolled 529 patients with previously untreated, symptomatic CLL, between January 2014, and June 2016. They had a median age of 59 and were divided into two groups. 354 patients received Ibrutinib plus Rituximab, and 175 received a 6-month course of FCR. Researchers had tracked patient outcomes for a median of 33.4 months at the time of the analysis.

Progression-free survival was noticeably better for those receiving Ibrutinib plus Rituximab compared to FCR. In addition, the Ibrutinib therapy conferred better overall survival and presented fewer side effects.

We know FCR does some collateral damage to the immune system that can be long-lasting and leave patients vulnerable to infections, whereas ibrutinib can enhance immune function”, Dr. Shanafelt said. “Understanding the long-term effects of these two therapies on the immune system and the risk of infection will be very informative”.