Survival Outcomes in CLL: Ibrutinib/Rituximab Versus Standard Chemoimmunotherapy
Posted: Monday, October 14, 2019
Although there are limited data regarding the efficacy of ibrutinib plus rituximab compared with standard chemoimmunotherapy for patients with chronic lymphocytic leukemia (CLL), the results of a phase III clinical trial suggest that the combination therapy seems to provide superior survival benefits and lower toxicity. The study was published in The New England Journal of Medicine.
“These results will fully usher the treatment of CLL into a new era,” said Tait D. Shanafelt, MD, of Stanford University School of Medicine, in Stanford Medicine press release. “This represents a paradigm shift in how these patients should be treated. We can now relegate chemotherapy to a fallback plan rather than a first-line course of action.”
The study authors randomly assigned 529 patients with treatment-naive CLL to receive ibrutinib and rituximab (n = 354) or standard chemoimmunotherapy (fludarabine, cyclophosphamide, and rituximab; n = 175). All of the patients were 70 years of age or younger.
After a median follow-up of 33.6 months, progression-free survival and overall survival rates were higher in the ibrutinib/rituximab group than the chemoimmunotherapy group. The progression-free survival rate for the investigational treatment versus the standard treatment was 89.4% and 72.9%, respectively (P < .001). The overall survival rate was also significantly higher among patients who received ibrutinib plus rituximab than among those who received standard chemoimmunotherapy (98.8% vs. 91.5%; P < .001). Furthermore, the combination therapy yielded better progression-free survival than chemoimmunotherapy (90.7% vs. 62.5% at 3 years, according to a subgroup analysis of patients without IgHV mutation.
The incidence of adverse events of grade 3 or higher was similar between the two groups. However, grade 3 or higher infectious complications were less common in patients treated with ibrutinib/rituximab than in those treated with chemoimmunotherapy (10.5% vs. 20.3%; P < .001).
Disclosure: The study author’s disclosure information can be found at nejm.org.