HealthDay News — For older patients with untreated mantle-cell lymphoma, the addition of ibrutinib to standard chemoimmunotherapy significantly prolongs progression-free survival, according to a study published online June 3 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from June 3 to 7 in Chicago.
Michael L. Wang, MD, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues randomly assigned patients with untreated mantle-cell lymphoma aged 65 years or older to receive ibrutinib or placebo (261 and 262 patients, respectively), plus 6 cycles of bendamustine and rituximab. Patients with an objective response received rituximab maintenance therapy.
The researchers found that the median progression-free survival was 80.6 and 52.9 months in the ibrutinib and placebo groups, respectively, at a median follow-up of 84.7 months (hazard ratio for disease progression or death, 0.75). The percentage of patients with a complete response was 65.5 and 57.6% in the ibrutinib and placebo groups, respectively. The groups had similar overall survival. The incidence of grade 3 or 4 adverse events was 81.5 and 77.3% in the ibrutinib and placebo groups, respectively.
“The phase 3 SHINE trial showed that ibrutinib in combination with bendamustine plus rituximab and rituximab maintenance therapy was an effective first-line treatment in patients with mantle-cell lymphoma who were 65 years of age or older and were considered to be unsuitable candidates for autologous stem-cell transplantation,” the authors write.
The study was funded by Janssen and Pharmacyclics, the manufacturers of ibrutinib.