FRIDAY, June 3, 2022 (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, M.D., 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 six 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 percent 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 percent 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.