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THURSDAY, Aug. 1, 2019 (HealthDay News) — For patients with previously untreated chronic lymphocytic leukemia (CLL), ibrutinib-rituximab is more efficacious than chemoimmunotherapy, according to a study published in the Aug. 1 issue of the New England Journal of Medicine<\/i>.<\/p>\n
Tait D. Shanafelt, M.D., from Stanford University in California, and colleagues randomly assigned 529 patients (aged \u226470 years) with previously untreated CLL in a 2:1 ratio to receive either ibrutinib and rituximab for six cycles (after a single cycle of ibrutinib alone) followed by ibrutinib until disease progression (354 patients) or chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for six cycles (175 patients).<\/p>\n
The researchers found that progression-free survival was superior in the ibrutinib-rituximab versus chemoimmunotherapy group (89.4 versus 72.9 percent at three years; hazard ratio for progression or death, 0.35; 95 percent confidence interval [CI], 0.22 to 0.56); the results met the protocol-defined efficacy threshold for the interim analysis. Overall survival also favored ibrutinib-rituximab versus chemoimmunotherapy (98.8 versus 91.5 percent at three years; hazard ratio for death, 0.17; 95 percent CI, 0.05 to 0.54). Ibrutinib-rituximab resulted in better progression-free survival than chemoimmunotherapy in patients without immunoglobulin heavy-chain variable region (IGHV<\/i>) mutation (90.7 versus 62.5 percent at three years; hazard ratio for progression or death, 0.26; 95 percent CI, 0.14 to 0.50). For patients with IGHV<\/i> mutation, three-year progression-free survival was 87.7 and 88.0 percent, respectively (hazard ratio for progression or death, 0.44; 95 percent CI, 0.14 to 1.36). The two groups had a similar incidence of adverse events of grade 3 or higher (80.1 versus 79.7 percent).<\/p>\n
“Indefinite use of ibrutinib therapy has been associated with substantial expense and the potential for long-term toxic effects and may increase the risk of clonal selection leading to drug resistance,” the authors write.<\/p>\n
Several authors disclosed financial ties to pharmaceutical companies, including Pharmacyclics, which manufactures ibrutinib and partially funded the study.<\/p>\n
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