Jeff P. Sharman, MD, discusses the secondary end points from the <u><strong><a href="https://www.targetedonc.com/conference/ash-2019/patients-with-cll-treated-on-the-elevatetn-trial-experience-improved-pfs-with-acalabrutinib">phase III ELEVATE-TN trial</a></strong></u>, which evaluated the role of acalabrutinib, either as a single agent or in combination with obinutuzumab in patients with treatment-naive chronic lymphocytic leukemia.
Jeff P. Sharman, MD, director of research at Willamette Valley Cancer Institute and medical director of hematology research for The US Oncology Network, discusses the secondary end points from thephase III ELEVATE-TN trial, which evaluated the role of acalabrutinib (Calquence), either as a single agent or in combination with obinutuzumab (Gazyva) in patients with treatment-naive chronic lymphocytic leukemia (CLL).
In comparison of acalabrutinib monotherapy and the control arm, the key secondary end point, the hazard ratio was 0.20, says Sharman.
Another secondary end point was safety in this trial. Approximately 30% of patients with CLL who received acalabrutinib developed a headache. However, these headaches tended to be relatively short-term and lasted just a few days, Sharman says. They were reasonably controlled with adequate oral hydration or caffeine, although some individuals also needed acetaminophen or ibuprofen. Overall, the event was short-lived in most cases.
Overall, Sharman says it is important to alert patients that headaches as an adverse event can occur, but these do tend to pass in time.
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