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EHA 2025 | The impact of ibrutinib on QoL in patients with early-stage, asymptomatic CLL: the CLL12 trial
Ellinor Goergen, MD, University Hospital Cologne, Cologne, Germany, discusses quality of life (QoL) outcomes in patients with early-stage, asymptomatic chronic lymphocytic leukemia (CLL) treated with ibrutinib in the CLL12 trial (NCT02863718). The findings indicate that treatment with ibrutinib worsens QoL, suggesting this may not be a suitable treatment for this patient population. This interview took place at the 30th Congress of the European Hematology Association (EHA) in Milan, Italy.
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Transcript
We know that CLL patients live longer, have better outcomes in terms of PFS and OS, but what is sometimes overlooked is the quality of life. So in the CLL12 trial, it’s a very valuable trial in general, because we compare placebo to ibrutinib in these early-stage asymptomatic patients. So what we did there is in general just randomize the patients into two groups...
We know that CLL patients live longer, have better outcomes in terms of PFS and OS, but what is sometimes overlooked is the quality of life. So in the CLL12 trial, it’s a very valuable trial in general, because we compare placebo to ibrutinib in these early-stage asymptomatic patients. So what we did there is in general just randomize the patients into two groups. One group has the placebo and the other group gets ibrutinib. They all have a very high risk of progression. So the interesting thing was we not only looked at the outcomes like OS and PFS, we didn’t see a statistically significant difference in these outcomes, but we did see a longer time to or better event-free survival in the ibrutinib group. But the quality of life we assessed it regularly like every three months and then the follow-up every six months or yearly and we saw that the patients actually did have, in terms of time to deterioration, in several scales that we looked at. For example, the physical functioning. We saw that the patients with ibrutinib had a shorter time to deterioration under placebo. But what I’m presenting here at the EHA, this is what I presented at ASH last year, what I presented here or what I’m presenting here at EHA is basically looking at the safety of the patients. So if a patient suffers an adverse event or a serious adverse event, we saw this in the placebo group interestingly and also in the treatment group with ibrutinib. And if these patients actually experience an adverse event, does the quality of life suffer? And we did see that the quality of life suffers more if the patients actually receive ibrutinib. So the adverse events that they experienced under placebo, which is probably also an expression of the disease itself, were not as heavily felt or didn’t have a heavy impact on the quality of life of the patients. Whereas the patients that had an AE or an SAE under ibrutinib actually did have a worsening of quality of life that we could measure. So this is one of the signals that leads us to believe that ibrutinib should not be used in these patients, like if they’re asymptomatic and early-stage disease.
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