Steven Coutre, MD: As I mentioned, we take a number of factors into consideration when making a decision about which regimens to use for a patient. It’s important to individualize things according to that particular patient. We have prognostic factors, and remember, prognostic factors mean they might predict time to initial treatment, for example, but they’re not predictive. Predictive factors really are factors that influence how patients may respond to a given therapy, and therefore they may influence what therapy you choose for that patient. Even if you don’t believe in measuring some of the prognostic factors, such as chromosome abnormalities that we measure by FISH or the immunoglobulin mutational status, in all patients at time of diagnosis, I would advocate obtaining that information when you’ve decided that a patient needs treatment.
Right now, the major issue there is deletion 17p. Fortunately, this is maybe 5% or 6% of patients at presentation. So admittedly, it’s not the majority, but it’s very important to know that, because those patients don’t respond to standard chemoimmunotherapy. Clearly, a drug like ibrutinib would be the treatment of choice. Getting that information at initiation of treatment is still quite helpful, especially later in their course if you’re having to decide on a second-line therapy.
As you know from your own practice, you have a lot of treatment choices for younger patients. Fitness, as I mentioned, can influence things. That may be a patient you’re not interested in giving FCR (fludarabine/cyclophosphamide/rituximab) to, and that’s one of the major reasons why bendamustine plus rituximab (BR) has become so popular. For that late 50-year-old patient who has significant comorbidities, you might have chosen bendamustine/rituximab. Remember, in the German trial of FCR versus BR, we learned that fludarabine/cyclophosphamide/rituximab was superior in terms of progression-free survival, but we also learned that BR was better tolerated. There was less of an infection risk associated with it. Historically, this patient would get bendamustine/rituximab. It’s still a reasonable choice. But, of course, we also have ibrutinib, and that’s also a very reasonable choice.
As we get more data on the use of ibrutinib in this kind of setting, and certainly data from randomized trials, then we’ll learn more about the role of ibrutinib here. In my practice, if it was outside of a clinical trial, I wouldn’t have any hesitation to prescribe ibrutinib. You have that conversation with the patient. Here’s the options, here’s the pros and cons, and then make a joint decision.
Case Scenario:Ibrutinib in Younger, Unfit Patients with Newly-Diagnosed CLL