SOHO 2025 | Dynamically adjusting the dose and dosing schedule of TKIs in patients with CML
Jorge Cortes, MD, Georgia Cancer Center, Augusta University, Augusta, GA, discusses the importance of adjusting the dose and dosing schedule of tyrosine kinase inhibitors (TKIs) in patients with chronic myeloid leukemia (CML). Dr Cortes notes that the approach of aiming for the maximum tolerated dose is not optimal, and that the dosing strategy should be dynamically tailored based on the patient and the TKI used. This interview took place at the 13th Annual Meeting of the Society of Hematologic Oncology (SOHO 2025) in Houston, TX.
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Transcript
That’s an important topic, the dose and the schedule, because, you know, for one, as we’ve developed the drugs from the phase one study to the approval, we’ve done this traditional model of a phase one, maximum recommended dose, and then, you know, a dose, and then you have a standard dose and you dose reduce if the patient has side effects. But I think little by little we’ve learned a number of things...
That’s an important topic, the dose and the schedule, because, you know, for one, as we’ve developed the drugs from the phase one study to the approval, we’ve done this traditional model of a phase one, maximum recommended dose, and then, you know, a dose, and then you have a standard dose and you dose reduce if the patient has side effects. But I think little by little we’ve learned a number of things.
Number one is that that model of going for maximum tolerated dose doesn’t work. Many times we’ve learned that that’s too much and it may vary by scenario. We’ve known for example with Nilotinib for many years that what you need for patients who have received prior therapies is higher than what you need for initial therapy, same thing for Bosutinib, more recently also with dasatinib. But also that the dynamics of the dose should be more flexible and there is, for example, the possibility of slowly increasing the dose. There’s been an interesting study with Bosutinib where it allows better tolerability when you start at a lower dose, aiming for the optimal dose. And then more recently with ponatinib, a study, the OPTIC study, where once a patient achieves a response, you lower the dose because they have a good response to minimize toxicity. And I think these approaches we have not explored as much. Maybe we do them in the clinic, but we haven’t really prospectively put enough effort to see what’s the best way of managing these drugs, especially because these are drugs for long term. These are not short term chemotherapy style of administration. These are drugs that the patients take sometimes for the rest of their lives and optimal management of the dose I think is important and we need to put more attention to that.
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