Rami Komrokji, MD:With CPX-351, the toxicity profile is similar to 3 + 7 chemotherapy. Those patients obviously will have the myelosuppression and sequelae of myelosuppressionmainly infections like febrile neutropenia. The rate of those infections and the complications were not higher with 3 + 7 chemotherapy. With CPX-351, as I mentioned earlier, the mortality was actually less at day 30 and day 60, keeping in mind that some of those patients, almost one-third, were above age 70 in those trials. Patients will have more distinguished rash with CPX-351. It’s more common to see the rash with CPX-351 than we see with cytarabine. There is also some delayed recovery of the counts—almost a week or 2 more than with 3 + 7. One has to keep that in mind. That’s also important in assessing the efficacy. Within that time period, patients will not be recognized as achieving complete remission if their counts did not recover.
In terms of other side effects, there is less hair loss with CPX-351. I think the most important one is really the delayed recovery. In most patients, it’s a week or 2 longer than expected with 3 + 7 chemotherapy. The average number of days to recover the counts is going to be 30 to 40 days. There is a very, very small subset of patients who have more delayed recovery with CPX-351. Many times, when we dig into those cases, we find that those patients actually had persistent disease rather than treatment. But with the liposomal packaging of the drug, it is expected that the effect is longer. One has to anticipate that delayed recovery, which could also set the timing for the consolidation, which is the next step of treatment for those patients.
Transcript edited for clarity.
Case: A 67-Year-Old Man with Therapy-Related AML