Charles Geyer, MD, advises his peers on how to manage the grade 3 or higher toxicities and any serious adverse events seen in the clinical trial setting with adjuvant olaparib.
Charles Geyer, MD, medical oncologist/breast cancer specialist, and chief scientific officer, NSABP, advises his peers on how to manage the grade 3 or higher toxicities and any serious adverse events seen in the clinical trial setting with adjuvant olaparib (Lynparza) in the clinic.
Based on findings from the phase 3 OlympiA study which showed a benefit in overall survival adjuvant olaparib vs placebo in patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer, the FDA approved the agent for this indication in March 2022.
Some of the most common grade 3 AEs observed with the agent included anemia (8.7%), decreased neutrophil count (4.8%), decreased white-cell count (3.0%), fatigue (1.8%), and lymphopenia (1.2%). There were also some serious AEs in 8% of patients. Geyer discusses what clinicians should keep in mind when treating this patient population with olaparib and how to combat these potential AEs.
TRANSCRIPTION
0:08 | We did not see severe cardiac events. The drug does not seem to have that, it's primarily the GI and the anemia, and I think the important thing for my colleagues will be to remember the first few months are the important months where you do need to monitor the lab work. We had conservative criteria in OlympiA in terms of the hemoglobin, if it dropped down below 9 and a half, we recommended that the drug be held and wait for the hemoglobin to come up. If it comes back quickly, in a week or 2, go back to the starting dose if it takes longer than reduce the dose levels.
0:50 | So, I think that early attention to monitoring the CBC and giving patients breaks, because it's a year of therapy. So, they have to find the dose that's right for the individual patient. And then, the patient will have a much better chance of tolerating it well and being able to complete a year of therapy. If there is substantial anemia, transfusion for once or maybe twice should be considered but if women are having that much difficulty in the curative setting with the drug, then stop it but for those adverse events [in the study] were relatively few.
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