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Adverse events in women switching from olaparib capsules to tablets: Retrospective observational study of US claims data
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Adverse events in women switching from olaparib capsules to tablets: Retrospective observational study of US claims data
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Upload Date:
2020-04-23T00:00:00.0000000
Transcript:
Language: EN.
Segment:1 Adverse events in women switching from olaparib capsules to tablets: Retrospective observational study of US claims data.
[UPLIFTING MUSIC] My name is Dr. Susana Banerjee. I'm a consultant medical oncologist at the Royal Marsden NHS Foundation Trust and a reader in women's cancers at the Institute of Cancer Research in London in the UK. I'm going to discuss the paper entitled, Adverse Events in Women Switching from Olaparib Capsules to Tablets A Retrospective Observational Study of US Claims Data and how clinicians can learn from the US experience of switching patients from olaparib capsules to tablets.
These data were published in Future Oncology.
Segment:2 What was the purpose of this study?.
So as we're aware, olaparib is approved as maintenance therapy, both in the first line setting but also for women with recurrent ovarian cancer. Olaparib was first approved as a capsule formulation and was available since 2014. But now, it's available as tablets. There was FDA approval towards the end of 2017 and EMA approval in 2018.
The tablet formulation offers similar efficacy benefits to the capsules, but with a reduced pill burden of four tablets a day. And this is a more convenient dosing regimen of two tablets twice a day, at the recommended dose. The capsule formulation of olaparib was voluntarily withdrawn in the US in September 2018, around four years after the FDA approval. At which point, any US patient on olaparib capsules switched to tablets.
So there is practical guidance available to help manage the transition from olaparib capsules to tablets. However, it's really important to have real world safety data. Real world safety data for olaparib tablets are limited. One of the questions, for example, is, what is the impact on tolerability for patients of switching from capsules to tablets in the real world clinical setting?
To answer this question, data were extracted by Symphony Health from a large US health insurance claims database in order to describe the pattern of pre-specified adverse events experienced in women who switched from olaparib capsules to tablets. So these real world data from US patients who have switched from olaparib capsules to tablets following capsule withdrawal, can provide insight since the tolerability of switching between the olaparib formulations.
Segment:3 How was the study undertaken?.
So this was a retrospective observational cohort analysis. The primary objective was to describe the incidence of eight key pre-specified adverse events among qualifying patients who transitioned from olaparib capsules to tablets. So anemia, fatigue, nausea, vomiting, diarrhea were included because these were among the most frequently reported adverse events of any grade in patients receiving olaparib in the clinical trial program.
Neutropenia, thrombocytopenia, and leukopenia were also selected because of their clinical importance. Eligible patients had a confirmed diagnosis of ovarian, peritoneal, or fallopian tube cancer and had switched from a prescription of olaparib capsules to tablets between January 2015 and February 2019. The proportion of patients with pre-specified adverse events is reported separately for the first 90 days following initiation of olaparib capsules and tablet therapy.
Adverse events immediately before and after switching for patients who switched with no days gap in therapy are also reported.
Segment:4 What were the results?.
48 patients met stability criteria, as described in this figure and are included in the main analysis. Most, so that is 79% of the 48 patients included in the main analysis, had received olaparib capsules for over a year before switching to tablets.
Now, the incidence of the 8 pre-specified adverse events during the 90 days following olaparib initiation was broadly similar for capsules and tablets. The median time to any adverse event after switching formulations was 27 days. For non-hematological events, this was 30 days. And for hematological events, 13 days. The proportion of patients experiencing any pre-specified adverse event during the first 90 days was 46% during capsule use and 35% during tablet use.
The likelihood of experiencing any pre-specified adverse event during the initial 90 days of therapy was similar with capsules and tablets, and not statistically associated with experiencing the given event prior to starting olaparib. 35% of patients switched without a day's gap between stopping capsules and starting tablets. Now, in this group, the proportion experiencing any pre-specified adverse event was 47 during the last 90 days of capsule use and 41 during the first 90 days of tablet use.
Most patients initiated olaparib with the license starting dose, 88% when starting capsules and 81% when starting tablets. After initiating either formulation, a proportion of patients, a small proportion of patients, had subsequent dose modifications within 90 days. So 8% while on capsules, 10% while on tablets. Almost all modifications during this period were single dose changes. 21 patients were prescribed a reduced dose of capsules at the time of switching.
And of these, 71% subsequently initiated tablets below the license starting dose.
Segment:5 What is the significance of these findings?.
So this retrospective observational cohort analysis of a real world population of patients with ovarian cancer offers insights for physicians transitioning their patients from olaparib capsules to tablets. It describes the incidence of pre-specified adverse events among patients who switched from capsules to tablets in the US following the voluntary withdrawal of capsules in September 2018.
The results are consistent with a known tolerability profile of both olaparib capsules and tablets. This analysis show that the transition from capsules to tablets is manageable, with no evidence of increased toxicities. Many patients transition directly from capsules to tablets without a day's treatment gap and without any apparent tolerability increased issues. Indeed, the tolerability outcomes in this group support switching from capsules to tablets with no gap in olaparib therapy.
Most patients initiated olaparib at the license starting dose, and didn't require dose modifications within the first 90 days of follow up. So in conclusion, this real world study supports the manageable tolerability and consistent toxicity profile of olaparib in women with ovarian cancer. [UPLIFTING MUSIC]
