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Time trends for drug specific adverse events in patients on sunitinib; implications for remote monitoring
Jacob Wise1, Raj Tiwari1, Sophie O'Halloran1
1Division of Urology, University Health Network, University of Toronto, Toronto, Ontario, Canada.
Introduction:
Sunitinib is a multi-targeted receptor tyrosine kinase inhibitor used to treat metastatic renal cell carcinoma (mRCC). Patients on sunitinib do require regular in-person appointments to monitor for adverse events (AEs). Given the Covid-19 pandemic, regular in-person visits expose patients to an increased risk of infection in addition to potentially preventable travel costs. This study investigated the feasibility of implementing a remote monitoring strategy for patients being treated with sunitinib for mRCC by examining the time trends of AEs.
Materials And Methods:
In this retrospective chart review of patients with a diagnosis of mRCC, 167 patients received sunitinib during their treatment. The time between initiation of treatment and the first AE was recorded. The AEs were categorized according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5. Survival analysis was used to calculate the time-to-AE.
Results:
Of the 167 patients identified, 145 experienced an AE (86.8%). Hypertension was the most common AE with 80% of AEs were ≤ Grade 2. Incidence of AE dropped by 91% after 3 months follow up and a further 36% after 6 months. The cumulative incidence of AEs were 87.8%, 94.6% and 98.0%, at 3, 6 and 9 months respectively. The severity of AEs observed were 39.3%, 38.6%, 20.7%, 1.4%,0% of Grade 1-5 events respectively. A trend of grade migration to less severe grades was also shown over time, with percentage of Grade ≥ 3 toxicity dropping from 22% between 0-3 months to 14% beyond 6 months follow up.
Conclusions:
The role of remote monitoring for mRCC patients on sunitinib remains relevant now with new waves of the Covid-19 pandemic, triggered by novel variants. The majority of AEs observed were of low severity ≤ Grade 2, with a trend of reduced AE frequency and severity most prevalent beyond 3 months of follow up. This data appears to support the implementation of a remote monitoring strategy 3 months after initiation of treatment.
Insights
Remote monitoring for metastatic renal cell carcinoma (mRCC) patients on sunitinib is feasible. Most adverse events (AEs) are low-grade and decrease over time, supporting remote monitoring after three months.
Area of Science:
- Oncology
- Pharmacology
- Medical Informatics
Background:
- Sunitinib is a tyrosine kinase inhibitor for metastatic renal cell carcinoma (mRCC).
- Regular in-person monitoring for adverse events (AEs) poses infection risks and costs, especially during pandemics.
- Investigating remote monitoring feasibility for mRCC patients on sunitinib is crucial.
Purpose of the Study:
- To assess the feasibility of remote monitoring for mRCC patients treated with sunitinib.
- To analyze time trends of AEs in patients receiving sunitinib for mRCC.
- To determine if AE frequency and severity decrease over time, supporting remote care.
Main Methods:
- Retrospective chart review of 167 mRCC patients treated with sunitinib.
- Recorded time to first AE and categorized AEs using CTCAE v5.
- Utilized survival analysis to calculate time-to-AE.
Main Results:
- 145 out of 167 patients (86.8%) experienced AEs, most commonly hypertension.
- AE incidence decreased significantly after 3 months (91%) and 6 months (36%).
- A trend towards less severe AEs (Grade migration) was observed over time.
Conclusions:
- The majority of AEs were low-grade (≤ Grade 2).
- AE frequency and severity showed a decreasing trend beyond 3 months.
- Remote monitoring is a viable strategy for mRCC patients on sunitinib, particularly after the initial 3 months of treatment.
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