Name:
Hedgehog inhibitors for basal cell carcinoma: real-world treatment patterns
Description:
Hedgehog inhibitors for basal cell carcinoma: real-world treatment patterns
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T00H06M33S
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Upload Date:
2023-07-19T00:00:00.0000000
Transcript:
Language: EN.
Segment:1 Hedgehog inhibitors for basal cell carcinoma: real-world treatment patterns.
[MUSIC PLAYING]
Segment:2 Introduction.
EMILY RUIZ: Hello. I am Emily Ruiz, director of the High Risk and Cancer Clinic at Dana-Farber Brigham Cancer Center and an Assistant Professor at Harvard Medical School. On behalf of all our authors, I will present results from our study hedgehog pathway inhibitor real-world treatment patterns in patients with basal cell carcinoma, a claims-based analysis.
EMILY RUIZ:
Segment:3 What was the purpose of this study?.
EMILY RUIZ: Basal cell carcinoma is the most common type of non-melanoma skin cancer, with more than 2 million cases diagnosed annually in the United States alone. Although most patients can be cured with surgery, approximately 1% develop advanced disease and require systemic therapy. Our current understanding of what causes basal cell carcinoma is that genetic mutations activate what is known as the hedgehog signaling pathway. Consequently, inhibitors of this pathway, referred to as hedgehog inhibitors, are used as treatment for unresectable disease.
EMILY RUIZ: Vismodegib and sonidegib are the two hedgehog inhibitors in widespread use. Until 2019, they were the only recommended therapies for advanced basal cell carcinoma, with no recommendations for patients whose disease had progressed on a hedgehog inhibitor or who could not tolerate a hedgehog inhibitor. And unfortunately, these drugs are associated with significant toxicities.
EMILY RUIZ: The updated recommendations of 2019 added a PD-1 inhibitor for patients in whom hedgehog inhibitors are unsuitable. In this study, we hope to get a better understanding of the real-world use of hedgehog inhibitors, including looking at whether they were being used for long periods of time in the period before PD-1 inhibitor approval.
Segment:4 How was the study undertaken?.
EMILY RUIZ: We examine treatment patterns using de-identified health insurance claims in the IBM market scan commercial and Medicare supplemental databases. We selected records between January 1st, 2013, and June 30th, 2019, that reported a claim for basal cell carcinoma and a hedgehog inhibitor prescription. We define the index date of hedgehog inhibitor treatment as the first day of the first dispensation to patients.
EMILY RUIZ: A discontinuation was defined as the expiration date of the last day of the last prescription supply. Although also allowing a 60-day grace period between prescriptions. Any subsequent hedgehog inhibitor prescription was considered as a re-initiation after a discontinuation. We also categorize the type of hedgehog inhibitor use. We considered a prescription as neoadjuvant use if it was issued up to 60 days before a surgery or radiation therapy. Adjuvant use was a prescription used up to 60 days after a surgery or radiation therapy. And primary therapy was a prescription with no surgery or radiation therapy reported in either 60-day window.
EMILY RUIZ:
Segment:5 What were the results?.
EMILY RUIZ: 526 patient records were identified over the 6 and 1/2 year period. 99% reported vismodegib as the hedgehog inhibitor. Median follow-up was 437 days after the hedgehog inhibitor index date. The hedgehog inhibitor was used as primary therapy in 70% of records, as an adjuvant in 22%, as a neoadjuvant in 4%, and appeared to be both adjuvant and neoadjuvant in 4%. At first use, the median duration of hedgehog inhibitor therapy was 144 days, with 60% of patients discontinuing within six months and 88% within 12 months.
EMILY RUIZ: Of patients who discontinued, 11% re-initiated a hedgehog inhibitor within six months of the discontinuation date, and 20% re-initiated by 12 months. Re-initiated hedgehog inhibitor therapy was taken for a median duration of 118 days.
EMILY RUIZ: When we examine the relationship between treatment type and duration, it appeared that patients received a hedgehog inhibitor for slightly longer when it was a primary therapy compared to as an adjuvant or neoadjuvant. The respective median durations were 148 days as the primary therapy compared to 128 days and 107 days as adjuvant or neoadjuvant.
EMILY RUIZ: As a final step, we ran a sensitivity analysis examining whether our findings were influenced by the length of grace period before a pause in treatment was categorized as a discontinuation. We tested the effect of the grace period as short as 14 days going up to 120 days as the longest. The time spent on the first hedgehog inhibitor ranged from 94 to 172 days. While the proportion of patients who re-initiated treatment within 12 months remained low at less than 41% across all grace periods.
Segment:6 What is the significance of these findings?.
EMILY RUIZ: The real-world data suggests that half of patients with advanced basal cell carcinoma discontinued hedgehog inhibitor treatment within approximately five months, which is less than half the 10 to 12 months shown in pivotal clinical trials.
EMILY RUIZ: Additionally, only a small proportion of patients re-initiated a hedgehog inhibitor. These findings are largely consistent with those found by other retrospective real-world studies of hedgehog inhibitors used in advanced basal cell carcinoma.
EMILY RUIZ: There are some important limitations to consider for our study. Health insurance records do not give information on reasons for hedgehog inhibitor discontinuation or whether treatment holidays were built into a dosing regimen. Additionally, we could not distinguish between permanent and temporary discontinuation. Future studies should probably examine these questions. It will also be interesting to see if hedgehog inhibitor treatment patterns have altered now that PD-1 therapy has been approved for patients in whom hedgehog inhibitor treatment is considered inappropriate.
Segment:7 Thank you for watching!.
EMILY RUIZ: Finally, on behalf of all authors, I would like to thank everyone who contributed to this study as well as everyone here for your time. Thank you. [MUSIC PLAYING]
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