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Cell Population Analyses During Skin Carcinogenesis
Published on: August 21, 2013
Increased Risk of Cutaneous Squamous Cell Carcinoma After Vismodegib Therapy for Basal Cell Carcinoma
Shalini V Mohan1, Julia Chang2, Shufeng Li3
1Department of Dermatology, Stanford University School of Medicine, Redwood City, California2currently with Genentech-Roche, South San Francisco, California.
Importance:
Smoothened inhibitors (SIs) are a new type of targeted therapy for advanced basal cell carcinoma (BCC), and their long-term effects, such as increased risk of subsequent malignancy, are still being explored.
Objective:
To evaluate the risk of developing a non-BCC malignancy after SI exposure in patients with BCC.
Design, Setting, And Participants:
A case-control study at Stanford Medical Center, an academic hospital. Participants were higher-risk patients with BCC diagnosed from January 1, 1998, to December 31, 2014. The dates of the analysis were January 1 to November 1, 2015.
Exposures:
The exposed participants (cases) comprised patients who had confirmed prior vismodegib treatment, and the nonexposed participants (controls) comprised patients who had never received any SI. Because vismodegib was the first approved SI, only patients exposed to this SI were included.
Main Outcomes And Measures:
Hazard ratio for non-BCC malignancies after vismodegib exposure, adjusting for covariates.
Results:
The study cohort comprised 180 participants. Their mean (SD) age at BCC diagnosis was 56 (16) years, and 68.9% (n = 124) were male. Fifty-five cases were compared with 125 controls, accounting for age, sex, prior radiation therapy or cisplatin treatment, Charlson Comorbidity Index, clinical follow-up time, immunosuppression, and basal cell nevus syndrome status. Patients exposed to vismodegib had a hazard ratio of 6.37 (95% CI, 3.39-11.96; P < .001), indicating increased risk of developing a non-BCC malignancy. Most non-BCC malignancies were cutaneous squamous cell carcinomas, with a hazard ratio of 8.12 (95% CI, 3.89-16.97; P < .001), accounting for age and basal cell nevus syndrome status. There was no significant increase in other cancers.
Conclusions And Relevance:
Increased risk for cutaneous squamous cell carcinomas after vismodegib therapy highlights the importance of continued skin surveillance after initiation of this therapy.
Insights
Vismodegib therapy for basal cell carcinoma (BCC) significantly increases the risk of developing other skin cancers, particularly cutaneous squamous cell carcinomas. Continued skin surveillance is crucial for patients undergoing this targeted treatment.
Area of Science:
- Oncology
- Dermatology
- Clinical Research
Background:
- Smoothened inhibitors (SIs) represent a novel targeted therapy for advanced basal cell carcinoma (BCC).
- Long-term effects of SIs, including the potential for secondary malignancies, require thorough investigation.
- Vismodegib is the first approved SI, making it a key focus for understanding treatment-related risks.
Purpose of the Study:
- To assess the risk of developing non-BCC malignancies in patients previously treated with vismodegib.
- To identify specific types of non-BCC malignancies associated with vismodegib exposure.
- To inform clinical practice regarding the long-term safety of SI therapy.
Main Methods:
- A case-control study was conducted at Stanford Medical Center, including high-risk BCC patients diagnosed between 1998 and 2014.
- Exposed cases received vismodegib, while non-exposed controls never received any SI.
- Statistical analysis calculated the hazard ratio for non-BCC malignancies, adjusting for relevant covariates.
Main Results:
- The study included 180 participants (55 cases, 125 controls).
- Vismodegib exposure was associated with a 6.37-fold increased risk of non-BCC malignancies (P < .001).
- Cutaneous squamous cell carcinomas showed a significantly higher risk (HR, 8.12; P < .001) with no increased risk for other cancers.
Conclusions:
- Vismodegib therapy is linked to an elevated risk of developing cutaneous squamous cell carcinomas.
- Close dermatological surveillance is essential for patients receiving vismodegib.
- These findings underscore the importance of monitoring for secondary malignancies during SI treatment.
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