From the Guidelines
Medications for metastatic basal cell carcinoma primarily include Hedgehog pathway inhibitors such as vismodegib (Erivedge) at 150 mg daily, which has been shown to have an objective response rate of 30-33% in patients with metastatic BCC, as reported by Sekulic et al 1.
Treatment Overview
The treatment of metastatic basal cell carcinoma (BCC) has evolved with the introduction of Hedgehog pathway inhibitors, which have demonstrated efficacy in managing this rare but challenging form of advanced skin cancer.
- Vismodegib, an oral medication, is a smoothened (SMO) inhibitor that targets the hedgehog pathway, which is aberrantly activated in BCC.
- The efficacy of vismodegib in metastatic BCC has been established through studies such as the one by Sekulic et al 1, showing an objective response rate of 30-33%, with the majority of patients experiencing tumor shrinkage and a median duration of objective response of 7.6 months.
Treatment Considerations
When considering treatment options for metastatic BCC, it is essential to weigh the benefits and risks, including the potential for serious adverse events, as reported in the STEVIE trial 1, where 36% of patients discontinued treatment due to adverse events.
- Treatment selection should be based on the patient's overall health, extent of disease, and previous treatments.
- Regular monitoring with imaging studies every 2-3 months is crucial to assess treatment response and adjust the treatment plan as necessary.
- Supportive care, including pain management and nutritional support, should be integrated into the treatment plan to optimize the patient's quality of life.
Multidisciplinary Management
Given the complexity of metastatic BCC, multidisciplinary management involving dermatology, medical oncology, and radiation oncology is recommended for optimal outcomes 1.
- This approach ensures that all aspects of the patient's care are considered, and the most appropriate treatment strategy is developed and implemented.
- The NCCN Guidelines for Basal Cell Skin Cancer, as outlined in the Journal of the National Comprehensive Cancer Network 1, provide a framework for managing BCC, including recommendations for surgical approaches, radiation therapy, superficial therapies, and hedgehog pathway inhibitors.
From the FDA Drug Label
ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. The recommended dosage of ERIVEDGE is 150 mg taken orally once daily, with or without food, until disease progression or until unacceptable toxicity.
Medications for metastatic basal cell carcinoma:
- Vismodegib (PO) is indicated for the treatment of adults with metastatic basal cell carcinoma.
- The recommended dosage is 150 mg orally once daily.
- Key points:
- Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE.
- Advise pregnant women of the potential risks to a fetus.
- Advise females of reproductive potential to use effective contraception during and after ERIVEDGE.
- Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential 2, 2, 2.
From the Research
Medications for Metastatic Basal Cell Carcinoma
- There are two approved hedgehog pathway inhibitors (HPIs) for the treatment of inoperable locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma (mBCC): vismodegib and sonidegib 3, 4, 5, 6, 7.
- Vismodegib has been shown to have an objective response rate of 30.3% in metastatic basal cell carcinoma and 42.9% in locally advanced basal cell carcinoma 4.
- Sonidegib has demonstrated an objective response rate of 56% in locally advanced BCC and 8% in metastatic BCC at the approved 200-mg daily dose 6.
- A systematic review and pooled analysis of interventional studies found that vismodegib had a significant and consistent effect on the median duration of therapy of laBCC and mBCC, with an objective response rate of 64.7% for laBCC and 33.6% for mBCC 5.
- Both sonidegib and vismodegib have been associated with similar patterns of adverse events, including muscle cramps, alopecia, and dysgeusia 4, 6, 7.
- The choice between sonidegib and vismodegib may depend on individual patient factors and the specific characteristics of their disease, as there are no head-to-head randomized controlled trials comparing the two treatments 7.