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Soo Park, MD
Soo Park, MD
Posted: Tuesday, June 18, 2024
Individuals with locally advanced, unresectable basal cell carcinoma may benefit from the combination of vismodegib and curative-intent radiation therapy, results of a 19-patient phase II study have revealed. The combination yielded high rates of locoregional tumor control and progression-free survival as well as durable improvements in patient-reported quality of life, according to Christopher A. Barker, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues in the Journal of Clinical Oncology.
Radiation therapy alone does not provide satisfactory locoregional tumor control rates, the team noted. However, the Hedgehog pathway inhibitor vismodegib is active in basal cell carcinoma and may radiosensitize it, they theorized.
The locoregional tumor control rate at 1 year after the end of treatment was 91%, reported Dr. Barker and co-investigators; this was the multicenter trial’s primary endpoint. The 19 patients completed 12 weeks of induction therapy with vismodegib, followed by 7 weeks of concurrent therapy with vismodegib and radiation.
Further, with a median follow-up of 5.7 years, 1-year progression-free survival and 1-year overall survival rates were 100% and 96%, respectively. At 5 years, the team noted, progression-free survival and overall survival rates were 78% and 83%, respectively. All were secondary endpoints. Additionally, no distant metastasis nor death related to basal cell carcinoma was observed. As for another secondary endpoint, patient-reported quality of life, there were “clinically meaningful improvements in all subscales.”
Regarding safety, no grade 4 or 5 treatment-related adverse events were reported. Most frequent—and mostly mild to moderate—were dysgeusia, fatigue, and myalgias in 83%, 75%, and 75% of patients, respectively.
A total of 5 of the original 24 patients beginning the trial could not complete the 12-week vismodegib induction, indicating “this approach will not be feasible in all patients,” wrote the authors. However, the results of this first-of-its-kind trial clearly suggest “vismodegib does not increase the toxicity of radiation therapy or compromise concurrent radiation therapy delivery.”
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
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