Phase II, Single-Arm Trial of Induction and Concurrent Vismodegib With Curative-Intent Radiation Therapy for Locally Advanced, Unresectable Basal Cell Carcinoma.

Autor:	Barker CA; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY., Dufault S; Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA., Arron ST; Department of Dermatology, University of California San Francisco, San Francisco, CA., Ho AL; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY., Algazi AP; Department of Medicine, University of California San Francisco, San Francisco, CA., Dunn LA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY., Humphries AA; Department of Radiation Oncology, University of California San Francisco, San Francisco, CA., Hultman C; Department of Radiation Oncology, University of California San Francisco, San Francisco, CA., Lian M; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY., Knott PD; Department of Department of Otolaryngology-Head and Neck Surgery, University of California San Francisco, San Francisco, CA., Yom SS; Department of Radiation Oncology, University of California San Francisco, San Francisco, CA.; Department of Department of Otolaryngology-Head and Neck Surgery, University of California San Francisco, San Francisco, CA.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Jul 01; Vol. 42 (19), pp. 2327-2335. Date of Electronic Publication: 2024 Apr 17.
DOI:	10.1200/JCO.23.01708
Abstrakt:	Purpose: Locally advanced, unresectable basal cell carcinoma (LA BCC) can be treated with radiation therapy (RT), but locoregional control (LRC) rates are unsatisfactory. Vismodegib is a hedgehog pathway inhibitor (HPI) active in BCC that may radiosensitize BCC. We evaluated the combination of vismodegib and RT for patients with LA BCC. Methods: In this multicenter, single-arm, phase II study, patients with unresectable LA BCC received 12 weeks of induction vismodegib, followed by 7 weeks of concurrent vismodegib and RT. The primary end point was LRC rate at 1 year after the end of treatment. Secondary end points included objective response, progression-free survival (PFS), overall survival (OS), safety, and patient-reported quality of life (PRQOL). Results: Twenty-four patients received vismodegib; five were unable to complete 12 weeks of induction therapy. LRC was achieved in 91% (95% CI, 68 to 98) of patients at 1 year. The response rate was 63% (95% CI, 38 to 84) after induction vismodegib and 83% (95% CI, 59 to 96) after concurrent vismodegib and RT. With a median follow-up of 5.7 years, 1-year PFS and OS rates were 100% and 96%, and at 5 years PFS and OS rates were 78% and 83%, respectively. Distant metastasis or BCC-related death has not been observed. The most frequent treatment-related adverse events (AEs) were dysgeusia, fatigue, and myalgias occurring in 83%, 75%, and 75% of patients. No grade 4 to 5 treatment-related AEs occurred. PRQOL demonstrated clinically meaningful improvements in all subscales, with emotions and functioning improvements persisting for a year after the end of treatment. Conclusion: In patients with unresectable LA BCC, the combination of vismodegib and RT yielded high rates of LRC and PFS and durable improvements in PRQOL.
Databáze:	MEDLINE
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