Italian journal of dermatology and venereology · 2026
Italian interim analysis of NISSO: long-term sonidegib safety in locally advanced basal cell carcinoma.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Ascierto Paolo A, Peris Ketty, Fargnoli Maria C, Bossi Paolo, DE Giorgi Vincenzo, Licitra Lisa, Savoia Paola, Guida Michele, Spagnolo Francesco, DE Galitiis Federica, Stanganelli Ignazio, Romano Loredana, Martelli Serena, Arntz Ramon, Scalvenzi Massimiliano
Аннотация
BACKGROUND: Following the pivotal Phase II BOLT trial, sonidegib was approved by EMA to treat laBCC in patients not amenable to surgery or radiotherapy.
METHODS: The NISSO study (NCT04066504) is a non-interventional, multinational, multi-center, long-term, post-authorization, real-world safety study. Patients with laBCC were treated with sonidegib 200 mg orally once-daily and followed for 3 years according to the Prescribing Information.
RESULTS: Ninety-three patients were enrolled at 12 Italian centers with a median age of 79. The median exposure to sonidegib exposure was 8.9 months. At the time of the analysis, treatment ended in 65.6% patients, mainly due to patient/guardian decision, treatment success and physician decision. Most patients (78.5%) experienced at least 1 treatment-emergent adverse event (TEAE) including muscle spasms (39.8%), dysgeusia (32.3%), fatigue (21.5%); all of them decreased substantially after 3 months. Most TEAEs were Grade 1 and led to treatment discontinuation in 12.9%, while serious drug-related TEAEs were reported in 2.1% of patients. The Italian interim analysis shows a better real-world safety profile than could be expected based on the pivotal BOLT trial. Most patients experienced the onset of common AEs after 3 months.
CONCLUSIONS: All the above supports the use of sonidegib as a manageable first-line systemic treatment in patients with laBCC.
METHODS: The NISSO study (NCT04066504) is a non-interventional, multinational, multi-center, long-term, post-authorization, real-world safety study. Patients with laBCC were treated with sonidegib 200 mg orally once-daily and followed for 3 years according to the Prescribing Information.
RESULTS: Ninety-three patients were enrolled at 12 Italian centers with a median age of 79. The median exposure to sonidegib exposure was 8.9 months. At the time of the analysis, treatment ended in 65.6% patients, mainly due to patient/guardian decision, treatment success and physician decision. Most patients (78.5%) experienced at least 1 treatment-emergent adverse event (TEAE) including muscle spasms (39.8%), dysgeusia (32.3%), fatigue (21.5%); all of them decreased substantially after 3 months. Most TEAEs were Grade 1 and led to treatment discontinuation in 12.9%, while serious drug-related TEAEs were reported in 2.1% of patients. The Italian interim analysis shows a better real-world safety profile than could be expected based on the pivotal BOLT trial. Most patients experienced the onset of common AEs after 3 months.
CONCLUSIONS: All the above supports the use of sonidegib as a manageable first-line systemic treatment in patients with laBCC.