Manchester Academic Health Science Centre, University of Manchester, Manchester, UK, Salford Royal NHS Foundation Trust, Salford, UK.
Department of Dermatology, Institut Gustave Roussy and Paris-Saclay University, Villejuif, France.
Eur J Dermatol. 2023 Jun 1;33(3):280-286. doi: 10.1684/ejd.2023.4498.
Sonidegib is approved to treat locally advanced basal cell carcinoma (laBCC) in patients not amenable to surgery or radiation. The BOLT trial demonstrated durable efficacy of sonidegib in laBCC patients over 42 months. BCC is most common in the elderly, who often take chronic medications.
We evaluated the efficacy of sonidegib (200 mg daily) in laBCC patients on select concomitant medications.
MATERIALS & METHODS: In the Phase II BOLT study, laBCC patients were randomized 1:2 to sonidegib 200 mg:800 mg daily. The primary endpoint was objective response rate (ORR) per central review. Post hoc assessments included ORR and duration of response (DOR) per investigator review for patients on concomitant medications.
At 42 months, ORR for laBCC patients taking sonidegib 200 mg daily (n=66) was 71.2% and DOR was 15.7 months according to investigator review. Patients on select concomitant medications (n=37) had an ORR of 73.0%; DOR was not estimable.
Administration of sonidegib with concomitant medications, excluding strong cytochrome P450 3A4/5 inhibitors/inducers, does not appear to alter its efficacy in laBCC patients.
索尼吉布已被批准用于治疗不能手术或放疗的局部晚期基底细胞癌（laBCC）患者。BOLT 试验表明，索尼吉布在 42 个月以上的 laBCC 患者中具有持久疗效。BCC 最常见于老年人，他们经常服用慢性药物。
我们评估了索尼吉布（每日 200mg）在服用某些伴随药物的 laBCC 患者中的疗效。
在 II 期 BOLT 研究中，laBCC 患者按 1:2 的比例随机分为索尼吉布 200mg：每日 800mg 组。主要终点为中央审查的客观缓解率（ORR）。事后评估包括研究者评估的服用伴随药物的患者的 ORR 和缓解持续时间（DOR）。
在 42 个月时，每日服用索尼吉布 200mg 的 laBCC 患者（n=66）的 ORR 为 71.2%，根据研究者评估，DOR 为 15.7 个月。服用某些伴随药物的患者（n=37）的 ORR 为 73.0%；DOR 不可估计。
在 laBCC 患者中，伴随药物（不包括强细胞色素 P450 3A4/5 抑制剂/诱导剂）的给药似乎不会改变索尼吉布的疗效。
