PLoS One :局部晚期基底细胞癌的评估和治疗

2022-09-10 医路坦克 MedSci原创

非黑色素瘤皮肤癌是最常见的恶性肿瘤之一,大多数基底细胞癌(BCC)在早期诊断可以手术治愈,本研究的主要结果是现实环境中局部晚期基底细胞癌患者的治疗模式和相关有效性和安全性。

非黑色素瘤皮肤癌是美国最常见的恶性肿瘤,大多数基底细胞癌(BCC)在早期诊断可以手术治愈;然而,由于治疗延迟、侵袭性亚型或手术后复发/进展,估计有1%至10%进展为晚期(即局部晚期或转移性)疾病。

晚期基底细胞癌的病程变化很大,可供选择的治疗方案很少。Mohs显微外科手术已用于治疗局部晚期基底细胞癌,并可能与淋巴结受累患者的淋巴结清扫结合使用。对于反复手术治疗后复发的患者或不适合手术的病变,放射治疗可能有效;然而,其有效性受限于病变位置、先前使用的辐射以及遗传综合征的存在,包括BCC痣综合征(BCCNS;也称为Gorlin综合征)。历史上尽管有使用铂类药物的报道,但没有晚期BCC的标准化疗方案。

BCC的一个关键分子驱动因素是通过肿瘤抑制基因(PTCH1)的突变和随后的平滑基因(SMO)的激活不当激活Hedgehog信号通路。靶向Hedgehog通路抑制剂(HPIs)的开发和批准为局部晚期BCC和BCCNS患者提供了新的选择。

在结构化临床试验之外,有关局部晚期BCC治疗的相对有效性、安全性和模式的信息很少。RegiSONIC(晚期基底细胞癌和基底细胞癌痣综合征患者的治疗模式、有效性和安全性结果的观察性研究)是在美国进行的一项晚期基底细胞肿瘤登记,旨在前瞻性评估临床医生如何诊断和治疗晚期基底细胞瘤,以及在现实世界临床实践中使用系统(HPIs和化疗)和局部(手术、放射、破坏性和局部)治疗,并采用广泛的纳入标准来捕捉未典型纳入临床试验的患者的治疗模式和结果。

本文描述了一组新诊断的局部晚期BCC患者的基线特征、诊断、治疗模式和结果,这些患者在基线时为HPI初始。本研究的主要结果是现实环境中局部晚期基底细胞癌患者的治疗模式和相关有效性和安全性。

方法:这项前瞻性、多中心、观察性注册研究包括在75个美国学术和社区实践中接受治疗的新诊断的Hedgehog通路抑制剂-未发生基底细胞癌痣综合征的局部晚期基底细胞癌患者(n=433),包括皮肤科、Mohs外科和医学肿瘤学站点。

基底细胞癌。随机选择的前90天内接受vismodegib治疗(n=40,A)、非vismodegib治疗(n=40,B)和观察(n=28,C)的患者的代表性治疗模式。Vismodegib=诊断后90天内收到VISMODIGIB;非vismodegib治疗=在诊断后90天内接受vismodegib以外的干预;观察=诊断后90天内未接受干预。条形长度表示从局部晚期基底细胞癌诊断日期到研究终止、死亡或数据截止日期的持续时间;>表示死亡;X表示初始进展;*表示手术。

结果:局部晚期基底细胞癌的确定主要基于病变大小(79.6%)、组织病理学(54.3%)、浸润程度(49.0%)和位置(46.2%)。在确定局部晚期疾病的90天内,115名患者(26.6%)接受了Vismodegib,251名(58.0%)接受了手术/其他(非Vismodegib)治疗,67名(15.5%)尚未接受治疗(观察)。与未接受Vismodegib治疗或观察的患者相比,接受Vismodegib治疗的患者预测局部复发的高危临床特征发生率较高。Vismodegib治疗的临床有效率为85.1%,非Vismodegib治疗(主要是手术)的临床有率为94.9%。Vismodegib最常见的不良事件是年龄/味觉障碍、肌肉痉挛、脱发和体重减轻。Vismodegib和非Vismodegib治疗组的皮肤鳞状细胞癌发生率具有可比性。

结论:这项前瞻性观察性研究为美国局部晚期基底细胞癌患者的全国代表性样本提供了现实世界实践、治疗选择和结果方面的见解。对于不适合手术的病变患者,Vismodegib治疗与临床试验中观察到的疗效和安全性一致。

文献来源:Sekulic A,  Yoo S,  Kudchadkar R,Real-world assessment and treatment of locally advanced basal cell carcinoma: Findings from the RegiSONIC disease registry.PLoS One 2022;17(1)

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    2022-09-10 chg122

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