背景:Lurbinectedin已被FDA批准用于治疗基于铂的化疗进展后或之后的转移性小细胞肺癌(SCLC)。前列腺小细胞或神经内分泌癌(SC/NEPC)表现类似SCLC;然而,在SC/NEPC中不存在lurbinectedin的安全性或疗效数据。
方法:确定了4个肿瘤学术中心所有接受lurbinectedin治疗的SC/NEPC患者。基线患者数据和lurbinectedin结果,包括放射学反应(完全反应[CR],部分响应[PR],稳定的疾病[SD],进行性疾病[PD]),无进展生存期(PFS),总生存期(OS),和治疗相关的不良事件(trAEs)进行了描述。临床获益率(CBR)包括CR,PR,或SD成像。进行描述性统计。
结果:在第一次lurbinectedin剂量时,所有18例患者均有转移性疾病.中位年龄为63.5(范围:53-84),先前的全身治疗次数为4次(范围:2-7次),完成的lurbinectedin循环为5(范围:1-10)。9/18例患者在lurbinectedin治疗期间给予ADT。CBR为9/16(56%)。最常见的trAE是疲劳和贫血。中位OS和PFS分别为6.01(0.23-16.69)和3.35(0.16-7.79)个月。
结论:Lurbinectedin在一些SC/NEPC患者中显示出适度但显著的临床获益,并且显示出可接受的毒性特征,没有因trAE而住院。SC/NEPC是一种预后不良的侵袭性疾病,需要更多的治疗选择。缺乏铂类化疗后后续治疗的证据。Lurbinectedin是SC/NEPC的积极治疗选择;然而,需要更大的验证性研究。
BACKGROUND: Lurbinectedin is FDA approved for treatment of metastatic small cell lung cancer (SCLC) following progression on or after platinum-based chemotherapy. Prostatic small cell or neuroendocrine carcinoma (SC/NEPC) behaves like SCLC; however, no safety or efficacy data for lurbinectedin in SC/NEPC exists.
METHODS: All SC/NEPC patients treated with lurbinectedin across 4 academic oncology centers were identified. Baseline patient data and lurbinectedin outcomes including radiographic responses (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]), progression free survival (PFS), overall survival (OS), and treatment-related adverse events (trAEs) were described. Clinical benefit rate (CBR) included CR, PR, or SD on imaging. Descriptive statistics were performed.
RESULTS: At first lurbinectedin dose, all 18 patients had metastatic disease. Median age was 63.5 (Range: 53-84), number of prior systemic therapies was 4 (Range: 2-7), and lurbinectedin cycles completed was 5 (Range: 1-10). ADT was administered during lurbinectedin treatment in 9/18 patients. CBR was 9/16 (56%). The most common trAEs were fatigue and anemia. Median OS and PFS were 6.01 (0.23-16.69) and 3.35 (0.16-7.79) months.
CONCLUSIONS: Lurbinectedin showed modest but significant clinical benefit in some patients with SC/NEPC and demonstrated an acceptable toxicity profile with no hospitalizations from trAEs. SC/NEPC is an aggressive disease with a poor prognosis for which more treatment options are needed. Evidence for subsequent treatments after platinum-based chemotherapy is lacking. Lurbinectedin is an active treatment option for SC/NEPC; however, larger confirmatory studies are needed.