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二线鲁比卡丁单药治疗小细胞肺癌的真实世界应用、有效性及安全性

Real-world use, effectiveness, and safety of second-line lurbinectedin monotherapy in small cell lung cancer.

作者信息

Ganti Apar Kishor, D'Agostino Ralph B, Allan Victoria, Prince Patricia, Estrin Adina, Gautam Nileesa, Boccuti Anne, Rengarajan Badri, Li Wenyan, Cao Yanyan, Fan Xiaozhou, Poole Elizabeth M

机构信息

Division of Oncology-Hematology, VA Nebraska Western Iowa Health Care System/University of Nebraska Medical Center, Omaha, NE, USA.

School of Medicine, Wake Forest University, Winston-Salem, NC, USA.

出版信息

Future Oncol. 2025 Jun;21(13):1675-1685. doi: 10.1080/14796694.2025.2499441. Epub 2025 May 26.

Abstract

AIM

Assess real-world outcomes of lurbinectedin and other second-line treatments (OST) in adults with small cell lung cancer that progressed on/after chemotherapy.

PATIENTS & METHODS: US-based electronic medical data from Flatiron Health (01/01/2013-03/31/2022) were used. Baseline characteristics, including chemotherapy-free interval (CTFI), in patients receiving lurbinectedin or OST were balanced using propensity score (PS) overlap weighting.

RESULTS

Before PS-weighting, median (95% confidence interval [CI]) real-world progression-free survival (rwPFS) was 2.46 months (2.07-2.73), and real-world response rate (rwRR) was 27.5% (23.1-32.4) in 374 eligible lurbinectedin-treated patients. After PS-weighting, median rwPFS was 2.73 months (2.33-3.32) and 2.53 months (2.23-2.99) in 291 lurbinectedin-treated patients and 261 OST-treated patients, respectively; rwRR was 30.9% and 31.8% (relative risk, 0.97). Lurbinectedin demonstrated numerically improved median rwPFS (3.61 versus 3.02 months) and rwRR (38.7% versus 36.1%) versus OST in patients with CTFI ≥90 days but not in patients with CTFI <90 days (2.00 months both; 20.5% versus 26.1%). Lurbinectedin-treated patients reported less grade ≥3 thrombocytopenia (11.7%) and anemia (6.5%) versus OST (27.2% and 20.3%, respectively); prevalence by CTFI status were similar.

CONCLUSION

Lurbinectedin demonstrated comparable real-world effectiveness with OST with a favorable safety profile; however, these findings are limited by small sample size.

摘要

目的

评估鲁比卡丁及其他二线治疗方案(OST)用于化疗后进展的成年小细胞肺癌患者的真实世界疗效。

患者与方法

使用来自Flatiron Health的美国电子医疗数据(2013年1月1日至2022年3月31日)。接受鲁比卡丁或OST治疗的患者的基线特征,包括无化疗间期(CTFI),采用倾向评分(PS)重叠加权进行平衡。

结果

在PS加权前,374例符合条件的接受鲁比卡丁治疗的患者中,真实世界无进展生存期(rwPFS)的中位数(95%置信区间[CI])为2.46个月(2.07 - 2.73),真实世界缓解率(rwRR)为27.5%(23.1 - 32.4)。PS加权后,291例接受鲁比卡丁治疗的患者和261例接受OST治疗的患者的rwPFS中位数分别为2.73个月(2.33 - 3.32)和2.53个月(2.23 - 2.99);rwRR分别为30.9%和31.8%(相对风险,0.97)。在CTFI≥90天的患者中,与OST相比,鲁比卡丁在数值上显示出rwPFS中位数有所改善(3.61对3.02个月)和rwRR有所提高(38.7%对36.1%),但在CTFI<90天的患者中并非如此(两者均为2.00个月;20.5%对26.1%)。接受鲁比卡丁治疗的患者报告的≥3级血小板减少症(11.7%)和贫血(6.5%)少于接受OST治疗的患者(分别为27.2%和20.3%);按CTFI状态划分的患病率相似。

结论

鲁比卡丁在真实世界中的疗效与OST相当,安全性良好;然而,这些发现受样本量小的限制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac69/12140460/e0598ae8f205/IFON_A_2499441_F0001_OC.jpg

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