Department of Oncology, Cumming School of Medicine, Health Research Innovation Centre (HRIC), University of Calgary, 3300 Hospital Drive NW, Room 2AA18, Calgary, AB, T2N 4N1, Canada.
Oncology Outcomes Research Initiative, University of Calgary, Calgary, AB, Canada.
Target Oncol. 2023 Sep;18(5):697-705. doi: 10.1007/s11523-023-00995-1. Epub 2023 Sep 1.
Based on findings from a single-arm, phase 2 basket trial (NCT02454972), lurbinectedin may be an effective treatment for individuals with small cell lung cancer (SCLC) who progressed on or after platinum-based chemotherapy.
To estimate the comparative effectiveness of lurbinectedin versus the historical standard of care for relapsed SCLC in Canada.
A synthetic control arm (SCA) analysis was conducted using real-world data. Population-level data were obtained from real-world databases in Alberta, Canada. Individuals diagnosed with SCLC who initiated post-platinum systemic therapy and met approximated eligibility criteria from the lurbinectedin trial were included in the SCA. Median overall survival (OS) in the SCA was estimated after adjusting for chemotherapy-free interval (CTFI; < 90 versus ≥ 90 days) and stage at initial diagnosis (extensive versus limited). The CTFI-adjusted hazard ratio was estimated using a Cox proportional hazards model.
One hundred seventy-four individuals were included in the SCA and 105 in the lurbinectedin trial. The adjusted median OS in the SCA was 6.1 months (95% CI 5.4-7.7 months; unadjusted: 6.7 months, 95% CI 6.0-7.7 months) versus 9.3 months (95% CI 6.3-11.8 months) in the lurbinectedin trial. The adjusted hazard ratio comparing lurbinectedin with the historical standard of care (referent group) was 0.61 (95% CI 0.45-0.82; unadjusted HR: 0.72; 95% CI 0.54-0.97). The hazard ratio was more pronounced among individuals with CTFI ≥ 90 days (HR: 0.49, 95% CI 0.33-0.73).
These findings suggest improved OS with lurbinectedin monotherapy versus the historical standard of care in Alberta, Canada.
基于单臂、2 期篮子试验（NCT02454972）的结果，洛布内塞丁可能是一种有效的治疗方法，适用于在铂类化疗后进展的小细胞肺癌（SCLC）患者。
评估洛布内塞丁与加拿大复发性 SCLC 历史标准治疗的比较疗效。
采用合成对照臂（SCA）分析方法，使用真实世界数据进行分析。人群水平数据从加拿大艾伯塔省的真实世界数据库中获得。符合洛布内塞丁试验近似入选标准，接受铂类化疗后系统治疗的 SCLC 患者被纳入 SCA。调整化疗无进展间隔（CTFI；<90 天与≥90 天）和初始诊断时的分期（广泛期与局限期）后，估计 SCA 中的中位总生存期（OS）。使用 Cox 比例风险模型估计 CTFI 调整后的风险比。
SCA 纳入 174 例患者，洛布内塞丁试验纳入 105 例患者。SCA 中调整后的中位 OS 为 6.1 个月（95%CI 5.4-7.7 个月；未调整：6.7 个月，95%CI 6.0-7.7 个月），而洛布内塞丁试验中为 9.3 个月（95%CI 6.3-11.8 个月）。与历史标准治疗（参照组）相比，洛布内塞丁比较的调整后风险比为 0.61（95%CI 0.45-0.82；未调整 HR：0.72；95%CI 0.54-0.97）。CTFI≥90 天的患者中，风险比更为显著（HR：0.49，95%CI 0.33-0.73）。
这些发现表明，在加拿大艾伯塔省，与历史标准治疗相比，洛布内塞丁单药治疗可改善 OS。
