Tislelizumab plus sitravatinib or anlotinib as maintenance therapy in extensive‐stage small‐cell lung cancer: Results of two prospective phase II studies

作者：Sizhe Yu, Hui Li, Hongyang Lu, Zhiyu Huang, Kaiyan Chen, Yanjun Xu, Lei Gong, Fajun Xie, Jing Qin, Xinmin Yu, Jun Zhao, Guangyuan Lou, Wenxian Wang, Cuiping Gu, Na Han, Xiaoling Xu, Lan Shao, Yun Fan · 发表于：International Journal of Cancer · 年份：2025 · DOI：10.1002/ijc.70224 · 被引用次数：1 · 研究领域：Lung Cancer Research Studies、Lung Cancer Treatments and Mutations、Peptidase Inhibition and Analysis

First-line chemo-immunotherapy has significantly improved survival in extensive-stage small-cell lung cancer (ES-SCLC). However, rapid disease progression still occurs, with a median progression-free survival (PFS) of only 4.5-5.8 months from induction therapy. We initiated two single-arm, phase II studies to assess the first-line maintenance therapy with tislelizumab plus anti-angiogenic drugs following induction therapy in ES-SCLC patients. Previously untreated ES-SCLC patients were enrolled to receive tislelizumab plus platinum-based chemotherapy as induction therapy for 4 cycles, followed by tislelizumab plus sitravatinib (Trial 1) or anlotinib (Trial 2) as maintenance therapy in a 21-day cycle. The primary endpoint was the 1-year PFS rate in the maintenance analysis set (MAS, including patients receiving ≥1 dose of maintenance therapy). Outcomes in MAS were calculated from the start of maintenance therapy. Twenty-one patients were enrolled, and 18 patients entered the maintenance phase in each trial. From the start of the maintenance therapy, the median PFS was 6.4 and 7.8 months (1-year PFS rates of 22.2% and not reached), respectively; the median overall survival (OS) was 18.3 months and not reached. From induction therapy, the corresponding median PFS was 9.1 and 10.8 months, with a median OS of 17.6 months and not reached. In MAS, the most common grade ≥3 treatment-related adverse events (TRAEs) included hypertension (22.2%) in Trial 1 and fatigue (5.6%) in Trial 2. ...