Lung cancer (Amsterdam, Netherlands) · 2026
Immunotherapy rechallenge in Extensive-Stage small cell lung Cancer: A Real-World retrospective study.
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Wang Jingyi, Zhong Yuling, Chen Bolin, Xu Yan, Xu Li, Li Jia, Xu Fang, Wang Qianzhi, Li Kang, Kong Yi, Liu Liyu, Peng Mei, Liang Yini, Wu Lin
Аннотация
BACKGROUND: Although extensive-stage small cell lung cancer (ES-SCLC) is susceptible to first-line immunotherapy combined with chemotherapy (immunochemotherapy), most patients experience relapse and resistance after initial treatment. Prospective clinical trial data with a sufficient sample size to support the safety and efficacy of ICI rechallenge after progression on first-line immunochemotherapy in patients with ES-SCLC remain lacking.
METHODS: This study retrospectively analyzed the clinical data of 151 patients with ES-SCLC treated with first-line immunochemotherapy at Hunan Cancer Hospital between September 2019 and April 2025. We compared the efficacy and safety between patients who received ICI rechallenge and those who did not. The assessed endpoints included the objective response rate (ORR), disease control rate (DCR), progression-free survival for ICI rechallenge or second-line chemotherapy (PFS2), overall survival (OS), and adverse events (AEs).
RESULTS: The ICI rechallenge group had a higher ORR (26.0% vs. 11.8%, p = 0.043) and DCR (75.0% vs. 47.1%, p < 0.001) than the non-ICI group. Median PFS2 (3.98 vs. 2.43 months, p < 0.001) and OS (9.43 vs. 6.23 months, p < 0.001) were also longer with the ICI rechallenge group. Subgroup analyses suggested benefit across rechallenge modes, ICI type, and combination regimens. On multivariate Cox analysis, first-line systemic progression was an independent adverse prognostic factor. First-line PFS (PFS1) > 6 months, ICI rechallenge, and receipt of third-line or above therapy were independently associated with improved outcomes. The incidence of grade ≥ 3 treatment-related adverse events (TRAEs) did not differ significantly between the two groups. In the ICI rechallenge group, immune-related adverse events (irAEs) were mostly grade 1-2. Grade ≥ 3 irAEs occurred in only 2.0% of patients.
CONCLUSION: In this real-world study, ICI rechallenge significantly improved efficacy and prognosis in patients with ES-SCLC who progressed after first-line immunochemotherapy. Prospective phase III studies are warranted to confirm these findings.
METHODS: This study retrospectively analyzed the clinical data of 151 patients with ES-SCLC treated with first-line immunochemotherapy at Hunan Cancer Hospital between September 2019 and April 2025. We compared the efficacy and safety between patients who received ICI rechallenge and those who did not. The assessed endpoints included the objective response rate (ORR), disease control rate (DCR), progression-free survival for ICI rechallenge or second-line chemotherapy (PFS2), overall survival (OS), and adverse events (AEs).
RESULTS: The ICI rechallenge group had a higher ORR (26.0% vs. 11.8%, p = 0.043) and DCR (75.0% vs. 47.1%, p < 0.001) than the non-ICI group. Median PFS2 (3.98 vs. 2.43 months, p < 0.001) and OS (9.43 vs. 6.23 months, p < 0.001) were also longer with the ICI rechallenge group. Subgroup analyses suggested benefit across rechallenge modes, ICI type, and combination regimens. On multivariate Cox analysis, first-line systemic progression was an independent adverse prognostic factor. First-line PFS (PFS1) > 6 months, ICI rechallenge, and receipt of third-line or above therapy were independently associated with improved outcomes. The incidence of grade ≥ 3 treatment-related adverse events (TRAEs) did not differ significantly between the two groups. In the ICI rechallenge group, immune-related adverse events (irAEs) were mostly grade 1-2. Grade ≥ 3 irAEs occurred in only 2.0% of patients.
CONCLUSION: In this real-world study, ICI rechallenge significantly improved efficacy and prognosis in patients with ES-SCLC who progressed after first-line immunochemotherapy. Prospective phase III studies are warranted to confirm these findings.