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Objective: This retrospective study aimed to compare the real-world effectiveness and safety of anlotinib plus immune checkpoint inhibitors (ICIs) combination therapy versus chemotherapy in elderly patients with extensive-stage small-cell lung cancer (ES-SCLC). Methods: A total of 119 elderly patients (age ≥ 65 years) with ES-SCLC were screened and included in this study. Patients who received anlotinib plus ICIs (N = 59) were treated as observation group (OG). Subjects who received single-agent chemotherapy (irinotecan, docetaxel or paclitaxel) (N = 60) were deemed as control group (CG). Overall survival (OS) was the primary endpoint. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), Duration of response (DoR) and tolerability. Kaplan–Meier methods and Log rank tests were used to analyze OS/PFS/DoR with Cox proportional hazards modeling for multivariate analysis. Results: Median age was comparable with 71 years in both groups. Anlotinib plus ICIs showed significantly prolonged survival: median OS was 11.9 months (95% CI: 8.93– 14.87) in OG versus 6.7 months (95% CI: 3.41– 9.99) in CG (HR=0.53, 95% CI: 0.35– 0.81, P =0.003). Median PFS was 5.5 months (95% CI: 4.43– 6.57) in OG and 3.1 months (95% CI: 2.82– 3.38) in CG (HR=0.56, 95% CI: 0.38– 0.83, P =0.003). ORR was higher in OG (33.9% vs 15.0%, P =0.016), as was DCR (79.7% vs 55.0%, P =0.004). Treatment-related adverse events (TRAEs) of grade ≥ 3 was 42.4% in anlotinib plus ICIs and 55.0% in chemotherapy group, and this difference was not statistically significant ( P =0.168). The most common TRAEs in OG were fatigue (54.2%), hypertension (45.8%), nausea/vomiting (39.0%) and hand–foot syndrome (27.1%). The frequent TRAEs in CG included myelosuppression (55.0%), nausea/vomiting (48.3%), Fatigue (41.7%) and AST/ALT elevation (33.3%). Conclusion: Anlotinib combined with ICIs demonstrated improved OS compared to single-agent chemotherapy with acceptable safety profile in elderly patients with ES-SCLC. These real-world findings were hypothesis-generating and required confirmation in prospective trials. Keywords: elderly, extensive-stage small-cell lung cancer, anlotinib, immune checkpoint inhibitors, chemotherapy, effectiveness, safety
Lu et al. (Fri,) studied this question.