Anlotinib Plus Immune Checkpoint Inhibitors versus Chemotherapy in Elderly Patients with Extensive-Stage Small-Cell Lung Cancer: A Real World, Exploratory Study.

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.