Efficacy and safety of anlotinib maintenance therapy in limited-stage small cell lung cancer.

BACKGROUND

Effective maintenance therapy options after first-line chemoradiotherapy for limited-stage small cell lung cancer (LS-SCLC) remain limited. Anlotinib, a multi-target tyrosine kinase inhibitor, was evaluated for its efficacy and safety in this setting.

METHODS

In this single-center, prospective, randomized controlled trial, 60 LS-SCLC patients who had completed first-line chemoradiotherapy were enrolled and randomly assigned (1:1) to receive either anlotinib maintenance therapy or best supportive care. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate (ORR), safety, and quality of life (QoL).

RESULTS

The anlotinib group demonstrated a significantly prolonged median PFS compared to the control group. Furthermore, patients in the anlotinib group experienced earlier and more significant improvement in QoL, and a strong positive correlation was observed between QoL scores and OS. The safety profile of anlotinib was consistent with its known characteristics, with hypertension and proteinuria being the most common adverse events, which were manageable through dose modifications.

CONCLUSION

Anlotinib as maintenance therapy significantly improved PFS and QoL in patients with LS-SCLC, with a manageable safety profile. This study provides initial evidence supporting the potential role of anlotinib in this treatment paradigm.