The efficacy and safety of nab-paclitaxel plus anlotinib in small-cell Lung Cancer for third- line therapy

Background: Small-cell lung cancer (SCLC) has a poor prognosis after failure of second-line therapy. This study investigated the efficacy and safety of nab-paclitaxel plus anlotinib as a third-line treatment for recurrent SCLC. Methods: In this retrospective study, patients with recurrent SCLC with disease progression after two chemotherapeutic regimens were enrolled. Patients were randomized to one of two groups. One group (ANLIB) received 12 mg of anlotinib daily for 14 days until disease progression or unacceptable toxicity. The other group (ANNAB) received 260mg/m ² of nab-paclitaxel on day 1 in combination with 12mg/d of anlotinib for 14 days. The ANNAB regimen was repeated every three weeks for up to 6 cycles, followed by maintenance with anlotinib until disease progression or unacceptable toxicity. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Results: Between January 1, 2021 and July 31, 2022, 48 patients were enrolled in this study and were randomly assigned to either the ANNAB or ANLIB group. The overall response rate (ORR) was significantly higher in the ANNAB group compared to the ANLIB group (37.5% vs. 8.3%, Fisher's exact test p = 0.0363). The median PFS was 6.0 months in the ANNAB group and 4.7 months in the ANLIB group ( p = 0.0004). The median OS was 10.0 months in the ANNAB group compared with 7.3 months in the ANLIB group ( p < 0.0001). Conclusions: The combined-modality therapy of nab-paclitaxel and anlotinib as a third-line treatment for recurrent SCLC represents a promising therapeutic strategy with an acceptable toxicity profile.