Clinical Activity and Safety of Anlotinib Combined with PD-1 Blockades for Patients with Previously Treated Small Cell Lung Cancer.

Objective: Anlotinib was the standard monotherapy for patients with previously treated small cell lung cancer (SCLC) in recent years. Programmed cell death protein 1 (PD-1) blockade combined with antiangiogenic targeted drugs have proved to play a synergistic action for cancer treatment clinically. Consequently, the present study was to investigate the efficacy and safety of anlotinib combined with PD-1 blockades for patients with previously treated SCLC.

Methods: A total of 36 patients with SCLC who were treated with at least one previous systemic chemotherapy regimen participated in this study retrospectively. All the patients were administered with anlotinib plus PD-1 blockades therapy. Clinical activity was assessed according to the change of target lesion by imaging evidence and all the subjects were followed up regularly. Safety profiles were collected and documented during the treatment. Univariate analysis was carried out using Log rank test and multivariate analysis was adjusted by Cox regression analysis.

Results: All the 36 patients with previously treated SCLC were able to have their efficacy and safety profile evaluated. The best overall response of the combination regimen showed that complete response was observed in one patient, partial response was noted in 9 patients, stable disease was reported in 19 patients, progressive disease was seen in 7 patients. Therefore, the objective response rate (ORR) of the 36 patients was 27.8% (95% CI: 14.2-45.2%), disease control rate (DCR) was 80.6% (95% CI: 64.0-91.8%). Regarding the prognostic data, the median PFS and OS of the 36 patients was 4.6 months (95% CI: 3.13-6.07) and 9.3 months (95% CI: 3.30-15.30), respectively. The most common treatment-related adverse reactions were hypertension (52.8%), fatigue (47.2%), diarrhea (38.9%), hand and foot reaction (38.9%) and dermal toxicity (33.3%). Furthermore, multivariate Cox regression analysis for PFS indicated that ECOG performance status was an independent factor to predict PFS.

Conclusion: Anlotinib combined with PD-1 blockades regimen preliminarily demonstrated encouraging efficacy and tolerable safety for patients with previously treated SCLC. The conclusion should be validated in prospective clinical trials subsequently.