355P - Anlotinib plus standard chemotherapy as first-line treatment in extensive-stage small cell lung cancer patients

Background

Extensive-stage small cell lung cancer was characterized by poor prognosis. Recently, anlotinib has demonstrated clinical activity as third- or further-line treatment. The aim of the study was to evaluate the efficacy and safety of adding anlotinib to first-line treatment with platinum and etoposide in patients with ES-SCLC.

Methods

This is a multicenter, single arm, prospective study (NCT04684017), conducting in 3 Chinese sites. Eligible patients were aged from 18 to 75 years; cytologically or histologically confirmed untreated ES-SCLC with performance-status of 0 or 1. Patients with asymptomatic central nervous system metastases were allowed. Patients were treated with up to six cycles chemotherapy consisted of etoposide 80-100 mg/m² (administered on days 1–3 of each 21-day cycle), with either carboplatin (area under the curve 5–6 mg/mL per min) or cisplatin (75-80 mg/m²) on day 1 of each cycle. Anlotinib (8mg, 10mg and 12mg at the treating physicians’ discretion) was orally taken once daily on day 1 to 14 per cycle (2 weeks on and 1 weeks off). Treatment was continued until disease progression, intolerable side effect or withdraw of consent. The primary end points of the study were safety and investigator assessed objective response rate (ORR).

Results

August 2018 and September 2021, 101 patients were screened and 86 patients who received at least one dose treatment and included into formal analysis. Median follow-up was 27.9 months. 2 patients and 73 patients were assessed as CR and PR, with an ORR of 87.2%. DCR was 97.7%. 78 and 47 patients occurred PFS and OS events. The median PFS and OS were 9.0 (95%CI: 7.5-10.5) months and 19 (95%CI: 16.7-21.3) months, respectively. The incidence of grade 3 or higher adverse events was 58.1%, and 24 (27.9%) patients experienced serious TRAEs. No patients died due to AEs.

Conclusions

In view of the encouraging efficacy, safety profile and durability, anlotinib combined with chemotherapy may provide a potential and novel treatment option for ES-SCLC patients. The study results need further validated in a randomized trial.

Clinical trial identification

NCT04684017.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.