Abstract 1795P
Background
Existing maintenance treatment strategies for patients with extensive-stage small cell lung cancer (ES-SCLC) experiencing no progression after the standard first-line chemotherapy are limited. Previous analysis in ALTER1202 showed anlotinib, a novel oral multitarget tyrosine kinase inhibitor, significantly prolonged progression-free survival (PFS) and overall survival (OS) in relapsed SCLC who failed ≥ 2 lines of chemotherapy. The aim of this study was to assess the efficacy and safety of anlotinib combined with etoposide as maintenance treatment in patients with ES-SCLC after the standard first-line EP chemotherapy.
Methods
Patients with histologically confirmed ES-SCLC who have not progressed after the standard first-line EP chemotherapy received anlotinib (12 mg, QD, from day 1 to 14, every 3 weeks) combined with etoposide (50 mg, QD, day 1 to 14 of a 21-day cycle, up to 6 cycles) until disease progression or unacceptable toxicity. The primary endpoint was PFS. Secondary endpoints were OS and safety. The study was registered at Chinese Clinical Trial Registry (ChiCTR1800019421).
Results
Between April 2019 and January 2020, we screened 15 patients and enrolled 12 patients in this trial. At data cut-off (April 30, 2020), 6 (50%) patients had discontinued the study, and 6 (50%) patients remained on treatment. The median follow-up time was 4.30 month (95% Cl, 3.25-5.36). Among the 12 patients, 4 patients reached partial response (PR) and 7 had stable disease (SD). The median PFS (mPFS) was not reached and the six-month PFS rate was 68.8% (95%CI, 44.0%-100%). The objective response rate (ORR) and the disease control rate (DCR) were 33.3% and 91.6%, respectively. The most common grade 1-2 adverse events (AEs) included anorexia (8 of 12, 66.7%), hypertension (7 of 12, 58.3%), fatigue (4 of 12, 33.3%) and vomiting (4 of 12, 33.3%). No grade 3 or higher AEs were observed.
Conclusions
The combination of anlotinib and etoposide appeared to have significant efficacy and favorable safety profile as maintenance treatment in patients with ES-SCLC having not progressed after the standard first-line EP chemotherapy.The further exploration is ongoing.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Bo Shen.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., LTD.
Disclosure
All authors have declared no conflicts of interest.