Abstract 1649P
Background
Patients with relapsed small cell lung cancer (SCLC) have limited treatment options and dismal survival. Phase II study shows the moderate activity of anlotinib monotherapy (a novel multitarget tyrosine kinase angiogenesis inhibitor) in previously treated SCLC. The purpose of this study is to assess the efficacy and safety of anlotinib combination with oral fluoropyrimidine S1 in patients with Refractory or Relapsed SCLC.
Methods
This open-label, multicentre, single-arm, phase II trial was done at three hospitals in China. Eligible patients were age 18 to 75 years. Patients with relapsed/refractory SCLC whose disease progressed or recurred after at least one prior platinum-based chemotherapy regimen. Pts received six cycles of anlotinib (12mg once daily [QD]) plus S-1 (60mg twice daily [BID]) for 14 consecutive days every 21 days followed by maintenance S-1 until disease progression. The primary outcome was objective response rate (ORR) or progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1. Secondary endpoints included overall survival (OS) and safety.
Results
Between March 2019 to June 2020, 71 patients were assessed for eligibility, of 52 pts enrolled, 48 were received at least two doses of the study drug. Median follow-up was months was 755 days. The overall response was seen in 21 patients (43.8%). Median PFS was 134 days (95% CI, 104-164 days). Median OS was 178 days (95% CI,137-219 days). The most common grade 3-4 adverse events were fatigue, hand-foot syndrome, hypertension, anorexia, and blurred vision. No treatment-related deaths were reported.
Conclusions
Anlotinib combination with oral fluoropyrimidine S1 was active for relapsed/refractory SCLC in terms of overall response and had an acceptable and manageable safety profile.
Clinical trial identification
NCT03823118.
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.