Abstract 1805P
Background
Further treatment of patients with locally advanced or metastatic small cell lung cancer(SCLC) suffering progression after one prior chemotherapy has become a challenging problem. Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2). Irinotecan is a highly active chemodrug in the treatment of advanced SCLC, both as a single agent or in combination regimens, and is well tolerated, with a low incidence of severe toxicity. Therefore, we evaluated the efficacy and safety of apatinib and irinotecan in the treatment of patients with SCLC.
Methods
On the basis of an expected response rate of 33% and a threshold response rate of 12%, a two-sided exact test was used to test the following hypothesis at a significance level of 5%: null hypothesis response rate ≤ 5%, alternative hypothesis response rate > 10%. The number of patients required for a power of 80% was calculated to be 25. Considering the drop rate of 15%, 30 patients need to be enrolled in the experiment. This open-label, single-arm study enrolled patients with SCLC, who failed in the first prior chemotherapy regimens between Mar 1, 2019, and Apr 10, 2020. Apatinib was administered 250mg daily according to patients ECOG (Eastern Cooperative Oncology Group) status, and irinotecan was administered 100mg/m2 for the first and eighth day in a 21-days cycle. The treatment was continued until disease progression or unacceptable toxic effects.
Results
In the study, 17 eligible patients received a combination of apatinib and irinotecan with a median age of 54 years old (range 35 to 67 years). Median follow up time was 12 months. 15 patients were eligible for efficacy analysis. ORR was 40 % (6/15). DCR was 80% (12/15). Median OS and median PFS was not yet achieved. The most common grade 3/4 treatment related AEs were hypertension (13.33%), proteinuria (6.67%), hand-foot syndrome (6.67%), and all adverse reactions could be recovered to less than grade 2 after suspension of medication or reduction of dose.
Conclusions
The combination of apatinib with irinotecan showed promising efficacy and manageable toxicities in patients with SCLC, and required more prospective patients to be enrolled.
Clinical trial identification
ChiCTR1800018642 2018/9/30.
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.