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Apatinib in patients with extensive-stage small-cell lung cancer after second-line or third-line chemotherapy: a
Yanjun Xu1, Zhiyu Huang1, Hongyang Lu1
1Department of Medical Thoracic Oncology, Zhejiang Cancer Hospital, No. 1 Banshan East Road, Hangzhou, China.
Background:
Small-cell lung cancer (SCLC) remains an aggressive cancer with short-term survival due to limited therapeutic options. Apatinib is a small-molecule tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptor-2. This study aimed to investigate the efficacy and safety of apatinib in patients with extensive-stage (EC) SCLC who had progressed after two or three previous therapies.
Methods:
Eligible patients were histologically confirmed ES-SCLC after two or three previous treatments, including a platinum-based regimen. Patients received apatinib at an initial dose of 500 mg once daily. The primary endpoint was the objective response rate.
Results:
Forty patients were enrolled. At the data cut-off time (November 15, 2018), the median follow-up was 7.4 months; no patients remained on treatment, and five were still in follow-up. An objective response was achieved in 7 of 40 patients (17.5%) in the intention-to-treat population, and 7 of 38 patients (18.4%) in the per-protocol population. The median progression-free survival and overall survival were 3.0 months and 5·8 months, respectively. The most commonly observed grade 3 or greater treatment-related adverse events were hypertension, hand-foot syndrome, increased L-gamma-glutamyltransferase.
Conclusions:
Apatinib exhibited efficacy and an acceptable safety profile in previously heavily-treated ES-SCLC patients. Further exploration of apatinib in phase III trials is warranted.
Trial Registration:
NCT02945852.
Insights
Apatinib showed efficacy in patients with extensive-stage small-cell lung cancer (SCLC) after prior treatments. Further phase III trials are recommended to explore apatinib
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Small-cell lung cancer (SCLC) is an aggressive malignancy with limited treatment options and poor prognosis.
- Apatinib, a tyrosine kinase inhibitor targeting VEGFR-2, offers a potential therapeutic avenue.
- This study evaluated apatinib in heavily pre-treated extensive-stage SCLC patients.
Purpose of the Study:
- To assess the efficacy and safety of apatinib in extensive-stage SCLC patients.
- To determine the objective response rate (ORR) as a primary endpoint.
- To evaluate progression-free survival (PFS) and overall survival (OS).
Main Methods:
- A single-arm trial involving 40 patients with histologically confirmed ES-SCLC.
- Patients received apatinib 500 mg once daily after two or three prior therapies, including platinum-based regimens.
- Objective response rate (ORR) was the primary endpoint; PFS and OS were secondary endpoints.
Main Results:
- An ORR of 17.5% (intention-to-treat) and 18.4% (per-protocol) was observed.
- Median progression-free survival (PFS) was 3.0 months, and median overall survival (OS) was 5.8 months.
- Common grade 3+ adverse events included hypertension, hand-foot syndrome, and elevated L-gamma-glutamyltransferase.
Conclusions:
- Apatinib demonstrated efficacy in previously treated extensive-stage SCLC patients.
- The safety profile of apatinib was acceptable in this patient population.
- Further investigation in phase III clinical trials is warranted to confirm these findings.
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