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Safety and Efficacy of Low-Dosage Apatinib Monotherapy in Advanced Lung Squamous-Cell Carcinoma: A Prospective Cohort
Qian Geng1, Hua Shen2, Wenyu Zhu1
1Cancer Center, The Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213000, People's Republic of China.
Background:
Lung squamous-cell carcinoma (SqCC) is the second most common histology in non-small-cell lung carcinomas (NSCLCs). The treatment options for advanced lung SqCC are still an unmet medical need. Apatinib, a small-molecule inhibitor of vascular endothelial growth factor receptor-2 (VEGFR-2), is beneficial in the therapy of advanced NSCLC patients. This study aimed to preliminarily assess the efficacy and safety of low-dosage apatinib in patients with advanced lung SqCC.
Methods:
In this single-arm, open-label, investigator-initiated phase II prospective study (ChiCTR1800019808), we enrolled patients aged 54-80 years with platinum-refractory or chemotherapy rejected advanced lung squamous-cell carcinoma. Key exclusion criteria included major blood vessel involvement and gross hemoptysis with an amount of more than 20 mL. Apatinib at an initial dose of 250 mg was administered to patients once daily until disease progression, unacceptable toxicity, withdrawal, or death. The primary endpoint was progression-free survival (PFS) in all patients. We assessed the adverse events according to the treatment received.
Results:
Thirty-eight patients were enrolled between June 11, 2015 and August 29, 2018. Two patients failed to evaluate treatment efficacy for personal reasons, and thus 36 patients were eligible for evaluation of tumor response to apatinib. Median PFS was 4.9 months (95% CI: 3.0-6.8 months). Six patients achieved partial response (PR); the objective response rate (ORR) was 16.7% (6/36), and the total disease control rate (DCR) was 77.8% (28/36). Followed up to March 2020, 35 of the 38 patients were dead, and the 1-year survival rate was 21.1% (8/38). The median overall survival (OS) was 6.9 months (95% CI: 5.2-8.5 months). The most common adverse events included fatigue (50.0%), hypertension (42.1%), proteinuria (23.7%), loss of appetite (23.1%) and hand-foot reaction (21.1%). No grade 4 adverse effect or drug-related mortality occurred.
Conclusions:
Low-dose apatinib monotherapy might be an option for patients with advanced lung squamous-cell carcinoma.
Insights
Low-dose apatinib shows potential for advanced lung squamous-cell carcinoma. This treatment offers a median progression-free survival of 4.9 months with manageable side effects.
Area of Science:
- Oncology
- Pharmacology
Background:
- Lung squamous-cell carcinoma (SqCC) is a significant cause of cancer mortality.
- Advanced SqCC treatment remains an unmet medical need.
- Apatinib, a VEGFR-2 inhibitor, shows promise in non-small-cell lung cancer (NSCLC).
Purpose of the Study:
- To evaluate the efficacy and safety of low-dose apatinib in advanced lung SqCC patients.
- To determine progression-free survival (PFS) and overall survival (OS).
- To assess the objective response rate (ORR) and disease control rate (DCR).
Main Methods:
- A single-arm, open-label, phase II prospective study.
- 36 patients with platinum-refractory or chemotherapy-rejected advanced lung SqCC were enrolled.
- Apatinib (250 mg daily) was administered until disease progression or unacceptable toxicity.
Main Results:
- Median PFS was 4.9 months; ORR was 16.7% (6/36); DCR was 77.8% (28/36).
- Median OS was 6.9 months, with a 1-year survival rate of 21.1%.
- Common adverse events included fatigue, hypertension, and proteinuria; no grade 4 adverse effects occurred.
Conclusions:
- Low-dose apatinib monotherapy may be a viable treatment option for advanced lung SqCC.
- The observed efficacy and safety profile warrant further investigation.
- Apatinib offers a potential new therapeutic avenue for this patient population.
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