A single-arm, prospective study of apatinib mesylate plus pemetrexed in patients of advanced non-squamous non-small cell lung cancer after failure of previous chemotherapy

Shuang Dong; Wuling Ou; Yi Zhong; Xianmin Zhu; Qian Cai; Jing Zhang; Fengming Ran; Yu Qian; Jun Wang; Sheng Hu

doi:10.21037/atm-22-79

A single-arm, prospective study of apatinib mesylate plus pemetrexed in patients of advanced non-squamous non-small cell lung cancer after failure of previous chemotherapy

Ann Transl Med. 2022 Jan;10(2):101. doi: 10.21037/atm-22-79.

Authors

Shuang Dong^#¹, Wuling Ou^#¹, Yi Zhong¹, Xianmin Zhu¹, Qian Cai¹, Jing Zhang¹, Fengming Ran¹, Yu Qian¹, Jun Wang¹, Sheng Hu¹

Affiliation

¹ Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

^# Contributed equally.

Abstract

Background: The outcomes of advanced non-small cell lung cancer (NSCLC) patients after first- or second-line therapy are still discouraging due to a lack of effective treatment strategies. As a novel oral anti-angiogenesis drug, apatinib, approved by the National Medical Products Administration of China only for advanced gastric cancer, has been increasingly used in off-label treatment across various cancer types in recent years, especially advanced NSCLC. It has shown strong anti-tumor efficacy and acceptable safety.

Methods: This prospective study (NCT02974933) was conducted in patients with advanced NSCLC, who had suffered disease progression from the first- or second-line treatment, in Hubei Cancer Hospital. Eligible patients were enrolled and administrated with apatinib mesylate (500 mg qd) in combination with pemetrexed (500 mg/m², every 4 weeks). The primary endpoint was progression-free survival (PFS).

Results: From September 2016 to September 2019, a total of 21 advanced NSCLC patients were enrolled in Hubei Cancer Hospital. As of January 2021, treatment was discontinued in all patients, with 1 still in follow-up. There were 7/21 (33.3%) patients who achieved objective response. The median PFS and median overall survival (OS) were 7.0 months (95% CI: 6.15-7.85 months) and 13.0 months (95% CI: 7.39-18.6 months), respectively. Toxicities were tolerable or could be clinically managed. The most common grade 3-4 adverse events (AEs) were hypertension (14.3%, 3/21), hand-foot syndrome (4.7%, 1/21), and proteinuria (4.7%, 1/21). Hematological toxicities were moderate, with rare occurrences of grade 3/4 toxicities. During the period of treatment, there was no occurrence of treatment-related death.

Conclusions: Apatinib plus pemetrexed demonstrated promising efficacy and a high level of safety profile in previously heavily-treated NSCLC patients. More definitive studies on the combination of apatinib and pemetrexed are warranted.

Keywords: Non-small cell lung cancer (NSCLC); apatinib; efficacy; pemetrexed; safety.