PMID- 32250517 OWN - NLM STAT- MEDLINE DCOM- 20210618 LR - 20210618 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 25 IP - 5 DP - 2020 May TI - A Prospective Study of Apatinib in Patients with Extensive-Stage Small Cell Lung Cancer After Failure of Two or More Lines of Chemotherapy. PG - e833-e842 LID - 10.1634/theoncologist.2019-0391 [doi] AB - BACKGROUND: Because of rapid disease progression and lack of optimal treatment strategies beyond the second-line, the prognosis of patients with extensive-stage (ES) small cell lung cancer (SCLC) still remains depressing. Alternative treatment strategies are required to improve their prognosis. In this prospective clinical study, we aimed to evaluate the feasibility of single-agent apatinib, a vascular endothelial growth factor receptor-2 tyrosine kinase inhibitor, as a treatment option for patients with ES-SCLC after failure of at least two prior chemotherapy regimens. MATERIALS AND METHODS: Twenty-two patients with ES-SCLC treated with 500 mg single-agent apatinib as subsequent-line regimen in our institution from November 2016 to August 2018 were enrolled in the study. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). RESULTS: Clinical outcomes included partial response in 3 patients (13.6%), stable disease in 18 patients (81.8%), and disease progression in 1 patient (4.5%), with an ORR of 13.6% and DCR of 95.5%. The median PFS and OS were 5.4 and 10.0 months, respectively. Apatinib demonstrated a manageable toxicity profile, with grade I-III secondary hypertension and proteinuria as the most common AEs. No grade IV and V AEs were observed among the patients. Multivariate analysis revealed secondary hypertension as an independent predictor of OS (p = .047); however, the association became insignificant after Q correction (p = .455). CONCLUSIONS: Apatinib was safe and effective in the management of patients with ES-SCLC and can be considered as a treatment option after failure of at least two prior chemotherapy regimens. ClinicalTrials.gov identifier. NCT02995187 IMPLICATIONS FOR PRACTICE: This study indicated the acceptable toxicity profile and promising efficacy of apatinib in the management of patients with extensive-stage small cell lung cancer after failure from at least two prior chemotherapy regimens. Secondary hypertension can be a potential prognostic factor for apatinib treatment. CI - (c) 2020 The Authors. The Oncologist published by Wiley Periodicals, Inc. on behalf of AlphaMed Press. FAU - Liu, Yutao AU - Liu Y AD - Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People's Republic of China. FAU - Hu, Xingsheng AU - Hu X AD - Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People's Republic of China. FAU - Jiang, Jun AU - Jiang J AD - Department of Radiology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. FAU - Yang, Lin AU - Yang L AD - Department of Pathology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China. FAU - Zhou, Shengyu AU - Zhou S AD - Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People's Republic of China. FAU - Liu, Peng AU - Liu P AD - Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People's Republic of China. FAU - Li, Junling AU - Li J AD - Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People's Republic of China. FAU - Wang, Yan AU - Wang Y AD - Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People's Republic of China. FAU - Hao, Xuezhi AU - Hao X AD - Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People's Republic of China. FAU - Shi, Yuankai AU - Shi Y AD - Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, People's Republic of China. LA - eng SI - ClinicalTrials.gov/NCT02995187 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200406 PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 0 (Antineoplastic Agents) RN - 0 (Pyridines) RN - 0 (Vascular Endothelial Growth Factor A) RN - 5S371K6132 (apatinib) SB - IM MH - *Antineoplastic Agents/adverse effects MH - Humans MH - *Lung Neoplasms/drug therapy MH - Prospective Studies MH - Pyridines MH - *Small Cell Lung Carcinoma/drug therapy MH - Vascular Endothelial Growth Factor A PMC - PMC7216448 OTO - NOTNLM OT - Apatinib OT - Small cell lung cancer OT - Subsequent-line treatment OT - Third-line treatment COIS- Disclosures of potential conflicts of interest may be found at the end of this article. EDAT- 2020/04/07 06:00 MHDA- 2021/06/22 06:00 PMCR- 2020/05/01 CRDT- 2020/04/07 06:00 PHST- 2019/05/22 00:00 [received] PHST- 2020/02/25 00:00 [accepted] PHST- 2020/04/07 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/04/07 06:00 [entrez] PHST- 2020/05/01 00:00 [pmc-release] AID - ONCO13292 [pii] AID - 10.1634/theoncologist.2019-0391 [doi] PST - ppublish SO - Oncologist. 2020 May;25(5):e833-e842. doi: 10.1634/theoncologist.2019-0391. Epub 2020 Apr 6.