PMID- 37208633 OWN - NLM STAT- MEDLINE DCOM- 20230522 LR - 20230523 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 23 IP - 1 DP - 2023 May 19 TI - Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: a phase II trial. PG - 463 LID - 10.1186/s12885-023-10768-8 [doi] LID - 463 AB - BACKGROUND: Treatment options for pretreated triple-negative breast cancer (TNBC) are limited. This study aimed to evaluate the efficacy and safety of apatinib, an antiangiogenic agent, in combination of etoposide for pretreated patients with advanced TNBC. METHODS: In this single-arm phase II trial, patients with advanced TNBC who failed to at least one line of chemotherapy were enrolled. Eligible patients received oral apatinib 500 mg on day 1 to 21, plus oral etoposide 50 mg on day 1 to 14 of a 3-week cycle until disease progression or intolerable toxicities. Etoposide was administered up to six cycles. The primary endpoint was progression-free survival (PFS). RESULTS: From September 2018 to September 2021, 40 patients with advanced TNBC were enrolled. All patients received previous chemotherapy in the advanced setting, with the median previous lines of 2 (1-5). At the cut-off date on January 10, 2022, the median follow-up was 26.8 (1.6-52.0) months. The median PFS was 6.0 (95% confidence interval [CI]: 3.8-8.2) months, and the median overall survival was 24.5 (95%CI: 10.2-38.8) months. The objective response rate and disease control rate was 10.0% and 62.5%, respectively. The most common adverse events (AEs) were hypertension (65.0%), nausea (47.5%) and vomiting (42.5%). Four patients developed grade 3 AE, including two with hypertension and two with proteinuria. CONCLUSIONS: Apatinib combined with oral etoposide was feasible in pretreated advanced TNBC, and was easy to administer. CLINICAL TRIAL REGISTRATION: Chictr.org.cn, (registration number: ChiCTR1800018497, registration date: 20/09/2018). CI - (c) 2023. The Author(s). FAU - Cao, Mengru AU - Cao M AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Lu, Hailing AU - Lu H AD - The First Ward of the Oncology Department, The First Affilliated Hospital of Harbin Medical University, Harbin, China. FAU - Yan, Shi AU - Yan S AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Pang, Hui AU - Pang H AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Sun, Lichun AU - Sun L AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Li, Chunhong AU - Li C AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Chen, Xuesong AU - Chen X AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Liu, Wei AU - Liu W AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Hu, Jing AU - Hu J AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Huang, Jian AU - Huang J AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Xing, Ying AU - Xing Y AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Zhang, Ningzhi AU - Zhang N AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Chen, Yingqi AU - Chen Y AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - He, Ting AU - He T AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Zhao, Danni AU - Zhao D AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Sun, Yuanyuan AU - Sun Y AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Zhao, Lin AU - Zhao L AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Liu, Xiaomeng AU - Liu X AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Cai, Li AU - Cai L AD - The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China. caiwenxin76@163.com. LA - eng GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ GR - NCC201808B018/National Cancer Fund Climbing Fund/ PT - Clinical Trial, Phase II PT - Journal Article DEP - 20230519 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 6PLQ3CP4P3 (Etoposide) RN - 0 (Antineoplastic Agents) RN - 5S371K6132 (apatinib) SB - IM MH - Humans MH - Etoposide/adverse effects MH - *Antineoplastic Agents/therapeutic use MH - *Triple Negative Breast Neoplasms/drug therapy MH - *Hypertension/chemically induced PMC - PMC10197030 OTO - NOTNLM OT - Angiogenesis inhibitors OT - Apatinib OT - Clinical trial OT - Etoposide OT - Triple negative breast neoplasms COIS- The authors have no competing interests to declare. EDAT- 2023/05/20 09:42 MHDA- 2023/05/22 06:42 PMCR- 2023/05/19 CRDT- 2023/05/19 23:33 PHST- 2022/12/13 00:00 [received] PHST- 2023/03/24 00:00 [accepted] PHST- 2023/05/22 06:42 [medline] PHST- 2023/05/20 09:42 [pubmed] PHST- 2023/05/19 23:33 [entrez] PHST- 2023/05/19 00:00 [pmc-release] AID - 10.1186/s12885-023-10768-8 [pii] AID - 10768 [pii] AID - 10.1186/s12885-023-10768-8 [doi] PST - epublish SO - BMC Cancer. 2023 May 19;23(1):463. doi: 10.1186/s12885-023-10768-8.