Vinorelbine plus platinum compared to vinorelbine plus capecitabine in treatment of patients with metastatic triple negative breast cancer previously treated with anthracycline and taxane: a prospective randomized study

IF 0.3 Q4 ONCOLOGY Oncology in Clinical Practice Pub Date : 2023-09-18 DOI:10.5603/ocp.96278
Heba Mohamed El-Zawahry, Ayman Abd Al-Samie Gaber, Amany Abd-Elhameed Abou-Bakr, Marwa Nabil Abd-Elhafez, Ahmed Mohamed El-Debawy
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Abstract

Introduction. This study aims to investigate the efficacy and tolerability of the vinorelbine-based combination chemotherapy with either cisplatin or capecitabine in metastatic triple-negative breast cancer (mTNBC) pretreated with anthracycline and taxane. Material and methods. This is an open-labeled randomized prospective single-institute study, that included all patients who received chemotherapy for mTNBC in the period between 1st of July 2016 and 30th of June 2017 and were pretreated with anthracycline and taxane. Patients were randomized to either vinorelbine 25 mg/m2 I.V on days 1 and 8 plus oral capecitabine 1000 mg/m2 twice daily, on days 1–14 (NX); or vinorelbine 25 mg/m2 I.V on days 1 and 8 plus cisplatin 75 mg/m2 (NP), every 21 days. The primary endpoint was time to progression (TTP), whereas the secondary endpoints were objective response rate (ORR), safety, and overall survival (OS). Results. Median TTP was 9.9 months with NP vs. 8 months with NX, (p = 0.22). ORR was 40% with NP vs . 36% with NX, (p = 0.77). Median OS was 13 months with NP vs . 13.2 months with NX (p = 0.599). Both regimens demonstrated similar rates of grade ≥ 3 vomiting and neutropenia. A higher incidence of thrombocytopenia, tinnitus, and kidney function alteration were reported with NP. A higher incidence of anorexia, diarrhea, mucositis, and hand-foot syndrome were reported with NX. Conclusions. Vinorelbine-based combination chemotherapy regimens with either cisplatin or capecitabine are active in the treatment of mTNBC pretreated with anthracycline and taxane with manageable toxicity profiles. Both regimens have comparable TTP, ORR, OS, and safety profiles.
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长春瑞滨加铂与长春瑞滨加卡培他滨治疗转移性三阴性乳腺癌患者的比较:一项前瞻性随机研究
介绍。本研究旨在探讨以长春瑞滨为基础的顺铂或卡培他滨联合化疗在蒽环类和紫杉烷预处理的转移性三阴性乳腺癌(mTNBC)中的疗效和耐受性。材料和方法。这是一项开放标签随机前瞻性单研究所研究,纳入了2016年7月1日至2017年6月30日期间接受化疗的mTNBC患者,并进行了蒽环类和紫杉烷预处理。患者随机接受静脉注射长春瑞滨25mg /m2,第1天和第8天加口服卡培他滨1000mg /m2,每天两次,第1 - 14天(NX);或长春瑞滨25mg /m2静脉注射,第1天和第8天加顺铂75mg /m2 (NP),每21天一次。主要终点是进展时间(TTP),次要终点是客观缓解率(ORR)、安全性和总生存期(OS)。结果。NP组的中位TTP为9.9个月,NX组为8个月,(p = 0.22)。与NP相比,ORR为40%。36%用NX, (p = 0.77)。NP组与NP组的中位OS为13个月。NX治疗13.2个月(p = 0.599)。两种方案均显示出相似的≥3级呕吐和中性粒细胞减少率。据报道,NP患者血小板减少、耳鸣和肾功能改变的发生率较高。据报道,NX患者厌食症、腹泻、黏膜炎和手足综合征的发生率较高。结论。以长春瑞滨为基础的联合化疗方案与顺铂或卡培他滨在蒽环类和紫杉烷预处理的mTNBC治疗中具有活性,毒性谱可控。两种方案在TTP、ORR、OS和安全性方面具有可比性。
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来源期刊
CiteScore
0.90
自引率
20.00%
发文量
46
审稿时长
15 weeks
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