Real-world data on the efficacy and safety of trastuzumab emtansine in patients with metastatic breast cancer previously treated with pertuzumab: Turkish oncology group multicenter study.

IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES
Özgecan Dülgar, Sema Türker, Gül Başaran, Murat Araz, Ahmet Taner Sümbül, Dilek Çağlayan, Özge Gümüşay, Sedat Biter, Ahmet Konca, Miraç Özen, Hacer Demir, Melek Özdemir, Fatih Karataş, Elif Şahin, Eyyüp Çavdar, Ayşe İrem Yasin, Alper Yaşar, Sümeyra Derin, Metin Pehlivan, Ümmügül Üyetürk, Özlem Özdemir, Erkan Kayıkçıoğlu, Naziye Ak, Teoman Şakalar, Abdullah Sakin, Mahmut Büyükşimşek, Seval Ay, İsmail Ertürk, Sinem Akbaş, Kadriye Bir Yücel, Mahmut Gümüş
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引用次数: 0

Abstract

We aimed to evaluate the efficacy and safety of trastuzumab emtansine in patients with metastatic breast cancer previously treated with pertuzumab plus trastuzumab and taxane. We reviewed the medical records of patients who were diagnosed with Human Epidermal Growth Factor Receptor 2 (HER-2) positive metastatic breast cancer and received pertuzumab and then TDM-1 between January 2014 and January 2021 from twenty- five cancer centers. The Kaplan- Meier method estimated progression-free survival (PFS) and overall survival (OS). Additionally, objective response rate (ORR), clinical benefit rate (CBR), and safety were evaluated. One hundred fifty-three patients were included,79.1% of the patients received TDM-1 in the second line, 90.8% had visceral metastasis, and 30.7% had central nervous system involvement. The PFS and OS of TDM-1 were evaluated according to the number of previous lines (on the 2nd line or more than two lines) metastatic sites (visceral and non-visceral) and the presence of central nervous metastasis. In TDM-1 therapy, PFS in second line therapy was ten months (95% CI: 7.7 - 12.2); this was statistically higher than later-line PFS, which was six months (95% CI: 3.3 to 8.6) (p = 0.004). The median OS time was 25 months (95% CI: 21.0 to 28.9) in patients treated with TDM-1 in the second line and 19 months (95% CI: 12.3 to 25.6) in patients who received later than the second line(p = 0.175). There were no significant differences in PFS time of patients with and without visceral and central nervous metastases. Our study showed that TDM-1 was also effective in patients using pertuzumab, contributes significantly to PFS when used in the second line compared to its use in the later line, and does not make any difference in OS.

曾接受过百妥珠单抗治疗的转移性乳腺癌患者使用曲妥珠单抗的疗效和安全性的真实世界数据:土耳其肿瘤学组多中心研究。
我们的目的是评估曲妥珠单抗埃坦新(trastuzumab emtansine)对既往接受过百妥珠单抗+曲妥珠单抗和紫杉类药物治疗的转移性乳腺癌患者的疗效和安全性。我们查阅了 25 家癌症中心在 2014 年 1 月至 2021 年 1 月期间确诊为人表皮生长因子受体 2 (HER-2) 阳性转移性乳腺癌并接受过百妥珠单抗治疗,随后又接受了 TDM-1 治疗的患者的病历。卡普兰-麦尔法估算了无进展生存期(PFS)和总生存期(OS)。此外,还评估了客观反应率(ORR)、临床获益率(CBR)和安全性。研究共纳入153例患者,其中79.1%的患者接受了TDM-1二线治疗,90.8%的患者有内脏转移,30.7%的患者有中枢神经系统受累。TDM-1治疗的PFS和OS根据既往治疗线的数量(二线或二线以上)、转移部位(内脏和非内脏)以及是否存在中枢神经转移进行了评估。在TDM-1疗法中,二线治疗的PFS为10个月(95% CI:7.7 - 12.2);在统计学上高于二线治疗的PFS,后者为6个月(95% CI:3.3 - 8.6)(P = 0.004)。在二线接受TDM-1治疗的患者中,中位OS时间为25个月(95% CI:21.0至28.9),而在二线之后接受治疗的患者中,中位OS时间为19个月(95% CI:12.3至25.6)(P = 0.175)。有内脏转移和无中枢神经转移患者的 PFS 时间无明显差异。我们的研究表明,TDM-1对使用培妥珠单抗的患者同样有效,与二线治疗相比,二线治疗对PFS的贡献更大,而对OS没有任何影响。
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来源期刊
Journal of Chemotherapy
Journal of Chemotherapy 医学-药学
CiteScore
3.70
自引率
0.00%
发文量
144
审稿时长
6-12 weeks
期刊介绍: The Journal of Chemotherapy is an international multidisciplinary journal committed to the rapid publication of high quality, peer-reviewed, original research on all aspects of antimicrobial and antitumor chemotherapy. The Journal publishes original experimental and clinical research articles, state-of-the-art reviews, brief communications and letters on all aspects of chemotherapy, providing coverage of the pathogenesis, diagnosis, treatment, and control of infection, as well as the use of anticancer and immunomodulating drugs. Specific areas of focus include, but are not limited to: · Antibacterial, antiviral, antifungal, antiparasitic, and antiprotozoal agents; · Anticancer classical and targeted chemotherapeutic agents, biological agents, hormonal drugs, immunomodulatory drugs, cell therapy and gene therapy; · Pharmacokinetic and pharmacodynamic properties of antimicrobial and anticancer agents; · The efficacy, safety and toxicology profiles of antimicrobial and anticancer drugs; · Drug interactions in single or combined applications; · Drug resistance to antimicrobial and anticancer drugs; · Research and development of novel antimicrobial and anticancer drugs, including preclinical, translational and clinical research; · Biomarkers of sensitivity and/or resistance for antimicrobial and anticancer drugs; · Pharmacogenetics and pharmacogenomics; · Precision medicine in infectious disease therapy and in cancer therapy; · Pharmacoeconomics of antimicrobial and anticancer therapies and the implications to patients, health services, and the pharmaceutical industry.
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