CDK 4-6 抑制剂一线治疗绝经前转移性乳腺癌患者的疗效以及因治疗相关中性粒细胞减少症而减少剂量对疗效的影响:土耳其肿瘤学组 (TOG) 研究。

IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES
Journal of Chemotherapy Pub Date : 2025-02-01 Epub Date: 2024-03-18 DOI:10.1080/1120009X.2024.2330835
Hasan Cagri Yildirim, Caner Kapar, Baris Koksal, Mustafa Seyyar, Pervin Can Sanci, Murad Guliyev, Perihan Perkin, Mustafa Buyukkor, Sendag Yaslikaya, Nargiz Majidova, Merve Keskinkilic, Duygu Ozaskin, Tugay Avci, Tugce Kubra Gunes, Murat Arcagok, Alper Topal, Gul Sema Yildiran Keskin, Gozde Kavgaci, Nilgun Yildirim, Ozde Melisa Celayir, Nilufer Avci, Ferit Aslan, Ali Alkan, Mert Erciyestepe, Muhammet Cengiz, Metin Pehlivan, Ahmet Gulmez, Ismail Beypinar, Tugba Basoglu Tuylu, Erkan Kayikcioglu, Elvin Chalabiyev, Serdal Turhal, Halil Goksel Guzel, Eyyup Ayas, Mustafa Sahbazlar, Ozgecan Dulgar, Hacer Demir, Tugba Yavuzsen, Vedat Bayoglu, Derya Kivrak Salim, Banu Ozturk, Feyyaz Ozdemir, Oguz Kara, Berna Oksuzoglu, Oznur Bal, Nebi Serkan Demirci, Mesut Yilmaz, Devrim Cabuk, Sercan Aksoy
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引用次数: 0

摘要

关于CDK 4-6抑制剂在激素受体(HR)阳性、HER2阴性转移性乳腺癌绝经前患者一线治疗中有效性的唯一一项3期研究是MONALEESA-7研究,而关于palbociclib有效性的数据也很有限。CDK 4-6 抑制剂最常见的副作用是嗜中性粒细胞减少症,而对于因嗜中性粒细胞减少症而减量的患者,CDK 4-6 抑制剂的疗效数据也很有限。在我们的研究中,我们旨在评估帕博西尼(palbociclib)和瑞博西尼(ribociclib)在绝经前转移性乳腺癌患者一线治疗中的有效性,以及因中性粒细胞减少而减量对无进展生存期的影响。我们的研究是一项多中心、回顾性研究,对来自 29 个不同中心、在转移阶段接受含有帕博西尼(palbociclib)或瑞博西尼(ribociclib)联合疗法的绝经前转移性乳腺癌患者的无进展生存期(PFS)影响因素进行了研究。研究共纳入了 319 名患者。接受palbociclib治疗的患者的mPFS为26.83个月,接受ribociclib治疗的患者的mPFS为29.86个月(p=0.924)。接受减量治疗的患者的mPFS为32.00个月,可以服用初始剂量的患者的mPFS为25.96个月,两者无统计学差异(p=0.238)。肝转移患者在使用氟维司群和CDK 4-6抑制剂的同时,发现ECOG PS 1是一个负面预后因素。未观察到新的不良事件。在我们的研究中,我们发现绝经前乳腺癌患者使用 CDK 4-6 抑制剂进行一线治疗后,PFS 超过 27 个月,与绝经后患者相似。我们没有发现两种CDK 4-6抑制剂的疗效有任何差异,而且我们发现,在因中性粒细胞减少而减量的患者中,CDK 4-6抑制剂的疗效没有下降。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of first-line CDK 4-6 inhibitors in premenopausal patients with metastatic breast cancer and the effect of dose reduction due to treatment-related neutropenia on efficacy: a Turkish Oncology Group (TOG) study.

The only phase 3 study on the effectiveness of CDK 4-6 inhibitors in first-line treatment in premenopausal patients with hormone receptor (HR) positive, HER2 negative metastatic breast cancer is the MONALEESA-7 study, and data on the effectiveness of palbociclib is limited. Data are also limited regarding the effectiveness of CDK 4-6 inhibitors in patients whose dose was reduced due to neutropenia, the most common side effect of CDK 4-6 inhibitors. In our study, we aimed to evaluate the effectiveness of palbociclib and ribociclib in first-line treatment in patients with premenopausal metastatic breast cancer and the effect of dose reduction due to neutropenia on progression-free survival. Our study is a multicenter, retrospective study, and factors affecting progression-free survival (PFS) were examined in patients diagnosed with metastatic premenopausal breast cancer from 29 different centers and receiving combination therapy containing palbociclib or ribociclib in the metastatic stage. 319 patients were included in the study. The mPFS for patients treated with palbociclib was 26.83 months, and for those receiving ribociclib, the mPFS was 29.86 months (p = 0.924). mPFS was 32.00 months in patients who received a reduced dose, and mPFS was 25.96 months in patients who could take the initial dose, and there was no statistical difference (p = 0.238). Liver metastasis, using a fulvestrant together with a CDK 4-6 inhibitor, ECOG PS 1 was found to be a negative prognostic factor. No new adverse events were observed. In our study, we found PFS over 27 months in patients diagnosed with premenopausal breast cancer with CDK 4-6 inhibitors used in first-line treatment, similar to post-menopausal patients. We did not detect any difference between the effectiveness of the two CDK 4-6 inhibitors, and we showed that there was no decrease in the effectiveness of the CDK 4-6 inhibitor in patients whose dose was reduced due to neutropenia.

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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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