比较Ribociclib与Palbociclib作为二线治疗,结合Fulvestrant在转移性乳腺癌:一个随机临床试验
Manar Hamed Ahmed Shaaban1, Mohamed Ali Elbaiomy2, Ahmed Eltantawy2
1Medical Oncology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Asian Pacific journal of cancer prevention : APJCP
|September 29, 2024
概括
在转移性乳腺癌患者中,Palbociclib和ribociclib表现出类似的临床效益反应 (CBR),无进展生存期 (PFS) 和毒性概况. 生活质量在治疗之间没有显著差异,除了Palbociclib增加的疲劳.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 转移性乳腺癌 (ER+/HER2-) 治疗通常涉及CDK4/6抑制剂.
- 帕尔博西克利布和里博西克利布是常用的CDK4/6抑制剂,与激素治疗结合使用.
- 对这些患者群体的疗效和安全性进行比较的数据至关重要.
研究的目的:
- 为了比较临床效益反应 (CBR),无进展生存期 (PFS),生活质量 (QOL) 和palbociclib加富勒弗兰特毒性概况与ribociclib加富勒弗兰特.
- 评估ER+/HER2-转移性乳腺癌患者的治疗结果,这些患者在先前的激素治疗中进展.
主要方法:
- 一个开放的,随机的III期临床试验,涉及2个分支:palbociclib + fulvestrant和ribociclib + fulvestrant.
- 患者接受了palbociclib (125毫克/天) 或ribociclib (600毫克/天) 在3周的时间内,1周的休息时间,与fulvestrant.
- 使用EORTC QLQ-C30评估了生活质量,并根据CTCAE v5.0.0对毒性进行了分级.
主要成果:
- 在CBR (58.6%对于6个月的两者) 或中位数PFS (总体13个月;Palbociclib的13.67个月与Ribociclib的12.69个月) 中没有观察到统计学上显著的差异.
- 在两只手臂中都注意到失眠的显著改善,只有在palbociclib手臂中便秘的改善.
- 除了疲劳和财务困难之外,没有明显的质量生活恶化,在palbociclib手臂中更为明显. 在不同组之间,常见的毒性是相似的.
结论:
- 在CBR和PFS方面,Palbociclib和ribociclib表现出类似的疗效.
- 两种治疗方法的毒性概况和整体生活质量是相似的.
- 这两种药物代表了ER+/HER2-转移性乳腺癌患者在激素治疗中进展的有效选择.
更多相关视频
13:38Synthesis and Characterization of an Aspirin-fumarate Prodrug that Inhibits NFκB Activity and Breast Cancer Stem Cells
Published on: January 18, 2017
12.2K
04:04Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
10.4K
相关概念视频
Clinical Trials
6.6K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.6K
Treatment Resistant Cancers
3.3K
Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
3.3K
Clinical Trials: Overview
2.9K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.9K
Cancer Survival Analysis
329
Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...
329
Bioequivalence: Overview
935
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
935
Targeted Cancer Therapies
7.5K
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against...
There are several types of targeted therapies against...
7.5K
