Rauthan Amit, Jain Ankita, Singh Manmohan, Sendur Mehmet A N
Department of Medical Oncology, Manipal Hospital, Bengaluru, India.
Medical Affairs Oncology and Field Medical Excellence, Regional Medical Affairs, Pfizer Healthcare India Private Limited, The Capital, 1802/1901, Plot No. C-70, G-Block, Bandra Kurla Complex, Bandra (E), Mumbai, 400 051, India.
Oncol Ther. 2024 Sep;12(3):395-418. doi: 10.1007/s40487-024-00295-2. Epub 2024 Aug 2.
Limited awareness exists regarding real-world data (RWD) for palbociclib in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced/metastatic breast cancer in populations from certain countries outside of Western regions.
A systematic scoping review was conducted using PubMed and Embase to evaluate RWD for palbociclib from countries outside of Western regions that are underrepresented in clinical trials. Search criteria were aligned with our research question for relevant English-language publications, without restrictions on publication date, followed by Phase 1 (title and abstract) and Phase 2 (full-text) screening of retrieved citations as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data analyses of eligible studies were done separately for abstracts and full-text publications to enhance the precision and reliability of the results.
Database search yielded 1485 non-duplicate records, 46 qualified for inclusion, of which 47.8% were published as full text. The analysis of outcomes, based exclusively on full-text publications that collectively included 2048 patients treated with palbociclib, revealed the median progression-free survival (PFS) of 20.2-36.7 months, overall survival (OS) of 39.9 months (reported in one publication) and objective response rate (ORR) of 45.3-80.0% with first-line treatment. In ≥ second line, the median PFS, OS and ORR ranged from 7.0 to 24.2 months, 11 to 19.6 months, and 13.9% to 47.9%, respectively. The safety profile of palbociclib was similar to that reported in pivotal clinical studies, and no new safety concerns were identified.
A comprehensive volume of evidence demonstrates that palbociclib's effectiveness and safety profile in real-world settings align with those observed in clinical trials, offering valuable insights for clinical decision-making in countries outside of Western regions underrepresented in clinical trials.
在西部地区以外某些国家的人群中，对于激素受体阳性、人表皮生长因子受体2阴性的晚期/转移性乳腺癌患者使用哌柏西利的真实世界数据（RWD），人们了解有限。
利用PubMed和Embase进行系统的范围综述，以评估来自临床试验中代表性不足的西部地区以外国家的哌柏西利真实世界数据。检索标准与我们针对相关英文出版物的研究问题一致，对出版日期无限制，随后按照系统评价和Meta分析的首选报告项目（PRISMA）指南对检索到的文献进行第一阶段（标题和摘要）和第二阶段（全文）筛选。对符合条件的研究分别进行摘要和全文出版物的数据分析，以提高结果的准确性和可靠性。
数据库检索产生1485条非重复记录，46条符合纳入标准，其中47.8%以全文形式发表。仅基于总共纳入2048例接受哌柏西利治疗患者的全文出版物进行的结局分析显示，一线治疗的中位无进展生存期（PFS）为20.2 - 36.7个月，总生存期（OS）为39.9个月（一篇出版物中报告），客观缓解率（ORR）为45.3% - 80.0%。在二线及以上治疗中，中位PFS、OS和ORR分别为7.0至24.2个月、11至19.6个月和13.9%至47.9%。哌柏西利的安全性与关键临床研究中报告的相似，未发现新的安全问题。
大量证据表明，哌柏西利在真实世界环境中的有效性和安全性与临床试验中观察到的一致，为临床试验中代表性不足的西部地区以外国家的临床决策提供了有价值的见解。
