贝叶斯框架中的多个真实世界数据源，为Mosunetuzumab在毛囊淋巴瘤患者中的长期生存估计提供信息。
IF 3.2
Q2 ONCOLOGY
引用次数: 0
摘要
简介：接受三线或更晚（3L）治疗的滤泡性淋巴瘤（FL）患者 +) 治疗的生存期很长，这使得从试验数据中估计长期总生存期（OS）具有挑战性。本研究的目的是在贝叶斯框架中使用多个真实世界数据库（RWD）来估计GO29781试验（NCT02500407）中莫舒妥珠单抗的长期OS。方法：接受3L治疗的FL患者的七种RWD来源 + 使用莫舒妥珠单抗GO29781试验中的治疗和扩展队列。分析了RWD来源的危害趋势，并使用RWD来源中的贝叶斯随机效应荟萃分析估计了疾病范围内的逐点OS及其相应的不确定性。获得的Pointwise OS被用作贝叶斯生存推断中的信息先验，以推断接受莫舒妥单抗治疗的患者的数据。将调整背景死亡率后的结果与仅使用试验数据的等效频率学家推断进行比较。结果：RWD源的危害模式支持恒定或线性下降的危害。FL患者接受3L治疗的平均点OS + 治疗8年时估计为0.52（95%可信区间，0.29-0.85）。mosunetuzumab的贝叶斯外推产生了11.6（6.7-20.7）年至17.0（6.4-22.7）年的中位生存估计，这取决于所使用的分布，相对于频率学家的估计，将不确定性降低了20%至46%。结论：可以综合多个RWD来源，以提高数据的可信度，随访时间短，患者生存期长，事件少，从而有效估计长期生存率，减少估计的不确定性。该方法可应用于具有类似特征的其他适应症。临床试验注册号和注册日期：NCT025004072015年7月16日。本文章由计算机程序翻译，如有差异，请以英文原文为准。
Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma.
Introduction: Patients with follicular lymphoma (FL) receiving third-line or later (3L +) therapy have long survival, which can make estimating long-term overall survival (OS) from trial data challenging. The objective of this study was to estimate long-term OS for mosunetuzumab from the GO29781 trial (NCT02500407) using multiple real-world databases (RWDs) in a Bayesian framework.
Methods: Seven RWD sources for patients with FL receiving 3L + therapy and the expansion cohort in the GO29781 trial for mosunetuzumab were used. Hazard trends from the RWD sources were analyzed, and disease-wide pointwise OS and its corresponding uncertainty were estimated using Bayesian random-effects meta-analysis from the RWD sources. Pointwise OS obtained was used as an informative prior in Bayesian survival extrapolations to data from patients receiving mosunetuzumab. Results after adjusting for background mortality were compared to equivalent frequentist extrapolations using trial data only.
Results: Hazard patterns from RWD sources supported a constant or linearly decreasing hazard. Mean pointwise OS for patients with FL receiving 3L + therapy was estimated at 0.52 (95% credible interval, 0.29-0.85) at 8 years. Bayesian extrapolations for mosunetuzumab produced median survival estimates of 11.6 (6.7-20.7) years to 17.0 (6.4-22.7) years depending on the distribution used, reducing uncertainty by 20% to 46% relative to the frequentist estimation.
Conclusion: Multiple RWD sources can be synthesized to augment the credibility of data with short follow-up, long patient survival, and few events to effectively estimate long-term survival and reduce estimated uncertainty. This method can be applied to other indications with similar characteristics.
Clinical trial registration number and date of registration: NCT02500407, July 16, 2015.
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来源期刊
Oncology and Therapy
ONCOLOGY-
CiteScore
3.40
自引率
0.00%
发文量
31
审稿时长
6 weeks
期刊介绍：
Now indexed in PubMed
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Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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