Lijuan Deng, Yuqin Song, Keshu Zhou, Dengju Li, Jianda Hu, Dehui Zou, Sujun Gao, Haiyan Yang, Huilai Zhang, Jie Ji, Wei Xu, Ru Feng, Jie Jin, Fangfang Lv, Cheng Fang, Sheng Xu, Jun Zhu
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引用次数: 0
摘要
我们之前的研究表明，对于复发或难治性套细胞淋巴瘤（R/R MCL）患者，zanubrutinib比orelabrutinib有更好的无进展生存期（PFS）。在这里，我们进行了一项更新的分析，以间接比较扎鲁替尼和奥瑞布替尼在R/R MCL患者中的长期疗效。方法：对来自zanubrutinib研究的个体患者数据进行调整，以匹配orelabrutinib研究的患者群体概况。进行非锚定匹配调整间接比较（MAIC）来调整效果修饰因子和预后变量。疗效结果包括研究者评估的PFS、总生存期（OS）和总缓解率（ORR）。在orelabrutinib研究中，疗效评估仅为基于计算机断层扫描（CT）的评估，而在zanubrutinib研究中，正电子发射断层扫描（PET）和基于CT的评估都进行了评估。通过CT评估扎鲁替尼和奥瑞布替尼的PFS的比较是主要结果。结果：匹配后，zanubrutinib和orelabrutinib的基线特征达到平衡，在zanubrutinib研究中有效样本量为70。CT评估的PFS在zanubrutinib研究中比orelabrutinib研究中明显更长(未达到的中位PFS vs. 22.0个月；风险比[HR] 0.54, 95%可信区间[CI] 0.34-0.86；p = 0.009)。随着随访时间的延长，扎鲁替尼的OS继续呈有利趋势，24个月的OS率更高（83.7% vs. 74.3%）；无统计学差异(HR 0.68, 95% CI 0.36-1.27；p = 0.223)。在扎鲁替尼研究中，ORR数值更高(85.5% vs. 82.1%；优势比1.28,95% CI 0.56-2.94；p = 0.556)。结论：MAIC结果表明，扎鲁替尼治疗R/R型MCL患者的PFS明显长于奥瑞布替尼。
Indirect Comparisons of Efficacy of Zanubrutinib Versus Orelabrutinib in Patients with R/R MCL: An Extended Follow-up Analysis
Introduction
Our previous study has suggested a favorable progression-free survival (PFS) with zanubrutinib over orelabrutinib in patients with relapsed or refractory mantle cell lymphoma (R/R MCL). Here, we conducted an updated analysis to indirectly compare the long-term efficacy between zanubrutinib and orelabrutinib in patients with R/R MCL.
Methods
Individual patient data from the zanubrutinib study were adjusted to match the patient population profile of the orelabrutinib study. An unanchored matching-adjusted indirect comparison (MAIC) was performed to adjust for effect modifiers and prognostic variables. The efficacy outcomes included investigator-assessed PFS, overall survival (OS), and overall response rate (ORR). Response evaluations were only computed tomography (CT)-based assessments in the orelabrutinib study, while positron emission tomography (PET)- and CT-based assessment were both performed in the zanubrutinib study. The comparison of PFS assessed by CT between zanubrutinib and orelabrutinib was the primary result.
Results
After matching, the baseline characteristics were balanced between zanubrutinib and orelabrutinib, with an effective sample size of 70 in the zanubrutinib study. PFS assessed by CT was significantly longer in the zanubrutinib study vs. the orelabrutinib study (median PFS, not reached vs. 22.0 months; hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.34–0.86; P = 0.009). With longer follow-up, OS continued to trend favorably for zanubrutinib, with OS rate at 24 months numerically higher (83.7% vs. 74.3%); no statistical difference was observed (HR 0.68, 95% CI 0.36–1.27; P = 0.223). ORR was numerically higher in the zanubrutinib study (85.5% vs. 82.1%; odds ratio 1.28, 95% CI 0.56–2.94; P = 0.556).
Conclusion
MAIC results demonstrated that zanubrutinib had significantly longer PFS compared with orelabrutinib in the treatment of patients with R/R MCL.
期刊介绍：
Advances in 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 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. Advances in 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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