Bijal Shah, Swetha Challagulla, Sheng Xu, Rhys Williams, Shijie Ren, Tushar Srivastava, Raju Gautam, Keri Yang, Nakhle S Saba, Constantine S Tam
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引用次数: 0
摘要
Zanubrutinib和acalabrutinib在单独的单臂临床试验中显示出对复发/难治性(R/R)套细胞淋巴瘤(MCL)患者的疗效。鉴于这些单臂试验缺乏共同的比较物,采用模拟治疗比较(STC)方法进行非锚定间接治疗比较,以评估zanubrutinib与acalabrutinib的比较疗效。在基本病例分析(针对所有协变量进行调整)中,与阿卡拉布替尼相比,扎鲁替尼治疗与显著改善的无进展生存(风险比[HR], 0.57[95%可信区间[CI], 0.35-0.94]; p = 0.0272)和总生存(HR, 0.43 [95% CI, 0.23-0.82], p = 0.0105)相关。zanubrutinib的总有效率高于acalabrutinib(比值比[OR], 2.05 [95% CI, 0.72-5.84]; p = 0.1798)。敏感性分析,包括协变量子集,提供了一致的结果。在没有正面试验的情况下,这些结果为扎鲁替尼和阿卡拉布替尼在治疗R/R MCL患者方面的比较疗效提供了重要的见解。
Zanubrutinib versus acalabrutinib indirect treatment comparison in relapsed or refractory mantle cell lymphoma.
Zanubrutinib and acalabrutinib have demonstrated efficacy in separate single-arm clinical trials in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL). Given these single-arm trials lacked a common comparator, an unanchored indirect treatment comparison was conducted to assess the comparative efficacy of zanubrutinib versus acalabrutinib using a simulated treatment comparison (STC) method. In the base case analysis (adjusted for all covariates), zanubrutinib treatment was associated with significantly improved progression-free survival (hazard ratio [HR], 0.57 [95% confidence interval [CI], 0.35-0.94]; p = 0.0272) and overall survival (HR, 0.43 [95% CI, 0.23-0.82]; p = 0.0105) versus acalabrutinib. Overall response rate was numerically higher with zanubrutinib versus acalabrutinib (odds ratio [OR], 2.05 [95% CI, 0.72-5.84]; p = 0.1798). Sensitivity analyses, including a subset of covariates, provided consistent results. In the absence of a head-to-head trial, these results provide important insights into the comparative efficacy of zanubrutinib and acalabrutinib for physicians managing patients with R/R MCL.
期刊介绍:
Leukemia & Lymphoma in its fourth decade continues to provide an international forum for publication of high quality clinical, translational, and basic science research, and original observations relating to all aspects of hematological malignancies. The scope ranges from clinical and clinico-pathological investigations to fundamental research in disease biology, mechanisms of action of novel agents, development of combination chemotherapy, pharmacology and pharmacogenomics as well as ethics and epidemiology. Submissions of unique clinical observations or confirmatory studies are considered and published as Letters to the Editor