Australian experience with ibrutinib in patients with relapsed/refractory mantle cell lymphoma: a study from the Lymphoma and Related Diseases Registry.

IF 1.8 4区管理学 Q2 INDUSTRIAL RELATIONS & LABOR

Economic and Industrial Democracy Pub Date : 2023-03-01 Epub Date: 2022-12-21 DOI:10.1080/10428194.2022.2157676

Diva Baggio, Cameron Wellard, Eliza Chung, Dipti Talaulikar, Colm Keane, Stephen Opat, Pratyush Giri, Adrian Minson, Chan Yoon Cheah, Tasman Armytage, Denise Lee, Geoffrey Chong, Anna Johnston, Tara Cochrane, Neil Waters, Nada Hamad, Erica M Wood, Eliza A Hawkes

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Abstract

Bruton's tyrosine kinase inhibitors (BTKi) have an established role in the management of patients with relapsed/refractory mantle cell lymphoma (MCL). However, scant data exist on outcomes of patients ineligible for clinical trials testing these therapies. We describe a contemporary cohort of relapsed/refractory MCL patients from the Australasian Lymphoma and Related Diseases Registry treated with ibrutinib December 2014 until July 2018, to determine the proportion potentially eligible for original trials, reasons for ineligibility and survival outcomes. Of 44 patients, 41% met one or more exclusion criteria from previous phase II/III MCL BTKi studies. Median progression-free and overall survival were 13.7 months (95% CI 6.2-28.1) and 15.6 months (95% CI 10.8-29.6) respectively and were shorter in patients excluded from clinical trials based on ECOG ≥2. Ibrutinib has demonstrable clinical effectiveness in a population enriched for unfit and trial-ineligible patients, and a need for more inclusive enrollment criteria in future BTKi studies is highlighted.

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伊布替尼治疗复发/难治套细胞淋巴瘤患者的澳大利亚经验：淋巴瘤及相关疾病登记处的一项研究。

布鲁顿酪氨酸激酶抑制剂（BTKi）在复发/难治套细胞淋巴瘤（MCL）患者的治疗中发挥着重要作用。然而，关于不符合这些疗法临床试验条件的患者的疗效数据却很少。我们描述了澳大利亚淋巴瘤及相关疾病登记处（Australasian Lymphoma and Related Diseases Registry）2014年12月至2018年7月接受伊布替尼治疗的复发/难治性MCL患者的当代队列，以确定可能符合原始试验条件的比例、不符合条件的原因和生存结果。在44名患者中，41%符合之前II/III期MCL BTKi研究的一项或多项排除标准。无进展生存期和总生存期的中位数分别为13.7个月（95% CI 6.2-28.1）和15.6个月（95% CI 10.8-29.6），因ECOG≥2而被排除在临床试验之外的患者生存期更短。伊布替尼在不适合和不符合试验条件的患者群体中具有明显的临床疗效，因此需要在未来的BTKi研究中采用更具包容性的入组标准。

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来源期刊

Economic and Industrial Democracy INDUSTRIAL RELATIONS & LABOR-

CiteScore

4.10

自引率

13.30%

发文量

期刊介绍： Economic and Industrial Democracy is an international peer reviewed journal that focuses on the study of initiatives designed to enhance the quality of working life through extending the democratic control of workers over the workplace and the economy. How those initiatives are affected by wider political, economic and technological factors are also of interest. Special emphasis is laid on international coverage of empirical material, including discussions of the social and economic conditions in various countries.