奥妥珠单抗与miniCHOP方案用于不适宜接受常规治疗的弥漫性大B细胞淋巴瘤患者。意大利淋巴瘤基金会开展的一项II期研究。
Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi.
作者信息
Merli Francesco, Cavallo Federica, Salvi Flavia, Tucci Alessandra, Musuraca Gerardo, Nassi Luca, Merli Michele, Tani Monica, Gini Guido, Ferrari Angela, Molinari Anna Lia, Liberati Anna Marina, Conconi Annarita, Matteucci Paola, Bari Alessia, Scalone Renato, Ferrero Simone, Zanni Manuela, Mammi Caterina, Luminari Stefano
机构信息
Hematology Unit, Arcispedale S.Maria Nuova, Azienda Unità Sanitaria Locale - IRCCS, Reggio Emilia, Italy.
Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino/AOU "Città della Salute e della Scienza di Torino", Torino, Italy.
出版信息
J Geriatr Oncol. 2020 Jan;11(1):37-40. doi: 10.1016/j.jgo.2019.06.020. Epub 2019 Jul 8.
OBJECTIVE
To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy.
MATERIALS AND METHODS
We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA).
RESULTS
Overall, 34 patients were enrolled (median age 82 years; range 68-89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3-4 adverse event was neutropenia in thirteen patients (26%).
CONCLUSIONS
Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL.
目的
评估奥妥珠单抗-小剂量CHOP方案（Ga101-小剂量CHOP）用于不适合接受全剂量免疫化疗的老年弥漫性大B细胞淋巴瘤（DLBCL）患者的活性及安全性。
材料与方法
我们开展了一项西蒙两阶段II期多中心试验，以研究Ga101-小剂量CHOP方案六个疗程用于老年DLBCL患者（≥65岁）的缓解率（主要终点）及安全性，根据简化综合老年评估（sCGA）前瞻性地定义为不适合接受全剂量免疫化疗。
结果
总体上，共纳入34例患者（中位年龄82岁；范围68 - 89岁），33例符合条件的患者中有27例完成了所有六个计划疗程。14例患者（42%）报告达到完全缓解（CR）。中位随访16个月后，两年无进展生存率和总生存率（PFS和OS）分别为49%（95%置信区间（CI），28%至67%）和68%（95% CI，49%至81%）。最常见的3 - 4级不良事件是13例患者（26%）出现的中性粒细胞减少。
结论
基于观察到的CR率，由于证明Ga101-小剂量CHOP方案可改善该组患者采用R-小剂量CHOP方案获得的历史数据这一初始研究假设的可能性非常低，研究入组被中断。尽管如此，33例接受治疗患者所取得的结果证实了Ga101-小剂量CHOP方案对于不适合接受全剂量免疫化疗的老年DLBCL成年患者具有活性且耐受性良好。
Zotero 插件