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Ann Hematol. 2020 Aug;99(8):1771-1778. doi: 10.1007/s00277-020-04159-3. Epub 2020 Jun 29.
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Blood. 2017 Oct 19;130(16):1800-1808. doi: 10.1182/blood-2017-03-769620. Epub 2017 Aug 3.
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依维莫司联合苯达莫司汀治疗复发/难治性淋巴血液系统恶性肿瘤的 I 期研究。

A Phase I Study of Everolimus and Bendamustine in Patients With Relapsed/Refractory Lymphoid Hematologic Malignancies.

机构信息

Division of Hematology/Oncology, Department of Internal Medicine, University of California Davis Comprehensive Cancer Center, Sacramento, CA.

Ridley-Tree Cancer Center, Santa Barbara, CA.

出版信息

Clin Lymphoma Myeloma Leuk. 2020 Jul;20(7):453-458. doi: 10.1016/j.clml.2020.02.006. Epub 2020 Feb 20.

DOI:10.1016/j.clml.2020.02.006
PMID:32171691
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8530379/
Abstract

INTRODUCTION

Everolimus and bendamustine both have single-agent activity against lymphoid hematologic malignancies. We examined this combination in a group of heavily pretreated patients with non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), and multiple myeloma (MM).

PATIENTS AND METHODS

In this phase I trial, 18 patients (8 with NHL, 6 with MM, and 4 with HL) were treated with bendamustine 90 mg/m on days 1 and 2 and everolimus from 5 to 10 mg daily on a 28-day cycle, for up to 4 cycles.

RESULTS

Adverse events were generally mild and mostly hematologic in nature. The most frequent grade 3/4 adverse events were lymphopenia (61%), thrombocytopenia (22%), leukopenia (22%), neutropenia (17%), and fatigue (17%). Overall response rate varied by malignancy: diffuse large B-cell lymphoma, 20% (1 of 5 patients); HL (2 of 4 patients), 50%; MM, 80% (4 of 5 patients); and indolent lymphomas, 100% (3 of 3 patients). The maximum tolerated dose of everolimus was determined to be 7.5 mg daily.

CONCLUSION

The combination of everolimus and bendamustine appeared to be well-tolerated and relatively efficacious.

摘要

简介

依维莫司和苯达莫司汀均对淋巴血液恶性肿瘤具有单药活性。我们在一组曾接受过多线治疗的非霍奇金淋巴瘤(NHL)、霍奇金淋巴瘤(HL)和多发性骨髓瘤(MM)患者中研究了该联合用药方案。

患者和方法

在这项 I 期试验中,18 名患者(8 名 NHL、6 名 MM 和 4 名 HL)接受苯达莫司汀 90 mg/m2 治疗,于第 1 和第 2 天给药,依维莫司每天 5 至 10 mg,28 天为一个周期,最多进行 4 个周期。

结果

不良事件通常较轻,主要为血液学毒性。最常见的 3/4 级不良事件是淋巴细胞减少症(61%)、血小板减少症(22%)、白细胞减少症(22%)、中性粒细胞减少症(17%)和疲劳(17%)。根据恶性肿瘤的不同,总缓解率也有所不同:弥漫性大 B 细胞淋巴瘤为 20%(5 例患者中 1 例);HL 为 50%(4 例患者中 2 例);MM 为 80%(5 例患者中 4 例);惰性淋巴瘤为 100%(3 例患者中 3 例)。依维莫司的最大耐受剂量确定为每天 7.5 mg。

结论

依维莫司和苯达莫司汀联合用药方案耐受性良好,疗效相对较好。