[多药抢救治疗后用pegfilgrastim治疗复发/难治性淋巴瘤的门诊管理安全性和可行性:一项单中心、开放标签、非随机、前瞻性介入研究]。

Hiromi Iwasaki, Satoshi Yamasaki, Masanori Kadowaki, Mariko Minami, Tomoyuki Nukada, Ken Takase
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引用次数: 0

摘要

目的:我们试图评估日本复发/难治性淋巴瘤患者在补救性治疗后接受pegfilgrastim的门诊管理的安全性和可行性。方法:这是一项单中心、开放标签、非随机、前瞻性干预分析。患者完全住院进行第1周期化疗。符合门诊管理标准的患者(门诊组)随后入院进行化疗周期,每个周期结束后出院。住院组待白细胞、血小板计数改善后出院。Pegfilgrastim在每个化疗周期结束后2天皮下注射,单剂量3.6 mg。结果:门诊组门诊管理天数(主要终点)占68.2% ~ 75.0%,住院组门诊管理天数占28.6% ~ 50.0%。根据次要终点,在门诊期间没有因发热性中性粒细胞减少而住院。没有提出重大的安全问题。结论:对于复发/难治性淋巴瘤患者,对于满足门诊管理标准的患者,在门诊抢救治疗后给予pegfilgrastim是可行且安全的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Safety and feasibility of outpatient management in relapsed/refractory lymphoma treated with pegfilgrastim after multi-agent salvage therapy: a single-center, open-label, non-randomized, prospective interventional study].

Objective: We sought to assess the safety and feasibility of outpatient management in Japanese patients with relapsed/refractory lymphoma who had received pegfilgrastim after salvage therapy.

Method: This was a single-center, open-label, non-randomized, prospective interventional analysis. Patients were completely hospitalized for cycle 1 of chemotherapy. Those who met the outpatient management criteria (outpatient group) were subsequently admitted to the hospital for chemotherapy cycles but were discharged after each cycle was completed. The inpatient group was discharged when white blood cell and platelet counts improved. Pegfilgrastim was given as a single 3.6 mg dose by subcutaneous injection 2 days after the completion of each chemotherapy cycle.

Results: The percentage of outpatient management days (primary endpoint) ranged from 68.2%-75.0% in the outpatient group and 28.6%-50.0% in the inpatient group. According to the secondary endpoints, there were no hospitalizations due to febrile neutropenia during the outpatient period. There were no major safety concerns raised.

Conclusions: For patients with relapsed/refractory lymphoma, pegfilgrastim administration after salvage therapy in an outpatient setting was feasible and safe for those who satisfied the outpatient management criteria.

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