首页> 外文期刊>BMC Cancer >Febrile neutropenia (FN) occurrence outside of clinical trials: occurrence and predictive factors in adult patients treated with chemotherapy and an expected moderate FN risk. Rationale and design of a real-world prospective, observational, multinational study
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Febrile neutropenia (FN) occurrence outside of clinical trials: occurrence and predictive factors in adult patients treated with chemotherapy and an expected moderate FN risk. Rationale and design of a real-world prospective, observational, multinational study

机译:发热中性粒细胞减少症(FN)发生在临床试验之外:化疗治疗的成人患者的发生和预测因素及预期的温和性FN风险。真实世界前瞻性,观测,跨国研究的理由与设计

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摘要

Febrile neutropenia (FN) is a common occurrence during chemotherapy. Granulocyte colony-stimulating factors (G-CSFs) can significantly reduce the risk of FN. International guidelines recommend G-CSF for patients receiving chemotherapy with FN risk of ≥20% or 10% to 20% with defined risk factors. Prophylaxis is not typically recommended for FN risk of ?18?years of age) will have a solid tumour or Hodgkin/non-Hodgkin lymphoma and a planned chemotherapy regimen with expected risk of FN of 10% to 20% (according to published guidelines). Patients will be observed for the duration of the chemotherapy line (first cycle administered without FN prophylaxis). Primary endpoint is incidence of FN after the first chemotherapy cycle. Secondary outcomes include: FN-associated morbidity and mortality; time to first FN occurrence; other FN risk factors and impact of FN on quality of life. A risk model using occurrence of FN as a binary outcome will be developed. Data will be stratified by age, comorbidities and other risk factors. This study will provide insight into the real FN risk for common chemotherapy regimens and predictive factors for FN, including patients generally excluded from randomised clinical trials, from which reported FN rates have been variable. This study builds on knowledge of predictive factors from other research and will provide information on patients with 10% to 20% FN risk.
机译:发热中性粒细胞贫症(FN)是化疗期间的常见发生。粒细胞菌落刺激因子(G-CSFS)可以显着降低FN的风险。国际指南推荐G-CSF用于接受化疗的患者,患有FN的风险≥20%或10%至20%,具有定义的风险因素。预防性通常不推荐用于FN?18年龄的FN风险)将具有实体肿瘤或霍奇金/非霍奇金淋巴瘤和计划化疗方案,预期风险为10%至20%(根据已发表的指南) 。将在化疗线的持续时间观察患者(没有FN预防施用的第一循环)。初级终点是第一次化疗循环后FN的发生率。二次结果包括:FN相关的发病率和死亡率;是第一次FN发生的时间;其他FN风险因素和FN对生活质量的影响。将开发使用FN作为二进制结果的发生的风险模型。数据将按年龄,合并症和其他危险因素分层。本研究将对普通化疗方案的真正FN风险提供了解,并包括FN的预测因素,包括通常被从随机临床试验中排除的患者,从中报告的FN率已经变化。本研究建立了对来自其他研究的预测因素的知识,并将提供有关10%至20%风险的患者的信息。

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