First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: A multicenter, double-blind, placebo-controlled phase III study
First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: A multicenter, double-blind, placebo-controlled phase III study
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DOI：
10.1200/jco.2005.09.102
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发表时间：
2005-02-20
影响因子：
45.3
通讯作者：
Schwartzberg, LS
中科院分区：
文献类型：
--
作者：
Vogel, CL;Wojtukiewicz, MZ;Schwartzberg, LS
研究目的：我们评价培非格司亭降低乳腺癌患者多西他赛相关性发热性中性粒细胞减少发生率的疗效。患者和方法：患者随机分为安慰剂组和培非格司亭组，每21天为1个化疗周期，每周期100 mg/m2多西他赛，第2天皮下注射6 mg。主要终点是发生发热性中性粒细胞减少症（定义为发热当天或次日体温≥ 38.2 ℃，中性粒细胞计数< 0.5 × 10（9）/L）的患者百分比。次要终点是与发热性中性粒细胞减少症诊断相关的住院发生率、发热性中性粒细胞减少症所需的静脉（IV）抗感染药物以及按时维持计划化疗剂量的能力。发热性中性粒细胞减少患者在随后的cycles.Results开放标签培非格司亭928例接受安慰剂（n = 465）或培非格司亭（n = 463）。接受培非格司亭治疗的患者与接受安慰剂治疗的患者相比，发热性中性粒细胞减少症的发生率较低（分别为1%和17%; P
Purpose We evaluated the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia associated with docetaxel in breast cancer patients.Patients and Methods Patients were randomly assigned to either placebo or pegfilgrastim 6 mg subcutaneously on day 2 of each 21-day chemotherapy cycle of 100 mg/m(2) docetaxel. The primary end point was the percentage of patients developing febrile neutropenia (defined as body temperature greater than or equal to 38.2degreesC and neutrophil count < 0.5 x 10(9)/L on the same day of the fever or the day after). Secondary end points were incidence of hospitalizations associated with a diagnosis of febrile neutropenia, intravenous (IV) anti-infectives required for febrile neutropenia, and the ability to maintain planned chemotherapy dose on time. Patients with febrile neutropenia were converted to open-label pegfilgrastim in subsequent cycles.Results Nine hundred twenty-eight patients received placebo (n = 465) or pegfilgrastim (n = 463). Patients receiving pegfilgrastim, compared with patients receiving placebo, had a lower incidence of febrile neutropenia (1% v 17%, respectively; P