Protroca：一项关于聚乙二醇化重组人粒细胞刺激因子预防非选择性乳腺癌患者化疗引起的中性粒细胞减少症的非干预性研究。
Protroca: A Noninterventional Study on Prophylactic Lipegfilgrastim against Chemotherapy-Induced Neutropenia in Nonselected Breast Cancer Patients.
作者信息
Wuerstlein Rachel, Harbeck Nadia, Grischke Eva-Maria, Forstmeyer Dirk, von Schumann Raquel, Krabisch Petra, Lüdtke-Heckenkamp Kerstin, Stefek Andrea, Stoetzer Oliver, Grafe Andrea, Kaltenecker Gabriele, Forstbauer Helmut, Augustin Doris, Schrader Iris, Tio Joke, Nitz Ulrike, Gluz Oleg, Kates Ronald E, Graeser Monika Karla
机构信息
Breast Center and CCC Munich, Department of Obstetrics and Gynecology, University of Munich (LMU), Munich, Germany.
West German Study Group, Mönchengladbach, Germany.
出版信息
Breast Care (Basel). 2021 Feb;16(1):50-58. doi: 10.1159/000506622. Epub 2020 Apr 6.
BACKGROUND
Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy (CT).
PATIENTS AND METHODS
Of the 255 patients enrolled, 248 patients were evaluable for the intent-to-treat (ITT) and 194 patients for the per-protocol set. Primary and secondary end points after lipegfilgrastim treatment were assessed.
RESULTS
Nine patients of the ITT set receiving lipegfilgrastim as primary prophylaxis ( = 222) had febrile neutropenia of grade 3-4 (5 patients) or infection of grade 3-4 (4 patients); 1/26 of those receiving secondary prophylaxis had an event. Dose reductions were performed in 9.5% of the patients. Postponement of cancer CT cycles for >3 days occurred in <15% of patients; 10.8% (92/851 AEs) and 8% (2/25 SAEs) of documented adverse events and serious adverse events, respectively, were related to lipegfilgrastim.
CONCLUSIONS
Application of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.
背景
Protroca评估了聚乙二醇非格司亭（Lonquex®）对接受新辅助或辅助化疗（CT）的乳腺癌患者中性粒细胞减少症进行一级和二级预防的疗效和安全性。
患者与方法
在纳入的255例患者中，248例患者可进行意向性治疗（ITT）评估，194例患者可进行符合方案集评估。评估了聚乙二醇非格司亭治疗后的一级和二级终点。
结果
ITT组中，222例接受聚乙二醇非格司亭作为一级预防的患者中有9例发生3 - 4级发热性中性粒细胞减少（5例）或3 - 4级感染（4例）；接受二级预防的患者中26例有1例发生事件。9.5%的患者进行了剂量减少。<15%的患者癌症CT周期推迟超过3天；记录的不良事件和严重不良事件分别有10.8%（92/851例不良事件）和8%（2/25例严重不良事件）与聚乙二醇非格司亭有关。
结论
聚乙二醇非格司亭作为一级和二级预防措施，在预防乳腺癌CT诱导的中性粒细胞减少方面是有效的。
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