Fruehauf Stefan, Otremba Burkhard, Stötzer Oliver, Rudolph Christine
Klinik Dr. Hancken, Hämatologie, Onkologie und Palliativmedizin, Stade, Germany.
Onkologische Praxis Oldenburg/Delmenhorst, Standort Oldenburg, Oldenburg, Germany.
Adv Ther. 2016 Nov;33(11):1983-2000. doi: 10.1007/s12325-016-0419-1. Epub 2016 Oct 14.
Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy. Biosimilar filgrastim (Nivestim™, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The primary goal of this VENICE study (ClinicalTrials.gov identifier, NCT01627990) was to observe the tolerability, safety and efficacy of biosimilar filgrastim in patients receiving cancer chemotherapy.
This was a prospective, multicenter, non-interventional, longitudinal study. Consenting adult patients with solid tumors or hematologic malignancies for whom cytotoxic chemotherapy and treatment with biosimilar filgrastim was planned were enrolled.
Among the enrolled patients (N = 386), 81% were female, with a median age (range) of 61 (22-92) years, with 39% >65 years old. Most patients (n = 338; 88%) had solid tumors and the remainder (n = 49; 13%) had hematological malignancies. The majority of the patients (64%) received biosimilar filgrastim as primary prophylaxis and 36% as secondary prophylaxis. At the follow-up visits, for the majority of patients (95.6%) there had been no change in chemotherapy dose due to FN. For two patients (0.5%) the chemotherapy was discontinued due to FN and for four patients (1.0%) the chemotherapy dose was reduced due to FN. For the majority of patients (96.9%) the chemotherapy cycle following the first biosimilar filgrastim treatment was not delayed due to FN. For 3 patients (0.8%), the chemotherapy was delayed following the first biosimilar filgrastim treatment. Less than one-third (29.8%) of the patients experienced ≥1 adverse event that was at least potentially related to biosimilar filgrastim treatment.
Biosimilar filgrastim was effective and well-tolerated in both the primary and secondary prophylactic setting in patients undergoing chemotherapy for solid tumors and hematological malignancies.
ClinicalTrials.gov identifier, NCT01627990.
Hospira Inc, A Pfizer Company, Lake Forest, IL, USA.
发热性中性粒细胞减少症（FN）是细胞毒性化疗常见的严重并发症。生物类似药非格司亭（Nivestim™，辉瑞公司旗下的美国伊利诺伊州湖林市 Hospira 公司生产）是一种粒细胞集落刺激因子，被批准用于治疗骨髓抑制性化疗引起的中性粒细胞减少症和 FN。这项 VENICE 研究（ClinicalTrials.gov 标识符：NCT01627990）的主要目的是观察生物类似药非格司亭在接受癌症化疗患者中的耐受性、安全性和疗效。
这是一项前瞻性、多中心、非干预性纵向研究。纳入了计划接受细胞毒性化疗和生物类似药非格司亭治疗的成年实体瘤或血液系统恶性肿瘤患者。
在纳入的患者（N = 386）中，81%为女性，中位年龄（范围）为 61（22 - 92）岁，39%的患者年龄大于 65 岁。大多数患者（n = 338；88%）患有实体瘤，其余患者（n = 49；13%）患有血液系统恶性肿瘤。大多数患者（64%）接受生物类似药非格司亭作为一级预防，36%作为二级预防。在随访中，大多数患者（95.6%）因 FN 导致化疗剂量未改变。2 例患者（0.5%）因 FN 停止化疗，4 例患者（1.0%）因 FN 减少化疗剂量。大多数患者（96.9%）首次使用生物类似药非格司亭治疗后的化疗周期未因 FN 而延迟。3 例患者（0.8%）首次使用生物类似药非格司亭治疗后化疗延迟。不到三分之一（29.8%）的患者发生了至少 1 次至少可能与生物类似药非格司亭治疗相关的不良事件。
生物类似药非格司亭在实体瘤和血液系统恶性肿瘤化疗患者的一级和二级预防中均有效且耐受性良好。
ClinicalTrials.gov 标识符：NCT01627990。
辉瑞公司旗下的美国伊利诺伊州湖林市 Hospira 公司。
