Combined Department of Medical Oncology, Gaeta Hospital M. Di Liegro, Lazio Local Health Authority, Gaeta, Italy.
Future Oncol. 2012 May;8(5):625-30. doi: 10.2217/fon.12.32. Epub 2012 Mar 8.
A biosimilar medicine is one with proven similarity to a reference biological product for which the patent has expired and whose active ingredient is produced or derived from a living organism. Recombinant granulocyte colony-stimulating growth factors (G-CSF) are used for the prophylaxis of febrile neutropenia.
MATERIALS & METHODS: In this observational, single-center study, a total of 48 patients with solid tumors were treated with a new biosimilar G-CSF (Zarzio(®)) for 4-14 days from the day following the end of chemotherapy.
Between October 2010 and July 2011, biosimilar G-CSF was administered as primary prophylaxis in 37 patients and as secondary prophylaxis in 11 patients in our clinic. The median length of G-CSF administration was 7 days (range: 1-12 days). Three cases of febrile neutropenia were reported: two in patients with prostate adenocarcinoma and one in a patient with pulmonary squamous cell carcinoma and multiple secondary skeletal lesions. These patients were treated with antibiotics and improved within 24 h without the need for hospitalization. Nonfebrile grade 4 neutropenia was observed in a further six patients.
Our experience indicates that the use of biosimilar G-CSF is safe and effective at reducing neutropenic complications in patients with solid tumors and may be associated with cost savings.
生物类似药是一种与已过专利期的参比生物制品具有相似性的药物,其活性成分是由生物体生产或衍生而来。重组粒细胞集落刺激因子(G-CSF)用于预防发热性中性粒细胞减少症。
在这项观察性、单中心研究中,共有 48 例实体瘤患者在化疗结束后的第 1 天至第 14 天期间使用新的生物类似 G-CSF(Zarzio(®))治疗,为期 4-14 天。
2010 年 10 月至 2011 年 7 月,我们诊所将生物类似 G-CSF 作为一线预防药物用于 37 例患者,作为二线预防药物用于 11 例患者。G-CSF 的中位给药时间为 7 天(范围:1-12 天)。报告了 3 例发热性中性粒细胞减少症:2 例前列腺腺癌患者,1 例肺鳞状细胞癌和多发性继发性骨骼病变患者。这些患者接受了抗生素治疗,在 24 小时内得到改善,无需住院治疗。另外 6 例患者出现非发热性 4 级中性粒细胞减少症。
我们的经验表明,使用生物类似 G-CSF 可安全有效地降低实体瘤患者中性粒细胞减少症并发症的发生率,并且可能与节省成本有关。