Department of Gastroenterology and Digestive Oncology, University Hospital of Saint Etienne, Saint Etienne, France.
Department of Thoracic Cancer, University Hospital of Lyon, Institut de Cancérologie des Hospices Civils de Lyon, Lyon 69002, France.
Cancer Treat Res Commun. 2023;35:100690. doi: 10.1016/j.ctarc.2023.100690. Epub 2023 Feb 10.
The objective of this study was to describe filgrastim biosimilar-Sandoz modalities of use in patients receiving cytotoxic chemotherapy regimens with a rest period of ≤14 days and to investigate the incidence of febrile neutropenia (FN) in routine clinical practice.
This was a French, multicenter, prospective and descriptive, non-interventional study including patients with breast, lung, gastrointestinal cancer or a lymphoma initiating filgrastim biosimilar-Sandoz treatment and in the context of cytotoxic chemotherapy with a rest period not exceeding 14 days. Data were collected during two routine clinical visits on the modalities of use of filgrastim biosimilar-Sandoz, on the incidence of neutropenia events and on adverse events.
Between November 2015 and June 2018, 1080 patients were enrolled in the study in 129 centers. Overall, 941 patients were evaluable for efficacy and 937 for safety. Of the 941 patients, 84.8% had a solid tumor and 15.2% had a lymphoid hemopathy. Filgrastim biosimilar-Sandoz was prescribed as primary prophylaxis in 74.0% of the patients and as secondary prophylaxis in 22.4% of the patients. FN was reported in 1.5% of patients with a solid tumor and 12.6% of patients with a lymphoma. A chemotherapy relative dose intensity of over 85% with regard to the reference dose was achieved by more than 80% of the patients in all tumor localizations.
The study showed that filgrastim biosimilar-Sandoz is safe to use and effective in preventing FN and in allowing to maintain the dose intensity of chemotherapy.
本研究旨在描述在接受≤14 天休息期的细胞毒性化疗方案的患者中使用非格司亭生物类似药-Sandoz 的方式，并调查常规临床实践中发热性中性粒细胞减少症（FN）的发生率。
这是一项法国、多中心、前瞻性和描述性、非干预性研究，纳入了起始使用非格司亭生物类似药-Sandoz 进行治疗的乳腺癌、肺癌、胃肠道癌或淋巴瘤患者，且细胞毒性化疗方案的休息期不超过 14 天。在两次常规临床访视中收集了非格司亭生物类似药-Sandoz 的使用方式、中性粒细胞减少症事件的发生率和不良事件的数据。
在 2015 年 11 月至 2018 年 6 月期间，该研究在 129 个中心纳入了 1080 例患者。共有 941 例患者可评估疗效，937 例患者可评估安全性。在这 941 例患者中，84.8%有实体瘤，15.2%有淋巴血液系统疾病。非格司亭生物类似药-Sandoz 被处方为一线预防的患者占 74.0%，二线预防的患者占 22.4%。有实体瘤的患者中有 1.5%报告了 FN，有淋巴瘤的患者中有 12.6%报告了 FN。所有肿瘤部位的患者中，超过 80%的患者达到了相对于参照剂量的化疗相对剂量强度超过 85%。
该研究表明，非格司亭生物类似药-Sandoz 安全且有效，可预防 FN，并允许维持化疗的剂量强度。
