早期乳腺癌的初级预防：真实世界经验。
Primary Prophylaxis Lapelga in Early Breast Cancer: A Real-World Experience.
机构信息
Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON N6A 5C1, Canada.
Department of Oncology, London Regional Cancer Program, London Health Sciences Centre, London, ON N6A 5W9, Canada.
出版信息
Curr Oncol. 2023 Mar 9;30(3):3217-3222. doi: 10.3390/curroncol30030244.
BACKGROUND
Lapelga was approved by Health Canada as a pegfilgrastim biosimilar in 2019 and remains the most commonly used biosimilar in Ontario and is fully reimbursed under the Ontario Drug Benefit program in this category. We explored the efficacy and tolerability of Lapelga in a retrospective analysis of patients with early breast cancer who underwent adjuvant chemotherapy supported with Lapelga as a primary prophylaxis.
METHODS
Adult patients with early breast cancer treated with adjuvant chemotherapy at the London Regional Cancer Program in London, ON, Canada between May 2019 and June 2022 were included. All of these patients were supported with Lapelga as the primary prophylaxis. Patients' age, tumour, and nodal status, their type of chemotherapy, co-morbid conditions, and incidence of febrile neutropenia (FN) and its related details as well as any reported side effects to Lapelga were collected.
RESULTS
A total of 201 patients were included in this review with majority (78%) of patients under 65 years of age. One third of patients were treated with the adriamycin and cyclophosphamide (AC)-Paclitaxel dose dense chemotherapy and a quarter of patients with either a docetaxel and cyclophosphamide (TC) combination or an AC-dose dense with Paclitaxel weekly, and 10% or less patients had FEC-D (5-fluorouracil, epirubicin, and cyclophosphamide) and AC chemotherapy. FN incidence was only 3.48% in this review (7/201 patients). Patients with FN were admitted to hospital and recovered completely with no mortality reported. No cases of a switch to a different granulocyte colony growth factor were seen. The most frequent side effects from Lapelga included musculoskeletal pain, fever, and headache. However, the majority of patients (88.6%; 178/201) did not have any reported side effects specifically assigned to Lapelga.
CONCLUSIONS
In this single centre retrospective study, early breast cancer patients (n = 201) treated with adjuvant chemotherapy supported with primary prophylaxis with Lapelga had a low incidence of FN (3.48%). This supports Lapelga being an effective strategy as the primary prophylaxis when used with common chemotherapy regimens in the real-world setting.
背景
Lapelga 于 2019 年获得加拿大卫生部批准为培非格司亭生物类似药，是安大略省最常用的生物类似药，在该类别下完全纳入安大略省药物福利计划报销。我们对接受 Lapelga 作为一线预防的早期乳腺癌患者进行了回顾性分析，探讨了 Lapelga 的疗效和耐受性。
方法
纳入 2019 年 5 月至 2022 年 6 月在加拿大安大略省伦敦伦敦地区癌症项目接受辅助化疗的早期乳腺癌成年患者。所有这些患者均接受 Lapelga 作为一线预防。收集了患者的年龄、肿瘤和淋巴结状态、化疗类型、合并症、发热性中性粒细胞减少症（FN）的发生率及其相关细节以及报告的任何 Lapelga 相关副作用。
结果
共有 201 例患者纳入本回顾性研究，其中大多数（78%）患者年龄在 65 岁以下。三分之一的患者接受阿霉素和环磷酰胺（AC）紫杉醇密集化疗，四分之一的患者接受多西他赛和环磷酰胺（TC）联合化疗或 AC 密集化疗联合紫杉醇每周一次，不到 10%的患者接受 FEC-D（氟尿嘧啶、表柔比星和环磷酰胺）和 AC 化疗。本研究 FN 发生率仅为 3.48%（7/201 例）。FN 患者住院并完全康复，无死亡报告。没有看到改用其他粒细胞集落生长因子的情况。Lapelga 最常见的副作用包括肌肉骨骼疼痛、发热和头痛。然而，大多数患者（88.6%；178/201）没有报告任何专门分配给 Lapelga 的副作用。
结论
在这项单中心回顾性研究中，接受辅助化疗并接受 Lapelga 一线预防的早期乳腺癌患者（n=201）FN 发生率较低（3.48%）。这支持在真实环境中使用常见化疗方案时，Lapelga 作为一线预防是一种有效的策略。
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