- 期刊
Clinical Response and the Safety of Bevacizumab-awwb Treatment in Patients with Metastatic Colorectal Cancer: A Case Series and Review of the Literature
轉移性大腸癌患者接受Bevacizumab-awwb治療的臨床反應與安全性：個案系列及文獻回顧
摘要
Background. Bevacizumab-awwb (MVASI®) is the first and only bevacizumab biosimilar to be made available in Taiwan. However, its extrapolation of indication and the lack of available real-world clinical data have raised some concern. This article is aimed at presenting our real-world experience in the use of MVASI for treating patients with metastatic colorectal cancer (mCRC) for purposes of evaluating tumor response and safety. Materials and Methods. Adult patients from a single institution initiating either MVASI or Avastin use following a mCRC diagnosis during the period of May 2020 to August 2021 were included in the study. Each patient's demographics and tumor characteristics were collated retrospectively. We have described treatment patterns and evaluated treatment efficacy stratified by initiating either or MVASI or Avastin in first line therapy and had at least six months of follow-up period. Results. In MVASI group, a total of 16 patients were identified, with 2 being excluded due to incomplete therapy and lost follow-up. The mean age of the subjects was 58.8 years. Most patients had a left-sided colorectal tumor (85.7%) and subsequently underwent a primary tumor resection (85.7%) prior to systemic antineoplastic therapy. The disease-control rate (DCR) was 85.7%. Only two patients (14.3%) encountered adverse events during therapy. In Avastin group, a total of 20 patients were identified with one being excluded due to lost follow-up. The mean age was 67.4 years. Thirteen patients had a left-sided colorectal tumor (68.4%) and seventeen patients (89.5%) underwent primary tumor resection before systemic therapy. The disease-control rate (DCR) was 73.7%. Conclusion. Our early experiences suggest the clinical adoption of bevacizumab- awwb (MVASI) has potential to serve as an alternative Avastin in treating mCRC patients. The strategy of switching between the biosimilar and reference product is currently controversial, and therefore further studies are still required.
並列摘要
目的：Bevacizumab-awwb（MVASI®）是第一個且目前唯一在台灣上市的bevacizumab生物相似藥。然而，其適應症的外推和缺乏現實世界的臨床數據引起了一些關注。本文旨在介紹我們使用MVASI治療轉移性結直腸癌（mCRC）患者方面的真實世界經驗，並以評估腫瘤反應和安全性。材料與方法：我們收錄2020年5月至2021年8月期間在單一機構診斷為mCRC後開始使用MVASI或Avastin的成年患者。回顧性收集每位患者的人口統計學和腫瘤特徵數據。我們描述了治療模式並根據首線治療中的MVASI或Avastin開始進行評估，並具有至少六個月的隨訪期。結果：在MVASI組中，共確定了16名患者，由於療程不完整和失去追蹤而排除了2名患者。被納入患者的平均年齡為58.8歲。大多數患者有左側結直腸腫瘤（85.7%），在全身抗腫瘤治療之前進行原發腫瘤切除手術（85.7%）。疾病控制率（DCR）為85.7%。在治療期間，只有兩名患者（14.3%）出現了不良事件。在Avastin組中，共確定了20名患者，其中一名因失去追蹤而被排除。平均年齡為67.4歲。十三名患者患有左側結直腸腫瘤（68.4%），十七名患者（89.5%）在全身治療之前接受了原發腫瘤切除手術。疾病控制率（DCR）為73.7%。結論：我們的早期經驗表明，Bevacizumab-awwb（MVASI）在治療mCRC患者中具有作為Avastin替代品的潛力。目前，生物相似藥和參考製劑之間切換的策略仍存在爭議，因此仍需要進一步研究。