Hospital Sírio-Libanês, Oncology Center, Rua Dona Adma Jafet, 91 - Bela Vista, São Paulo - SP, 01308-050, Brazil.
Future Oncol. 2020 Nov;16(32):2595-2609. doi: 10.2217/fon-2020-0219. Epub 2020 Jul 31.
Trastuzumab emtansine (T-DM1), given postoperatively for 14 cycles to patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer (EBC) who failed to achieve a pathological complete response after standard chemotherapy and HER2 blockade, represents probably the greatest progress in the management of this aggressive form of breast cancer since the adjuvant trastuzumab pivotal trials. This article addresses the rationale behind the conception of the KATHERINE trial, T-DM1's structure and pharmacokinetics data, clinical efficacy data of the KATHERINE trial and of other EBC trials with T-DM1, safety aspects, implications of the KATHERINE trial results to clinical practice and future perspectives in the management of HER2-positive EBC.
曲妥珠单抗-美坦新偶联物（T-DM1），在标准化疗和曲妥珠单抗靶向治疗后未能达到病理完全缓解的人表皮生长因子受体 2 阳性（HER2 阳性）早期乳腺癌（EBC）患者术后给予 14 个周期治疗，这可能是自辅助曲妥珠单抗关键试验以来在管理这种侵袭性乳腺癌方面取得的最大进展。本文介绍了 KATHERINE 试验构思背后的原理、T-DM1 的结构和药代动力学数据、KATHERINE 试验和其他使用 T-DM1 的 EBC 试验的临床疗效数据、安全性方面、KATHERINE 试验结果对临床实践的影响以及 HER2 阳性 EBC 管理的未来展望。
