Department of Haematology and Oncology, University Hospital Mannheim, Heidelberg University, Mannheim, Germany.
Klinik für Innere Medizin II, Schwarzwald-Baar-Klinikum, Villingen-Schwenningen, Germany.
Acta Haematol. 2024;147(3):344-351. doi: 10.1159/000533666. Epub 2023 Oct 17.
Based on the new data from the primary analysis of the OPTIC (Optimizing Ponatinib Treatment in CP-CML) trial on dose optimization of ponatinib in patients with chronic phase (CP)-CML, the German consensus paper on ponatinib published in 2020 (Saussele S et al., Acta Haematol. 2020) has been updated in this addendum.
Focus is on the update of efficacy and safety of ponatinib, reflecting the new data set, as well as the update of the benefit-risk assessment and recommendations for ponatinib starting dose in CP-CML - provided that the decision to use ponatinib has already been made. Furthermore, based on OPTIC and additional empirical data, the expert panel collaborated to develop a decision tree for ponatinib dosing, specifically for intolerant and resistant patients. The recommendations on cardiovascular management have also been updated based on the most recent 2021 guidelines of the European Society of Cardiology (ESC) on cardiovascular disease prevention in clinical practice.
The OPTIC data confirm the high efficacy of ponatinib in patients with CP-CML and provide the basis for individualized dose adjustment during the course of treatment.
基于优化 Ponatinib 治疗 CP-CML 患者剂量的 OPTIC（Optimizing Ponatinib Treatment in CP-CML）试验的首次分析的新数据，2020 年发表的德国 Ponatinib 共识文件（Saussele S 等人，Acta Haematol. 2020）在本附录中进行了更新。
重点关注 Ponatinib 的疗效和安全性更新，反映了新数据集，以及 Ponatinib 在 CP-CML 起始剂量的获益-风险评估和建议的更新-前提是已决定使用 Ponatinib。此外，基于 OPTIC 和额外的经验数据，专家小组合作制定了 Ponatinib 剂量决策树，特别是针对不耐受和耐药患者。根据欧洲心脏病学会（ESC）关于临床实践中心血管疾病预防的 2021 年最新指南，心血管管理建议也进行了更新。
OPTIC 数据证实了 Ponatinib 在 CP-CML 患者中的高效性，并为治疗过程中的个体化剂量调整提供了依据。
