BACKGROUND 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. SUMMARY 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 (CVD) prevention in clinical practice. KEY MESSAGES 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.

中文翻译：

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关于帕纳替尼治疗慢性粒细胞白血病的德国共识建议附录。

背景 基于 OPTIC（CP-CML 优化帕纳替尼治疗）试验对慢性期（CP）-CML 患者帕纳替尼剂量优化的初步分析的新数据，2020 年发表的德国帕纳替尼共识文件（Saussele） S 等人，Acta Haematol. 2020）已在本附录中更新。摘要 重点是更新 ponatinib 的疗效和安全性，反映新的数据集，以及更新 CP-CML 中 ponatinib 起始剂量的获益-风险评估和建议 - 前提是已经决定使用 ponatinib被做了。此外，根据 OPTIC 和其他经验数据，专家小组合作开发了 ponatinib 剂量决策树，特别是针对不耐受和耐药患者。心血管管理建议也根据欧洲心脏病学会 (ESC) 最新的 2021 年临床实践心血管疾病 (CVD) 预防指南进行了更新。关键信息 OPTIC 数据证实了 ponatinib 对 CP-CML 患者的高效疗效，并为治疗过程中个体化剂量调整提供了基础。