PDF(Pubmed)
Abstract：
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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
摘要：
背景：基于OPTIC（优化CP-CML中的Ponatinib治疗）试验对慢性期（CP）-CML患者的剂量优化的初步分析的新数据，2020年发表的关于普纳替尼的德国共识论文(SausseleS等人。,Haematol学报.2020)已在本附录中更新。
结论：重点是更新ponatinib的疗效和安全性，反映新的数据集，以及CP-CML中有关普纳替尼起始剂量的获益-风险评估和建议的更新-前提是已经决定使用普纳替尼.此外，基于光学和其他经验数据，专家小组合作开发了普纳替尼给药的决策树，特别适用于不耐受和耐药的患者。有关心血管管理的建议也已根据欧洲心脏病学会（ESC）关于临床实践中心血管疾病（CVD）预防的最新2021指南进行了更新。
结论：OPTIC数据证实了ponatinib对CP-CML患者的高疗效，为治疗过程中个体化剂量调整提供了依据。
结论：重点是更新ponatinib的疗效和安全性，反映新的数据集，以及CP-CML中有关普纳替尼起始剂量的获益-风险评估和建议的更新-前提是已经决定使用普纳替尼.此外，基于光学和其他经验数据，专家小组合作开发了普纳替尼给药的决策树，特别适用于不耐受和耐药的患者。有关心血管管理的建议也已根据欧洲心脏病学会（ESC）关于临床实践中心血管疾病（CVD）预防的最新2021指南进行了更新。
结论：OPTIC数据证实了ponatinib对CP-CML患者的高疗效，为治疗过程中个体化剂量调整提供了依据。
