University of Milano-Bicocca, Monza, Italy.
Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Leukemia. 2024 Oct;38(10):2162-2170. doi: 10.1038/s41375-024-02372-x. Epub 2024 Aug 20.
This final analysis from the phase 4 BYOND trial reports outcomes with bosutinib in patients with previously treated chronic myeloid leukemia (CML); 163 patients with CML resistant/intolerant to previous tyrosine kinase inhibitors received bosutinib (starting dose: 500 mg QD). At study completion (median follow-up, 47.8 months), 48.1% (n = 75/156) of patients with Philadelphia chromosome-positive chronic phase CML were still receiving treatment. Among evaluable patients, 71.8% (95% CI, 63.9-78.9) and 59.7% (95% CI, 51.4-67.7) attained or maintained major molecular response (MMR) and molecular response (MR), respectively, at any time on treatment. The majority of patients achieved a deeper molecular response relative to baseline while on bosutinib. Kaplan-Meier probabilities (95% CI) of maintaining MMR and MR at 36 months were 87.2% (78.0-92.7) and 80.7% (69.4-88.1), respectively. At 48 months, the Kaplan-Meier overall survival rate was 88.3% (95% CI, 81.8-92.6); there were 17 deaths, including 2 that were considered CML related. Long-term adverse events (AEs) were consistent with the known safety profile of bosutinib, and no new safety issues were identified. The management of AEs through dose reduction maintained efficacy while improving tolerability. These results support the use of bosutinib in patients with previously treated CML.ClinicalTrials.gov, NCT02228382.
这是来自 4 期 BYOND 试验的最终分析报告，结果显示博舒替尼可用于治疗先前接受过治疗的慢性髓性白血病（CML）患者；163 例对先前的酪氨酸激酶抑制剂耐药/不耐受的 CML 患者接受博舒替尼（起始剂量：500mg QD）治疗。在研究结束时（中位随访时间，47.8 个月），仍有 48.1%（n=75/156）的费城染色体阳性慢性期 CML 患者接受治疗。在可评估的患者中，71.8%（95%CI，63.9-78.9）和 59.7%（95%CI，51.4-67.7）分别在任何时间点达到或维持主要分子学反应（MMR）和分子学反应（MR）。大多数患者在接受博舒替尼治疗时相对于基线获得了更深层次的分子反应。Kaplan-Meier 概率（95%CI）在 36 个月时维持 MMR 和 MR 的分别为 87.2%（78.0-92.7）和 80.7%（69.4-88.1）。在 48 个月时，Kaplan-Meier 总生存率为 88.3%（95%CI，81.8-92.6）；有 17 例死亡，包括 2 例被认为与 CML 相关。长期不良反应（AE）与博舒替尼已知的安全性特征一致，未发现新的安全性问题。通过减少剂量来管理 AE 可在提高耐受性的同时保持疗效。这些结果支持博舒替尼用于治疗先前接受过治疗的 CML 患者。ClinicalTrials.gov，NCT02228382。
