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简明摘要:洛拉替尼与克唑替尼治疗非小细胞肺癌的CROWN研究5年结果

Plain language summary: 5-year results from the CROWN study of lorlatinib vs crizotinib in non-small-cell lung cancer.

作者信息

Solomon Benjamin J, Liu Geoffrey, Felip Enriqueta, K Mok Tony S, Soo Ross A, Mazieres Julien, Shaw Alice T, Marinis Filippo de, Goto Yasushi, Wu Yi-Long, Kim Dong-Wan, Martini Jean-François, Messina Rossella, Paolini Jolanda, Polli Anna, Thomaidou Despina, Toffalorio Francesca, Bauer Todd M

机构信息

Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.

Princess Margaret Cancer Centre, Toronto, ON, Canada.

出版信息

Future Oncol. 2024 Dec;20(40):3377-3387. doi: 10.1080/14796694.2024.2406117. Epub 2024 Oct 3.

Abstract

WHAT IS THIS STUDY ABOUT?: This is a summary of the results of an ongoing study called CROWN. In the CROWN study, researchers looked at the effects of two medicines called lorlatinib (Lorbrena) and crizotinib (Xalkori) for people with advanced non-small cell lung cancer (NSCLC) who had not been treated yet. Everyone in the study had changes in a called anaplastic lymphoma kinase, or , in their cancer cells. The changes in the gene can make cancer grow. This analysis looked at how well lorlatinib and crizotinib worked and their in people with advanced -positive NSCLC after 5 years.

WHAT DID THIS STUDY FIND?: After observing people for an average of 5 years, researchers found that more people who took lorlatinib were still alive without their cancer getting worse than the people who took crizotinib. At 5 years, the probability of being alive without their cancer getting worse was 60% in people who took lorlatinib compared with 8% in people who took crizotinib. Fewer people who took lorlatinib had their cancer spread within or to the brain than the people who took crizotinib. In more than half of the people who took lorlatinib, tumors that had spread to the brain did not get worse, and no new tumors spread to the brain after 5 years. In contrast, in about half of the people who took crizotinib, tumors that had spread to the brain got worse or new tumors spread to the brain after 16.4 months. More people who took lorlatinib (115 out of 149, or 77%) had or than people who took crizotinib (81 out of 142, or 57%). These side effects were like the ones reported in the earlier 3-year analysis.

WHAT DO THE FINDINGS OF THE STUDY MEAN?: The 5-year results from the CROWN study showed that more people who took lorlatinib continued to benefit from their treatment than those who took crizotinib. The 5-year benefit of lorlatinib in people with -positive NSCLC has never been seen before. NCT03052608 (Phase 3 CROWN study) (ClinicalTrials.gov).

摘要

这项研究是关于什么的?:这是一项正在进行的名为CROWN研究结果的总结。在CROWN研究中,研究人员观察了两种药物劳拉替尼(Lorbrena)和克唑替尼(Xalkori)对尚未接受治疗的晚期非小细胞肺癌(NSCLC)患者的疗效。研究中的每个人癌细胞中一种名为间变性淋巴瘤激酶(ALK)的物质都有变化。ALK基因的变化会促使癌症生长。该分析观察了劳拉替尼和克唑替尼在晚期ALK阳性NSCLC患者中5年后的疗效及安全性。

这项研究发现了什么?:在对患者进行平均5年的观察后,研究人员发现,与服用克唑替尼的患者相比,服用劳拉替尼的患者中更多人存活且癌症未恶化。5年后,服用劳拉替尼的患者癌症未恶化且存活的概率为60%,而服用克唑替尼的患者这一概率为8%。与服用克唑替尼的患者相比,服用劳拉替尼的患者中癌症扩散至脑内或脑部的人数更少。服用劳拉替尼的患者中,超过一半扩散至脑内的肿瘤未恶化,且5年后没有新的肿瘤扩散至脑部。相比之下,服用克唑替尼的患者中,约一半扩散至脑内的肿瘤在16.4个月后恶化或有新的肿瘤扩散至脑部。服用劳拉替尼的患者中出现实验室异常或副作用的人数更多(149人中有115人,即77%),而服用克唑替尼的患者中这一比例为142人中有81人,即57%。这些副作用与早期3年分析中报告的类似。

该研究的结果意味着什么?:CROWN研究的5年结果表明,与服用克唑替尼的患者相比,更多服用劳拉替尼的患者继续从治疗中获益。劳拉替尼对ALK阳性NSCLC患者的5年益处前所未见。NCT03052608(3期CROWN研究)(ClinicalTrials.gov)

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