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二代 ALK 抑制剂治疗失败的 ALK 阳性 NSCLC 患者中洛拉替尼的疗效和生活质量:加拿大真实世界经验。

Lorlatinib Effectiveness and Quality-of-Life in Patients with ALK-Positive NSCLC Who Had Failed Second-Generation ALK Inhibitors: Canadian Real-World Experience.

机构信息

Pfizer Canada, 17300 Trans-Canada Hwy, Kirkland, QC H9J 2M5, Canada.

Queen Elizabeth II Health Sciences Centre, Dalhousie University, 1276 South Park Street, Halifax, NS B3H 2Y9, Canada.

出版信息

Curr Oncol. 2023 Jul 8;30(7):6559-6574. doi: 10.3390/curroncol30070481.

DOI:10.3390/curroncol30070481
PMID:37504341
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10377946/
Abstract

Lorlatinib is the only targeted therapy approved in Canada to treat patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) whose tumor has progressed despite treatment with second-generation ALK tyrosine kinase inhibitor (TKI), a patient population with high unmet need and lack of publicly reimbursed targeted treatments in Canada. We prospectively examined the real-world effectiveness and impact of lorlatinib on quality-of-life in 59 lorlatinib-treated patients, characterized as: median age of 62.0 years; 47.5% were female; 32.2% had central nervous system metastases; 50.8% had 2+ prior ALK TKI lines; and alectinib was the most common ALK TKI (72.9%) administered before lorlatinib, including 44.1% who received first-line alectinib. With a median follow-up of 15.3 months (IQR: 6.2-19.2), median time-to-treatment discontinuation of lorlatinib was 15.3 months (95% CI: 7.9-not reached), with 54.2% (95% CI: 40.8-65.9%) of patients without treatment discontinuation at 12 months. At baseline, the mean health utility score (HUS) was 0.744 (SD: 0.200). At 3 months, patients receiving lorlatinib demonstrated a 0.069 (95% CI: 0.020-0.118; = 0.007) average HUS increase over baseline; HUS was maintained at 6 and 12 months. Thus, patients with ALK-positive NSCLC post second-generation ALK TKI remained on lorlatinib for a meaningful duration of time while their quality-of-life was preserved.

摘要

洛拉替尼是唯一在加拿大被批准用于治疗间变性淋巴瘤激酶 (ALK) 阳性非小细胞肺癌 (NSCLC) 患者的靶向治疗药物,这些患者在接受第二代 ALK 酪氨酸激酶抑制剂 (TKI) 治疗后肿瘤进展,他们是一个具有高度未满足需求且在加拿大缺乏公共报销的靶向治疗药物的患者群体。我们前瞻性地研究了 59 名接受洛拉替尼治疗的患者的真实世界疗效和对生活质量的影响,这些患者的特征包括:中位年龄 62.0 岁;47.5%为女性;32.2%有中枢神经系统转移;50.8%有 2+种以上的 ALK TKI 治疗线;阿来替尼是最常见的 ALK TKI(72.9%),在接受洛拉替尼治疗之前使用,包括 44.1%的患者接受了一线阿来替尼治疗。中位随访时间为 15.3 个月(IQR:6.2-19.2),洛拉替尼的中位停药时间为 15.3 个月(95%CI:7.9-未达到),54.2%(95%CI:40.8-65.9%)的患者在 12 个月时没有停药。基线时,平均健康效用评分(HUS)为 0.744(SD:0.200)。在 3 个月时,接受洛拉替尼治疗的患者的 HUS 平均增加了 0.069(95%CI:0.020-0.118; = 0.007);HUS 在 6 个月和 12 个月时保持稳定。因此,ALK 阳性 NSCLC 患者在第二代 ALK TKI 治疗后继续接受洛拉替尼治疗的时间较长,同时保持了生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/11ba51243ff4/curroncol-30-00481-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/f3343c081d49/curroncol-30-00481-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/1fef67fd90da/curroncol-30-00481-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/5915472a1135/curroncol-30-00481-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/11ba51243ff4/curroncol-30-00481-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/f3343c081d49/curroncol-30-00481-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/1fef67fd90da/curroncol-30-00481-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/5915472a1135/curroncol-30-00481-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9528/10377946/11ba51243ff4/curroncol-30-00481-g004.jpg

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