Effect of anlotinib as a third- or further-line therapy in advanced non-small cell lung cancer patients with different histologic types: Subgroup analysis in the ALTER0303 trial
Effect of anlotinib as a third- or further-line therapy in advanced non-small cell lung cancer patients with different histologic types: Subgroup analysis in the ALTER0303 trial
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DOI：
10.1002/cam4.2913
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发表时间：
2020-02-16
期刊：
影响因子：
4
通讯作者：
Zhu, Jing
中科院分区：
文献类型：
--
作者：
Cheng, Ying;Han, Baohui;Zhu, Jing
背景：在ALTER0303试验中，安洛替尼作为第三或进一步的一线治疗对晚期非小细胞肺癌(NSCLC)患者的生存有显著的好处。我们旨在评价安洛替尼在不同组织学类型患者中的疗效。方法ALTER0303试验是在中国的31个中心进行的关于安洛替尼治疗非小细胞肺癌患者的随机、开放标签、3期研究。患者按2：1的比例随机分配，接受安洛替尼(从21天周期的第1天到第14天，每天12毫克)或安慰剂，直到病情进展或无法忍受的毒性。主要终点是总存活率(OS)。结果在ALTER0303试验中，336例患者为腺癌(ACC)组织学亚型，86例为鳞癌(SCC)组织学亚型，15例为其他亚型。在ACC亚组中，与安慰剂组相比，服用安洛替尼的中位OS时间(9.6个月比6.9个月，P=0.0051)和中位无进展生存(PFS)时间(5.5个月比1.4个月，P<；0.0001)显著改善。在鳞癌亚组中，安洛替尼组和安慰剂组的中位OS时间分别为10.7个月和6.5个月(P=.2570)，中位PFS时间分别为4.8个月和2.7个月(P=.0004)。结论安洛替尼可显著改善ACC患者的PFS和OS，并有延长SCC患者生存期的趋势。
Background Anlotinib showed significant survival benefits in advanced non-small cell lung cancer (NSCLC) patients as a third- or further-line treatment in the ALTER0303 trial. We aimed to evaluate the efficacy of anlotinib in patients with different histologies.Methods The ALTER0303 trial was a randomized, open-label, phase 3 study of anlotinib in NSCLC patients previously treated with at least two lines of chemotherapy or a tyrosine kinase inhibitor (TKI) in 31 centers in China. Patients were randomly assigned at a 2:1 ratio to receive anlotinib (12 mg QD from days 1 to 14 of a 21-day cycle) or placebo until progression or intolerable toxicity. The primary endpoint was overall survival (OS). We assessed the efficacy of anlotinib in histological subgroups in the full analysis set.Results In the ALTER0303 trial, 336 patients had the histological subtype of adenocarcinoma (ACC), 86 patients had the histological subtype of squamous cell carcinoma (SCC), and 15 patients had another subtype. In the ACC subgroup, the median OS time was significantly improved with anlotinib compared with placebo (9.6 months vs 6.9 months, P = .0051), as was the median progression-free survival (PFS) time (5.5 months vs 1.4 months, P < .0001). In the SCC subgroup, the median OS time was 10.7 months in the anlotinib group and 6.5 months in the placebo group (P = .2570), and the median PFS time was 4.8 months and 2.7 months (P = .0004), respectively. The common adverse events observed in the SCC and ACC subgroups were similar.Conclusions Our findings suggest that anlotinib significantly improves PFS and OS in ACC patients and has a tendency to prolong survival in SCC patients.