Open AccessEffect 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
Author(s) -
Cheng Ying,
Han Baohui,
Li Kai,
Wang Qiming,
Zhang Li,
Shi Jianhua,
Wang Zhehai,
He Jianxing,
Shi Yuankai,
Chen Weiqiang,
Wang Xiuwen,
Luo Yi,
Nan Kejun,
Jin Faguang,
Li Baolan,
Zhu Jing
Publication year - 2020
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.2913
Subject(s) - medicine , placebo , clinical endpoint , lung cancer , subgroup analysis , adenocarcinoma , adverse effect , gastroenterology , oncology , progression free survival , randomized controlled trial , chemotherapy , cancer , confidence interval , pathology , alternative medicine
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.