Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
The efficacy of anlotinib in squamous cell carcinoma (SCC) patients with or without hypertension in ALTER0303: Anlotinib as a third-line therapy in patients with advanced non-small cell lung cancer (NSCLC).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr e20503)
Author(s): Jianhua Shi, Baohui Han, Kai Li, Qiming Wang, Li Zhang, Wang Zhe-Hai, Ying Cheng, Jianxing He, Yuankai Shi, Weiqiang Chen, Yi Luo, Lin Wu, Xiuwen Wang, Kejun Nan, Faguang Jin, Jian Dong, Baolan Li; Shandong Linyi Tumor Hospital, Linyi, China; Department of Pulmonary, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China; Tianjin Medical University Cancer Institute and Hospital, Tianjin, China; Henan Cancer Hospital, Zhengzhou, China; Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Shandong Cancer Hospital, Shangdong, China; Department of Oncology, Jilin Province Cancer Hospital, Changchun, China; The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China; National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China; Lanzhou Military General Hospital, Lanzhou, China; Hunan Cancer Hospital, Changsha, China; Department of Thoracic Medicine, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University (Hunan Cancer Hospital), Changsha, China; Qilu Hospital of Shandong University, Jinan, China; The First Affiliated Hospital of Xi'An Jiaotong University, Xi'an, China; Tang Du Hospital, Xian, China; Yunnan Cancer Hospital, Kunming, China; Beijing Chest Hospital, Capital Medical University, Beijing, China
Background: As a promising multi-target tyrosine kinase inhibitor (TKI), anlotinib hydrochloride significantly improved overall survival (OS) and progression-free survival (PFS) in advanced NSCLC patients in the phase 3 trial (ALTER0303). Here, we demonstrated the efficacy of anlotinib in SCC patients with or without hypertension. Methods: Patients (n = 439) were randomized in a 2:1 ratio to receive anlotinib (12mg daily for 14 days in a 21 day cycle) or placebo. The primary endpoint was OS and second endpoints were PFS, ORR, DCR and QoL. The correlation between hypertension and efficacy (PFS and OS) was analyzed in SCC patients treated with anlotinib. Results: For different ECOG score (0 and 1) SCC patients (n = 46) in the anlotinib arm, the PFS was significantly improved in patients with hypertension in ECOG 1 group (7.00 vs 4.83 months, p = 0.043). There is no statistical difference in other subgroups. Moreover, for the SCC patients in anlotinib arm, PFS was significantly prolonged in patients with hypertension compared to the patients without hypertension (7.23 vs 3.23 months; HR = 0.36; 95% CI, 0.16–0.84; P = 0.001). However, the median OS of the patients with hypertension was numerically but not statistically longer than the patients without hypertension (13.93 vs 6.30 months; HR = 0.56; 95%CI, 0.26-1.22; P = 0.100). Conclusions: In the ALTER0303 trial, anlotinib significantly improved PFS with a potential benefit of OS for SCC patients with hypertension. And ECOG score does not affect the efficacy of anlotinib in SCC patients with or without hypertension. Clinical trial information: NCT02388919
(n = 2)
(n = 6)
|1.83 ± 0.45||7.30 ± 4.19|
(n = 28)
|7.00 ± 2.06||0.043||13.07 ± 2.61||0.184|
(n = 10)
|4.83 ± 1.86||4.83 ± 2.06|