Abstract
Anlotinib has been proven to prolong the progression-free survival (PFS) and overall survival (OS) as a third line or further therapy compared with placebo for non-small cell lung cancer (NSCLC). Herein we evaluate the effects and prognosis in patients with liver metastasis (LM) treated with anlotinib/placebo. The post-hoc analysis was based on the ALTER 0303 phase 3 randomized clinical trial (ClinicalTrials.gov identifier: NCT02388919). Clinicopathological characteristics, driven genes’ status (EGFR, ALK, and ROS1) and survival time were extracted, PFS and OS were evaluated with clinical profile data, together with treatment-associated adverse events (AEs). A total of 78 cases with liver metastasis were enrolled from 439 randomly assigned patients. The anlotinib was associated with longer PFS (median, 3.0 months; 95% CI, 2.0-3.9) compared with placebo (median, 0.9 months; 95% CI, 0.7-1.1), with a hazard ratio (HR) of 0.23 (95%CI, 0.12-0.42;P<0.0001). Furthermore, OS was also better in anlotinib group (median 6.6 months; 95% CI, 5.3-7.9), compared with placebo (median 4.0 months; 95% CI, 2.2-5.8), HR 0.61 (95%CI, 0.36-1.02; P = 0.055). The lower baseline ECOG score (0 vs 1 vs 2), normal serum LDH/AST and albumin level appeared a longer OS (all P<0.005), besides, normal serum LDH/γ-GT/amylase/alkaline phosphatase level showed a better PFS (all P<0.05). Anlotinib was more associated with hand-foot syndrome (7.7% vs 0) and serum TSH level rise (7.7% vs 3.8%), all AEs were no more than grade 3. Anlotinib could lead to a better overall survival and progression-free survival in pretreated NSCLC patients with LM, the AEs were manageable, which suggested anlotinib is a potential third line or further therapy in this group.
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