Nan X, et al. Int J Clin Oncol 2020.
BACKGROUND: The ALTER 0303 study showed that anlotinib can significantly improve overall survival (OS) compared with the placebo in advanced non-small-cell lung cancer (NSCLC). Hand-foot syndrome (HFS) is a common anlotinib-related adverse event. The aim of this study was to assess the association of HFS with clinical benefit.
METHODS: A subgroup analysis of patients treated with anlotinib from the ALTER 0303 study was performed. Our analysis assessed if the appearance of anlotinib-related HFS in the first 42 days (second-cycle HFS) and at any time could produce better clinical benefits.
RESULTS: In this study, 294 patients were treated with anlotinib. Of which, 129 patients had HFS at any time, and 76 patients developed HFS in the first 2 cycles. Patients who received anlotinib and developed HFS had significantly prolonged OS, progression-free survival (PFS) compared to those who did not develop HFS in the first 2 cycles (13.5 vs 8.7 months, p = 0.001; adjusted hazard ratio (HR) 0.63 (95% confidence interval [CI] 0.44-0.89), p = 0.009; 5.8 vs 4.5 months, p = 0.001; adjusted HR, 0.59 [0.43-0.81], p = 0.001). The significant OS and PFS benefits for patients with HFS versus without were seen at any time (14.5 vs 7.3 months, p = 0.000; adjusted HR, 0.50 [0.36-0.67], p = 0.000; 5.8 vs 4.2 months, p = 0.000; adjusted HR, 0.49 [0.37-0.65], p = 0.000). In addition, the grade of severity of HFS was strongly correlated with OS (p = 0.000).
CONCLUSION: Presence of HFS may be a potential clinical marker for the treatment of NSCLC with anlotinib.