Abstract 3003
Background
ALTER0203 was a randomized phase IIB trial (NCT02449343) that demonstrated single-agent activity of anlotinib in advanced STS (aSTS). The primary endpoint progression-free survival (PFS) was met and presented as an oral presentation in 2018 ASCO. Similar to other vascular endothelial growth factor pathway-targeted therapies, hypertension and hand-foot syndrome (HFS) have been observed as major adverse events of anlotinib. The goal of our study was to assess if hypertension and hand-foot syndrome induced during treatment with anlotinib were associated with clinical outcome in aSTS patients treated with anlotinib.
Methods
We conducted a review of patients enrolled in ALTER0203. Median PFS was analysed in patients with hypertension and HFS vs patients with no hypertension and HFS. All analyses were exploratory and required cautious interpretation.
Results
A total of 158 patients received anlotinib in the ALTER0203 study. During the study, hypertension was observed in 99 patients (62.66%). HFS was observed in 76 patients (48.1%). Median PFS was longer in patients with hypertension vs patients with no hypertension (7.00 vs 4.37 months, p = 0.36). Patients with any grade hypertension while on anlotinib had an adjusted hazard ratio for progression of 0.81 compared to those without hypertension. Also, median PFS was longer in patients with HFS vs patients with no HFS (9.83 vs 4.3 months, p < 0.01). Patients with any grade HFS while on anlotinib had an adjusted hazard ratio for progression of 0.47 compared to those without hypertension.
Conclusions
Our data indicate that HFS may represent an interesting prognostic factor for clinical outcome in aSTS patients receiving anlotinib. There is a trend that mPFS of patients with hypertension is longer than those with no hypertension.
Clinical trial identification
NCT02449343.
Legal entity responsible for the study
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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