Abstract:
Objective To investigate the efficacy and safety of anlotinib hydrochloride capsules for the treatment of advanced soft tissuesarcoma based on the data from Department of Bone and Soft Tissue Tumor, Peking University Cancer Hospital & Institute.
Methods Patientswere randomized allocated at 2:1 ratio for the anlotinib treatment and placebo group. The treatment group received 12 mg/day of anlotinibfor 14 consecutive days in a 21-day cycle. The primary end-point was progression-free survival (PFS), and the secondary end-points weredisease control rate (DCR), overall survival (OS), and adverse event rate.
Results A total of 46 patients were enrolled in this study; 7 of themwere excluded from per protocol set (PPS). Among the remaining 39 patients, 28 were included in the anlotinib group and 11 in the placebogroup. In the anlotinib group, 4 patients had partial remission and 13 had stable disease (SD), whereas in the placebo group, 3 patients hadSD. The difference in DCR between the 2 groups was statistically significant (60.7% vs. 27.3%, P=0.082). The DCR of the advanced soft tissuesarcoma in the anlotinib group was 78.6% (11/14). The median PFS in the anlotinib group was 12.4 (95% confidence interval CI: 7.6 to17.2) months, which was significantly longer than 4 months in the placebo group (95% CI: 1.7 to 6.3 months, P=0.043); however, thedifference in OS between the 2 groups was not significant (19.4 vs. 17.6 months, P=0.961). Regarding the safety, 2 patients had severe adverseevents (7.14%) possibly related with treatment in the anlotinib group; one of them had pneumothorax. The other adverse events were grade1 to 2.
Conclusions Soft tissue sarcoma is highly responsive to anlotinib, with prolonged PFS. Anlotinib is well tolerated and can be usedas a treatment option for advanced soft tissue sarcoma.
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