Abstract 1764
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. We evaluated the relationship between age, prior lines of therapy, and dose reductions on the efficacy of anlotinib in aSTS.
Methods
Median PFS (mPFS) was evaluated in subgroups of prior lines of therapy (0 or 1 prior line; 2+ prior lines), age (< 65 y; ≥65 y), and dose reductions (no dose reduction; ≥1 dose reduction). All analyses were descriptive and exploratory and required cautious interpretation.
Results
A total of 158 patients received anlotinib in the ALTER0203 study. Before enrollment, 20 patients of alveolar soft part sarcoma and clear cell sarcoma had no prior line of chemotherapy, 84 patients had received 1 prior line of chemotherapy and 54 patients had received 2+ prior lines of chemotherapy. Median PFS was similar in patients receiving anlotinib who had only 0 or 1 prior line of therapy vs 2+ prior lines of therapy (mPFS, 6.7 vs 6.33 months). In patients receiving anlotinib, mPFS was similar in ages < 65 than ≥65 y (6.33 and 5.9 months, respectively). In patients receiving anlotinib, mPFS was longer in patients requiring ≥ 1 dose reduction vs no reduction (10.43 and 5.73 months, respectively).Table: 1630P
| Subgroups | N | Anlotinib, mPFS, months (95% CI) |
|---|---|---|
| Lines of therapy | ||
| 0 or 1 prior line | 104 | 6.7 (4.07-9.33) |
| 2+ prior lines | 54 | 6.33 (3.90-8.76) |
| Age | ||
| < 65 y | 152 | 6.33 (5.06-7.60) |
| ≥65 y | 6 | 5.9 (0.00-14.86) |
| Dose reduction | ||
| No dose reduction | 144 | 5.73 (3.76-7.7) |
| ≥ 1 dose reduction | 14 | 10.43 (-) |
mPFS, median progression-free survival; CI, confidence interval.
Conclusions
In patients receiving anlotinib, longer mPFS was observed in patients requiring ≥ 1 dose reduction. Additionally, mPFS with anlotinib was maintained regardless of lines of therapy or patient age.
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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