Abstract 3710
Background
In the ALTER0203 trial (NCT02449343), anlotinib hydrochloride was used as subsequence therapy for adult advanced soft tissue sacorma (STS) pts who progressed after prior systemic therapies. It has demonstrated that anlotinib significantly prolonged PFS in advanced STS with multiple pathological subgroups. There’s rare treatment method for alveolar soft part sarcoma (ASPS) due to chemotherapy insensitive. Here we report the efficacy of anlotinib on ASPS in 1st line or ≥ 2nd line.
Methods
233 pts were randomised in a 2:1 ratio to receive anlotinib (12 mg QD from day 1 to 14 of a 21-day cycle) or placebo till progression or intolerable toxicity. ASPS pts could be treated at 1st line without prior systemic therapies. Primary endpoint is progression-free survival (PFS). Data cutoff by 2017.4.30, follow-up is still ongoing.
Results
Median PFS of ASPS (n = 56) was significantly improved in the anlotinib arm (n = 38) compared with placebo arm (n = 18) (18.23 vs. 3.00 months, p < 0.0001), and the most common grade ≥3 treatment-related AEs were hypertension, γ-glutamyltransferase increased, hand-foot syndrome and hypertriglyceridemia. Furthermore, remarkable advantages in PFS were observed in the anlotinib arm as well regardless of the treatment line. Meanwhile, the DCR in anlotinib arm was also significantly increased compared to the placebo arm. (Data presented in the table)Table:
1694P Efficacy (date is immature)
| 1st line | ≥2nd line | |||||||
|---|---|---|---|---|---|---|---|---|
| Anlotinib (n = 18) | Placebo (n = 10) | HR | p-vaule | Anlotinib (n = 20) | Placebo (n = 8) | HR | P-vaule | |
| Events/ Censored (n/n) | 6/12 | 5/5 | 5/15 | 6/2 | ||||
| mPFS (mos) | 15.4 | 3.00 | 0.24 | 0.0073 | NR | 1.50 | 0.14 | <0.0001 |
| ORR(%) | 22.22 | 0.00 | 0.2652 | 25.00 | 0.00 | 0.2808 | ||
| DCR(%) | 83.33 | 40.00 | 0.0346 | 90.00 | 37.50 | 0.0095 |
Conclusions
In the ALTER0203 trial, a significant improvement in PFS was found in anlotinib treated ASPS from both subgroups (1st line or ≥ 2nd line treatment). This is indicating that anlotinib could be an appropriate option for ASPS pts regardless of the treatment line.
Clinical trial identification
NCT02449343.
Editorial acknowledgement
Legal entity responsible for the study
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
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