Abstract 3157
Background
Leiomyosarcoma (LMS) is one of the most common pathologic subtypes of soft tissue sarcoma (STS) with limited treatment options. An earlier analysis in ALTER0203 showed efficacy and safety of anlotinib in overall subtype of STS. Here we report subgroup analysis of the patients with Leiomyosarcoma in ALTER0203.
Methods
Key inclusion criteria: aged from 18 to 70, confirmed histological diagnosis of advanced LMS, angiogenesis inhibitor naive, progressing after anthracycline-contained chemotherapy, measurable disease (RECIST 1.1), ECOG performance status (PS) 1-2. Anlotinib 12 mg per day 2 weeks on and 1 week off or placebo was given after 2:1 randomization. Primary endpoint: progression-free survival (PFS). Secondary endpoints: overall response rate (ORR), disease control rate (DCR) and so on.
Results
41 eligible LMS patients, 9 males (21.95%), median age 49 (range 28-66), received either anlotinib (n = 27) or placebo (n = 14). The median PFS was 1.43 months for placebo and 5.83 months for anlotinib (P<0.0001). CR or PR was not observed for both placebo and anlotinib. SD was 2/14 for placebo versus 16/27 for anlotinib (P = 0.01). The most common adverse events (AEs) were hypertension, elevated TSH, hypertriglyceridaemia. The most common grade 3 or higher AEs were hypertension, gamma glutamyl transferase elevation, hyponatremia.Table:
1693P
Efficacy | Alotinib (n = 27) | Placebo (n = 14) | P-value |
---|---|---|---|
mPFS (mos) | 5.83 | 1.43 | < 0.0001 |
HR(95%CI) | 2.85-8.81 | 1.41-1.45 | |
ORR, n(%) | 0(0%) | 0(0%) | N/A |
DCR, n(%) | 16(59.26%) | 2(14.29%) | 0.01 |
The most common AEs, n(%) | |||
Hypertension | 20(74.07%) | 1(7.14%) | < 0.0001 |
TSH elevation | 19(70.37%) | 0(0%) | < 0.0001 |
Hypertriglyceridaemia | 13(48.15%) | 4(28.57%) | 0.32 |
Grade≥3 AEs, n(%) | |||
Hypertension | 5(18.52%) | 0(0%) | < 0.0001 |
Gamma glutamyl transferase elevation | 2(7.41%) | 1(7.14%) | 1.0 |
Hyponatremia | 2(7.41%) | 0(0%) | 0.54 |
Conclusions
Anlotinib not only improves PFS and DCR significantly, but also presents good safety in patients with LMS, which suggests that anlotinib could be an option for LMS patients.
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.
Resources from the same session
4925 - Prognostic role of CD73 in metastatic Non Small Cell Lung Cancer according to the presence of driver alterations
Presenter: Giulia Galli
Session: Poster Display session 1
Resources:
Abstract
785 - JAK-STAT inhibitor overcomes interferon γ-reduced, NK cell-mediated cytotoxicity in non-small-cell lung cancer cells
Presenter: Riki Okita
Session: Poster Display session 1
Resources:
Abstract
2326 - Low LATS2 expression is associated with poor prognosis in non small cell lung cancer
Presenter: Si-hyong Jang
Session: Poster Display session 1
Resources:
Abstract
5960 - Application of ESCAT and OncoKB scales in Liquid biopsy (LB) in Advanced NSCLC patients (pts): Is it feasible and reliable?
Presenter: Michael McCusker
Session: Poster Display session 1
Resources:
Abstract
4855 - IDH1R132H mutation induces a less aggressive phenotype of glioma cells and affects the radiosensitivity by interacting with Wnt/β-catenin signaling
Presenter: Xuetao Han
Session: Poster Display session 1
Resources:
Abstract
2641 - Impact of Angiopoietin-2 on glioblastoma response to combined chemo-radiotherapy
Presenter: Charly Helaine
Session: Poster Display session 1
Resources:
Abstract
5743 - The Discovery of RNA-aptamers That Selectively Bind and Inhibit Glioblastoma Stem Cells by targeting EphA2
Presenter: Alessandra Affinito
Session: Poster Display session 1
Resources:
Abstract
4160 - Impact of tumor reoxygenation by nanoparticles on Tumor Associated Macrophages (TAMs)
Presenter: Aurélie Ferré
Session: Poster Display session 1
Resources:
Abstract
2474 - Prognostic significance of c-Rel/p50 heterodimer in the tumor microenvironment of uveal melanoma
Presenter: Seema Kashyap
Session: Poster Display session 1
Resources:
Abstract
1769 - Synergistic role of BAP1 and DNA damage response pathway in uveal melanoma and its prognostic significance.
Presenter: JAYANTI JHA
Session: Poster Display session 1
Resources:
Abstract