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
4658 - Patient-reported outcomes associated with switching to rivaroxaban for the treatment of venous thromboembolism (VTE) in patients with active cancer
Presenter: Alexander Cohen
Session: Poster Display session 1
Resources:
Abstract
5638 - Incidence of Vascular Thromboembolism Events in Cancer Patients Receiving Immunotherapy: A Single Institution Experience.
Presenter: Laura Gutiérrez Sainz
Session: Poster Display session 1
Resources:
Abstract
5182 - High Incidence of Venous Thromboembolic Events (VTE) in Patients with Diffuse Large B-Cell Lymphoma.
Presenter: Alaa Abufara
Session: Poster Display session 1
Resources:
Abstract
1504 - Weight Loss over Time in Non-Small Cell Lung Cancer: Results from a Landmark Analysis of 800+ Prospectively-Treated Patients
Presenter: Jennifer Le-rademacher
Session: Poster Display session 1
Resources:
Abstract
3972 - The prognostic significance of preoperative nutritional status in resected pancreatic ductal adenocarcinoma (PDAC).
Presenter: Salvatore Paiella
Session: Poster Display session 1
Resources:
Abstract
2313 - Impact of Timing and Technique of Gastrostomy Placement on the Outcome of Patients (pts) with Head and Neck Cancer (HNC)
Presenter: M Julia Lostes Bardaji
Session: Poster Display session 1
Resources:
Abstract
5219 - Clinical & nutritional determinants of quality of life in patients with incurable cancer
Presenter: Louise Daly
Session: Poster Display session 1
Resources:
Abstract
4075 - Loss of skeletal muscle mass during palliative chemotherapy is a poor prognostic factor in patients with advanced gastric cancer
Presenter: In Gyu Hwang
Session: Poster Display session 1
Resources:
Abstract
4159 - Impact of nutritional derangement on treatment outcome in advanced non-small-cell lung cancer (A-NSCLC) patients (pts).
Presenter: Ilaria Trestini
Session: Poster Display session 1
Resources:
Abstract
1210 - Sarcopenia and pretreatment anemia as prognostic factors for patients with localized muscle invasive bladder cancer treated by neoadjuvant chemotherapy and radical cystectomy
Presenter: Emilien Billon
Session: Poster Display session 1
Resources:
Abstract