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
5135 - Dose adjustment of chemotherapy in aggressive lymphoma using automated and standardized analysis and evaluation of DNA double strand breaks
Presenter: Julia Schröder
Session: Poster Display session 1
Resources:
Abstract
4883 - A New Population Model Validated Pharmacokinetic Similarity of HLX01 and Rituximab in B-Cell Lymphoma
Presenter: Yuankai Shi
Session: Poster Display session 1
Resources:
Abstract
4908 - Efficacy of salvage therapy in the treatment of Helicobacter pylori-positive gastric low-grade mucosa-associated lymphoid tissue lymphoma
Presenter: Sung-Nam Lim
Session: Poster Display session 1
Resources:
Abstract
2360 - Mutational analysis of extranodal marginal zone lymphoma using next generation sequencing
Presenter: Seok Jae Huh
Session: Poster Display session 1
Resources:
Abstract
2430 - Clinical features, treatment and outcomes of colon and rectum mucosa-associated lymphoid tissue (MALT) lymphoma: Literature reviews published in English between 1993 and 2017
Presenter: Jeong Yeon Kim
Session: Poster Display session 1
Resources:
Abstract
4654 - Splenic marginal zone lymphoma: clinical characteristics and prognostic factors in a series of 52 patients
Presenter: Guldane Cengiz Seval
Session: Poster Display session 1
Resources:
Abstract
1732 - Safety and efficacy of Bendamustine and Rituximab (BR) regimen in Indian Chronic Lymphocytic Leukemia patients
Presenter: Ajay Gogia
Session: Poster Display session 1
Resources:
Abstract
5784 - N-terminal B-type natriuretic peptide (NT-proBNP) as an independed prognostic marker for patients with newly diagnosed multiple myeloma complicated by dialysis-dependent renal failure
Presenter: Sergey Semochkin
Session: Poster Display session 1
Resources:
Abstract
836 - The first-line effect of Bortezomib-based Therapy on Clinical Outcomes for Taiwanese Patients with multiple myeloma
Presenter: Ching-Liang Ho
Session: Poster Display session 1
Resources:
Abstract
2085 - Impact of Donor Lymphocyte Infusion in Relapsing Myeloid Neoplasms Post Allogeneic Hematopoietic Stem Cell Transplantation
Presenter: Hanafy Hafez
Session: Poster Display session 1
Resources:
Abstract