scholarly journals Efficacy and safety of anlotinib, a multikinase angiogenesis inhibitor, in combination with epirubicin in preclinical models of soft tissue sarcoma

2020 ◽  
Vol 9 (10) ◽  
pp. 3344-3352
Author(s):  
Zhi‐Ming Wang ◽  
Shi‐Long Zhang ◽  
Hua Yang ◽  
Rong‐Yuan Zhuang ◽  
Xi Guo ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Angiogenesis Inhibitor ◽  
Efficacy And Safety ◽  
Preclinical Models

Efficacy and safety of anlotinib in advanced soft tissue sarcoma: results from one of multi-centers in a phase IIB trial (ALTER0203).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e22518-e22518 ◽  
Author(s):  
Lina Tang ◽  
Yonggang Wang ◽  
Jianjun Zhang ◽  
Wenxi Yu ◽  
Yujing Huang ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Regional Differences ◽  
Soft Part ◽  
Angiogenesis Inhibitor ◽  
Progression Free Survival ◽  
Clear Cell Sarcoma ◽  
Gamma Glutamyl Transferase ◽  
Efficacy And Safety ◽  
Glutamyl Transferase

e22518 Background: There is no standard therapy for soft tissue sarcoma (STS) patients progressing after first-line chemotherapy. Anlotinib significantly prolonged PFS in advanced STS patients in the earlier results of ALTER0203. In view of regional differences, we further analysis results from Affiliated Sixth People’s Hospital, Shanghai Jiaotong University, one center in this IIB trial. Methods: Patients aged from 18 to 70 with advanced STS, progressing after anthracycline-based chemotherapy (not adapted to alveolar soft part sarcoma (ASPS) and clear cell sarcoma (CSC)), angiogenesis inhibitor naive, at least one measurable lesion according to RECIST 1.1, were eligible. Patients were randomised in a 2:1 ratio to receive anlotinib (12 mg per day 2 weeks on and 1 week off) or placebo. Primary endpoint was progression free survival (PFS). Secondary endpoints were overall response rate (ORR), disease control rate (DCR). Results: This center of ALTER0203 enrolled 48 eligible patients who received either anlotinib (n = 32) or placebo (n = 16). Leiomyosarcoma (LMS) (13/48), ASPS (12/48), synovial sarcoma (SS) (11/48) were major subtypes. The median PFS was 1.57 months (95% CI: 1.19-1.95) for placebo versus 6.27 months (95% CI: 1.89-10.65) for anlotinib ( P= 0.009). ORR was 0% (0/16) for placebo versus 18.75% (6/32) for anlotinib ( P= 0.16); DCR was 18.75% (3/16) for placebo versus 56.25% (18/32) for anlotinib ( P= 0.02). The most common adverse events (AEs) were hypertension, elevated TSH, hypertriglyceridaemia (HTG). The most common Grade ≥3 AEs were menstrual disorder, hypertension, gamma glutamyl transferase (GGT) elevation and lipase elevation. Conclusions: The efficacy and safety of anlotinib is further confirmed in advanced STS patients regarding regional differences. Clinical trial information: NCT02449343. [Table: see text]

Efficacy and safety of anlotinib plus TQB2450 in patients with advanced soft tissue sarcoma: A multicenter, single armed, phase 1b trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11547-11547
Author(s):  
Jiayong Liu ◽  
Zhengfu Fan ◽  
Wei Guo ◽  
Tian Gao ◽  
Shu Li ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Kinase Inhibitor ◽  
Soft Part ◽  
Epithelioid Sarcoma ◽  
Objective Response ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Phase 1B ◽  
Anthracycline Chemotherapy

11547 Background: Anlotinib, a multitargeted tyrosine kinase inhibitor, had been prove to be effective for the treatment of advanced or metastatic soft tissue sarcoma(STS) faild anthracycline chemotherapy. With the lack of prospective data of combination of PDL-1 inhibitor and antiangiogenic agent, we designed a phase 1b study to investigated the efficacy and safety of anlotinib plus TQB2450 in patients with STS. Methods: Eligible patients (age 18-70, ECOG 0-1, with histopathologically confirmed advanced STS, at least one measurable lesion according to RECIST 1.1, and previously received front-line anthracycline chemotherapy) were included and received anlotinib (12mg qd, D1-14, 21d/cycle) plus TQB2450 (1200 mg, IV, D1, 21d/cycle) until disease progression or intolerable toxicities.The primary endpoint was objective response rate (ORR), secondary endpoints included safety, overall survival (OS), progression-free survival (PFS), disease control rate (DCR). Results: From January 2019 to January 2021, 30 pts were enrolled1, 12 alveolar soft part sarcoma and 18 others (7 synovial sarcoma, 4 leiomyosarcoma, 5 undifferentiated pleomorphic sarcoma, 1 fibrosarcoma and 1 epithelioid sarcoma). ORR by RECIST was 36.7%, DCR was 83.3%, 11/30 pts had PR, 14/30 (46.7%) had SD, 5/30 (16.7%) PD. Median PFS was 9.6 m in all pts and 4.9m. in non-ASPS, respectively. Median OS in non-ASPS was 10.27m, while mOS in all pts and both mPFS and mOS in ASPS had not been reached. Notably, to ASPS pts, ORR was 75%, and DCR was 100%. The most common 1-2 grade treatment-related adverse reaction (TRAE) was hypothyroidism (19/30,63.3%)，hypercholesterolemia (16/30, 53.3%) and hypertriglyceridemia (16/30, 53.3%), the most common ≥3 grade TRAEs were hypertriglyceridemia (3/30, 10%). 6 SAE (20%) occurred, including 2 pneumothorax, 1 Immune associated hapatic injury, 1 hypotension, 1 Immune myocarditis and 1 diabetic ketoacidosis. Conclusions: The combination of anlotinib and TQB2450 showed promising activity in second-line treatment of advanced STS, especially in ASPS, with well tolerance and acceptable toxicity.

scholarly journals Efficacy and safety of apatinib monotherapy in advanced bone and soft tissue sarcoma: An observational study

2018 ◽  
Vol 19 (3) ◽  
pp. 198-204 ◽  
Author(s):  
Baorang Zhu ◽  
Jing Li ◽  
Qiaosheng Xie ◽  
Liyan Diao ◽  
Lvhua Gai ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Observational Study ◽  
Efficacy And Safety

Predictive biomarkers of trabectedin (TR) and olaparib (OL) synergism in preclinical models of bone and soft tissue sarcoma (BSTS).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 10569-10569
Author(s):  
Ymera Pignochino ◽  
Federica Capozzi ◽  
Carmine Dell' Aglio ◽  
Marco Basiricò ◽  
Annalisa Lorenzato ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Predictive Biomarkers ◽  
Preclinical Models

scholarly journals Uncertainties that threaten the benefit/risk balance in early treatment lines for advanced or metastatic soft tissue sarcoma

2021 ◽  
Author(s):  
Peter Reichardt
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Efficacy And Safety ◽  
Early Management ◽  
Best Response ◽  
Metastatic Soft Tissue Sarcoma ◽  
Risk Balance ◽  
Treatment Alternatives ◽  
To Receive

Sarcoma oncologists face many uncertainties which can threaten the benefit/risk balance during early management of patients with advanced or metastatic soft tissue sarcoma. This point is illustrated by a clinical case involving an elderly patient with comorbidities and a diagnosis of metastatic leiomyosarcoma. The patient was not a candidate for doxorubicin-based chemotherapy because of his cardiac history and was hesitant about systemic chemotherapy, ultimately expressing a preference for a well-tolerated regimen. After evaluating the treatment alternatives, trabectedin was chosen based on its indication for use in persons unsuited to receive anthracyclines and evidence supporting its efficacy and safety in elderly patients. The patient received 17 cycles of trabectedin for a best response of stable disease with good quality of life.

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