SARC018_SPORE02: Phase II Study of Mocetinostat Administered with Gemcitabine for Patients with Metastatic Leiomyosarcoma with Progression or Relapse following Prior Treatment with Gemcitabine-Containing Therapy
Joint Authors
Okuno, Scott H.
Dickson, Mark A.
Pollock, Raphael E.
George, Suzanne
Chugh, Rashmi
Choy, Edwin
Ballman, Karla
Chen, James
Patel, Rajiv M.
Hoering, Antje
Patel, Shreyaskumar
Source
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-10-24
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Histone deacetylase inhibitors (HDACi) can reverse chemoresistance, enhance chemotherapy-induced cytotoxicity, and reduce sarcoma proliferation in cell lines and animal models.
We sought to determine the safety and toxicity of mocetinostat and its ability to reverse chemoresistance when administered with gemcitabine in patients with metastatic leiomyosarcoma resistant to prior gemcitabine-containing therapy.
Participants with metastatic leiomyosarcoma received mocetinostat orally, 70 mg per day, three days per week, increasing to 90 mg after three weeks if well tolerated.
Gemcitabine was administered at 1,000 mg/m2 intravenously at 10 mg/m2/minute on days five and 12 of every 21-day cycle.
Disease response was evaluated with CT or MRI.
Twenty participants with leiomyosarcoma were evaluated for toxicity.
Median time to disease progression was 2.0 months (95% CI 1.54–3.12).
Eighteen participants were evaluated for radiologic response by RECIST 1.1.
Best responses included one PR and 12 SD.
Tumor size reduced in 3 patients.
Most common toxicities were fatigue, thrombocytopenia, anemia, nausea, and anorexia.
One patient experienced a significant pericardial adverse event.
No study-related deaths were observed.
Rechallenging with gemcitabine by adding mocetinostat was feasible and demonstrated modest activity in patients with leiomyosarcoma.
Further studies are needed to better define the role of HDAC inhibitors in patients with metastatic leiomyosarcoma.
American Psychological Association (APA)
Choy, Edwin& Ballman, Karla& Chen, James& Dickson, Mark A.& Chugh, Rashmi& George, Suzanne…[et al.]. 2018. SARC018_SPORE02: Phase II Study of Mocetinostat Administered with Gemcitabine for Patients with Metastatic Leiomyosarcoma with Progression or Relapse following Prior Treatment with Gemcitabine-Containing Therapy. Complexity،Vol. 2018, no. 2018, pp.1-9.
https://search.emarefa.net/detail/BIM-1212803
Modern Language Association (MLA)
Choy, Edwin…[et al.]. SARC018_SPORE02: Phase II Study of Mocetinostat Administered with Gemcitabine for Patients with Metastatic Leiomyosarcoma with Progression or Relapse following Prior Treatment with Gemcitabine-Containing Therapy. Complexity No. 2018 (2018), pp.1-9.
https://search.emarefa.net/detail/BIM-1212803
American Medical Association (AMA)
Choy, Edwin& Ballman, Karla& Chen, James& Dickson, Mark A.& Chugh, Rashmi& George, Suzanne…[et al.]. SARC018_SPORE02: Phase II Study of Mocetinostat Administered with Gemcitabine for Patients with Metastatic Leiomyosarcoma with Progression or Relapse following Prior Treatment with Gemcitabine-Containing Therapy. Complexity. 2018. Vol. 2018, no. 2018, pp.1-9.
https://search.emarefa.net/detail/BIM-1212803
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1212803