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|Ref Type||Journal Article|
|Authors||Cho J, Kim HS, Ku BM, Choi YL, Cristescu R, Han J, Sun JM, Lee SH, Ahn JS, Park K, Ahn MJ|
|Title||Pembrolizumab for Patients With Refractory or Relapsed Thymic Epithelial Tumor: An Open-Label Phase II Trial.|
|Journal||Journal of clinical oncology : official journal of the American Society of Clinical Oncology|
|Date||2019 Aug 20|
|Abstract Text||Limited treatment options exist for patients with thymic epithelial tumor (TET) whose disease progresses after platinum-based chemotherapy. We conducted a phase II study of pembrolizumab in patients with TET to evaluate its efficacy and safety.Patients with histologically confirmed TET whose disease progressed after at least one line of platinum-based chemotherapy were eligible for the study. Patients were excluded if they had an active autoimmune disease requiring systemic treatment within the past year or documented history of clinically severe autoimmune disease. Patients received 200 mg of pembrolizumab intravenously every 3 weeks until tumor progression or unacceptable toxicity. The primary objective of response rate was assessed every 9 weeks by investigators.Of 33 patients enrolled, 26 had thymic carcinoma and seven had thymoma. Of seven thymoma, two (28.6%; 95% CI, 8.2% to 64.1%) had partial response, and five (71.6%) had stable disease. Of 26 thymic carcinoma, five (19.2%; 95% CI, 8.5% to 37.9%) had partial response and 14 (53.8%) had stable disease. The median progression-free survival was 6.1 months for both groups. The most common adverse events of any grade included dyspnea (11; 33.3%), chest wall pain (10; 30.3%), anorexia (seven; 21.2%), and fatigue (seven; 21.2%). Five (71.4%) of seven patients with thymoma and four (15.4%) of 26 patients with thymic carcinoma reported grade ≥ 3 immune-related adverse events, including hepatitis (four; 12.1%), myocarditis (three; 9.1%), myasthenia gravis (two; 6.1%), thyroiditis (one; 3.0%), antineutrophil cytoplasmic antibody-associated rapidly progressive glomerulonephritis (one; 3.0%), colitis (one; 3.0%), and subacute myoclonus (one; 3.0%).Pembrolizumab showed encouraging antitumor activity in patients with advanced TET. Given the high incidence of autoimmunity, additional studies are needed to identify those who can benefit from pembrolizumab without immune-related adverse events.|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Therapy Name||Drugs||Efficacy Evidence||Clinical Trials|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||thymic carcinoma||no benefit||Pembrolizumab||Phase II||Actionable||In a Phase II trial, Keytruda (pembrolizumab) treatment resulted in partial response in 19.2% (5/26) and stable disease in 53.8% (14/26) of patients with refractory or relapsed thymic carcinoma, with a median progression-free survival of 6.1 months, however, grade 3 or higher immune-related adverse events were seen in 15.4% (4/26) of the patients (PMID: 29906252).||29906252|
|Unknown unknown||thymoma||no benefit||Pembrolizumab||Phase II||Actionable||In a Phase II trial, Keytruda (pembrolizumab) treatment resulted in partial response in 28.6% (2/7) and stable disease in 71.6% (5/7) of patients with refractory or relapsed thymoma, with a median progression-free survival of 6.1 months, however, grade 3 or higher immune-related adverse events were seen in 71.4% (5/7) of the patients (PMID: 29906252).||29906252|