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Clinical trials in Phase II AcS? Pembrolizumab evaluated the effectiveness and safety of Pembrolizumab monotherapy in treating rare sarcoma, and the results showed that progress-free survival (PFS) and overall survival (OS) were different in patients with sarcoma of different tissue types.
study was recently published at the 2020 ESMO Virtual Conference.
AcS? Pembrolizumab study is a non-randomized, parallel arm, open label, multi-center Phase II clinical trial that assesses tissue types that are rare sarcoma with an annual incidence of less than 0.2 cases/100,000 people.
the standard: patients aged 18 years, ECOG s1, and patients with advanced diseases who are resistant to standard therapies.
Pembrolizumab was administered intravenously at 200 mg for 30 minutes on the first day of every 21-day cycle.
the main endpoint of the study was the Objective Mitigation Rate (ORR).
secondary endpoints include Clinical Benefit Rate (CBR), Response Duration (DoR), PFS, OS, and Safety.
divided 80 patients with rare sarcoma into five groups by histological type: spinal cord tumor (n s 24), alba soft sarcoma (ASPS, n s 13), hypertrophia small circular cell tumor (DSRCT, n s6), smarca4 missing malignant transverse fibroids (SMBT, n s6) and other tissue types (n s 31).
results showed that the medium PFS was 5.7 months in spinal cord tumors, 14 months in ASPS, 5 months in DSCRCT, 5 months in SMBT, and 2.7 months in other histological types (p - 0.00016).
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