Gustavo Viani: Pembrolizumab as a novel systemic therapy option for stage III undifferentiated pleomorphic sarcoma
Gustavo Viani, Associate Professor in the Department of Medical Imaging, Hematology, and Oncology at Hospital das Clínicas, shared on LinkedIn:
“SU2C-SARC032 shows pembrolizumab as a novel systemic therapy option for participants with stage III undifferentiated pleomorphic sarcoma or liposarcoma(grade 2 or 3) of the extremity‼️
OBJECTIVE
• Assess whether adding pembrolizumab to preoperative radiation therapy and surgery increaces disease-free survival(DFS) in participants with high-risk soft tissue sarcoma of the extremity.
METHODS
• Design: Open-label, randomized clinical trial
• Participants: Participants with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma or dedifferentiated/pleomorphic liposarcoma of the extremity and limb
• Intervention:
• Control group: Preoperative surgery
• Experimental group: Preoperative pembrolizumab with surgery and postoperative pembrolizumab
• Pembrolizumab dosage: 200 mg intravenously every 3 weeks (3 neoadjuvant cycles and up to 14 adjuvant cycles)
• Endpoint: Disease-free survival.
RESULTS
• Sample Size: 143 participants were randomized; 127 included in the modified ITT analysis
• Follow-up: Median of 43 months
• Disease-Free Survival:
• Experimental group significantly high disease-free survival compared to control (HR 0.61; 90% CI 0.39–0.96; p=0.035)
• 2-year DFS:
• Control group: 52% (90% CI 42–64).
• Experimental group: 67% (90% CI 58–78)
• Adverse Events:
• Grade 3 or higher adverse events were more high in the experimental group (56%) compared to the control group (31%).”
Authors: Yvonne M Mowery, Karla V Ballman, Angela M Hong, Scott M Schuetze, Andrew J Wagner, Varun Monga, Rachel S Heise, Steven Attia, Edwin Choy, Melissa A Burgess, Susie Bae, David I Pryor, Brian A Van Tine, Gabriel Tinoco, Bartosz Chmielowski, Carolyn Freeman, Alessandro Gronchi, Christian F Meyer, Mark A Dickson, Lee Hartner, Lara E Davis, Benjamin C Powers, Everett J Moding, Kent J Weinhold, Matt van de Rijn, Brian E Brigman, Richard F Riedel, David G Kirsch
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Gustavo Viani, MD is an Associate Professor in the Department of Medical Imaging, Hematology, and Oncology at Hospital das Clínicas, Faculty of Medicine of Ribeirão Preto, University of São Paulo (FMRP-USP).
Dr. Viani’s research focuses on radiation oncology, with expertise in brachytherapy, stereotactic radiosurgery, dose fractionation, radiation tolerance, and overall oncology practices.
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