Pembrolizumab with radiotherapy and surgery improves survival in high-risk soft tissue sarcoma

1. Pembrolizumab plus radiotherapy and surgery significantly improved disease-free survival.

2. Grade 3 or higher adverse events were more common in the pembrolizumab group compared to control.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Many patients with localized, high-risk soft tissue sarcomas develop metastatic disease. Immunotherapy, such as pembrolizumab, has shown potential when combined with conventional therapies such as radiotherapy and surgery. This randomized controlled trial aimed to evaluate whether adding pembrolizumab to preoperative radiotherapy and surgery could improve disease-free survival in patients with stage III undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma of the extremity. The primary outcome of this study was disease-free survival, while a key secondary outcome was the assessment of safety and adverse event rates between treatment groups. According to study results, pembrolizumab significantly increased disease-free survival compared to the control group but was associated with a higher rate of severe adverse events. Although this study was well done, it was limited by a modest sample size, affecting the generalizability of results.

Click to read the study in The Lancet

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In-depth [randomized controlled trial]: Between Nov 18, 2017, and Nov 14, 2023, 143 patients were screened for eligibility across 20 institutions in Australia, Canada, Italy, and the USA. Patients with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma of the extremities were included. Altogether, 127 patients were included in the final analysis. The addition of pembrolizumab to preoperative radiotherapy and surgery significantly improved disease-free survival (hazard ratio [HR] 0.61, 90% confidence interval [CI] 0.39-0.96), increasing the 2-year survival rate by 15% compared to the control group. The secondary outcome revealed a higher incidence of grade 3 or greater adverse events (56% in pembrolizumab vs. 31% in control). Findings from this study suggest that pembrolizumab combined with preoperative radiotherapy and surgery is a promising approach to improve disease-free survival in high-risk soft tissue sarcoma.

Image: PD

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