THURSDAY, Nov. 21, 2024 (HealthDay News) — For patients with stage III undifferentiated pleomorphic sarcoma or dedifferentiated or pleomorphic liposarcoma of the extremity and limb girdles, adding pembrolizumab to preoperative radiotherapy and surgery improves disease-free survival, according to a study published online Nov. 12 in The Lancet.
Yvonne M. Mowery, M.D., from the University of Pennsylvania in Pittsburgh, and colleagues conducted an open-label, randomized clinical trial in patients with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma or dedifferentiated or pleomorphic liposarcoma of the extremity and limb girdles. Patients were randomly assigned to preoperative radiotherapy then surgery (control group) or preoperative pembrolizumab with radiotherapy, then surgery and postoperative pembrolizumab (experimental group). Pembrolizumab was administered as three neoadjuvant cycles before, during, and after radiotherapy, and as 14 or less adjuvant cycles.
The modified intention-to-treat analysis included 127 patients with median follow-up of 43 months (64 in the experimental group and 63 in the control group). The researchers found that disease-free survival was significantly longer for the experimental group than the control group (hazard ratio, 0.61). With the addition of pembrolizumab, two-year disease-free survival increased by 15 percent (52 and 67 percent for control and experimental groups, respectively). For the intention-to-treat patient population, disease-free survival was similarly improved (hazard ratio, 0.61). Compared with the control group, in the experimental group, grade 3 or higher adverse events occurred more frequently (56 versus 31 percent).
“Findings from SU2C-SARC032 indicate that pembrolizumab is a promising new treatment option for these patients and suggest a path for even greater therapeutic effect by further optimizing immunotherapy,” the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Merck, which manufactures pembrolizumab and funded the study.
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