Safety and efficacy of pembrolizumab, radiation therapy, and surgery versus radiation therapy and surgery for stage III soft tissue sarcoma of the extremity (SU2C-SARC032): an open-label, randomised clinical trial
Approximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether the addition of pembrolizumab to preoperative radiotherapy and surgery would improve disease-free survival. We completed an open-label, randomised clinical tri...
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| Published in: | The Lancet (British edition) Vol. 404; no. 10467; pp. 2053 - 2064 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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England
Elsevier Ltd
23.11.2024
Elsevier Limited |
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| ISSN: | 0140-6736, 1474-547X, 1474-547X |
| Online Access: | Get full text |
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| Abstract | Approximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether the addition of pembrolizumab to preoperative radiotherapy and surgery would improve disease-free survival.
We completed an open-label, randomised clinical trial in patients with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma or dedifferentiated or pleomorphic liposarcoma of the extremity and limb girdle. Patients were enrolled at 20 academic institutions in Australia, Canada, Italy, and the USA. Patients were randomly assigned to preoperative radiotherapy then surgery (control group) or preoperative pembrolizumab with radiotherapy (initiated 1–14 days after the first dose of pembrolizumab) then surgery and postoperative pembrolizumab (experimental group). Pembrolizumab (200 mg intravenously every 3 weeks) was administered as three neoadjuvant cycles (before, during, and after radiotherapy) and 14 or less adjuvant cycles. Primary endpoint was disease-free survival. This study is registered with ClincialTrials.gov (NCT03092323).
Between Nov 18, 2017, and Nov 14, 2023, 143 participants were randomly assigned to treatment. A modified intention-to-treat analysis of 127 patients with median follow-up of 43 months showed that the experimental group (n=64) had significantly longer disease-free survival than the control group (n=63; log-rank one-sided p=0·035; hazard ratio [HR] 0·61; 90% CI 0·39–0·96). The 2-year disease-free survival increased by 15% with addition of pembrolizumab: 52% (90% CI 42–64) and 67% (90% CI 58–78) for the control and experimental groups, respectively. Disease-free survival was similarly improved with pembrolizumab for the intention-to-treat patient population (HR 0·61 [90% CI 0·39–0·95]). Grade 3 or higher adverse events occurred more frequently in the experimental group (56%) than the control group (31%).
Addition of pembrolizumab to preoperative radiotherapy and surgery improves disease-free survival for patients with stage III undifferentiated pleomorphic sarcoma and pleomorphic or dedifferentiated liposarcoma of the extremity, which establishes a promising new treatment option for these patients.
Stand Up to Cancer and Merck Sharp & Dohme. |
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| AbstractList | Approximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether the addition of pembrolizumab to preoperative radiotherapy and surgery would improve disease-free survival.
We completed an open-label, randomised clinical trial in patients with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma or dedifferentiated or pleomorphic liposarcoma of the extremity and limb girdle. Patients were enrolled at 20 academic institutions in Australia, Canada, Italy, and the USA. Patients were randomly assigned to preoperative radiotherapy then surgery (control group) or preoperative pembrolizumab with radiotherapy (initiated 1–14 days after the first dose of pembrolizumab) then surgery and postoperative pembrolizumab (experimental group). Pembrolizumab (200 mg intravenously every 3 weeks) was administered as three neoadjuvant cycles (before, during, and after radiotherapy) and 14 or less adjuvant cycles. Primary endpoint was disease-free survival. This study is registered with ClincialTrials.gov (NCT03092323).
Between Nov 18, 2017, and Nov 14, 2023, 143 participants were randomly assigned to treatment. A modified intention-to-treat analysis of 127 patients with median follow-up of 43 months showed that the experimental group (n=64) had significantly longer disease-free survival than the control group (n=63; log-rank one-sided p=0·035; hazard ratio [HR] 0·61; 90% CI 0·39–0·96). The 2-year disease-free survival increased by 15% with addition of pembrolizumab: 52% (90% CI 42–64) and 67% (90% CI 58–78) for the control and experimental groups, respectively. Disease-free survival was similarly improved with pembrolizumab for the intention-to-treat patient population (HR 0·61 [90% CI 0·39–0·95]). Grade 3 or higher adverse events occurred more frequently in the experimental group (56%) than the control group (31%).
Addition of pembrolizumab to preoperative radiotherapy and surgery improves disease-free survival for patients with stage III undifferentiated pleomorphic sarcoma and pleomorphic or dedifferentiated liposarcoma of the extremity, which establishes a promising new treatment option for these patients.
Stand Up to Cancer and Merck Sharp & Dohme. Approximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether the addition of pembrolizumab to preoperative radiotherapy and surgery would improve disease-free survival.BACKGROUNDApproximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether the addition of pembrolizumab to preoperative radiotherapy and surgery would improve disease-free survival.We completed an open-label, randomised clinical trial in patients with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma or dedifferentiated or pleomorphic liposarcoma of the extremity and limb girdle. Patients were enrolled at 20 academic institutions in Australia, Canada, Italy, and the USA. Patients were randomly assigned to preoperative radiotherapy then surgery (control group) or preoperative pembrolizumab with radiotherapy (initiated 1-14 days after the first dose of pembrolizumab) then surgery and postoperative pembrolizumab (experimental group). Pembrolizumab (200 mg intravenously every 3 weeks) was administered as three neoadjuvant cycles (before, during, and after radiotherapy) and 14 or less adjuvant cycles. Primary endpoint was disease-free survival. This study is registered with ClincialTrials.gov (NCT03092323).METHODSWe completed an open-label, randomised clinical trial in patients with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma or dedifferentiated or pleomorphic liposarcoma of the extremity and limb girdle. Patients were enrolled at 20 academic institutions in Australia, Canada, Italy, and the USA. Patients were randomly assigned to preoperative radiotherapy then surgery (control group) or preoperative pembrolizumab with radiotherapy (initiated 1-14 days after the first dose of pembrolizumab) then surgery and postoperative pembrolizumab (experimental group). Pembrolizumab (200 mg intravenously every 3 weeks) was administered as three neoadjuvant cycles (before, during, and after radiotherapy) and 14 or less adjuvant cycles. Primary endpoint was disease-free survival. This study is registered with ClincialTrials.gov (NCT03092323).Between Nov 18, 2017, and Nov 14, 2023, 143 participants were randomly assigned to treatment. A modified intention-to-treat analysis of 127 patients with median follow-up of 43 months showed that the experimental group (n=64) had significantly longer disease-free survival than the control group (n=63; log-rank one-sided p=0·035; hazard ratio [HR] 0·61; 90% CI 0·39-0·96). The 2-year disease-free survival increased by 15% with addition of pembrolizumab: 52% (90% CI 42-64) and 67% (90% CI 58-78) for the control and experimental groups, respectively. Disease-free survival was similarly improved with pembrolizumab for the intention-to-treat patient population (HR 0·61 [90% CI 0·39-0·95]). Grade 3 or higher adverse events occurred more frequently in the experimental group (56%) than the control group (31%).FINDINGSBetween Nov 18, 2017, and Nov 14, 2023, 143 participants were randomly assigned to treatment. A modified intention-to-treat analysis of 127 patients with median follow-up of 43 months showed that the experimental group (n=64) had significantly longer disease-free survival than the control group (n=63; log-rank one-sided p=0·035; hazard ratio [HR] 0·61; 90% CI 0·39-0·96). The 2-year disease-free survival increased by 15% with addition of pembrolizumab: 52% (90% CI 42-64) and 67% (90% CI 58-78) for the control and experimental groups, respectively. Disease-free survival was similarly improved with pembrolizumab for the intention-to-treat patient population (HR 0·61 [90% CI 0·39-0·95]). Grade 3 or higher adverse events occurred more frequently in the experimental group (56%) than the control group (31%).Addition of pembrolizumab to preoperative radiotherapy and surgery improves disease-free survival for patients with stage III undifferentiated pleomorphic sarcoma and pleomorphic or dedifferentiated liposarcoma of the extremity, which establishes a promising new treatment option for these patients.INTERPRETATIONAddition of pembrolizumab to preoperative radiotherapy and surgery improves disease-free survival for patients with stage III undifferentiated pleomorphic sarcoma and pleomorphic or dedifferentiated liposarcoma of the extremity, which establishes a promising new treatment option for these patients.Stand Up to Cancer and Merck Sharp & Dohme.FUNDINGStand Up to Cancer and Merck Sharp & Dohme. Summary Background Approximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether the addition of pembrolizumab to preoperative radiotherapy and surgery would improve disease-free survival. Methods We completed an open-label, randomised clinical trial in patients with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma or dedifferentiated or pleomorphic liposarcoma of the extremity and limb girdle. Patients were enrolled at 20 academic institutions in Australia, Canada, Italy, and the USA. Patients were randomly assigned to preoperative radiotherapy then surgery (control group) or preoperative pembrolizumab with radiotherapy (initiated 1–14 days after the first dose of pembrolizumab) then surgery and postoperative pembrolizumab (experimental group). Pembrolizumab (200 mg intravenously every 3 weeks) was administered as three neoadjuvant cycles (before, during, and after radiotherapy) and 14 or less adjuvant cycles. Primary endpoint was disease-free survival. This study is registered with ClincialTrials.gov ( NCT03092323). Findings Between Nov 18, 2017, and Nov 14, 2023, 143 participants were randomly assigned to treatment. A modified intention-to-treat analysis of 127 patients with median follow-up of 43 months showed that the experimental group (n=64) had significantly longer disease-free survival than the control group (n=63; log-rank one-sided p=0·035; hazard ratio [HR] 0·61; 90% CI 0·39–0·96). The 2-year disease-free survival increased by 15% with addition of pembrolizumab: 52% (90% CI 42–64) and 67% (90% CI 58–78) for the control and experimental groups, respectively. Disease-free survival was similarly improved with pembrolizumab for the intention-to-treat patient population (HR 0·61 [90% CI 0·39–0·95]). Grade 3 or higher adverse events occurred more frequently in the experimental group (56%) than the control group (31%). Interpretation Addition of pembrolizumab to preoperative radiotherapy and surgery improves disease-free survival for patients with stage III undifferentiated pleomorphic sarcoma and pleomorphic or dedifferentiated liposarcoma of the extremity, which establishes a promising new treatment option for these patients. Funding Stand Up to Cancer and Merck Sharp & Dohme. |
| Author | Gronchi, Alessandro Attia, Steven Choy, Edwin Mowery, Yvonne M Pryor, David I Brigman, Brian E Kirsch, David G Bae, Susie Van Tine, Brian A Davis, Lara E Weinhold, Kent J Heise, Rachel S Meyer, Christian F Powers, Benjamin C Tinoco, Gabriel Wagner, Andrew J Riedel, Richard F Freeman, Carolyn van de Rijn, Matt Schuetze, Scott M Ballman, Karla V Dickson, Mark A Hong, Angela M Chmielowski, Bartosz Hartner, Lee Burgess, Melissa A Moding, Everett J Monga, Varun |
| Author_xml | – sequence: 1 givenname: Yvonne M surname: Mowery fullname: Mowery, Yvonne M organization: Department of Radiation Oncology, UPMC Hillman Cancer Center–University of Pittsburgh, Pittsburgh, PA, USA – sequence: 2 givenname: Karla V surname: Ballman fullname: Ballman, Karla V organization: Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA – sequence: 3 givenname: Angela M surname: Hong fullname: Hong, Angela M organization: Department of Radiation Oncology, Chris O'Brien Lifehouse–Royal Prince Alfred Hospital, Sydney, NSW, Australia – sequence: 4 givenname: Scott M surname: Schuetze fullname: Schuetze, Scott M organization: Division of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA – sequence: 5 givenname: Andrew J surname: Wagner fullname: Wagner, Andrew J organization: Sarcoma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA – sequence: 6 givenname: Varun surname: Monga fullname: Monga, Varun organization: Division of Hematology and Oncology, Department of Medicine, Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA – sequence: 7 givenname: Rachel S surname: Heise fullname: Heise, Rachel S organization: Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA – sequence: 8 givenname: Steven surname: Attia fullname: Attia, Steven organization: Division of Hematology and Oncology, Department of Medicine, Mayo Clinic in Florida, Jacksonville, FL, USA – sequence: 9 givenname: Edwin surname: Choy fullname: Choy, Edwin organization: Division of Hematology Oncology, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA – sequence: 10 givenname: Melissa A surname: Burgess fullname: Burgess, Melissa A organization: Division of Hematology and Oncology, Department of Medicine, UPMC Hillman Cancer Center, Pittsburgh, PA, USA – sequence: 11 givenname: Susie surname: Bae fullname: Bae, Susie organization: Department of Medical Oncology, Peter MacCallum Cancer Centre and Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC, Australia – sequence: 12 givenname: David I surname: Pryor fullname: Pryor, David I organization: Department of Radiation Oncology, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, QLD, Australia – sequence: 13 givenname: Brian A surname: Van Tine fullname: Van Tine, Brian A organization: Division of Oncology, Department of Medicine, Washington University in St Louis School of Medicine, St Louis, MO, USA – sequence: 14 givenname: Gabriel surname: Tinoco fullname: Tinoco, Gabriel organization: Division of Medical Oncology, Department of Medicine, The Ohio State University, Arthur G James Comprehensive Cancer Center, Columbus, OH, USA – sequence: 15 givenname: Bartosz surname: Chmielowski fullname: Chmielowski, Bartosz organization: Division of Hematology and Medical Oncology, Department of Medicine, Jonsson Comprehensive Cancer Center, The University of California Los Angeles, Los Angeles, CA, USA – sequence: 16 givenname: Carolyn surname: Freeman fullname: Freeman, Carolyn organization: Department of Radiation Oncology, McGill University Health Centre, Montreal, QC, Canada – sequence: 17 givenname: Alessandro surname: Gronchi fullname: Gronchi, Alessandro organization: Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy – sequence: 18 givenname: Christian F surname: Meyer fullname: Meyer, Christian F organization: Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 19 givenname: Mark A surname: Dickson fullname: Dickson, Mark A organization: Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA – sequence: 20 givenname: Lee surname: Hartner fullname: Hartner, Lee organization: Division of Hematology and Medical Oncology, Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA – sequence: 21 givenname: Lara E surname: Davis fullname: Davis, Lara E organization: Division of Hematology and Medical Oncology, Department of Medicine, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA – sequence: 22 givenname: Benjamin C surname: Powers fullname: Powers, Benjamin C organization: Division of Medical Oncology, Department of Internal Medicine, The University of Kansas Cancer Center, Kansas City, KS, USA – sequence: 23 givenname: Everett J surname: Moding fullname: Moding, Everett J organization: Department of Radiation Oncology, Stanford University, Palo Alto, CA, USA – sequence: 24 givenname: Kent J surname: Weinhold fullname: Weinhold, Kent J organization: Department of Surgery, Duke University, Durham, NC, USA – sequence: 25 givenname: Matt surname: van de Rijn fullname: van de Rijn, Matt organization: Department of Pathology, Stanford University, Palo Alto, CA, USA – sequence: 26 givenname: Brian E surname: Brigman fullname: Brigman, Brian E organization: Department of Orthopaedic Surgery, Duke University, Durham, NC, USA – sequence: 27 givenname: Richard F surname: Riedel fullname: Riedel, Richard F organization: Division of Medical Oncology, Department of Medicine, Duke University, Durham, NC, USA – sequence: 28 givenname: David G surname: Kirsch fullname: Kirsch, David G email: david.kirsch@uhn.ca organization: Department of Radiation Oncology, Duke University, Durham, NC, USA |
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| DOI | 10.1016/S0140-6736(24)01812-9 |
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publication-title: Nature doi: 10.1038/nature14292 – reference: 39547248 - Lancet. 2024 Nov 23;404(10467):2022-2023. doi: 10.1016/S0140-6736(24)02252-9. |
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| Snippet | Approximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether the addition of... Summary Background Approximately half of patients with localised, high-risk soft tissue sarcoma of the extremity develop metastases. We aimed to assess whether... |
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| SubjectTerms | Adult Aged Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Agents, Immunological - adverse effects Antineoplastic Agents, Immunological - therapeutic use Cancer surgery Cancer therapies Cell death Chemotherapy Clinical outcomes Clinical trials Combined Modality Therapy Disease control Disease-Free Survival Extremities Female Health services Histology Humans Immunotherapy Labels Liposarcoma Male Metastases Metastasis Middle Aged Monoclonal antibodies Neoadjuvant Therapy - methods Neoplasm Staging Oncology Patients Pembrolizumab Radiation dosage Radiation therapy Sarcoma Sarcoma - drug therapy Sarcoma - mortality Sarcoma - radiotherapy Sarcoma - therapy Soft tissue sarcoma Soft tissues Surgery Survival Targeted cancer therapy Toxicity Treatment Outcome |
| Title | Safety and efficacy of pembrolizumab, radiation therapy, and surgery versus radiation therapy and surgery for stage III soft tissue sarcoma of the extremity (SU2C-SARC032): an open-label, randomised clinical trial |
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