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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Vydáno v:	The Lancet (British edition) Ročník 404; číslo 10467; s. 2053 - 2064
Hlavní autoři:	Mowery, Yvonne M, Ballman, Karla V, Hong, Angela M, Schuetze, Scott M, Wagner, Andrew J, Monga, Varun, Heise, Rachel S, Attia, Steven, Choy, Edwin, Burgess, Melissa A, Bae, Susie, Pryor, David I, Van Tine, Brian A, Tinoco, Gabriel, Chmielowski, Bartosz, Freeman, Carolyn, Gronchi, Alessandro, Meyer, Christian F, Dickson, Mark A, Hartner, Lee, Davis, Lara E, Powers, Benjamin C, Moding, Everett J, Weinhold, Kent J, van de Rijn, Matt, Brigman, Brian E, Riedel, Richard F, Kirsch, David G
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	England Elsevier Ltd 23.11.2024 Elsevier Limited
Témata:	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
ISSN:	0140-6736, 1474-547X, 1474-547X
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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.
AbstractList	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. 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.
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
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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, 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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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with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial publication-title: Lancet Oncol doi: 10.1016/S1470-2045(20)30737-3 – volume: 23 start-page: 135 year: 2023 ident: 10.1016/S0140-6736(24)01812-9_bib10 article-title: Overview of the synergistic use of radiotherapy and immunotherapy in cancer treatment: current challenges and scopes of improvement publication-title: Expert Rev Anticancer Ther doi: 10.1080/14737140.2023.2173175 – volume: 124 start-page: 3819 year: 2018 ident: 10.1016/S0140-6736(24)01812-9_bib4 article-title: Rationale and emerging strategies for immune checkpoint blockade in soft tissue sarcoma publication-title: Cancer doi: 10.1002/cncr.31517 – volume: 9 start-page: 1205 year: 2023 ident: 10.1016/S0140-6736(24)01812-9_bib21 article-title: Checkpoint inhibitors in combination with stereotactic body radiotherapy in patients with advanced solid tumors: the CHEERS phase 2 randomized clinical trial publication-title: JAMA Oncol doi: 10.1001/jamaoncol.2023.2132 – volume: 78 start-page: 822 year: 2020 ident: 10.1016/S0140-6736(24)01812-9_bib26 article-title: Final analysis of the ipilimumab versus placebo following radiotherapy phase III trial in postdocetaxel metastatic castration-resistant prostate cancer identifies an excess of long-term survivors publication-title: Eur Urol doi: 10.1016/j.eururo.2020.07.032 – volume: 402 start-page: 871 year: 2023 ident: 10.1016/S0140-6736(24)01812-9_bib22 article-title: Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: an open-label, randomised, phase 2 trial publication-title: Lancet doi: 10.1016/S0140-6736(23)01384-3 – volume: 520 start-page: 373 year: 2015 ident: 10.1016/S0140-6736(24)01812-9_bib18 article-title: Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer 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
URI	https://www.clinicalkey.com/#!/content/1-s2.0-S0140673624018129 https://dx.doi.org/10.1016/S0140-6736(24)01812-9 https://www.ncbi.nlm.nih.gov/pubmed/39547252 https://www.proquest.com/docview/3131758547 https://www.proquest.com/docview/3128979529
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