Evidence map›Paper›PMID 39547252›Full record

Trial reportLancet (London, England)2024

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.

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 and 18 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03092323 (SU2C-SARC032), which is not on this map. Cited by 58 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03092323 phase2active not recruitingnot on this map

SU2C-SARC032: A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity

TypeinterventionalSponsorSarcoma Alliance for Research through CollaborationRan2017 to 2028Enrolled126ConditionsSoft Tissue Sarcoma of the ExtremityArmsPembrolizumab
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. The Next Frontier in Quantitative Co-Clinical Imaging to Advance Functional Precision Oncology.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. How I treat soft tissue sarcomas.Future oncology (London, England) · 2026
    Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Yvonne M MoweryDepartment of Radiation Oncology, UPMC Hillman Cancer Center-University of Pittsburgh, Pittsburgh, PA, USA; Department of Radiation Oncology, Duke University, Durham, NC, USA; Duke Cancer Institute, Durham, NC, USA.
Karla V BallmanDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.
Angela M HongDepartment of Radiation Oncology, Chris O'Brien Lifehouse-Royal Prince Alfred Hospital, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Scott M SchuetzeDivision of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Andrew J WagnerSarcoma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Varun MongaDivision of Hematology and Oncology, Department of Medicine, Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; Division of Hematology and Oncology, Department of Medicine, UCSF Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.
Rachel S HeiseDepartment of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Steven AttiaDivision of Hematology and Oncology, Department of Medicine, Mayo Clinic in Florida, Jacksonville, FL, USA.
Edwin ChoyDivision of Hematology Oncology, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Melissa A BurgessDivision of Hematology and Oncology, Department of Medicine, UPMC Hillman Cancer Center, Pittsburgh, PA, USA.
Susie BaeDepartment of Medical Oncology, Peter MacCallum Cancer Centre and Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC, Australia.
David I PryorDepartment of Radiation Oncology, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, QLD, Australia.
Brian A Van TineDivision of Oncology, Department of Medicine, Washington University in St Louis School of Medicine, St Louis, MO, USA.
Gabriel TinocoDivision of Medical Oncology, Department of Medicine, The Ohio State University, Arthur G James Comprehensive Cancer Center, Columbus, OH, USA.
Bartosz ChmielowskiDivision of Hematology and Medical Oncology, Department of Medicine, Jonsson Comprehensive Cancer Center, The University of California Los Angeles, Los Angeles, CA, USA.
Carolyn FreemanDepartment of Radiation Oncology, McGill University Health Centre, Montreal, QC, Canada.
Alessandro GronchiDepartment of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Christian F MeyerDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Mark A DicksonDivision of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Lee HartnerDivision of Hematology and Medical Oncology, Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
Lara E DavisDivision of Hematology and Medical Oncology, Department of Medicine, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.
Benjamin C PowersDivision of Medical Oncology, Department of Internal Medicine, The University of Kansas Cancer Center, Kansas City, KS, USA.
Everett J ModingDepartment of Radiation Oncology, Stanford University, Palo Alto, CA, USA.
Kent J WeinholdDepartment of Surgery, Duke University, Durham, NC, USA; Department of Immunology, Duke University, Durham, NC, USA; Duke Cancer Institute, Durham, NC, USA.
Matt van de RijnDepartment of Pathology, Stanford University, Palo Alto, CA, USA.
Brian E BrigmanDepartment of Orthopaedic Surgery, Duke University, Durham, NC, USA; Duke Cancer Institute, Durham, NC, USA.
Richard F RiedelDivision of Medical Oncology, Department of Medicine, Duke University, Durham, NC, USA; Duke Cancer Institute, Durham, NC, USA.
David G KirschDepartment of Radiation Oncology, Duke University, Durham, NC, USA; Duke Cancer Institute, Durham, NC, USA; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada; Department of Radiation Oncology, University of Toronto, Toronto, ON, Canada. Electronic address: david.kirsch@uhn.ca.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Eric R. Fearon · 1988 to 2026
$178.2M
Advancing Cancer Therapy through Ground Breaking Research in Radiation BiologyR35CA197616 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI David Guy Kirsch · 2016 to 2026
$10.7M
Employing Novel Primary Mouse Models of Head and Neck Cancer to Overcome Chemoradiation ResistanceK08DE029887 · NIDCR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI MOWERY, YVONNE MARIE · 2020 to 2024
$804k
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA046592NCI NIH HHS R35 CA197616NIDCR NIH HHS K08 DE029887
6 · The paper itself

Abstract

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.

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).

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%).

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.

fundingStand Up to Cancer and Merck Sharp & Dohme.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalExtremitiesSarcomaAdultAgedCombined Modality TherapyDisease-Free SurvivalFemaleHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm StagingTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumab

Identifiers

PMID39547252
PMCPMC11842127

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.