Cited by 145Sarcoma Diagnosis and TreatmentCancer Immunotherapy and BiomarkersLymphoma Diagnosis and Treatment

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Assessment of Doxorubicin and Pembrolizumab in Patients With Advanced Anthracycline-Naive Sarcoma: A Phase 1/2 Nonrandomized Clinical Trial

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Pollack, Seth M., Redman, Mary W., Baker, Kelsey K., Wagner, Michael J., Schroeder, Brett A., Loggers, Elizabeth T., Trieselmann, Kathryn, Copeland, Vanessa C., Zhang, Shihong, Black, Graeme, McDonnell, Sabrina, Gregory, Jeffrey, Johnson, Rylee, Moore, Roxanne, Jones, Robin L., Cranmer, Lee D.·2020·JAMA Oncology

DOI 10.1001/jamaoncol.2020.3689PMC PMC7489365

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Abstract

IMPORTANCE: Anthracycline-based therapy is standard first-line treatment for most patients with advanced and metastatic sarcomas. Although multiple trials have attempted to show improved outcomes in patients with soft-tissue sarcoma over doxorubicin monotherapy, each has fallen short of demonstrating improved outcomes. OBJECTIVE: To evaluate the safety and efficacy of doxorubicin in combination with pembrolizumab in patients with advanced, anthracycline-naive sarcomas. DESIGN, SETTING, AND PARTICIPANTS: This nonrandomized clinical trial used a 2-stage phase 2 design and was performed at a single, academic sarcoma specialty center. Patients were adults with good performance status and end-organ function. Patients with all sarcoma subtypes were allowed to enroll with the exception of osteosarcoma, Ewing sarcoma, and alveolar and embryonal rhabdomyosarcoma. INTERVENTIONS: Two dose levels of doxorubicin (45 and 75 mg/m2) were tested for safety in combination with pembrolizumab. MAIN OUTCOMES AND MEASURES: Objective response rate (ORR) was the primary end point. Overall survival (OS) and progression-free survival (PFS) were secondary end points. Correlative studies included immunohistochemistry, gene expression, and serum cytokines. RESULTS: A total of 37 patients (22 men; 15 women) were treated in the combined phase 1/2 trial. The median (range) patient age was 58.4 (25-80) years. The most common histologic subtype was leiomyosarcoma (11 patients). Doxorubicin plus pembrolizumab was well tolerated without significant unexpected toxic effects. The ORR was 13% for phase 2 patients and 19% overall. Median PFS was 8.1 (95% CI, 7.6-10.8) months. Median OS was 27.6 (95% CI, 18.7-not reached) months at the time of this analysis. Two of 3 patients with undifferentiated pleomorphic sarcoma and 2 of 4 patients with dedifferentiated liposarcoma had durable partial responses. Tumor-infiltrating lymphocytes were present in 21% of evaluable tumors and associated with inferior PFS (log-rank P = .03). No dose-limiting toxic effects were observed. CONCLUSIONS AND RELEVANCE: In this nonrandomized clinical trial, doxorubicin plus pembrolizumab was well tolerated. Although the primary end point for ORR was not reached, the PFS and OS observed compared favorably with prior published studies. Further studies are warranted, especially those focusing on undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02888665.

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Figure. Patient Responses A, Waterfall plot demonstrating the percentage change in tumor size from baseline constituting the best response for each patient. B, Spider plots showing responses for all patients.CC BY-NC-ND · PubMed Central

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Authors: Pollack, S. M., Redman, M. W., Baker, K. K., Wagner, M. J., Schroeder, B. A., Loggers, E. T., Trieselmann, K., Copeland, V. C., Zhang, S., Black, G., McDonnell, S., Gregory, J., Johnson, R., Moore, R., Jones, R. L., & Cranmer, L. D.
Affiliations: University of Washington (US)
Fred Hutch Cancer Center (US)
Virginia Mason Medical Center (US)
Institute of Cancer Research (GB)
Corresponding author: Pollack, Seth M.
ORCID: Pollack, Seth M.
Redman, Mary W.
Baker, Kelsey K.
Wagner, Michael J.
Schroeder, Brett A.
Loggers, Elizabeth T.
Copeland, Vanessa C.
Zhang, Shihong
Black, Graeme
Jones, Robin L.
Cranmer, Lee D.
Venue: JAMA Oncology
Publisher: American Medical Association (AMA)
Published: 2020-11-01
Volume: 6
Issue: 11
Pages: 1778
ISSN: 2374-2437 (ISSN-L)
DOI: 10.1001/jamaoncol.2020.3689
PMC: PMC7489365
OpenAlex: W3083776688
Cited by: 142
References: 17
Citations by year: 2026: 16 · 2025: 31 · 2024: 29 · 2023: 25 · 2022: 25 · 2021: 15 · 2020: 1
FWCI: 9.72
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
Locations: JAMA Oncology (publishedVersion, cc-by-nc-nd)
PubMed Central (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Oncology › Sarcoma Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
Keywords: doxorubicin, pembrolizumab, soft tissue sarcoma, immune checkpoint inhibitors, combination chemotherapy, objective response rate, progression-free survival, overall survival, tumor-infiltrating lymphocytes, leiomyosarcoma, malignant fibrous histiocytoma, dedifferentiated liposarcoma, drug safety and tolerability
MeSH terms: Adult, Aged, Aged, 80 and over, Doxorubicin, Female, Humans, Male, Middle Aged, Sarcoma, Anthracyclines, Antibodies, Monoclonal, Humanized

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Assessment of Doxorubicin and Pembrolizumab in Patients With Advanced Anthracycline-Naive Sarcoma: A Phase 1/2 Nonrandomized Clinical Trial

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