Assessment of Doxorubicin and Pembrolizumab in Patients With Advanced Anthracycline-Naive Sarcoma: A Phase 1/2 Nonrandomized Clinical Trial
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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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In a trial of doxorubicin and pembrolizumab in chemo-naive sarcoma patients, three cases with conventional chondrosarcoma had no dimensional responses.
“This trial included three cases with conventional chondrosarcoma, with no dimensional responses observed.”
From Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single‐arm, phase 2 trial (2025) · cites this paper as [55]
Table 1 (Results, Patient Demographic Characteristics) confirms that the trial included three patients with conventional chondrosarcoma. But the Tumor Response section reports a 26% decrease in tumor size in one patient with conventional chondrosarcoma, contrary to the claim that no dimensional responses were observed. (LLM, conf=0.88)
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Self-citation
- 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
- Venue
- JAMA Oncology
- Publisher
- American Medical Association (AMA)
- Published
- 2020-11-01
- Volume
- 6
- Issue
- 11
- Pages
- 1778
- ISSN
- 2374-2437 (ISSN-L)
- 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 › Pulmonary and Respiratory Medicine › 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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