Abstract | PURPOSE: PATIENTS AND METHODS: This single-center, single-arm, phase II trial enrolled patients with unresectable or metastatic STS with no prior anthracycline therapy. Patients received pembrolizumab 200 mg i.v. and doxorubicin (60 mg/m2 cycle 1 with subsequent escalation to 75 mg/m2 as tolerated). The primary endpoint was safety. Secondary endpoints included overall survival (OS), objective response rate (ORR), and progression-free survival (PFS) based on RECIST v1.1 guidelines. RESULTS: Thirty patients were enrolled (53.3% female; median age 61.5 years; 87% previously untreated) with 4 (13.3%) patients continuing treatment. The study met its primary safety endpoint by prespecified Bayesian stopping rules. The majority of grade 3+ treatment-emergent adverse events were hematologic (36.7% 3+ neutropenia). ORR was 36.7% [95% confidence interval (CI), 19.9-56.1%], with documented disease control in 80.0% (95% CI, 61.4-92.3%) of patients. Ten (33.3%) patients achieved partial response, 1 (3.3%) patient achieved complete response, and 13 (43.3%) patients had stable disease. Median PFS and OS were 5.7 months (6-month PFS rate: 44%) and 17 months (12-month OS rate: 62%), respectively. Programmed cell death ligand-1 (PD-L1) expression was associated with improved ORR, but not OS or PFS. CONCLUSIONS:
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Authors | Michael B Livingston, Megan H Jagosky, Myra M Robinson, William A Ahrens, Jennifer H Benbow, Carol J Farhangfar, David M Foureau, Deirdre M Maxwell, Emily A Baldrige, Xhevahire Begic, James T Symanowski, Nury M Steuerwald, Colin J Anderson, Joshua C Patt, Jeffrey S Kneisl, Edward S Kim |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 27
Issue 23
Pg. 6424-6431
(12 01 2021)
ISSN: 1557-3265 [Electronic] United States |
PMID | 34475102
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | ©2021 American Association for Cancer Research. |
Chemical References |
- Antibodies, Monoclonal, Humanized
- Doxorubicin
- pembrolizumab
|
Topics |
- Antibodies, Monoclonal, Humanized
(adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Bayes Theorem
- Doxorubicin
(adverse effects)
- Female
- Humans
- Male
- Middle Aged
- Sarcoma
(pathology)
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