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방사선생물학
- 2021년 04월호
[Clin Cancer Res.] Ipilimumab and Radiation in Patients with High-risk Resected or Regionally Advanced MelanomaDuke University / April K S Salama et al.*
- 출처
- Clin Cancer Res.
- 등재일
- 2021 Mar 1
- 저널이슈번호
- 27(5):1287-1295. doi: 10.1158/1078-0432.CCR-20-2452.
- 내용
Abstract
Purpose: In this prospective trial, we sought to assess the feasibility of concurrent administration of ipilimumab and radiation as adjuvant, neoadjuvant, or definitive therapy in patients with regionally advanced melanoma.Patients and methods: Twenty-four patients in two cohorts were enrolled and received ipilimumab at 3 mg/kg every 3 weeks for four doses in conjunction with radiation; median dose was 4,000 cGy (interquartile range, 3,550-4,800 cGy). Patients in cohort 1 were treated adjuvantly; patients in cohort 2 were treated either neoadjuvantly or as definitive therapy.
Results: Adverse event profiles were consistent with those previously reported with checkpoint inhibition and radiation. For the neoadjuvant/definitive cohort, the objective response rate was 64% (80% confidence interval, 40%-83%), with 4 of 10 evaluable patients achieving a radiographic complete response. An additional 3 patients in this cohort had a partial response and went on to surgical resection. With 2 years of follow-up, the 6-, 12-, and 24-month relapse-free survival for the adjuvant cohort was 85%, 69%, and 62%, respectively. At 2 years, all patients in the neoadjuvant/definitive cohort and 10/13 patients in the adjuvant cohort were still alive. Correlative studies suggested that response in some patients were associated with specific CD4+ T-cell subsets.
Conclusions: Overall, concurrent administration of ipilimumab and radiation was feasible, and resulted in a high response rate, converting some patients with unresectable disease into surgical candidates. Additional studies to investigate the combination of radiation and checkpoint inhibitor therapy are warranted.
Affiliations
April K S Salama 1 , Manisha Palta 2 , Christel N Rushing 3 , M Angelica Selim 4 , Kristen N Linney 5 , Brian G Czito 2 , David S Yoo 2 , Brent A Hanks 6 7 , Georgia M Beasley 8 , Paul J Mosca 8 , Chelsae Dumbauld 9 , Katelyn N Steadman 8 , John S Yi 8 , Kent J Weinhold 8 , Douglas S Tyler 10 , Walter T Lee 11 , David M Brizel 2 11
1 Department of Medicine, Division of Medical Oncology, Duke University, Durham, North Carolina. april.salama@duke.edu.
2 Department of Radiation Oncology, Duke University, Durham, North Carolina.
3 Biostatistics, Duke Cancer Institute, Durham, North Carolina.
4 Department of Pathology, Duke University, Durham, North Carolina.
5 Duke Clinical Research Institute, Durham, North Carolina.
6 Department of Medicine, Division of Medical Oncology, Duke University, Durham, North Carolina.
7 Department of Pharmacology and Cancer Biology, Durham, North Carolina.
8 Department of Surgery, Duke University, Durham, North Carolina.
9 Department of Immunology, Mayo Clinic Scottsdale, Scottsdale, Arizona.
10 Department of Surgery, The University of Texas Medical Branch at Galveston, Galveston, Texas.
11 Department of Head and Neck Surgery & Communication Sciences, Duke University, Durham, North Carolina.
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