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Baseline Peripheral Blood Biomarkers Associated with Clinical Outcome of Advanced Melanoma Patients Treated with Ipilimumab
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Abstract
Purpose: To identify baseline peripheral blood biomarkers associated with clinical outcome following ipilimumab treatment in advanced melanoma patients. Experimental Design: Frequencies of myeloid-derived suppressor cells (MDSC) and regulatory T cells (Treg), serum lactate dehydrogenase (LDH), routine blood counts, and clinical characteristics were assessed in 209 patients. Endpoints were overall survival (OS) and best overall response. Statistical calculations were done by Kaplan–Meier and Cox regression analysis, including calibration and discrimination by C-statistics. Results: Low baseline LDH, absolute monocyte counts (AMC), Lin−CD14+HLA-DR−/low-MDSC frequencies, and high absolute eosinophil counts (AEC), relative lymphocyte counts (RLC), and CD4+CD25+FoxP3+-Treg frequencies were significantly associated with better survival, and were considered in a combination model. Patients (43.5%) presenting with the best biomarker signature had a 30% response rate and median survival of 16 months. In contrast, patients with the worst biomarkers (27.5%) had only a 3% response rate and median survival of 4 months. The occurrence of adverse events correlated with neither baseline biomarker signatures nor the clinical benefit of ipilimumab. In another model, limited to the routine parameters LDH, AMC, AEC, and RLC, the number of favorable factors (4 vs. 3 vs. 2–0) was also associated with OS (P < 0.001 for all pairwise comparisons) in the main study and additionally in an independent validation cohort. Conclusions: A baseline signature of low LDH, AMC, and MDSCs as well as high AEC, Tregs, and RLC is associated with favorable outcome following ipilimumab. Prospective investigation of the predictive impact of these markers following ipilimumab and other treatments, e.g., PD-1 antibodies, is warranted. Clin Cancer Res; 22(12); 2908–18. ©2016 AACR.
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“Furthermore, an elevated eosinophil count prior to treatment was associated with longer overall survival in several studies.8–12”
In the citing paper
“increased lymphocyte counts in the blood are associated not only with favorable treatment outcome but also with increased overall survival in patients with melanoma treated with ICIs (132-135).”
From Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance (2021) · cites this paper as [134]
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“numerous studies of patients with cancer have indeed found that these myeloid cell subsets, whether in the tumor or in peripheral tissues, were negatively correlated with effective ICI therapy (134, 161, 168-171).”
From Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance (2021) · cites this paper as [134]
In the citing paper
“both a low baseline frequency of MDSCs and a low frequency of MDSCs in the blood of patients with melanoma following ipilimumab treatment were associated with favorable therapy outcome (134, 169-171).”
From Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance (2021) · cites this paper as [134]
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MethodT-helper-1-cell cytokines drive cancer into senescence
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“CD4þ T helper cells (15), CD8þ cytotoxic T cells (16, 17), and those targeting melanoma-associated- (18) or neoantigens (19, 20) are in principle able to attack cancer cells and are most likely responsible for the beneficial effects of ipilimumab.”
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“An association of high AMC with poor prognosis was reported before (37, 38), but baseline counts were not predictive for ipilimumab-treated patients in the study of Kitano and colleagues (10).”
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MethodTIL therapy broadens the tumor-reactive CD8+T cell compartment in melanoma patients
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“CD4þ T helper cells (15), CD8þ cytotoxic T cells (16, 17), and those targeting melanoma-associated- (18) or neoantigens (19, 20) are in principle able to attack cancer cells and are most likely responsible for the beneficial effects of ipilimumab.”
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“In contrast, this correlation was neither observed in the current study, nor in recent investigations of large patient cohorts treated within early access programs (12, 49).”
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“Interestingly, higher baseline frequencies of circulating CD4þCD25þFoxP3þ Tregs were associated with improved OS.”
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“MDSCs have also been reported as predictive marker candidates for following ipilimumab administration (10, 30, 31).”
BackgroundMethodResultInfluentialSelf-citationBiomarkers on melanoma patient T Cells associated with ipilimumab treatment
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“CD4þ T helper cells (15), CD8þ cytotoxic T cells (16, 17), and those targeting melanoma-associated- (18) or neoantigens (19, 20) are in principle able to attack cancer cells and are most likely responsible for the beneficial effects of ipilimumab.”
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Self-citationPrognostic score for patients with advanced melanoma treated with ipilimumab
Diem, S., Kasenda, B., Martín-Liberal, J., Lee, A. T. J., Chauhan, D., Gore, M. E., & Larkin, J. (2015) · European Journal of Cancer · doi:10.1016/j.ejca.2015.09.007 · Cited by 66 · cited 1×
“A model based on the number of involved organs, the Eastern Cooperative Oncology Group (ECOG) performance status, and LDH prior to initiation of ipilimumab treatment was recently reported by Diem and colleagues (46).”
MethodValpione, S., Martinoli, C., Fava, P., D, S. M. M., Campana, L. G., Quaglino, P., Ferrucci, P. F., Pigozzo, J., Astrua, C., Testori, A., et al. (2015) · European Journal of Cancer · doi:10.1016/j.ejca.2015.06.130 · Cited by 51 · cited 1×
“11–13, 23, 24), the neutrophil count (25), or the neutrophil to lymphocyte ratio (26)was reported by different groups as other possible biomarkers.”
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“An association of high AMC with poor prognosis was reported before (37, 38), but baseline counts were not predictive for ipilimumab-treated patients in the study of Kitano and colleagues (10).”
BackgroundSchindler, K., Harmankaya, K., Postow, M. A., Frantal, S., Bello, D., Ariyan, C. E., Michielin, O. A., Hoeller, C., Pehamberger, H., & Wolchok, J. D. (2013) · Journal of Clinical Oncology · doi:10.1200/jco.2013.31.15_suppl.9024 · Cited by 30 · cited 1×
“Similar findings were reported by Schindler and colleagues at the ASCOmeeting 2013 (36) and an increase of eosinophils during ipilimumab was associated with OS in the study of Delyon and colleagues (12).”
ResultSelf-citationHarrell, F., Jr. (1996) · doi:10.1002/(sici)1097-0258(19960229)15:4
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Metadata
- Authors
- Martens, A., Wistuba-Hamprecht, K., Foppen, M. G., Yuan, J., Postow, M. A., Wong, P., Romano, E., Khammari, A., Dreno, B., Capone, M., Ascierto, P. A., Di Giacomo, A. M., Maio, M., Schilling, B., Sucker, A., Schadendorf, D., Hassel, J. C., Eigentler, T. K., Martus, P., Wolchok, J. D., Blank, C., Pawelec, G., Garbe, C., & Weide, B.
- Affiliations
- Universitätsklinikum Tübingen (DE)
- 1Department of Dermatology, University Medical Center, Tübingen, Germany.
- The Netherlands Cancer Institute (NL)
- Memorial Sloan Kettering Cancer Center (US)
- Institut Curie (FR)
- Inserm (FR)
- 7Department of Oncodermatology, INSERM Research Unit 892, University Hospital, Nantes, France.
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- 9Division of Medical Oncology and Immunotherapy, University Hospital of Siena, Italy.
- University of Siena (IT)
- Essen University Hospital (DE)
- Heidelberg University (DE)
- University of Tübingen (DE)
- Corresponding author
- Weide, Benjamin
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2016-06-14
- Volume
- 22
- Issue
- 12
- Pages
- 2908-2918
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC5770142
- OpenAlex
- W2282962877
- Semantic Scholar
- 687f623ec6cd13653346165ccad52a8570919d07
- Cited by
- 541
- References
- 55
- Citations by year
- 2026: 10 · 2025: 29 · 2024: 21 · 2023: 42 · 2022: 50 · 2021: 75 · 2020: 85 · 2019: 61 · 2018: 70 · 2017: 63 · 2016: 33
- FWCI
- 40.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Use Siena air (University of Siena) (submittedVersion, other-oa)
- HAL (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Funders
- Bristol-Myers-Squibb (Munich, Germany) and EU Seventh Framework Program "PRIAT" (305309 and DFG PA 361-22/1)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Health Sciences › Medicine › Oncology › Inflammatory Biomarkers in Disease Prognosis
- Keywords
- advanced melanoma, ipilimumab, predictive biomarkers, myeloid-derived suppressor cells, regulatory T cells, lactate dehydrogenase, absolute monocyte count, absolute eosinophil count, overall survival, best overall response, immune checkpoint inhibitors, anti-PD-1
- MeSH terms
- Myeloid-Derived Suppressor Cells, Antineoplastic Agents, Immunological, Ipilimumab, Aged, Erythrocyte Count, Female, Humans, L-Lactate Dehydrogenase, Male, Melanoma, Skin Neoplasms, Biomarkers, Tumor, Treatment Outcome, Lymphocyte Count, T-Lymphocytes, Regulatory
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