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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]
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“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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BackgroundFinal Version of 2009 AJCC Melanoma Staging and Classification
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BackgroundIpilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma
Robert, C., Thomas, L., Bondarenko, I., O'Day, S., Weber, J., Garbe, C., Lebbe, C., Baurain, J.-F., Testori, A., Grob, J.-J., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1104621 · Cited by 4,496 · cited 1×
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Snyder, A., Makarov, V., Merghoub, T., Yuan, J., Zaretsky, J. M., Desrichard, A., Walsh, L. A., Postow, M. A., Wong, P., Ho, T. S., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1406498 · Cited by 4,286 · cited 3×
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Items 401–500 of 543
Xu, T., Dai, J., Tang, L., Sun, L., Si, L., & Guo, J. (2023) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-023-03502-7 · Cited by 10
“Cancer is a systemic disease in which cell components in the peripheral blood are associated with clinical outcomes in patients with melanoma receiving immunotherapy [32].”
BackgroundBiomarqueurs prédictifs de réponse aux traitements bloquant les voies de costimulation inhibitrices
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“In 209 patients with advanced melanoma treated with ipilimumab, low baseline LDH, low absolute monocyte counts, and low Lin−CD14+HLA−DR−/low-myeloid-derived suppressor cell (MDSC) frequencies were significantly associated with improved survival, as were high absolute eosinophil counts, high relative lymphocyte counts,…”
BackgroundSelf-citationGenetic and epigenetic strategies for advancing ovarian cancer immunotherapy
Cho, Y., Milane, L. S., & Amiji, M. M. (2019) · Expert Opinion on Biological Therapy · doi:10.1080/14712598.2019.1602605 · Cited by 7
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“Many studies have associated MDSC expansion with worse patient clinical outcomes in solid tumors, including skin (25), pancreatic (26), brain (27), prostate (28), lung (29), and breast cancers (30, 31), and have uncovered MDSC enumeration as a prognostic biomarker of response to immune therapies (32, 33).”
BackgroundNon-Small Cell Lung Cancer – from Immunobiology to Immunotherapy
Bílek, O., Bohovicová, L., Demlová, R., Poprach, A., Lakomý, R., & Dubská, L. Z. (2016) · Klinicka onkologie · doi:10.14735/amko20164s78 · Cited by 8
Oncogenic Signalling Pathways in Cancer Immunotherapy: Leader or Follower in This Delicate Dance?
Cartwright, D., Kidd, A. C., Ansel, S., Ascierto, M. L., & Spiliopoulou, P. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26094393 · Cited by 9
“Multiple trials have shown that the presence of circulating MDSCs is associated with poor response to immune checkpoint inhibition [38–40].”
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“Many indicators were reported to be used to predict the curative effect of immunotherapy, such as lactate dehydrogenase (LDH) (23), neutrophil-to-lymphocyte ratio (20), and neutrophil count (24, 25).”
MethodMartínez-Vila, C., Moreno, F. A., Estebanez, M. M., Ares, G. R., Villacampa, G. J., Dashti, P., Oberoi, H., Huertas, R. M., Jares, P., Alós, L., et al. (2021) · Clinical & Translational Oncology · doi:10.1007/s12094-021-02692-9 · Cited by 7
“Limited reports have investigated peripheral blood counts as biomarkers for the ipilimumab plus nivolumab combination, with one study describing a worse OS in patients with a higher NLR treated with this drug combination [16].”
BackgroundResultNovel Biomarkers and Druggable Targets in Advanced Melanoma
Ferrucci, P. F., & Cocorocchio, E. (2021) · Cancers · doi:10.3390/cancers14010081 · Cited by 7
“Furthermore, another analysis of 209 advanced melanoma patients showed that baseline levels of low Lin−CD14+HLA−DR−/low-MDSCs and high CD4+CD25+FoxP3+-Tregs, were significantly associated with better survival [69].”
ResultNutritional Regulation of Mammary Tumor Microenvironment
Thakkar, N., Shin, Y. B., & Sung, H. (2022) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2022.803280 · Cited by 7
“As eosinophils counts are predictive for cancer prognosis (Martens et al., 2016) and play at least a partial role in mediating immune checkpoint blockade antibody response in mammary tumors (Zheng et al.”
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“Various approaches have been explored to identify biomarkers associated with efficacy in ICI-treated patients, such as immunophenotyping [12–14], cytokine profiling [15, 16], immune-related transcriptional signature [17–23], TCR clonality [24, 25], and multiplex IHC [26–28].”
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“Relative lymphocyte count demonstrates significant prognostic value in melanoma (155,156), non‑small cell lung cancer and RCC (157).”
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“Earlier studies have shown that immune cell infiltration in tumors, immune activation, and the pre-existing level of immunity are critical for the response to immunotherapy [14–16].”
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PREDICTIVE RESPONSE MARKERS FOR IMMUNE RESPONSE BLOCKS
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Lung Adenocarcinoma with Paraneoplastic Hyper-Eosinophilia Not Responding To Pembrolizumab
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MYO1F in neutrophils is required for the response to immune checkpoint blockade therapy
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“Previously reported baseline predictive factors [4,5] failed in both cases.”
BackgroundSelf-citationIsolation and Phenotyping of Splenic Myeloid-Derived Suppressor Cells in Murine Cancer Models
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“Unexpectedly, we did not see differences in monocytic and MDSC subsets between the two patient groups, suggesting no direct associations between dynamics of MAE-specific CD8+ T cell populations and the peripheral frequencies of these cells that were previously reported as biomarker candidates in melanoma under ICB (8,…”
ResultSelf-citationSpisarová, M., Melichar, B., Juráňová, J., Zemánková, A., Adam, T., Matoušová, K., Javorská, L., Krčmová, L. K., Turoňová, D., & Študentová, H. (2023) · In Vivo · doi:10.21873/invivo.13091 · Cited by 5
“In some series, increased baseline level of lymphocytes has been observed as a prognostic and predictive biomarker with better response to immunotherapy (16).”
BackgroundQuantitative evaluation of tumor-specific T cells in tumors and lymphoid tissues
Kokolus, K. M., Obermajer, N., & Kaliński, P. (2019) · Methods in enzymology on CD-ROM/Methods in enzymology · doi:10.1016/bs.mie.2019.05.041 · Cited by 5
“In a clinical setting, frequency of circulating MDSCs is associated with a poor response to the ICI αCTLA-4 (Meyer et al., 2014; Weide et al., 2014; Martens et al., 2016; Sade-Feldman et al., 2016) and thus neutralization of this subset of cells has become an important topic of ongoing research (Weber et al.”
BackgroundInfluentialPeripheral eosinophils and immunotherapy response in patients with recurrent or metastatic HNSCC
Qin, Y., Yao, S., Huang, H., Xiao, Y., Wang, J., She, L., Chen, C., Wang, X., Luo, A., & Zhu, G. (2025) · Scientific Reports · doi:10.1038/s41598-025-01457-6 · Cited by 4
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“Serum lactate dehydrogenase (LDH) remains one of the most established and clinically implemented biomarkers in melanoma [58,59].”
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“Regarding LDH as assessed by peripheral blood, some studies have shown that elevations are associated with favorable OS after ICI therapy whilst others have shown correlations in the opposite direction [75, 80, 81].”
BackgroundRadiation-induced eosinophil increase ratio predicts patient outcomes in non-small celllung cancer
Wang, N.-H., Zhang, X., Sui, J.-D., Wang, Y., Wu, Y., Lei, Q., Tu, H., Yang, L., Liu, Y.-C., Yang, M., et al. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.999555 · Cited by 4
“High levels of eosinophils in colorectal tumor (12), nasopharyngeal carcinomas (13), and melanomas (14) correlated with better outcomes.”
BackgroundWang, H.-L., Ye, Z.-M., He, Z.-Y., Huang, L. H., & Liu, Z. (2023) · Hereditas · doi:10.1186/s41065-023-00267-y · Cited by 4
“Additionally, MDSCs often become tumorassociated macrophages [22], even shadowing the risk of death in tumor-ridden patients and increasing the risk of checkpoint inhibitor resistance [23, 24].”
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“…in patients with various tumor types, including chemotherapy for breast, colorectal, and lung cancer [12–16]; trastuzumab for HER2-positive breast cancer [17]; immune checkpoint inhibitors (ICIs) for lung, head and neck cancer, and melanoma [18–21]; and immuno-radiotherapy for solid tumors [22].”
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“Several studies, trying to identify useful biomarkers associated with melanoma response to ICI administration, have demonstrated that an increase of eosinophils during immuno-therapy in those patients has been associated with a higher OS rate [8, 12, 13].”
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“In recent years, the emergence of immune checkpoint inhibitors(ICIs) has changed the treatment strategies of many advanced solid tumors, including NSCLC. ICIs in neoadjuvant therapy, blocking the inhibitory signal on the surface of cancer cells and re-activate the antitumor response by activating T cells, can promote…”
BackgroundFlow Cytometry in Cancer Immunotherapy: Applications, Quality Assurance, and Future
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“Recently, altered monocyte phenotypes in the blood of patients with different cancers were shown to serve as diagnostic (30, 31), predictive (32), and prognostic (33) biomarkers (34).”
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Flow Cytometry in Cancer Immunotherapy: Applications, Quality Assurance, and Future
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Immune Monitoring during Cancer Immunotherapy
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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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