Universität zu Köln

Weide, Benjamin, Martens, Alexander, Hassel, Jessica C., Berking, Carola, Postow, Michael A., Bisschop, Kees, Simeone, Ester, Mangana, Johanna, Schilling, Bastian ORCID: 0000-0001-8859-4103, Di Giacomo, Anna Maria, Brenner, Nicole, Kaehler, Katharina, Heinzerling, Lucie, Gutzmer, Ralf, Bender, Armin, Gebhardt, Christoffer ORCID: 0000-0001-7090-9584, Romano, Emanuela, Meier, Friedegund, Martus, Peter, Maio, Michele ORCID: 0000-0002-0323-6321, Blank, Christian, Schadendorf, Dirk, Dummer, Reinhard, Ascierto, Paolo A., Hospers, Geke, Garbe, Claus ORCID: 0000-0001-8530-780X and Wolchok, Jedd D. (2016). Baseline Biomarkers for Outcome of Melanoma Patients Treated with Pembrolizumab. Clin. Cancer Res., 22 (22). S. 5487 - 5497. PHILADELPHIA: AMER ASSOC CANCER RESEARCH. ISSN 1557-3265

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Abstract

Purpose: Biomarkers for outcome after immune-checkpoint blockade are strongly needed as these may influence individual treatment selection or sequence. We aimed to identify baseline factors associated with overall survival (OS) after pembrolizumab treatment in melanoma patients. Experimental Design: Serum lactate dehydrogenase (LDH), routine blood count parameters, and clinical characteristics were investigated in 616 patients. Endpoints were OS and best overall response following pembrolizumab treatment. Kaplan-Meier analysis and Cox regression were applied for survival analysis. Results: Relative eosinophil count (REC) >= 1.5%, relative lymphocyte count (RLC) >= 17.5%, <= 2.5-fold elevation of LDH, and the absence of metastasis other than soft-tissue/lung were associated with favorable OS in the discovery (n = 177) and the confirmation (n = 182) cohort and had independent positive impact (all P < 0.001). Their independent role was subsequently confirmed in the validation cohort (n = 257; all P < 0.01). The number of favorable factors was strongly associated with prognosis. One-year OS probabilities of 83.9% versus 14.7% and response rates of 58.3% versus 3.3% were observed in patients with four of four compared to those with none of four favorable baseline factors present, respectively. Conclusions: High REC and RLC, low LDH, and absence of metastasis other than soft-tissue/lung are independent baseline characteristics associated with favorable OS of patients with melanoma treated with pembrolizumab. Presence of four favorable factors in combination identifies a subgroup with excellent prognosis. In contrast, patients with no favorable factors present have a poor prognosis, despite pembrolizumab, and additional treatment advances are still needed. A potential predictive impact needs to be further investigated. (C)2016 AACR.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Weide, Benjamin UNSPECIFIED UNSPECIFIED UNSPECIFIED Martens, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED Hassel, Jessica C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Berking, Carola UNSPECIFIED UNSPECIFIED UNSPECIFIED Postow, Michael A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bisschop, Kees UNSPECIFIED UNSPECIFIED UNSPECIFIED Simeone, Ester UNSPECIFIED UNSPECIFIED UNSPECIFIED Mangana, Johanna UNSPECIFIED UNSPECIFIED UNSPECIFIED Schilling, Bastian UNSPECIFIED orcid.org/0000-0001-8859-4103 UNSPECIFIED Di Giacomo, Anna Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Brenner, Nicole UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaehler, Katharina UNSPECIFIED UNSPECIFIED UNSPECIFIED Heinzerling, Lucie UNSPECIFIED UNSPECIFIED UNSPECIFIED Gutzmer, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Bender, Armin UNSPECIFIED UNSPECIFIED UNSPECIFIED Gebhardt, Christoffer UNSPECIFIED orcid.org/0000-0001-7090-9584 UNSPECIFIED Romano, Emanuela UNSPECIFIED UNSPECIFIED UNSPECIFIED Meier, Friedegund UNSPECIFIED UNSPECIFIED UNSPECIFIED Martus, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Maio, Michele UNSPECIFIED orcid.org/0000-0002-0323-6321 UNSPECIFIED Blank, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Schadendorf, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Dummer, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Ascierto, Paolo A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hospers, Geke UNSPECIFIED UNSPECIFIED UNSPECIFIED Garbe, Claus UNSPECIFIED orcid.org/0000-0001-8530-780X UNSPECIFIED Wolchok, Jedd D. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-255671
DOI:	10.1158/1078-0432.CCR-16-0127
Journal or Publication Title:	Clin. Cancer Res.
Volume:	22
Number:	22
Page Range:	S. 5487 - 5497
Date:	2016
Publisher:	AMER ASSOC CANCER RESEARCH
Place of Publication:	PHILADELPHIA
ISSN:	1557-3265
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CELL LUNG-CANCER; METASTATIC MELANOMA; LACTATE-DEHYDROGENASE; UNTREATED MELANOMA; PD-1 BLOCKADE; T-CELLS; IPILIMUMAB; NIVOLUMAB; SAFETY; RESPONSES Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/25567