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Book ; Thesis: Isolierte, extrakorporale, xenogene Perfusion normaler und transgener Schweinelebern mit Humanblut

Pöhlein, Christian H.

Entwicklung eines experimentellen Modells ; Basisuntersuchungen als Vorbereitung auf einen zukünftigen, klinischen Einsatz bei akutem Leberversagen

1998

Author's details	vorgelegt von Christian H. Pöhlein
Language	German
Size	149 S. : Ill., graph. Darst.
Document type	Book ; Thesis
Thesis / German Habilitation thesis	München, Univ., Diss., 1998
HBZ-ID	HT010399557
Database	Catalogue ZB MED Medicine, Health

In stock of ZB MED Cologne/Königswinter

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Article ; Online: Measuring Tumor Mutational Burden (TMB) in Plasma from mCRPC Patients Using Two Commercial NGS Assays.

Qiu, Ping / Poehlein, Christian H / Marton, Matthew J / Laterza, Omar F / Levitan, Diane

Scientific reports

2019 Volume 9, Issue 1, Page(s) 114

Abstract: Tumor tissue mutational burden (TMB) has emerged as a promising predictive biomarker for immune checkpoint therapy. Measuring TMB from circulating tumor DNA (ctDNA) found in plasma is attractive in tissue-constrained indications. We compared the ... ...

Abstract	Tumor tissue mutational burden (TMB) has emerged as a promising predictive biomarker for immune checkpoint therapy. Measuring TMB from circulating tumor DNA (ctDNA) found in plasma is attractive in tissue-constrained indications. We compared the performance of two plasma-based commercial TMB assays including the effect of two different collection methods. Our findings suggest that the two plasma based TMB assays are highly correlated and they are also both correlated with a tissue-based TMB assay for relatively high TMB samples. The two collection methods are also found to be very comparable. Plasma-based TMB assays may be mature enough to be clinically useful in mCRPC and potentially other indications.
MeSH term(s)	Biomarkers, Tumor/blood ; Circulating Tumor DNA/blood ; Humans ; Immunotherapy ; Liquid Biopsy ; Male ; Mutation ; Prostatic Neoplasms, Castration-Resistant/blood ; Prostatic Neoplasms, Castration-Resistant/genetics ; Prostatic Neoplasms, Castration-Resistant/therapy ; Tumor Burden
Chemical Substances	Biomarkers, Tumor ; Circulating Tumor DNA
Language	English
Publishing date	2019-01-14
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-018-37128-y
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Article ; Online: Pembrolizumab and Enzalutamide in Patients with Abiraterone Acetate-Pretreated Metastatic Castration-Resistant Prostate Cancer: Cohort C of the Phase 1b/2 KEYNOTE-365 Study.

European urology oncology

2023

Abstract: Background: Limited responses have been observed in patients treated with enzalutamide after disease progression on abiraterone for metastatic castration-resistant prostate cancer (mCRPC), but androgen receptor signaling impacts T-cell function.: ... ...

Abstract	Background: Limited responses have been observed in patients treated with enzalutamide after disease progression on abiraterone for metastatic castration-resistant prostate cancer (mCRPC), but androgen receptor signaling impacts T-cell function. Objective: To evaluate the efficacy and safety of pembrolizumab plus enzalutamide in mCRPC. Design, setting, and participants: Patients in cohort C of the phase 1b/2 KEYNOTE-365 study, who received ≥4 wk of treatment with abiraterone acetate in the prechemotherapy mCRPC state and experienced treatment failure or became drug-intolerant, were included. Intervention: Pembrolizumab 200 mg intravenously every 3 wk plus enzalutamide 160 mg orally once daily. Outcome measurements and statistical analysis: The primary endpoints were safety, the confirmed prostate-specific antigen (PSA) response rate, and the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1 on blinded independent central review (BICR). Secondary endpoints included radiographic progression-free survival (rPFS) on BICR and overall survival (OS). Results and limitations: A total of 102 patients received pembrolizumab plus enzalutamide. Median follow-up was 51 mo (interquartile range 37-56). The confirmed PSA response rate was 24% (95% confidence interval [CI] 16-33%). The confirmed ORR was 11% (95% CI 2.9-25%; 4/38 patients; two complete responses). Median rPFS was 6.0 mo (95% CI 4.1-6.3). Median OS was 20 mo (95% CI 17-24). Treatment-related adverse events (TRAEs) occurred in 94 patients (92%); grade 3-5 TRAEs occurred in 44 patients (43%). The incidence of treatment-related rash was higher with combination therapy than expected from the safety profile of each drug. One patient (1.0%) died of a TRAE (cause unknown). Study limitations include the single-arm design. Conclusions: Pembrolizumab plus enzalutamide had limited antitumor activity in patients who received prior abiraterone treatment without previous chemotherapy for mCRPC, with a safety profile consistent with the individual profiles of each agent. Patient summary: Pembrolizumab plus enzalutamide showed limited antitumor activity and manageable safety in patients with metastatic castration-resistant prostate cancer. The KEYNOTE-365 trial is registered on ClinicalTrials.gov as NCT02861573.
Language	English
Publishing date	2023-11-06
Publishing country	Netherlands
Document type	Journal Article
ISSN	2588-9311
ISSN (online)	2588-9311
DOI	10.1016/j.euo.2023.10.008
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Pembrolizumab Plus Docetaxel and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort B Study.

European urology

2022 Volume 82, Issue 1, Page(s) 22–30

Abstract: Background: Patients with metastatic castration-resistant prostate cancer (mCRPC) frequently receive docetaxel after they develop resistance to abiraterone or enzalutamide and need more efficacious treatments.: Objective: To evaluate the efficacy and ...

Abstract	Background: Patients with metastatic castration-resistant prostate cancer (mCRPC) frequently receive docetaxel after they develop resistance to abiraterone or enzalutamide and need more efficacious treatments. Objective: To evaluate the efficacy and safety of pembrolizumab plus docetaxel and prednisone in patients with mCRPC. Design, setting, and participants: The trial included patients with mCRPC in the phase 1b/2 KEYNOTE-365 cohort B study who were chemotherapy naïve and who experienced failure of or were intolerant to ≥4 wk of abiraterone or enzalutamide for mCRPC with progressive disease within 6 mo of screening. Intervention: Pembrolizumab 200 mg intravenously (IV) every 3 wk (Q3W), docetaxel 75 mg/m Outcome measurements and statistical analysis: The primary endpoints were safety, the prostate-specific antigen (PSA) response rate, and the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR). Secondary endpoints included time to PSA progression; the disease control rate (DCR) and duration of response (DOR) according to RECIST v1.1 by BICR; ORR, DCR, DOR, and radiographic progression-free survival (rPFS) according to Prostate Cancer Working Group 3-modified RECIST v1.1 by BICR; and overall survival (OS). Results and limitations: Among 104 treated patients, 52 had measurable disease. The median time from allocation to data cutoff (July 9, 2020) was 32.4 mo, during which 101 patients discontinued treatment, 81 (78%) for disease progression. The confirmed PSA response rate was 34% and the confirmed ORR (RECIST v1.1) was 23%. Median rPFS and OS were 8.5 mo and 20.2 mo, respectively. Treatment-related adverse events (TRAEs) occurred in 100 patients (96%). Grade 3-5 TRAEs occurred in 46 patients (44%). Seven AE-related deaths (6.7%) occurred (2 due to treatment-related pneumonitis). Limitations of the study include the single-arm design and small sample size. Conclusions: Pembrolizumab plus docetaxel and prednisone demonstrated antitumor activity in chemotherapy-naïve patients with mCRPC treated with abiraterone or enzalutamide for mCRPC. Safety was consistent with profiles for the individual agents. Further investigation is warranted. Patient summary: We evaluated the efficacy and safety of the anti-PD-1 antibody pembrolizumab combined with the chemotherapy drug docetaxel and the steroid prednisone for patients with metastatic prostate cancer resistant to androgen deprivation therapy , and who never received chemotherapy. The combination showed antitumor activity and manageable safety in this patient population. This trial is registered on ClinicalTrials.gov as NCT02861573.
MeSH term(s)	Abiraterone Acetate ; Androgen Antagonists/therapeutic use ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Disease-Free Survival ; Docetaxel/therapeutic use ; Humans ; Male ; Prednisone/therapeutic use ; Prostate-Specific Antigen ; Prostatic Neoplasms, Castration-Resistant/drug therapy ; Prostatic Neoplasms, Castration-Resistant/pathology ; Treatment Outcome
Chemical Substances	Androgen Antagonists ; Antibodies, Monoclonal, Humanized ; Docetaxel (15H5577CQD) ; pembrolizumab (DPT0O3T46P) ; Prostate-Specific Antigen (EC 3.4.21.77) ; Abiraterone Acetate (EM5OCB9YJ6) ; Prednisone (VB0R961HZT)
Language	English
Publishing date	2022-04-06
Publishing country	Switzerland
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, Non-U.S. Gov't
ZDB-ID	193790-x
ISSN	1873-7560 ; 1421-993X ; 0302-2838
ISSN (online)	1873-7560 ; 1421-993X
ISSN	0302-2838
DOI	10.1016/j.eururo.2022.02.023
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 1247: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Corrigendum to "Pembrolizumab plus Olaparib in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort A Study" [Eur Urol 83 (2023) 15-26].

European urology

2022 Volume 83, Issue 3, Page(s) e87

Language	English
Publishing date	2022-12-15
Publishing country	Switzerland
Document type	Published Erratum
ZDB-ID	193790-x
ISSN	1873-7560 ; 1421-993X ; 0302-2838
ISSN (online)	1873-7560 ; 1421-993X
ISSN	0302-2838
DOI	10.1016/j.eururo.2022.11.025
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 1247: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Pembrolizumab plus Olaparib in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort A Study.

European urology

2022 Volume 83, Issue 1, Page(s) 15–26

Abstract: Background: Pembrolizumab and olaparib have shown single-agent activity in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC).: Objective: To evaluate the efficacy and safety of pembrolizumab plus olaparib in ... ...

Abstract	Background: Pembrolizumab and olaparib have shown single-agent activity in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC). Objective: To evaluate the efficacy and safety of pembrolizumab plus olaparib in mCRPC. Design, setting, and participants: Cohort A of the phase 1b/2 KEYNOTE-365 study enrolled patients with molecularly unselected, docetaxel-pretreated mCRPC whose disease progressed within 6 mo of screening. Intervention: Pembrolizumab 200 mg intravenously every 3 wk plus olaparib 400-mg capsule or 300-mg tablet orally twice daily. Outcome measurements and statistical analysis: The primary endpoints were safety, confirmed prostate-specific antigen (PSA) response rate, and objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, by blinded independent central review. The secondary endpoints included radiographic progression-free survival (rPFS) and overall survival (OS). Results and limitations: Of 104 enrolled patients, 102 were treated. The median age was 70 yr (interquartile range [IQR], 65-76), and 59 patients (58%) had measurable disease as per RECIST v1.1. The median time from the first dose to database cutoff was 24 mo (IQR, 22-47). The confirmed PSA response rate was 15%. The confirmed ORR was 8.5% (five partial responses) for patients with measurable disease. The median rPFS was 4.5 mo (95% confidence interval [CI], 4.0-6.5) and median OS was 14 mo (95% CI, 10.4-18.2). Clinical activity was consistent across the programmed death ligand 1 (PD-L1)-positive and homologous recombination repair mutation subgroups. Treatment-related adverse events (TRAEs) occurred in 93 patients (91%). Grade 3-5 TRAEs occurred in 49 patients (48%). Six deaths (5.9%) were due to adverse events; two (myocardial infarction and unknown cause) were attributed to treatment. Limitations of the study include the single-arm design. Conclusions: Pembrolizumab plus olaparib had a safety profile consistent with the profiles of the individual agents and demonstrated antitumor activity in previously treated patients with molecularly unselected, docetaxel-pretreated mCRPC. Patient summary: Pembrolizumab plus olaparib showed antitumor activity and expected safety in patients with metastatic castration-resistant prostate cancer.
MeSH term(s)	Male ; Humans ; Aged ; Prostatic Neoplasms, Castration-Resistant/pathology ; Docetaxel/therapeutic use ; Prostate-Specific Antigen ; Response Evaluation Criteria in Solid Tumors ; Progression-Free Survival
Chemical Substances	Docetaxel (15H5577CQD) ; Prostate-Specific Antigen (EC 3.4.21.77)
Language	English
Publishing date	2022-08-30
Publishing country	Switzerland
Document type	Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article
ZDB-ID	193790-x
ISSN	1873-7560 ; 1421-993X ; 0302-2838
ISSN (online)	1873-7560 ; 1421-993X
ISSN	0302-2838
DOI	10.1016/j.eururo.2022.08.005
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 1247: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 294: Show issues

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Article ; Online: Pembrolizumab Plus Olaparib for Patients With Previously Treated and Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer: The Randomized, Open-Label, Phase III KEYLYNK-010 Trial.

Antonarakis, Emmanuel S / Park, Se Hoon / Goh, Jeffrey C / Shin, Sang Joon / Lee, Jae Lyun / Mehra, Niven / McDermott, Ray / Sala-Gonzalez, Núria / Fong, Peter C / Greil, Richard / Retz, Margitta / Sade, Juan Pablo / Yanez, Patricio / Huang, Yi-Hsiu / Begbie, Stephen D / Gafanov, Rustem Airatovich / De Santis, Maria / Rosenbaum, Eli / Kolinsky, Michael P /

Rey, Felipe / Chiu, Kun-Yuan / Roubaud, Guilhem / Kramer, Gero / Sumitomo, Makoto / Massari, Francesco / Suzuki, Hiroyoshi / Qiu, Ping / Zhang, Jinchun / Kim, Jeri / Poehlein, Christian H / Yu, Evan Y

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2023 Volume 41, Issue 22, Page(s) 3839–3850

Abstract: Purpose: There is an unmet need for therapeutic options that prolong survival for patients with heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC). The phase III, open-label KEYLYNK-010 study evaluated pembrolizumab plus ... ...

Abstract	Purpose: There is an unmet need for therapeutic options that prolong survival for patients with heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC). The phase III, open-label KEYLYNK-010 study evaluated pembrolizumab plus olaparib versus a next-generation hormonal agent (NHA) for biomarker-unselected, previously treated mCRPC. Methods: Eligible participants had mCRPC that progressed on or after abiraterone or enzalutamide (but not both) and docetaxel. Participants were randomly assigned (2:1) to pembrolizumab plus olaparib or NHA (abiraterone or enzalutamide). The dual primary end points were radiographic progression-free survival (rPFS) by blinded independent central review per Prostate Cancer Working Group-modified RECIST 1.1 and overall survival (OS). Time to first subsequent therapy (TFST) was a key secondary end point. Safety and objective response rate (ORR) were secondary end points. Results: Between May 30, 2019, and July 16, 2021, 529 participants were randomly assigned to pembrolizumab plus olaparib and 264 to NHA. At final rPFS analysis, median rPFS was 4.4 months (95% CI, 4.2 to 6.0) with pembrolizumab plus olaparib and 4.2 months (95% CI, 4.0 to 6.1) with NHA (hazard ratio [HR], 1.02 [95% CI, 0.82 to 1.25]; Conclusion: Pembrolizumab plus olaparib did not significantly improve rPFS or OS versus NHA in participants with biomarker-unselected, heavily pretreated mCRPC. The study was stopped for futility. No new safety signals occurred.
MeSH term(s)	Male ; Humans ; Prostatic Neoplasms, Castration-Resistant/pathology ; Treatment Outcome ; Prednisone ; Disease-Free Survival ; Biomarkers ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
Chemical Substances	enzalutamide (93T0T9GKNU) ; pembrolizumab (DPT0O3T46P) ; olaparib (WOH1JD9AR8) ; Prednisone (VB0R961HZT) ; Biomarkers
Language	English
Publishing date	2023-06-08
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.23.00233
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Zs.A 1847: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Book ; Thesis: Isolierte, extrakorporale, xenogene Perfusion normaler und transgener Schweinelebern mit Humanblut

Pöhlein, Christian H

Entwicklung eines experimentellen Modells. Basisuntersuchungen als Vorbereitung auf einen zukünftigen, klinischen Einsatz bei akutem Leberversagen

1998

Author's details	vorgelegt von Christian H. Pöhlein
Language	German
Size	149 S, Ill., graph. Darst, 21 cm
Document type	Book ; Thesis
Thesis / German Habilitation thesis	Univ., Diss.--München, 1998
Database	Former special subject collection: coastal and deep sea fishing

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Article ; Online: Depletion of tumor-induced Treg prior to reconstitution rescues enhanced priming of tumor-specific, therapeutic effector T cells in lymphopenic hosts.

Poehlein, Christian H / Haley, Daniel P / Walker, Edwin B / Fox, Bernard A

European journal of immunology

2009 Volume 39, Issue 11, Page(s) 3121–3133

Abstract: We reported previously that vaccination of reconstituted, lymphopenic mice resulted in a higher frequency of tumor-specific effector T cells with therapeutic activity than vaccination of normal mice. Here, we show that lymphopenic mice reconstituted with ...

Abstract	We reported previously that vaccination of reconstituted, lymphopenic mice resulted in a higher frequency of tumor-specific effector T cells with therapeutic activity than vaccination of normal mice. Here, we show that lymphopenic mice reconstituted with spleen cells from tumor-bearing mice (TBM), a situation that resembles the clinical condition, failed to generate tumor-specific T cells with therapeutic efficacy. However, depletion of CD25(+) Treg from the spleen cells of TBM restored tumor-specific priming and therapeutic efficacy. Adding back TBM CD25(+) Treg to CD25(-) naïve and TBM donor T cells prior to reconstitution confirmed their suppressive role. CD25(+) Treg from TBM prevented priming of tumor-specific T cells since subsequent depletion of CD4(+) T cells did not restore therapeutic efficacy. This effect may not be antigen-specific as three histologically distinct tumors generated CD25(+) Treg that could suppress the T-cell immune response to a melanoma vaccine. Importantly, since ex vivo depletion of CD25(+) Treg from TBM spleen cells prior to reconstitution and vaccination fully restored the generation of therapeutic effector T cells, even in animals with established tumor burden, we have initiated a translational clinical trial of this strategy in patients with metastatic melanoma.
MeSH term(s)	Animals ; Cancer Vaccines/immunology ; Cell Separation ; Enzyme-Linked Immunosorbent Assay ; Female ; Flow Cytometry ; Interleukin-2 Receptor alpha Subunit/immunology ; Lymphocyte Depletion ; Lymphopenia/immunology ; Melanoma, Experimental/immunology ; Mice ; Mice, Inbred C57BL ; Mice, Knockout ; T-Lymphocyte Subsets/immunology ; T-Lymphocytes, Regulatory/immunology
Chemical Substances	Cancer Vaccines ; Interleukin-2 Receptor alpha Subunit
Language	English
Publishing date	2009-10-14
Publishing country	Germany
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	120108-6
ISSN	1521-4141 ; 0014-2980
ISSN (online)	1521-4141
ISSN	0014-2980
DOI	10.1002/eji.200939453
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 489: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Depletion of tumor-induced Treg prior to reconstitution rescues enhanced priming of tumor-specific, therapeutic effector T cells in lymphopenic hosts

Poehlein, Christian H / Haley, Daniel P / Walker, Edwin B / Fox, Bernard A

European journal of immunology. 2009 Nov., v. 39, no. 11

2009

Abstract	We reported previously that vaccination of reconstituted, lymphopenic mice resulted in a higher frequency of tumor-specific effector T cells with therapeutic activity than vaccination of normal mice. Here, we show that lymphopenic mice reconstituted with spleen cells from tumor-bearing mice (TBM), a situation that resembles the clinical condition, failed to generate tumor-specific T cells with therapeutic efficacy. However, depletion of CD25⁺ Treg from the spleen cells of TBM restored tumor-specific priming and therapeutic efficacy. Adding back TBM CD25⁺ Treg to CD25⁻ naïve and TBM donor T cells prior to reconstitution confirmed their suppressive role. CD25⁺ Treg from TBM prevented priming of tumor-specific T cells since subsequent depletion of CD4⁺ T cells did not restore therapeutic efficacy. This effect may not be antigen-specific as three histologically distinct tumors generated CD25⁺ Treg that could suppress the T-cell immune response to a melanoma vaccine. Importantly, since ex vivo depletion of CD25⁺ Treg from TBM spleen cells prior to reconstitution and vaccination fully restored the generation of therapeutic effector T cells, even in animals with established tumor burden, we have initiated a translational clinical trial of this strategy in patients with metastatic melanoma.
Language	English
Dates of publication	2009-11
Size	p. 3121-3133.
Publishing place	Wiley-VCH Verlag
Document type	Article
ZDB-ID	120108-6
ISSN	1521-4141 ; 0014-2980
ISSN (online)	1521-4141
ISSN	0014-2980
DOI	10.1002/eji.200939453
Database	NAL-Catalogue (AGRICOLA)

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