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Article ; Online: Mitotic Checkpoints and the Role of WEE1 Inhibition in Head and Neck Squamous Cell Carcinoma.

Khan, Shihan N / Swiecicki, Paul L / Doroshow, Deborah B

2022 Volume 28, Issue 5, Page(s) 381–386

Abstract: Abstract: The WEE1 kinase family plays a crucial role in cell cycle regulation and DNA damage response pathways in malignant cells. Inhibition of WEE1 effectively overrides G2 cell cycle arrest and results in the accumulation of extensive DNA damage ... ...

Abstract	Abstract: The WEE1 kinase family plays a crucial role in cell cycle regulation and DNA damage response pathways in malignant cells. Inhibition of WEE1 effectively overrides G2 cell cycle arrest and results in the accumulation of extensive DNA damage within dividing cells, potentiating mitotic catastrophe and cell death. As such, the development of WEE1 inhibitors as antineoplastic therapeutics has gained increasing interest in recent years. In particular, the role of WEE1 inhibitors for treatment of head and neck squamous cell carcinomas remains an area of active research with both preclinical and clinical studies investigating their use as both single-agent therapy and chemosensitizers when used in tandem with traditional chemotherapy, particularly in the context of TP53-mutant tumors. Here, we review the relevant available preclinical and clinical data on hand investigating the efficacy of WEE1 inhibitors for the treatment of head and neck cancers.
MeSH term(s)	Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Cell Cycle Proteins/genetics ; Cell Cycle Proteins/metabolism ; Cell Line, Tumor ; Head and Neck Neoplasms/drug therapy ; Humans ; M Phase Cell Cycle Checkpoints ; Nuclear Proteins ; Protein-Tyrosine Kinases ; Squamous Cell Carcinoma of Head and Neck/drug therapy
Chemical Substances	Antineoplastic Agents ; Cell Cycle Proteins ; Nuclear Proteins ; Protein-Tyrosine Kinases (EC 2.7.10.1) ; WEE1 protein, human (EC 2.7.10.2)
Language	English
Publishing date	2022-09-27
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2018400-1
ISSN	1540-336X ; 1528-9117 ; 1081-4442
ISSN (online)	1540-336X
ISSN	1528-9117 ; 1081-4442
DOI	10.1097/PPO.0000000000000613
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Article ; Online: From the Broad Phase II Trial to Precision Oncology: A Perspective on the Origins of Basket and Umbrella Clinical Trial Designs in Cancer Drug Development.

Doroshow, Deborah B / Doroshow, James H

Cancer journal (Sudbury, Mass.)

2019 Volume 25, Issue 4, Page(s) 245–253

Abstract: Oncologic phase II trials that evaluate the activity of new therapeutic agents have evolved dramatically over the past 50 years. The standard approach beginning in the late 1960s focused on individual studies that evaluated new anticancer agents against ... ...

Abstract	Oncologic phase II trials that evaluate the activity of new therapeutic agents have evolved dramatically over the past 50 years. The standard approach beginning in the late 1960s focused on individual studies that evaluated new anticancer agents against a wide range of both solid and hematopoietic malignancies often in a single "broad phase II trial" that included hundreds of patients; such studies efficiently established the landscape for subsequent development of a specific drug with respect to likely disease focus, toxicity, dose, and schedule. In the 1980s and 1990s, emphasis on histological context drove an explosion in the number of individual phase II trials conducted; despite this increase in trial activity, investigations based on histology per se failed to improve the success rate of new agents brought to the clinic. Over the past 20 years, evolution toward a molecular drug development paradigm has demonstrably improved our ability to select patients more likely to benefit from systemic treatment; simultaneously, technological advances have permitted initial attempts at the rapid assignment of therapy based on predefined molecular characteristics of tumor or germline in broad-based master protocols that are inclusive of many diseases and molecularly characterized disease subsets, akin to but much more sophisticated scientifically than the broad phase II platforms of the past.
MeSH term(s)	Clinical Trials, Phase II as Topic ; Disease Susceptibility ; Drug Design ; Drug Development ; History, 20th Century ; History, 21st Century ; Humans ; Medical Oncology/history ; Medical Oncology/methods ; Medical Oncology/standards ; Precision Medicine/history ; Precision Medicine/methods ; Precision Medicine/standards ; Treatment Outcome
Language	English
Publishing date	2019-07-11
Publishing country	United States
Document type	Historical Article ; Journal Article
ZDB-ID	2018400-1
ISSN	1540-336X ; 1528-9117 ; 1081-4442
ISSN (online)	1540-336X
ISSN	1528-9117 ; 1081-4442
DOI	10.1097/PPO.0000000000000386
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Zs.MO 163: Show issues

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Article ; Online: Genomics and the History of Precision Oncology.

Doroshow, Deborah B / Doroshow, James H

Surgical oncology clinics of North America

2019 Volume 29, Issue 1, Page(s) 35–49

Abstract: Progress toward the implementation of a molecular characterization paradigm in cancer drug development over the past 20 years has markedly enhanced our capability to select patients who are more likely to benefit from cancer therapy. Improvements in ... ...

Abstract	Progress toward the implementation of a molecular characterization paradigm in cancer drug development over the past 20 years has markedly enhanced our capability to select patients who are more likely to benefit from cancer therapy. Improvements in genomic and related diagnostic testing platforms have permitted evaluation of the efficacy of treatment assignment based on predefined biologic features of a patient's tumor or germline using master protocols that may include many malignancies and their molecularly characterized subsets. With this approach, a wide range of new targeted and immunologic treatment approaches have been defined for patients who, heretofore, lacked effective therapeutic options.
MeSH term(s)	Antineoplastic Agents/therapeutic use ; Biomarkers, Tumor/genetics ; History, 21st Century ; Humans ; Molecular Targeted Therapy/methods ; Neoplasms/drug therapy ; Neoplasms/genetics ; Pharmacogenetics/methods ; Precision Medicine/history ; Precision Medicine/methods
Chemical Substances	Antineoplastic Agents ; Biomarkers, Tumor
Language	English
Publishing date	2019-10-29
Publishing country	United States
Document type	Historical Article ; Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1196919-2
ISSN	1558-5042 ; 1055-3207
ISSN (online)	1558-5042
ISSN	1055-3207
DOI	10.1016/j.soc.2019.08.003
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Article ; Online: The Dangers of "Us Versus Them": Epidemics Then and Now.

Barr, Justin / McKay, Richard A / Doroshow, Deborah B

Journal of general internal medicine

2021 Volume 36, Issue 3, Page(s) 795–796

MeSH term(s)	Epidemics ; Humans
Language	English
Publishing date	2021-01-08
Publishing country	United States
Document type	Editorial
ZDB-ID	639008-0
ISSN	1525-1497 ; 0884-8734
ISSN (online)	1525-1497
ISSN	0884-8734
DOI	10.1007/s11606-020-06368-y
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Zs.A 2205: Show issues

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Article ; Online: C-reactive protein (CRP) as a prognostic biomarker in patients with urothelial carcinoma: A systematic review and meta-analysis.

Fujiwara, Yu / Karol, Alexander B / Joshi, Himanshu / Reford, Emma / Izadmehr, Sudeh / Doroshow, Deborah B / Galsky, Matthew D

Critical reviews in oncology/hematology

2024 Volume 197, Page(s) 104352

Abstract: C-reactive protein (CRP) may reflect a pro-inflammatory tumor microenvironment and could represent a biomarker to select patients with urothelial carcinoma more likely to benefit from therapies directed at modulating tumor-promoting inflammation. We ... ...

Abstract	C-reactive protein (CRP) may reflect a pro-inflammatory tumor microenvironment and could represent a biomarker to select patients with urothelial carcinoma more likely to benefit from therapies directed at modulating tumor-promoting inflammation. We performed a systematic review to evaluate survival outcomes based on pre-treatment CRP values in urothelial carcinoma. The hazard ratios (HRs) of survival such as overall survival (OS) and progression-free survival (PFS) between groups with high versus low CRP values were pooled by the random-effect model meta-analyses. Overall, 28 studies comprising 6789 patients were identified for meta-analyses. High CRP levels were associated with shorter OS (HR=1.96 [95% CI: 1.64-2.33], p < 0.01), particularly in advanced disease treated with immune checkpoint blockade (ICB, HR=1.78 [1.47-2.15], p < 0.01). Similar findings were observed in ICB-treated patients with PFS. These findings suggest that CRP could be an attractive biomarker to select patients with urothelial carcinoma for strategies seeking to modulate tumor-promoting inflammation.
MeSH term(s)	Humans ; Biomarkers, Tumor/blood ; C-Reactive Protein/analysis ; Carcinoma, Transitional Cell/blood ; Carcinoma, Transitional Cell/pathology ; Carcinoma, Transitional Cell/diagnosis ; Carcinoma, Transitional Cell/mortality ; Carcinoma, Transitional Cell/drug therapy ; Prognosis ; Urinary Bladder Neoplasms/mortality ; Urinary Bladder Neoplasms/blood ; Urinary Bladder Neoplasms/pathology ; Urinary Bladder Neoplasms/diagnosis ; Urologic Neoplasms/mortality ; Urologic Neoplasms/pathology ; Urologic Neoplasms/diagnosis ; Urologic Neoplasms/blood
Language	English
Publishing date	2024-04-16
Publishing country	Netherlands
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2024.104352
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Zs.A 1931: Show issues

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Article ; Online: Treatment of Advanced Non-Small Cell Lung Cancer in 2018.

Doroshow, Deborah B / Herbst, Roy S

JAMA oncology

2018 Volume 4, Issue 4, Page(s) 569–570

MeSH term(s)	Antineoplastic Agents, Immunological/therapeutic use ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/pathology ; Carcinoma, Non-Small-Cell Lung/therapy ; Cell Cycle Checkpoints/drug effects ; Cell Cycle Checkpoints/immunology ; Clinical Trials as Topic/methods ; Disease Progression ; Humans ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; Lung Neoplasms/therapy ; Medical Oncology/methods ; Medical Oncology/trends ; Molecular Targeted Therapy/methods ; Molecular Targeted Therapy/trends ; Protein Kinase Inhibitors/therapeutic use
Chemical Substances	Antineoplastic Agents, Immunological ; Protein Kinase Inhibitors
Language	English
Publishing date	2018-02-21
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2374-2445
ISSN (online)	2374-2445
DOI	10.1001/jamaoncol.2017.5190
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Article ; Online: Phase II Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations.

Doroshow, Deborah B / O'Donnell, Peter H / Hoffman-Censits, Jean H / Gupta, Sumati V / Vaishampayan, Ulka / Heath, Elisabeth I / Garcia, Philip / Zhao, Qianqian / Yu, Menggang / Milowsky, Matthew I / Galsky, Matthew D

JCO precision oncology

2023 Volume 7, Page(s) e2300095

Abstract: Purpose: Poly (ADP-ribose) polymerase (PARP) inhibitors have demonstrated clinical benefit for patients with solid tumors bearing germline or somatic alterations in DNA damage response (DDR) genes. Somatic alterations in DDR genes are common in advanced ...

Abstract	Purpose: Poly (ADP-ribose) polymerase (PARP) inhibitors have demonstrated clinical benefit for patients with solid tumors bearing germline or somatic alterations in DNA damage response (DDR) genes. Somatic alterations in DDR genes are common in advanced urothelial cancer, raising the possibility that PARP inhibition may confer therapeutic benefit in a molecularly selected subgroup of patients with metastatic urothelial cancer (mUC). Methods: This single-arm, open-label, multi-institutional, investigator-initiated phase II study evaluated the antitumor activity of olaparib 300 mg twice a day in participants with mUC harboring somatic DDR alterations. Patients had progressed despite previous platinum-based chemotherapy, or were cisplatin-ineligible, and harbored somatic alterations in at least one of a prespecified list of DDR genes. The primary end point was objective response rate; secondary end points were safety, progression-free survival (PFS), and overall survival (OS). Results: Overall, 19 patients with mUC were enrolled and received olaparib; the trial closed early before slow accrual. The median age was 66 years (range, 45-82). Nine patients (47.4%) had received previous cisplatin chemotherapy. Ten patients (52.6%) had alterations in homologous recombination (HR) genes: eight patients (42.1%) had pathogenic Conclusion: Single-agent olaparib showed limited antitumor activity in patients with mUC and DDR alterations, which may be related to poorly characterized functional implications of particular DDR alterations and/or cross-resistance with platinum-based chemotherapy in a disease where such therapy represents standard first-line treatment.
MeSH term(s)	Aged ; Aged, 80 and over ; Humans ; Middle Aged ; Cisplatin ; DNA Damage ; Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use ; Urologic Neoplasms/drug therapy ; Urothelium/pathology
Chemical Substances	Cisplatin (Q20Q21Q62J) ; olaparib (WOH1JD9AR8) ; Poly(ADP-ribose) Polymerase Inhibitors
Language	English
Publishing date	2023-07-07
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.23.00095
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Article ; Online: Trastuzumab emtansine: determining its role in management of HER2+ breast cancer.

Doroshow, Deborah B / LoRusso, Patricia M

Future oncology (London, England)

2017 Volume 14, Issue 7, Page(s) 589–602

Abstract: Trastuzumab emtansine is an antibody-drug conjugate comprised of the anti-HER2 monoclonal antibody trastuzumab linked to DM1 (emtansine), a potent cytotoxic maytansinoid derivative, by a stable linker. This structure results in improved tumor-directed ... ...

Abstract	Trastuzumab emtansine is an antibody-drug conjugate comprised of the anti-HER2 monoclonal antibody trastuzumab linked to DM1 (emtansine), a potent cytotoxic maytansinoid derivative, by a stable linker. This structure results in improved tumor-directed cytotoxicity in HER2+ breast cancer with reduced systemic toxicities, particularly the cardiac toxicities associated with single agent trastuzumab. Phase III trials have demonstrated improved progression-free and overall survival in heavily pretreated patients with advanced HER2+ breast cancer, with an acceptable toxicity profile. However, its role in first-line treatment is less clear. Ongoing studies continue to evaluate its role in neoadjuvant and adjuvant management of HER2+ breast cancer.
MeSH term(s)	Antibodies, Monoclonal, Humanized/chemistry ; Antibodies, Monoclonal, Humanized/therapeutic use ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Breast Neoplasms/pathology ; Cell Proliferation/drug effects ; Clinical Trials as Topic ; Disease-Free Survival ; Female ; Humans ; Immunoconjugates/chemistry ; Immunoconjugates/therapeutic use ; Maytansine/analogs & derivatives ; Maytansine/chemistry ; Maytansine/therapeutic use ; Receptor, ErbB-2/genetics ; Trastuzumab/chemistry ; Trastuzumab/therapeutic use
Chemical Substances	Antibodies, Monoclonal, Humanized ; Immunoconjugates ; Maytansine (14083FR882) ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) ; ado-trastuzumab emtansine (SE2KH7T06F)
Language	English
Publishing date	2017-12-07
Publishing country	England
Document type	Journal Article
ZDB-ID	2184533-5
ISSN	1744-8301 ; 1479-6694
ISSN (online)	1744-8301
ISSN	1479-6694
DOI	10.2217/fon-2017-0477
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Article ; Online: Clinical Efficacy of Olaparib in

Eder, Joseph P / Doroshow, Deborah B / Do, Khanh T / Keedy, Vicki L / Sklar, Jeffrey S / Glazer, Peter / Bindra, Ranjit / Shapiro, Geoffrey I

JCO precision oncology

2021 Volume 5, Page(s) 466–472

Abstract: Purpose: Tumors with neomorphic mutations in IDH1/2 have defective homologous recombination repair, resulting in sensitivity to poly (ADP-ribose) polymerase (PARP) inhibition. The Olaparib Combination trial is a phase II, open-label study in which ... ...

Abstract	Purpose: Tumors with neomorphic mutations in IDH1/2 have defective homologous recombination repair, resulting in sensitivity to poly (ADP-ribose) polymerase (PARP) inhibition. The Olaparib Combination trial is a phase II, open-label study in which patients with solid tumors harboring IDH1/2 mutations were treated with olaparib as monotherapy, with objective response and clinical benefit rates as the primary end points. Methods: Ten patients with IDH1/2-mutant tumors by next-generation sequencing were treated with olaparib 300 mg twice daily. Results: Three of five patients with chondrosarcomas had clinical benefit, including one patient with a partial response and two with stable disease lasting > 7 months. A patient with pulmonary epithelioid hemangioendothelioma had stable disease lasting 11 months. In contrast, clinical benefit was not observed among four patients with cholangiocarcinoma. Conclusion: These results indicate preliminary activity of PARP inhibition in patients with IDH1/2-mutant chondrosarcoma and pulmonary epithelioid hemangioendothelioma. Further studies of PARP inhibitors alone and in combination in this patient population are warranted.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Cholangiocarcinoma/drug therapy ; Chondrosarcoma, Mesenchymal/drug therapy ; Chondrosarcoma, Mesenchymal/genetics ; Female ; Hemangioendothelioma, Epithelioid/drug therapy ; Humans ; Isocitrate Dehydrogenase/genetics ; Lung Neoplasms/drug therapy ; Male ; Middle Aged ; Mutation ; Phthalazines/adverse effects ; Phthalazines/therapeutic use ; Piperazines/adverse effects ; Piperazines/therapeutic use ; Poly(ADP-ribose) Polymerase Inhibitors/adverse effects ; Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use ; Treatment Outcome
Chemical Substances	Phthalazines ; Piperazines ; Poly(ADP-ribose) Polymerase Inhibitors ; IDH2 protein, human (EC 1.1.1.41) ; Isocitrate Dehydrogenase (EC 1.1.1.41) ; IDH1 protein, human (EC 1.1.1.42.) ; olaparib (WOH1JD9AR8)
Language	English
Publishing date	2021-12-30
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.20.00247
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Article ; Online: Programmed Death-Ligand 1 Tumor Proportion Score and Overall Survival From First-Line Pembrolizumab in Patients With Nonsquamous Versus Squamous NSCLC.

Doroshow, Deborah B / Wei, Wei / Gupta, Swati / Zugazagoitia, Jon / Robbins, Charles / Adamson, Blythe / Rimm, David L

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

2021 Volume 16, Issue 12, Page(s) 2139–2143

Abstract: Introduction: For patients with NSCLC receiving immune checkpoint inhibitors, programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) has been validated as a predictive biomarker for improved overall survival (OS). Nevertheless, its histology- ... ...

Abstract	Introduction: For patients with NSCLC receiving immune checkpoint inhibitors, programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) has been validated as a predictive biomarker for improved overall survival (OS). Nevertheless, its histology-specific predictive value in patients with advanced squamous versus nonsquamous cancers remains unclear. To evaluate the differential value of PD-L1 TPS as a predictive biomarker for OS after first-line pembrolizumab in patients with squamous versus nonsquamous NSCLC. Methods: Retrospective, observational study of patients diagnosed with having advanced NSCLC who were treated between October 2015 and April 2019 at community oncology clinics and academic medical centers in a deidentified electronic health record-derived database. Included patients were diagnosed with having advanced or metastatic NSCLC, received treatment with first-line, single-agent pembrolizumab, and had documentation of PD-L1 testing with a numeric result. Exclusion criteria included alterations in EGFR, ALK, and ROS1. The primary end point was OS from start of first-line pembrolizumab therapy by squamous or nonsquamous histology and PD-1 expression level measured by TPS (low, <50% or high, ≥50%). Results: The cohort of 1460 patients with NSCLC who received pembrolizumab as a first-line therapy had a mean age of 72 years. Histology was 28% squamous and 72% nonsquamous. PD-L1 expression was low in 13% and high in 87%. No meaningful differences in age, sex, or smoking history were observed by PD-L1 TPS or histology type. A generalized gamma model adjusting for sex and stage at diagnosis found that for patients with nonsquamous histology, high PD-L1 TPS was significantly associated with improved OS by a median OS difference of 8.4 months (p < 0.001). In contrast, for patients with squamous histology, there was no evidence of association between PD-L1 expression level and OS (p = 0.283). PD-L1-related incremental differences in median OS between the patients with squamous and nonsquamous tumors were significantly different (p = 0.034). Conclusions: Among patients with NSCLC treated with first-line pembrolizumab, high PD-L1 TPS is associated with OS among patients with nonsquamous NSCLC, but not among patients with squamous NSCLC.
MeSH term(s)	Aged ; Antibodies, Monoclonal, Humanized/therapeutic use ; B7-H1 Antigen/antagonists & inhibitors ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Humans ; Immune Checkpoint Inhibitors/therapeutic use ; Lung Neoplasms/drug therapy ; Protein-Tyrosine Kinases ; Proto-Oncogene Proteins ; Retrospective Studies
Chemical Substances	Antibodies, Monoclonal, Humanized ; B7-H1 Antigen ; Immune Checkpoint Inhibitors ; Proto-Oncogene Proteins ; pembrolizumab (DPT0O3T46P) ; Protein-Tyrosine Kinases (EC 2.7.10.1)
Language	English
Publishing date	2021-08-26
Publishing country	United States
Document type	Journal Article ; Observational Study
ZDB-ID	2432037-7
ISSN	1556-1380 ; 1556-0864
ISSN (online)	1556-1380
ISSN	1556-0864
DOI	10.1016/j.jtho.2021.07.032
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Zs.MO 652: Show issues

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