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Article ; Online: Dual function of Langerhans cells in skin TSLP-promoted T

Marschall, Pierre / Wei, Ruicheng / Segaud, Justine / Yao, Wenjin / Hener, Pierre / German, Beatriz Falcon / Meyer, Pierre / Hugel, Cecile / Ada Da Silva, Grace / Braun, Reinhard / Kaplan, Daniel H / Li, Mei

The Journal of allergy and clinical immunology

2020 Volume 147, Issue 5, Page(s) 1778–1794

Abstract: Background: Atopic dermatitis (AD) is among the most common chronic inflammatory skin diseases, usually occurring early in life, and often preceding other atopic diseases such as asthma. T: Objectives: This study aimed at investigating how T: ... ...

Abstract	Background: Atopic dermatitis (AD) is among the most common chronic inflammatory skin diseases, usually occurring early in life, and often preceding other atopic diseases such as asthma. T Objectives: This study aimed at investigating how T Methods: Two experimental AD mouse models were employed: (1) triggered by the overproduction of TSLP through topical application of MC903, and (2) induced by epicutaneous allergen ovalbumin (OVA) sensitization. Results: This study demonstrated that the development of T Conclusions: Together, these studies revealed a dual functionality of LCs in TSLP-promoted T
MeSH term(s)	Allergens/immunology ; Animals ; Calcitriol/analogs & derivatives ; Calcitriol/pharmacology ; Cell Differentiation ; Cytokines/immunology ; Dermatitis, Atopic/immunology ; Dermatologic Agents/pharmacology ; Gene Expression Profiling ; Langerhans Cells/immunology ; Mice, Inbred BALB C ; Mice, Transgenic ; Ovalbumin/immunology ; Skin/immunology ; T-Lymphocytes, Helper-Inducer/immunology ; Thymic Stromal Lymphopoietin ; Mice
Chemical Substances	Allergens ; Cytokines ; Dermatologic Agents ; calcipotriene (143NQ3779B) ; Ovalbumin (9006-59-1) ; Calcitriol (FXC9231JVH) ; Thymic Stromal Lymphopoietin (GT0IL38SP4) ; TSLP protein, mouse
Language	English
Publishing date	2020-10-15
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2020.10.006
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Article ; Online: Reply to Araki et al.

Lipton, Allan / Fizazi, Karim / Stopeck, Alison T / Henry, David H / Braun, Ada H

European journal of cancer (Oxford, England : 1990)

2013 Volume 49, Issue 9, Page(s) 2266–2268

MeSH term(s)	Antibodies, Monoclonal, Humanized/therapeutic use ; Bone Density Conservation Agents/therapeutic use ; Bone Neoplasms/drug therapy ; Bone Neoplasms/secondary ; Diphosphonates/therapeutic use ; Female ; Humans ; Imidazoles/therapeutic use ; Male
Chemical Substances	Antibodies, Monoclonal, Humanized ; Bone Density Conservation Agents ; Diphosphonates ; Imidazoles
Language	English
Publishing date	2013-06
Publishing country	England
Document type	Comment ; Letter
ZDB-ID	82061-1
ISSN	1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0277-5379 ; 0959-8049 ; 0964-1947
DOI	10.1016/j.ejca.2013.02.037
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Zs.A 456: 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: Phase III trials in oncology: setting standards of care?

Seeber, Siegfried / Braun, Ada H

Nature clinical practice. Oncology

2005 Volume 2, Issue 9, Page(s) 426–427

MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Clinical Trials, Phase II as Topic ; Humans ; Medical Oncology/standards ; Neoplasm Metastasis ; Neoplasms/drug therapy ; Neoplasms/pathology ; Prognosis ; Quality of Health Care ; Randomized Controlled Trials as Topic ; Salvage Therapy ; Survival Analysis
Language	English
Publishing date	2005-09
Publishing country	England
Document type	Editorial
ZDB-ID	2173301-6
ISSN	1743-4254
ISSN	1743-4254
DOI	10.1038/ncponc0284
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Zs.A 6029: Show issues

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Article: Lysophosphatidic acid, a disintegrin and metalloprotease-17 and heparin-binding epidermal growth factor-like growth factor in ovarian cancer: the first word, not the last.

Braun, Ada H / Coffey, Robert J

Clinical cancer research : an official journal of the American Association for Cancer Research

2005 Volume 11, Issue 13, Page(s) 4639–4643

MeSH term(s)	ADAM Proteins/metabolism ; ADAM17 Protein ; Antineoplastic Agents/therapeutic use ; Epidermal Growth Factor/metabolism ; Female ; Heparin-binding EGF-like Growth Factor ; Humans ; Intercellular Signaling Peptides and Proteins ; Lysophospholipids/physiology ; Models, Biological ; Ovarian Neoplasms/drug therapy ; Ovarian Neoplasms/metabolism ; Ovarian Neoplasms/physiopathology ; Signal Transduction/drug effects
Chemical Substances	Antineoplastic Agents ; HBEGF protein, human ; Heparin-binding EGF-like Growth Factor ; Intercellular Signaling Peptides and Proteins ; Lysophospholipids ; Epidermal Growth Factor (62229-50-9) ; ADAM Proteins (EC 3.4.24.-) ; ADAM17 Protein (EC 3.4.24.86) ; lysophosphatidic acid (PG6M3969SG)
Language	English
Publishing date	2005-07-01
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S. ; Comment
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-05-0973
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Zs.A 4223: Show issues

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Article ; Online: Assessing analgesic use in patients with advanced cancer: development of a new scale--the Analgesic Quantification Algorithm.

Chung, Karen C / Barlev, Arie / Braun, Ada H / Qian, Yi / Zagari, Martin

Pain medicine (Malden, Mass.)

2014 Volume 15, Issue 2, Page(s) 225–232

Abstract: Objective: Many patients with advanced cancer frequently use analgesic medications for their pain. Systematically assessing and quantifying changes in analgesic use remains challenging in the clinical trials setting. Currently, there is no sensitive ... ...

Abstract	Objective: Many patients with advanced cancer frequently use analgesic medications for their pain. Systematically assessing and quantifying changes in analgesic use remains challenging in the clinical trials setting. Currently, there is no sensitive scale for categorizing the intensity of analgesic medications to understand the reasons for changes in patient-reported pain. We assessed whether the Analgesic Quantification Algorithm (AQA) is more sensitive than the World Health Organization Analgesic Treatment Ladder (WHO-AL) for quantifying analgesic medication use among patients with advanced cancer. Methods: An expanded equianalgesic potency conversion table was developed to establish oral morphine equivalents for use in the AQA. Categories of opioid use were selected to increase sensitivity within the higher dose range of opioids and to better capture increases in analgesic dose intensity. The resulting 8-point AQA scale corresponds to no analgesic use, non-opioid analgesics, weak opioids only, ≤75 mg, >75-150 mg, >150-300 mg, >300-600 mg, and >600 mg oral morphine equivalents per day. Baseline and 6-month analgesic data from a clinical trial of cancer patients were compared for each instrument. Results: At both time points, the 4-point WHO-AL demonstrated a ceiling effect with a clustering of patients in the strong opioid category, whereas the AQA resulted in a distribution of scores throughout the eight categories, including the five strong opioid categories. Conclusions: The AQA represents a more sensitive measure of analgesic use than the WHO-AL, and may better determine whether changes in pain assessments in clinical trials are due to the intervention or changes in analgesic use.
MeSH term(s)	Algorithms ; Analgesics, Opioid/therapeutic use ; Humans ; Neoplasms/complications ; Pain/drug therapy ; Pain/etiology ; Pain Measurement/methods
Chemical Substances	Analgesics, Opioid
Language	English
Publishing date	2014-02
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2015903-1
ISSN	1526-4637 ; 1526-2375
ISSN (online)	1526-4637
ISSN	1526-2375
DOI	10.1111/pme.12299
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Zs.A 6119: Show issues

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Article ; Online: Hypocalcaemia in patients with metastatic bone disease treated with denosumab.

Body, Jean-Jacques / Bone, Henry G / de Boer, Richard H / Stopeck, Alison / Van Poznak, Catherine / Damião, Ronaldo / Fizazi, Karim / Henry, David H / Ibrahim, Toni / Lipton, Allan / Saad, Fred / Shore, Neal / Takano, Toshimi / Shaywitz, Adam J / Wang, Huei / Bracco, Oswaldo L / Braun, Ada / Kostenuik, Paul J

European journal of cancer (Oxford, England : 1990)

2015 Volume 51, Issue 13, Page(s) 1812–1821

Abstract: Background: This analysis was performed to further characterise treatment-emergent hypocalcaemia in patients with bone metastases receiving denosumab.: Methods: Laboratory abnormalities and adverse events of hypocalcaemia in patients with metastatic ... ...

Abstract	Background: This analysis was performed to further characterise treatment-emergent hypocalcaemia in patients with bone metastases receiving denosumab. Methods: Laboratory abnormalities and adverse events of hypocalcaemia in patients with metastatic bone disease were analysed using data from three identically designed phase 3 trials of subcutaneous denosumab 120 mg (n = 2841) versus intravenous zoledronic acid 4 mg (n = 2836). Results: The overall incidence of laboratory events of hypocalcaemia grade ⩾ 2 was higher with denosumab (12.4%) than with zoledronic acid (5.3%). Hypocalcaemia events were primarily grade 2 in severity and usually occurred within the first 6 months of treatment. Patients who reported taking calcium and/or vitamin D supplements had a lower incidence of hypocalcaemia. Prostate cancer or small-cell lung cancer, reduced creatinine clearance and higher baseline bone turnover markers of urinary N-telopeptide of type I collagen (uNTx; > 50 versus ⩽ 50 nmol/mmol) and bone-specific alkaline phosphatase (BSAP; > 20.77 μg/L [median] versus ⩽ 20.77 μg/L) values were important risk factors for developing hypocalcaemia. The risk associated with increased baseline BSAP levels was greater among patients who had > 2 bone metastases at baseline versus those with ⩽ 2 bone metastases at baseline. Conclusion: Hypocalcaemia was more frequent with denosumab versus zoledronic acid, consistent with denosumab's greater antiresorptive effect. Low serum calcium levels and potential vitamin D deficiency should be corrected before initiating treatment with a potent osteoclast inhibitor, and corrected serum calcium levels should be monitored during treatment. Adequate calcium and vitamin D intake appears to substantially reduce the risk of hypocalcaemia.
MeSH term(s)	Antineoplastic Agents/adverse effects ; Biomarkers/blood ; Bone Density Conservation Agents/adverse effects ; Bone Neoplasms/drug therapy ; Bone Neoplasms/secondary ; Calcium/blood ; Clinical Trials, Phase III as Topic ; Denosumab/adverse effects ; Diphosphonates/adverse effects ; Humans ; Hypocalcemia/blood ; Hypocalcemia/chemically induced ; Hypocalcemia/diagnosis ; Hypocalcemia/epidemiology ; Hypocalcemia/prevention & control ; Imidazoles/adverse effects ; Incidence ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Severity of Illness Index ; Time Factors ; Treatment Outcome ; Vitamin D Deficiency/complications ; Vitamin D Deficiency/diagnosis
Chemical Substances	Antineoplastic Agents ; Biomarkers ; Bone Density Conservation Agents ; Diphosphonates ; Imidazoles ; Denosumab (4EQZ6YO2HI) ; zoledronic acid (6XC1PAD3KF) ; Calcium (SY7Q814VUP)
Language	English
Publishing date	2015-09
Publishing country	England
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	82061-1
ISSN	1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0277-5379 ; 0959-8049 ; 0964-1947
DOI	10.1016/j.ejca.2015.05.016
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Zs.A 456: 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: New systemic frontline treatment for metastatic colorectal carcinoma.

Braun, Ada H / Achterrath, Wolf / Wilke, Hansjochen / Vanhoefer, Udo / Harstrick, Andreas / Preusser, Peter

Cancer

2004 Volume 100, Issue 8, Page(s) 1558–1577

Abstract: Options for first-line chemotherapy in patients with metastatic colorectal carcinoma have broadened considerably with the introduction of irinotecan and oxaliplatin. Furthermore, the oral fluoropyrimidine capecitabine has demonstrated efficacy in Phase ... ...

Abstract	Options for first-line chemotherapy in patients with metastatic colorectal carcinoma have broadened considerably with the introduction of irinotecan and oxaliplatin. Furthermore, the oral fluoropyrimidine capecitabine has demonstrated efficacy in Phase III trials and recently was approved for first-line treatment in Europe and the United States. Capecitabine yielded similar median times to disease progression and median survival rates compared with bolus 5-fluorouracil (5-FU)/leucovorin (LV) (Mayo Clinic/North Central Cancer Treatment Group regimen), with superior and similar response rates, respectively. However, its role as a first-line, single-agent substitute for intermittent infusional 5-FU/LV remains to be defined. The addition of irinotecan or oxaliplatin to 5-FU/LV resulted in improved response rates and progression-free survival in large, randomized trials; moreover, irinotecan-containing regimens resulted in improved overall survival. Prevalent regimens of irinotecan/5-FU/LV and oxaliplatin/5-FU/LV have been compared in two randomized Phase III trials. One study demonstrated the statistical superiority of oxaliplatin/infusional 5-FU/LV over irinotecan/bolus 5-FU/LV in terms of response, time to disease progression, and median survival; however, those advantages may have been attributable to infusional administration or to major differences in second-line therapy. A randomized Phase III study comparing irinotecan and oxaliplatin in combination with the same infusional 5-FU/LV regimens and crossover in case of disease progression showed equivalent efficacy for both schedules in the first-line setting, but the irinotecan combination proved beneficial in terms of safety. New molecular targeted agents, such as angiogenesis-modulating compounds (e.g., bevacizumab) and epidermal growth factor receptor inhibitors (e.g., cetuximab), are under clinical investigation. This review updates current systemic frontline treatments and future perspectives for patients with advanced colorectal carcinoma.
MeSH term(s)	Angiogenesis Inhibitors/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma/drug therapy ; Carcinoma/secondary ; Clinical Trials as Topic ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/pathology ; Humans ; Neoplasm Metastasis ; Prognosis
Chemical Substances	Angiogenesis Inhibitors
Language	English
Publishing date	2004-04-15
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1429-1
ISSN	1097-0142 ; 0008-543X ; 1934-662X
ISSN (online)	1097-0142
ISSN	0008-543X ; 1934-662X
DOI	10.1002/cncr.20154
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Article ; Online: Effects of denosumab on pain and analgesic use in giant cell tumor of bone: interim results from a phase II study.

Martin-Broto, Javier / Cleeland, Charles S / Glare, Paul A / Engellau, Jacob / Skubitz, Keith M / Blum, Ronald H / Ganjoo, Kristin N / Staddon, Arthur / Dominkus, Martin / Feng, Amy / Qian, Yi / Braun, Ada / Jacobs, Ira / Chung, Karen / Atchison, Carolyn

Acta oncologica (Stockholm, Sweden)

2014 Volume 53, Issue 9, Page(s) 1173–1179

Abstract: Background: Giant cell tumor of bone (GCTB) is an aggressive primary osteolytic tumor. GCTB often involves the epiphysis, usually causing substantial pain and functional disability. Denosumab, a fully human monoclonal antibody against receptor activator ...

Abstract	Background: Giant cell tumor of bone (GCTB) is an aggressive primary osteolytic tumor. GCTB often involves the epiphysis, usually causing substantial pain and functional disability. Denosumab, a fully human monoclonal antibody against receptor activator of nuclear factor κΒ ligand (RANKL), is an effective treatment option for patients with advanced GCTB. This analysis of data from an ongoing, open-label study describes denosumab's effects on pain and analgesic use in patients with GCTB. Material and methods: Patients with unresectable disease (e.g. sacral or spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into Cohort 1 (N = 170), and patients with resectable disease whose planned surgery was associated with severe morbidity (e.g. joint resection, limb amputation, or hemipelvectomy) were enrolled into Cohort 2 (N = 101). Patients received denosumab (120 mg) subcutaneously every four weeks, with additional doses on study days 8 and 15. Patients assessed worst pain severity with the Brief Pain Inventory - Short Form (BPI-SF) at baseline, at each visit for the first six months, and every three months thereafter. Results: Clinically relevant pain improvement was reported by 29% of patients in Cohort 1 and 35% in Cohort 2 during week 1 and by ≥ 50% of patients in each cohort at each study visit from months 2-30. Median time to clinically relevant improvement was 30 (95% CI 16, 57) days in Cohort 1 and 15 (95% CI 15, 29) days in Cohort 2. Results in patients with moderate/severe pain at baseline were similar. Fewer than 30% of patients in Cohort 1 and 10% in Cohort 2 experienced clinically relevant pain worsening at any visit through 27 months. Most patients had no/low analgesic use during the study. Conclusion: Most patients treated with denosumab experienced clinically relevant decreases in pain within two months.
MeSH term(s)	Adolescent ; Adult ; Antibodies, Monoclonal, Humanized/therapeutic use ; Bone Neoplasms/complications ; Cohort Studies ; Denosumab ; Drug Administration Schedule ; Female ; Giant Cell Tumor of Bone/complications ; Humans ; Injections, Subcutaneous ; Male ; Pain/drug therapy ; Pain Measurement/methods ; RANK Ligand/antagonists & inhibitors ; Time Factors ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal, Humanized ; RANK Ligand ; Denosumab (4EQZ6YO2HI)
Language	English
Publishing date	2014-09
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	896449-x
ISSN	1651-226X ; 0349-652X ; 0284-186X ; 1100-1704
ISSN (online)	1651-226X
ISSN	0349-652X ; 0284-186X ; 1100-1704
DOI	10.3109/0284186X.2014.910313
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Zs.A 6348: Show issues

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Article: Bone-related complications and quality of life in advanced breast cancer: results from a randomized phase III trial of denosumab versus zoledronic acid.

Martin, Miguel / Bell, Richard / Bourgeois, Hugues / Brufsky, Adam / Diel, Ingo / Eniu, Alexandru / Fallowfield, Lesley / Fujiwara, Yasuhiro / Jassem, Jacek / Paterson, Alexander H G / Ritchie, Diana / Steger, Günther G / Stopeck, Alison / Vogel, Charles / Fan, Michelle / Jiang, Qi / Chung, Karen / Dansey, Roger / Braun, Ada

Clinical cancer research : an official journal of the American Association for Cancer Research

2012 Volume 18, Issue 17, Page(s) 4841–4849

Abstract: Purpose: Denosumab was shown to be superior to zoledronic acid in preventing skeletal related events (SRE) in patients with breast cancer and bone metastases in a randomized, double-blind phase III study. We evaluated further results from this study ... ...

Abstract	Purpose: Denosumab was shown to be superior to zoledronic acid in preventing skeletal related events (SRE) in patients with breast cancer and bone metastases in a randomized, double-blind phase III study. We evaluated further results from this study related to skeletal complications and health-related quality of life (HRQoL). Experimental design: Patients were randomized 1:1 to receive subcutaneous denosumab 120 mg (n = 1,026) and intravenous placebo, or intravenous zoledronic acid 4 mg (n = 1,020) and subcutaneous placebo every 4 weeks. Analyses reported here include the proportion of patients with one or multiple on-study SREs, time to first radiation to bone, time to first SRE or hypercalcemia of malignancy, and change in HRQoL (functional assessment of cancer therapy-general). Results: Fewer patients receiving denosumab than zoledronic acid had an on-study SRE (31% vs. 36%, P = 0.006). The incidence of first radiation to bone was 12% (n = 123) with denosumab versus 16% (n = 162) with zoledronic acid. Denosumab prolonged the time to first radiation to bone by 26% versus zoledronic acid (HR, 0.74; 95% confidence interval [CI], 0.59-0.94, P = 0.012) and prolonged the time to first SRE or hypercalcemia of malignancy by 18% (HR, 0.82; 95% CI, 0.70-0.95; P = 0.007). Ten percent more patients had a clinically meaningful improvement in HRQoL with denosumab relative to zoledronic acid, regardless of baseline pain levels. Conclusions: Denosumab was superior to zoledronic acid in reducing bone-related complications of metastatic breast cancer and maintained HRQoL, providing an efficacious, well-tolerated treatment option for patients with bone metastases from breast cancer.
MeSH term(s)	Aged ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Bone Neoplasms/drug therapy ; Bone Neoplasms/pathology ; Bone Neoplasms/secondary ; Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Denosumab ; Diphosphonates/administration & dosage ; Diphosphonates/adverse effects ; Drug-Related Side Effects and Adverse Reactions/chemically induced ; Female ; Humans ; Imidazoles/administration & dosage ; Imidazoles/adverse effects ; Middle Aged ; Neoplasm Staging ; Quality of Life ; RANK Ligand/antagonists & inhibitors ; RANK Ligand/immunology
Chemical Substances	Antibodies, Monoclonal, Humanized ; Diphosphonates ; Imidazoles ; RANK Ligand ; TNFSF11 protein, human ; Denosumab (4EQZ6YO2HI) ; zoledronic acid (6XC1PAD3KF)
Language	English
Publishing date	2012-09-01
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-11-3310
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Zs.A 4223: Show issues

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Article ; Online: Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials.

Lipton, Allan / Fizazi, Karim / Stopeck, Alison T / Henry, David H / Brown, Janet E / Yardley, Denise A / Richardson, Gary E / Siena, Salvatore / Maroto, Pablo / Clemens, Michael / Bilynskyy, Boris / Charu, Veena / Beuzeboc, Philippe / Rader, Michael / Viniegra, Maria / Saad, Fred / Ke, Chunlei / Braun, Ada / Jun, Susie

European journal of cancer (Oxford, England : 1990)

2012 Volume 48, Issue 16, Page(s) 3082–3092

Abstract: Background: Patients with bone metastases from advanced cancer often experience skeletal-related events (SRE), which cause substantial pain and morbidity. Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone- ... ...

Abstract	Background: Patients with bone metastases from advanced cancer often experience skeletal-related events (SRE), which cause substantial pain and morbidity. Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone-targeted agent with a distinct mechanism of action relative to the bisphosphonate zoledronic acid, for prevention of SRE. This pre-planned analysis evaluates the efficacy and safety of denosumab versus zoledronic acid across three pivotal studies. Methods: Patient-level data from three identically designed, randomised, double-blind, active-controlled, phase 3 trials of patients with breast cancer, prostate cancer, other solid tumours or multiple myeloma were combined. End-points included time to first SRE, time to first and subsequent (multiple) SRE, adverse events, time to disease progression and overall survival. Findings: Denosumab was superior to zoledronic acid in delaying time to first on-study SRE by a median 8.21months, reducing the risk of a first SRE by 17% (hazard ratio, 0.83 [95% confidence interval (CI): 0.76-0.90]; P<0.001). Efficacy was demonstrated for first and multiple events and across patient subgroups (prior SRE status; age). Disease progression and overall survival were similar between the treatments. In contrast to zoledronic acid, denosumab did not require monitoring or dose modification/withholding based on renal status, and was not associated with acute-phase reactions. Hypocalcaemia was more common for denosumab. Osteonecrosis of the jaw occurred at a similar rate (P=0.13). Conclusion: Denosumab was superior to zoledronic acid in preventing SRE with favourable safety and convenience in patients with bone metastases from advanced cancer.
MeSH term(s)	Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Bisphosphonate-Associated Osteonecrosis of the Jaw/etiology ; Bone Density Conservation Agents/adverse effects ; Bone Density Conservation Agents/therapeutic use ; Bone Neoplasms/complications ; Bone Neoplasms/drug therapy ; Bone Neoplasms/mortality ; Bone Neoplasms/secondary ; Clinical Trials, Phase III as Topic ; Denosumab ; Diphosphonates/adverse effects ; Diphosphonates/therapeutic use ; Disease Progression ; Female ; Humans ; Hypocalcemia/chemically induced ; Imidazoles/adverse effects ; Imidazoles/therapeutic use ; Male ; Middle Aged ; Proportional Hazards Models ; Randomized Controlled Trials as Topic ; Risk Assessment ; Risk Factors ; Survival Analysis ; Time Factors ; Treatment Outcome ; Zoledronic Acid
Chemical Substances	Antibodies, Monoclonal, Humanized ; Bone Density Conservation Agents ; Diphosphonates ; Imidazoles ; Denosumab (4EQZ6YO2HI) ; Zoledronic Acid (6XC1PAD3KF)
Language	English
Publishing date	2012-09-10
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't
ZDB-ID	82061-1
ISSN	1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0277-5379 ; 0959-8049 ; 0964-1947
DOI	10.1016/j.ejca.2012.08.002
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 456: 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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