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Association between immune-related adverse events (irAEs) and disease control or overall survival in patients (pts) with advanced melanoma treated with 10 mg/kg ipilimumab in three phase II clinical trials

Published on May 20, 2009in Journal of Clinical Oncology28.349
Jose Lutzky30
Estimated H-index: 30
,
Jedd D. Wolchok105
Estimated H-index: 105
+ 7 AuthorsSteven J. O'Day51
Estimated H-index: 51
Abstract
9034 Background: The monoclonal antibody ipilimumab targets cytotoxic T-lymphocyte antigen-4. The most common AEs associated with ipilimumab are irAEs, and both antitumor and irAE responses likely ...
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#1Satya Das (VUMC: Vanderbilt University Medical Center)H-Index: 3
#2Douglas B. Johnson (VUMC: Vanderbilt University Medical Center)H-Index: 40
Although immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for patients with many advanced malignancies, only 15–60% of patients respond, leaving a broad swath of patients who do not derive benefit. Identifying biomarkers to optimally identify patients who will benefit from ICIs is a major research focus for the oncology community. Thus far, predictive biomarker research has focused on tumor signatures such as microsatellite instability, programmed death-ligand 1 (PD-L...
10 CitationsSource
#1Alessio Cortellini (University of L'Aquila)H-Index: 3
#2Sebastiano ButiH-Index: 14
Last. Melissa Bersanelli (University of Parma)H-Index: 10
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ABSTRACT The correlation between clinical outcomes and treatment-related adverse events (AEs) has always been a debated topic in clinical oncology. Despite toxicities pharmacodynamics effects, the misunderstanding has always been around the corner: AEs themselves could lead to morbidity and mortality; on the other hand, the choice of the clinical outcomes to measure is not univocal. After the advent of immune checkpoint inhibitors (ICIs), such as anti-cytotoxic T-lymphocyte-associated protein 4 ...
4 CitationsSource
#1Katerina Deike-Hofmann (DKFZ: German Cancer Research Center)H-Index: 3
#2Lukas Gutzweiler (DKFZ: German Cancer Research Center)
Last. Philipp Bäumer (DKFZ: German Cancer Research Center)H-Index: 21
view all 9 authors...
Immunotherapies demand for predictive biomarkers to avoid unnecessary adverse effects and costs. Analytic morphomics is the technique to use body composition measures as imaging biomarkers for underlying pathophysiology to predict prognosis or outcome to therapy. We investigated different body composition measures to predict response to immunotherapy. This IRB approved retrospective analysis encompassed 147 patients with ipilimumab therapy. Degree of macroangiopathy was quantified with the newly...
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#1Hammad Shafqat (MUSC: Medical University of South Carolina)H-Index: 5
#2Theodore Stewart Gourdin (MUSC: Medical University of South Carolina)H-Index: 3
Last. Amy Sion (MUSC: Medical University of South Carolina)H-Index: 2
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Abstract Background Immune-related adverse events (irAEs) are commonly encountered, when using programmed death-1/programmed death-ligand-1 (anti-PD-1/PD-L1) therapy and are often managed with corticosteroids. The effect of irAEs, particularly when steroids are required, on patient survival is not well established. Methods In this retrospective analysis, data for 157 patients with various tumor types treated with anti-PD-1/PD-L1 therapy were obtained. Kaplan–Meier and Cox regression analyses wer...
11 CitationsSource
Immunotherapy through checkpoint inhibitors is now standard practice for a growing number of cancer types, supported by overall improvement of clinical outcomes and better tolerance. One anti-CTLA-...
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#1Chloe GoldmanH-Index: 3
#2Jeremy TchackH-Index: 3
Last. Melissa WilsonH-Index: 12
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Objectives: Since 2011, metastatic melanoma treatment has evolved with commercial approval of BRAF- and MEK-targeted therapy and CTLA-4- and PD-1-blocking antibodies (immune checkpoint inhibitors, ICI). While novel therapies have demonstrated improved prognosis in clinical trials, few studies have examined the evolution of prognosis and toxicity of these drugs among an unselected population. We assess whether survival and toxicity reported in trials, which typically exclude most patients with br...
1 CitationsSource
#1Vera Damuzzo (UNIPD: University of Padua)H-Index: 6
#2Saniantha Solito (UNIPD: University of Padua)H-Index: 2
Last. Susanna Mandruzzato (UNIPD: University of Padua)H-Index: 33
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ABSTRACTIpilimumab, the first immune-checkpoint inhibitor extending overall survival (OS) in metastatic melanoma patients, has a survival benefit only in a proportion of patients and the development of reliable predictive biomarkers is still an unmet need. To meet this request, we used a multivariate statistical approach to test whether myeloid-derived suppressor cells (MDSC) or other tumor-associated and immunological parameters may serve as predictive or prognostic biomarkers in melanoma patie...
14 CitationsSource
#1Romany A.N. Johnpulle (VUMC: Vanderbilt University Medical Center)H-Index: 6
#2Robert M. Conry (UAB: University of Alabama at Birmingham)H-Index: 30
Last. Douglas B. Johnson (VUMC: Vanderbilt University Medical Center)H-Index: 40
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ABSTRACTThe incidence of melanoma continues to rise with the most rapid increase seen in the elderly population. Historically, elderly patients with advanced melanoma have had dismal clinical outcomes, in part, due to distinct tumor biology, and often ineligibility for effective therapies during their development. In addition, due to relatively few geriatric patients being accrued to clinical trials of novel immunotherapeutics, there is a paucity of data regarding their safety and efficacy. Here...
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#1Céline BoutrosH-Index: 5
#2Ahmad A. TarhiniH-Index: 37
Last. Caroline RobertH-Index: 83
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Immune checkpoint inhibition is a novel approach to cancer treatment with enormous potential to improve the outcomes of patients with a range of malignancies. However, owing to this novel approach, a range of adverse events have emerged with different aetiologies to those of more conventional cancer treatments. In this Review, the authors describe the occurrence, and optimal management of adverse events resulting from use of immune checkpoint inhibitors.
245 CitationsSource
#1Katharina LankesH-Index: 1
Last. Lucie HeinzerlingH-Index: 25
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ABSTRACTImmune-related adverse events (irAEs) induced by checkpoint inhibitors are well known. Since fatal outcomes have been reported early detection and adequate management are crucial. In particular, colitis is frequently observed and can result in intestinal perforation. This is the first report of an autoimmune colitis that was treated according to algorithms but became resistant due to a CMV reactivation. The 32-y-old male patient with metastatic melanoma treated within an anti-PD-1/ipilim...
17 CitationsSource