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Open AccessCommon variation in a long non-coding RNA gene modulates variation of circulating TGF-β2 levels in metastatic colorectal cancer patients (Alliance)
Herein, we report results from a genome-wide study conducted to identify protein quantitative trait loci (pQTL) for circulating angiogenic and inflammatory protein markers in patients with metastatic colorecta...
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Sotorasib dosing and incremental cost ineffectiveness — implications and lessons for stakeholders
The US FDA Accelerated Approval of sotorasib required the sponsor to conduct a randomized trial that compared the safety and efficacy of the approved dose with a lower dose. These results, recently disclosed, ...
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Article
Open AccessPharmacogenetic and clinical risk factors for bevacizumab-related gastrointestinal hemorrhage in prostate cancer patients treated on CALGB 90401 (Alliance)
The objective of this study was to discover clinical and pharmacogenetic factors associated with bevacizumab-related gastrointestinal hemorrhage in Cancer and Leukemia Group B (Alliance) 90401. Patients with m...
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Article
Do patent applications and Cooperative Research and Development Agreements between the National Cancer Institute and industry serve the public interest?
Policy changes are needed to ensure that Cooperative Research and Development Agreements and patent applications filed by the US National Institutes of Health are aligned with the interests of the American pub...
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Interventional pharmacoeconomics for immune checkpoint inhibitors through alternative dosing strategies
Immune checkpoint inhibitors (ICIs) are approved for the treatment of a variety of cancer types. The doses of these drugs, though approved by the Food and Drug Administration (FDA), have never been optimised, ...
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Open AccessEftozanermin alfa (ABBV-621) monotherapy in patients with previously treated solid tumors: findings of a phase 1, first-in-human study
Eftozanermin alfa (eftoza), a second-generation tumor necrosis factor-related apoptosis-inducing ligand receptor (TRAIL-R) agonist, induces apoptosis in tumor cells by activation of death receptors 4/5. This p...
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Article
Lurbinectedin-induced thrombocytopenia: the role of body surface area
Lurbinectedin is an alkylating agent approved for the second-line treatment of small cell lung cancer. Although initial studies showed no association between body surface area (BSA) and drug clearance, the rec...
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Open AccessAlternative trastuzumab dosing strategies in HER2-positive early breast cancer are associated with patient out-of-pocket savings
Patients with breast cancer frequently experience financial hardship, often due to the high costs of anti-cancer drugs. We sought to develop alternative trastuzumab dosing strategies, compare their pharmacokin...
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Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients
Hypertension and proteinuria are common bevacizumab-induced toxicities. No validated biomarkers are available for identifying patients at risk of these toxicities.
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Correction: Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients
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Appraisal and development of evidence-based clinical decision support to enable perioperative pharmacogenomic application
Variable responses to medications complicates perioperative care. As a potential solution, we evaluated and synthesized pharmacogenomic evidence that may inform anesthesia and pain prescribing to identify clin...
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Article
Combination therapy patents: a new front in evergreening
As pharmaceutical companies seek patent protection for combinations of cancer therapeutics, it is worthwhile to assess what constitutes an ‘unexpected result’ for the purpose of an appropriate patent and wheth...
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Open AccessUnderrepresented patient views and perceptions of personalized medication treatment through pharmacogenomics
Within an institutional pharmacogenomics implementation program, we surveyed 463 outpatients completing preemptive pharmacogenomic testing whose genetic results were available to providers for guiding medicati...
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Article
Negative innovation: when patents are bad for patients
Incentives in patent law have driven innovation into spaces that are affirmatively harmful to patients, and patentees are discouraged from taking steps to improve the product so as to prevent adverse health ou...
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Clinical evaluation of germline polymorphisms associated with capecitabine toxicity in breast cancer: TBCRC-015
Capecitabine is important in breast cancer treatment but causes diarrhea and hand-foot syndrome (HFS), affecting adherence and quality of life. We sought to identify pharmacogenomic predictors of capecitabine ...
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Optimal Sampling Strategies for Irinotecan (CPT-11) and its Active Metabolite (SN-38) in Cancer Patients
Irinotecan (CPT-11) is an anticancer agent widely used in the treatment of a variety of adult solid tumors. The objective of this study was to develop an optimal sampling strategy model that accurately estimat...
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Pharmacogenomic genotypes define genetic ancestry in patients and enable population-specific genomic implementation
The importance of genetic ancestry characterization is increasing in genomic implementation efforts, and clinical pharmacogenomic guidelines are being published that include population-specific recommendations...
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Alternative dosing regimens for atezolizumab: right dose, wrong frequency
The population pharmacokinetics of atezolizumab demonstrate that the trough concentrations are well above the putative target of 6 µg/ml. Thus, alternative dosing schedules are indeed of interest, focusing on ...
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Patient-provider communications about pharmacogenomic results increase patient recall of medication changes
Effective doctor–patient communication is critical for disease management, especially when considering genetic information. We studied patient-provider communications after implementing a point-of-care pharmac...
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Open AccessGenetic variation determines VEGF-A plasma levels in cancer patients
Angiogenesis is essential in tumor biology and is regulated by vascular endothelial growth factor (VEGF) ligands and receptors. Here we aimed to discover genetic variants associated with levels of circulating ...