A5039768907- Cancer Treatment and Pharmacology
- Cancer survivorship and care
- Pain Management and Opioid Use
- Cancer Genomics and Diagnostics
- Cancer Immunotherapy and Biomarkers
- Advanced Breast Cancer Therapies
- Clinical practice guidelines implementation
- Biomedical Text Mining and Ontologies
- Endometrial and Cervical Cancer Treatments
- Breast Cancer Treatment Studies
- HER2/EGFR in Cancer Research
- Patient-Provider Communication in Healthcare
- PI3K/AKT/mTOR signaling in cancer
- Radiomics and Machine Learning in Medical Imaging
- Monoclonal and Polyclonal Antibodies Research
- Musculoskeletal pain and rehabilitation
- Gene expression and cancer classification
- Health Systems, Economic Evaluations, Quality of Life
- Angiogenesis and VEGF in Cancer
- PARP inhibition in cancer therapy
- Mental Health and Psychiatry
- Pharmacovigilance and Adverse Drug Reactions
- Medical and Biological Sciences
- Cancer, Stress, Anesthesia, and Immune Response
- MRI in cancer diagnosis
University of California, San Francisco
2020-2024
UCSF Helen Diller Family Comprehensive Cancer Center
2021
City College of San Francisco
2021
Memorial Sloan Kettering Cancer Center
2009-2018
University of North Carolina at Chapel Hill
2018
UNC Lineberger Comprehensive Cancer Center
2016
Children's Hospital of Philadelphia
2015
Mayo Clinic in Arizona
2015
Duke University
2014
Emory University
2014
Purpose There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, but evidence of impact on clinical outcomes limited. Methods We randomly assigned patients receiving outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center report 12 common symptoms via tablet computers or receive usual consisting the discretion clinicians. Those with home received weekly e-mail prompts between visits. Treating...
The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria Adverse Events (CTCAE). Because this underdetects AEs, NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as companion CTCAE, called PRO-CTCAE. This Commentary describes development of PRO-CTCAE by group multidisciplinary investigators and patient...
In cancer treatment trials, the standard source of adverse symptom data is clinician reporting by use items from National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). Patient self-reporting has been proposed as an additional source, but implications such a shift are not understood. Patients with lung receiving chemotherapy and their clinicians independently reported six CTCAE symptoms Karnofsky Performance Status longitudinally at sequential office visits. To...
Using pre-treatment gene expression, protein/phosphoprotein, and clinical data from the I-SPY2 neoadjuvant platform trial (NCT01042379), we create alternative breast cancer subtypes incorporating tumor biology beyond hormone receptor (HR) human epidermal growth factor receptor-2 (HER2) status to better predict drug responses. We assess predictive performance of mechanism-of-action biomarkers ∼990 patients treated with 10 regimens targeting diverse biology. explore >11 subtyping schemas...
In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This guidance outlines psychometric aspects that should be considered when designing PRO measure, including conceptual framework, content validity, construct reliability, ability detect clinically meaningful score changes. When finalized, it may provide blueprint evaluations measures...
Hypertension is a mechanism-based toxicity of sorafenib and other cancer therapeutics that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. This prospective, single-center, cohort study characterized ambulatory blood pressure monitoring as an early pharmacodynamic biomarker VEGF pathway inhibition by sorafenib.Fifty-four normotensive advanced patients underwent 24-hour before between days 6 10 therapy. After changes were detected among first within days, was done...
Patient-reported outcomes are increasingly used in routine outpatient cancer care to guide clinical decisions and enhance communication. Prior evidence suggests good patient compliance with reporting at scheduled clinic visits, but there is limited about long-term longitudinal between visits.
The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." PRO-CTCAE consists library items which can be administered in clinical trials to directly capture patient experience adverse events during cancer treatment, as well software platform administering these via computer or telephone. In order better understand impressions stakeholders involved research about potential value approach capturing...
The authors' results provide a method for estimating accruals along the disease continuum, and enabling design of trials appropriately powered to assess pain.
The US National Cancer Institute (NCI) developed software to gather symptomatic adverse events directly from patients participating in clinical trials. administers surveys using items the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) through Web-based or automated telephone interfaces and facilitates management survey administration resultant data by professionals (clinicians research associates).
Molecular subtyping of breast cancer is based mostly on HR/HER2 and gene expression-based immune, DNA repair deficiency, luminal signatures. We extend this description via functional protein pathway activation mapping using pre-treatment, quantitative expression data from 139 proteins/phosphoproteins 736 patients across 8 treatment arms the I-SPY 2 Trial (ClinicalTrials.gov: NCT01042379). identify predictive fit-for-purpose, mechanism-of-action-based signatures individual biomarker...
The Brief Pain Inventory (BPI) was designed to yield separate scores for pain intensity and interference. It has been proposed that the interference factor can be further broken down into unique factors of affective (e.g., mood) activity work) purpose this analysis confirm affective/activity dichotomy.A retrospective confirmatory completed a sample 184 individuals diagnosed with castrate-resistant prostate cancer (age 40-86, mean = 65.46, 77% White non-Hispanic) who had administered BPI as...
9558 Background: Sexual dysfunction (SD) is reported after chemotherapy and endocrine therapies, causes a substantial burden on women with breast cancer. However, the prevalence severity of SD in this population not well defined. Improved understanding may allow for enhanced treatment interventions patients cancer undergoing active treatment, survivors disease. Methods: We developed survey that includes previously validated questionnaire, female sexual function index (FSFI), disease-specific...
e19633 Background: NCI PRO-CTCAE is a new patient-reported outcome measure designed to enhance adverse event (AE) reporting in clinical trials by integrating the patient experience. The item bank includes items representing frequency (F), severity (S) and interference (I) with usual activities of 78 symptomatic AEs. aim this study was examine acceptability subset women receiving treatment for HER2+ MBC. Methods: 207 on active MBC (median 47 months since diagnosis) were recruited from 6 U.S....
Purpose To investigate the impact of longitudinal variation in functional tumor volume (FTV) underestimation and overestimation predicting pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC). Materials Methods Women with breast cancer who were enrolled prospective I-SPY 2 TRIAL (Investigation Serial Studies to Predict Your Therapeutic Response Imaging Molecular Analysis 2) from May 2010 November 2016 eligible for this retrospective analysis. Participants underwent four...
Abstract Inhibition of vascular endothelial growth factor (VEGF) signaling increases red blood cell (RBC) counts, and erythropoiesis markers have been proposed to guide antiangiogenic therapy in humans. We analyzed RBC measurements patients enrolled three studies: a phase II trial axitinib thyroid cancer; study sorafenib advanced solid tumors; randomized fluorouracil, hydroxyurea, radiation with without bevacizumab for head neck cancer. In the trial, plasma erythropoietin concentrations were...
3091 Background: Hyperglycemia and hypertriglyceridemia are mechanism-based toxicities of mammalian target rapamycin (mTOR) inhibitors, but have not been intensively studied as potential pharmacodynamic biomarkers. Methods: Changes in fasting serum glucose triglyceride concentrations were determined 127 patients (pts) before, 4 weeks after treatment with the mTOR inhibitor sirolimus/rapamycin (S). Pts enrolled three different trials S administered to achieve AUC 1,000-6,000 ng-hr/ml....
Abstract Background: Pembrolizumab, an anti-PD-1 immune checkpoint inhibitor, is approved for treatment in multiple cancers and has been shown to increase pathologic complete response (pCR) survival the neoadjuvant setting breast cancer. Pembrolizumab combined with paclitaxel followed by doxorubicin/cyclophosphamide (P+T->AC) was evaluated HER2- patients I-SPY 2 TRIAL graduated HER2-, HR+HER2- triple negative (TN) signatures. Our biomarker analysis revealed that cell abundance MP2...