Michelle D. Hackshaw

ORCID: 0000-0001-7319-895X
Publications
Citations
Views
---
Saved
---
About
Contact & Profiles
Research Areas
  • Economic and Financial Impacts of Cancer
  • Renal cell carcinoma treatment
  • HER2/EGFR in Cancer Research
  • Pancreatic and Hepatic Oncology Research
  • Renal and related cancers
  • Health Systems, Economic Evaluations, Quality of Life
  • Cancer Genomics and Diagnostics
  • Medication Adherence and Compliance
  • Cancer survivorship and care
  • Sarcoma Diagnosis and Treatment
  • Vascular Tumors and Angiosarcomas
  • Gastric Cancer Management and Outcomes
  • Lung Cancer Treatments and Mutations
  • Statistical Methods in Clinical Trials
  • Multiple and Secondary Primary Cancers
  • Peptidase Inhibition and Analysis
  • Cancer Treatment and Pharmacology
  • Cancer-related cognitive impairment studies
  • Global Cancer Incidence and Screening
  • Colorectal Cancer Treatments and Studies
  • Cancer Diagnosis and Treatment
  • Colorectal and Anal Carcinomas
  • Occupational and environmental lung diseases
  • Nonmelanoma Skin Cancer Studies
  • Lung Cancer Research Studies

Daiichi Sankyo (United States)
2020-2022

Daiichi Sankyo (Germany)
2021

Daiichi-Sankyo (South Korea)
2021

GlaxoSmithKline (United States)
2013-2016

Novartis (Switzerland)
2016

GlaxoSmithKline (United Kingdom)
2013-2014

Merck & Co., Inc., Rahway, NJ, USA (United States)
2012

Eli Lilly (United States)
2012

Pazopanib and sunitinib provided a progression-free survival benefit, as compared with placebo or interferon, in previous phase 3 studies involving patients metastatic renal-cell carcinoma. This 3, randomized trial the efficacy safety of pazopanib first-line therapy. We randomly assigned 1110 clear-cell, carcinoma, 1:1 ratio, to receive continuous dose (800 mg once daily; 557 patients) 6-week cycles (50 daily for 4 weeks, followed by 2 weeks without treatment; 553 patients). The primary end...

10.1056/nejmoa1303989 article EN New England Journal of Medicine 2013-08-21

BACKGROUND: Current first-line treatments for metastatic renal cell carcinoma (mRCC) include the multityrosine kinase inhibitors pazopanib and sunitinib. Both agents had similar progression-free survival (PFS) overall (OS) in COMPARZ trial (Comparing Efficacy, Safety Tolerability of Pazopanib versus Sunitinib); however, adverse event profiles 2 are different. In PISCES (Patient Preference Study Sunitinib Advanced or Metastatic Kidney Cancer), patients physicians preferred primarily because...

10.18553/jmcp.2015.21.1.46 article EN Journal of Managed Care & Specialty Pharmacy 2015-01-01

BACKGROUND In a phase 3, randomized, open‐label trial (Pazopanib versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma, COMPARZ; NCT00720941), pazopanib was found to be noninferior sunitinib terms progression‐free survival patients with metastatic renal cell carcinoma no prior therapy. Overall treatment differences were evaluated post hoc analysis quality‐adjusted time without symptoms or toxicity (Q‐TWiST) methodology. METHODS Each patient's overall...

10.1002/cncr.29888 article EN Cancer 2016-01-27

Abstract Regulatory approval of new therapies often depends on demonstrating prolonged survival. Particularly when these survival benefits are modest, consideration therapeutic to patient-reported outcomes (PROs) may add value the traditional biomedical clinical trial endpoints. We extend a popular class joint models for longitudinal and data accommodate excessive zeros common in PROs, building hierarchical Bayesian that combine information from PRO measurements outcomes. The model...

10.1080/01621459.2012.664517 article EN Journal of the American Statistical Association 2012-05-24

BACKGROUND: Pazopanib was noninferior to sunitinib in progression-free survival a phase III, open-label, randomized clinical trial comparing the efficacy and safety of 2 drugs for treatment patients with advanced renal cell carcinoma (RCC). A secondary analysis this conducted on patient-reported health care resource utilization (HCRU) endpoints revealed significantly fewer monthly telephone consultations emergency department visits among treated pazopanib over first 6 months treatment....

10.18553/jmcp.2015.21.1.37 article EN Journal of Managed Care & Specialty Pharmacy 2015-01-01

Pazopanib is an oral tyrosine kinase inhibitor with demonstrated efficacy and tolerability in patients advanced renal cell carcinoma (RCC).To examine pazopanib persistence compliance (adherence) other drug utilization patterns both treatment-naïve (first-line) those previously treated RCC therapy the real-world setting. Key factors affecting were also explored.This was a retrospective claims analysis using Truven Health MarketScan Databases to cover activity from October 2007 through March...

10.18553/jmcp.2014.20.6.603 article EN Journal of Managed Care Pharmacy 2014-06-01

Purpose . To assess epidemiology, treatment patterns, and outcomes of metastatic soft tissue sarcoma (mSTS) patients in USA community oncology practices. Methods This retrospective, descriptive study used US Oncology’s iKnowMed electronic health records database. Adults (≥18 years) with mSTS at least two visits between July 2007 June 2010 were included. Key practice overall survival (OS), progression-free (PFS). Results 363 (174 treated 189 untreated) met the prespecified exclusion/inclusion...

10.1155/2014/145764 article EN cc-by Sarcoma 2014-01-01

For first-line therapy options for advanced renal cell carcinoma (RCC), clinical trials have demonstrated similar efficacy pazopanib and sunitinib as well differing side-effect profiles, which may affect patient persistence in self-administration of these oral medications. However, the treatment patterns each drug real-world practice, opposed to controlled environment a trial, not been directly compared.

10.18553/jmcp.2015.21.6.515 article EN Journal of Managed Care & Specialty Pharmacy 2015-06-01

Several systemic therapies are now approved for first- and second-line treatment of metastatic renal cell carcinoma (mRCC). Although the National Comprehensive Cancer Network (NCCN) guidelines offer physicians evidence-based recommendations therapy, there few real-world studies to help inform utilization these agents in clinical practice.To (a) describe patterns use associated with mRCC among Humana members United States diagnosed mRCC, (b) assess consistency NCCN treatment, (c) initial...

10.18553/jmcp.2016.22.3.219 article EN Journal of Managed Care & Specialty Pharmacy 2016-02-22

To estimate the costs of adverse events (AEs) in patients aged ≥65 years with metastatic renal cell carcinoma (mRCC).Retrospective study using linked Surveillance, Epidemiology and End Results (SEER) Medicare database. Study subjects consisted persons SEER-Medicare, years, evidence newly diagnosed mRCC between January 1, 2007 December 31, 2007. Adverse interest Grade 3 or 4 toxicities that have been reported frequency ≥5% randomized controlled trials sunitinib, sorafenib, bevacizumab,...

10.3111/13696998.2013.838570 article EN Journal of Medical Economics 2013-09-04

346 Background: Pazopanib and sunitinib are targeted therapies associated with particular treatment-related side effects that may affect patients’ QoL. COMPARZ was a randomized, open-label, parallel group, phase III study of pazopanib vs. in 1,110 subjects advanced RCC who had not received prior systemic therapy. The demonstrated is non-inferior to respect progression-free survival. also confirmed the differentiated safety profiles two drugs. Methods: QoL endpoints were assessed using...

10.1200/jco.2013.31.6_suppl.346 article EN Journal of Clinical Oncology 2013-02-20

Background: The purpose of this study was to identify a real-world US population having undergone surgery for malignant melanoma and describe treatment patterns, health care resource utilization, costs patients who subsequently received interferon alfa-2b (IFN) therapy or other standard chemotherapies. Methods: A retrospective cohort conducted using administrative claims from MarketScan ® databases among diagnosed between 2004 2008 had were treated with IFN Health utilization services...

10.2147/ceor.s32349 article EN cc-by-nc ClinicoEconomics and Outcomes Research 2012-06-01

567 Background: The COMPARZ trial demonstrated that pazopanib was non-inferior to sunitinib regarding their efficacy as first line of therapy (LOT) for advanced/metastatic RCC (aRCC). However, no studies have compared the effectiveness outside clinical setting. purpose this study compare outcomes two therapies in a US community oncology Methods: A retrospective conducted using Oncology’s (USON) iKnowMed electronic health record (EHR) database, supplemented with chart review. Patient...

10.1200/jco.2016.34.2_suppl.567 article EN Journal of Clinical Oncology 2016-01-10

4581 Background: In a phase 3, randomized, open-label trial (NCT00720941), PAZ demonstrated non-inferiority for progression-free survival vs SUN in mRCC patients with no prior therapy (NEJM 2013; 369: 722). Overall treatment differences were evaluated post-hoc analysis using the quality-adjusted time without symptoms of progression or toxicity (Q-TWiST). Methods: Each patient’s overall (OS) was partitioned into 3 health states: grade 4 (TOX), (TWiST), and after relapse (REL). The spent each...

10.1200/jco.2014.32.15_suppl.4581 article EN Journal of Clinical Oncology 2014-05-20

4057 Background: DESTINY-Gastric01 (NCT03329690) is a randomized, phase 2 study evaluating trastuzumab deruxtecan (T-DXd) in patients with HER2-positive advanced gastric cancer who progressed after ≥2 regimens. T-DXd significantly improved objective response rate (51% vs. 14%; P < 0.001) and overall survival (median OS; 12.5 8.4 months; = 0.01) relative to chemotherapy (irinotecan or paclitaxel), leading regulatory approval USA Japan. This post hoc analysis evaluated the effect of...

10.1200/jco.2021.39.15_suppl.4057 article EN Journal of Clinical Oncology 2021-05-20

Background. The most common chemotherapies in metastatic soft tissue sarcoma (mSTS) require intravenous (IV) administration. This often requires patients to make multiple outpatient visits per chemotherapy cycle, possibly impeding patients' daily activities and increasing caregiver burden medical costs. study investigated costs associated with IV cancer therapy administration mSTS from the payer perspective of health care system. Patients Methods. From Experian Healthcare database, 1,228...

10.1155/2013/947413 article EN cc-by Sarcoma 2013-01-01
Coming Soon ...