Medicaid Expansion Reduced Racial Disparities in Cancer Treatment

MedicalResearch.com Interview with:

Blythe J.S. Adamson, PhD, MPH Senior Quantitative Scientist Flatiron Health

Dr. Adamson

Blythe J.S. Adamson, PhD, MPH
Senior Quantitative Scientist
Flatiron Health

MedicalResearch.com: What is the background for this study?

Response: Racial disparities in access and outcomes have been documented across the full trajectory of cancer-related care. This includes access to prevention and screening, to early diagnosis, treatment, survival and other health outcomes. While these disparities have been well documented, finding mechanisms to reduce disparities is more challenging. One potential mechanism to reduce treatment disparities is to improve access to insurance coverage. The Affordable Care Act (ACA), passed in March 2010, included as its overall goals the improvement in healthcare quality and access, and enhancing equity in treatment and outcomes. The ACA allowed states to expand Medicaid to poor and near-poor adults, and this was implemented by many states starting in 2014. In addition, the ACA established private insurance marketplaces with income-based premium subsidies and limits on out-of-pocket spending for qualifying low-income enrollees.

Prior research has demonstrated that ACA Medicaid expansions are associated with increased coverage and improved overall access for cancer survivors; and for newly diagnosed patients, the ACA was associated with increased coverage and shifts to earlier stage diagnosis for some cancers. To our knowledge, no research has yet demonstrated that the ACA coverage expansions affected the process of cancer care, specific cancer treatments received or specific treatment outcomes, let alone whether disparities were reduced.  In this study we looked at the time from advanced/metastatic diagnosis to start of systemic treatment for black vs. white patients and based on whether they were diagnosed at a time and in a state that had vs. had not implemented Medicaid expansion. Our study hypothesis was that Medicaid expansion reduced disparity in timely treatment of black patients compared to white patients with advanced cancer. We defined timely treatment as start of systemic therapy within 30 days of advanced/metastatic diagnosis.

This is a retrospective observational study, not a randomized controlled trial. In other words, we selected a cohort of patients diagnosed with advanced or metastatic cancers over time and observed whether they received timely treatment. The Flatiron Health EHR-derived database was the principal data source for this research. Flatiron contributing practices include 280 cancer community based clinics and academic hospital outpatient settings (~800 sites of care) representing more than 2.2 million patients with cancer in the United States. Practices are located in 40 states. To produce the database, Flatiron extracted data from structured fields, including demographics, and recorded medication orders and administrations. Flatiron also abstracted unstructured data, using technology assisted review by highly trained clinicians. Abstracted data include diagnosis date, stage, and prescribed oral anticancer medications. The database used for research purposes was de-identified. We also used data from the Kaiser Family Foundation which has tracked Medicaid implementation policies for over twenty years, and the US Bureau of Labor Statistics from which we pulled state-year unemployment rates.

Continue reading

Accumulation of Metabolite M-2 Predicts Overall Survival of Chemorefractory Metastatic Colorectal Cancer Patients Treated with Regorafenib (Stivarga®)

MedicalResearch.com Interview with:
Joseph Germino, M.D., PhD
Vice President US Medical Affairs Oncology
Bayer Healthcare Pharmaceuticals
Whippany, N.J. 07981

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R).

This prospective pharmacokinetic (PK) ancillary study is part of a prospective phase II study evaluating treatment response with regorafenib in patients with chemorefractory metastatic colorectal cancer (mCRC) called TEXAN, which aimed to investigate correlations between overall survival (OS) and regorafenib, or its enterohepatic cycle-dependent active metabolites M-2 and M-5 concentrations.

As measured by LC-MS/MS, the main findings showed that regorafenib, M-2 and M-5 were respectively 1.99 (1.03-2.73), 1.44 (0.89-2.49) and 1.61 (0.79-2.37) mg/L during the first cycle at day 15 (C1D15) and 1.90 (1.10-2.76), 1.29 (0.77-2.24) and 1.17 (0.45-2.42) mg/L at during the second cycle at day 15 (C2D15).  Continue reading

Children with High Risk AML: Intensification of Induction II Chemotherapy and Liberalization of Stem Cell Donor Source does not Improve Outcomes

MedicalResearch.com Interview with:
Joseph Germino, M.D., PhD
Vice President US Medical Affairs Oncology
Bayer Healthcare Pharmaceuticals
Whippany, N.J. 07981

MedicalResearch.com: What is the background for this study?

Response: Sorafenib (Nexavar®) is an oral anticancer therapy approved in more than 100 countries worldwide. It is approved for the treatment of patients with advanced hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; progressive, locally advanced or metastatic differentiated thyroid carcinoma (papillary/follicular/Hürthle cell), that is refractory to radioactive iodine (RAI).

The AAML 1031 is a recently completed Phase III clinical trial evaluating the use of bortezomib and sorafenib in patients 30 years or younger with newly diagnosed acute myeloid leukemia (AML).

At the 2019 ASCO Annual meeting, results of a report from the AAML1031 trial, which assessed whether intensification of Induction II chemotherapy (ADE or AraC/ Mitoxantrone) and liberalized stem cell transplant (SCT) donor source criteria improved clinical outcomes in patients with residual AML.  Continue reading

SPARTAN Study: Older Castration-Resistant Prostate Cancer Patients Can Tolerate and Benefit from Apalutamide (ERLEADA®)

Dr. Julie Graff

MedicalResearch.com Interview with:
Julie N. Graff, MD
Associate Professor of Medicine
Knight Cancer Institute
Chief of Hematology/Oncology
VA Portland Health Care System

MedicalResearch.com: What is the background for this study?

Response: Androgen deprivation therapy is often deployed in patients with a rising PSA after local therapy (such as radical prostatectomy or radiation therapy). With time, the prostate cancer can develop resistance to ADT, at which point it is called castration resistant prostate cancer (CRPC). There were 6 treatments for metastatic CRPC that have shown improved survival. However, in non-metastatic disease, there was nothing that showed improved survival.

The SPARTAN study was designed to determine if a next generation androgen receptor antagonist could delay the time to metastatic disease. Overall survival was a secondary endpoint.  Continue reading

CLL: Ibrutinib (IMBRUVICA®) Demonstrated Durable Responses for High Risk Patients

MedicalResearch.com Interview with:

Paul M. Barr, M.D. Associate Professor of Medicine and Director of the Clinical Trials Office Director of the Clinical Trials Office Wilmot Cancer Institute

Dr. Barr

Paul M. Barr, M.D.
Associate Professor of Medicine and Director of the Clinical Trials Office
Director of the Clinical Trials Office
Wilmot Cancer Institute 

MedicalResearch.com: What is the background for this study?  

Response: When the study was designed, chronic lymphocytic leukemia (CLL)  treatment options were largely limited to chemotherapy and monoclonal antibodies.

Ibrutinib had shown promise in early studies. The intent was to compare ibrutinib to a standard of care treatment option at that time, of atumumab, in patients with relapsed or refractory disease. The goal of the current analysis is to evaluate the durability of ibrutinib and report the long-term safety results.

Continue reading