E-Newsletter - October 2015

Alliance Researchers approved for $4.3 million research funding awards

Two Alliance researchers recently were approved to receive multi-year awards from the Patient-Centered Outcomes Research Institute (PCORI) to fund comparative effectiveness research that will help patients and their providers make better informed decisions about their care, including cancer care. Ronald C. Chen, MD, MPH, of University of North Carolina at Chapel Hill, and Deborah Schrag, MD, MPH, of Dana-Farber Cancer Institute, are members of the Alliance American College of Surgeons Clinical Research Program’s Cancer Care Delivery Research Committee. Dr. Chen is an Associate Professor in the Department of Radiation Oncology at UNC-Chapel Hill, and Director of the UNC CyberKnife Radiosurgery Program. Dr. Schrag is a Professor of Medicine, Harvard Medical School and Chief, Division of Population Sciences, Department of Medical Oncology.  

The PCORI awards will fund studies on post-treatment surveillance and anticoagulation strategies to manage venous blood cots in patients with cancer:

  • Optimizing the Effectiveness of Routine Post-Treatment Surveillance in Prostate Cancer Survivors (Dr. Chen; $1,714,811 over three years)
  • Rivaroxaban versus Low-Molecular Weight Heparin or Coumadin for Treatment of Venous Thromboembli (VTEs) in Cancer Patients (Dr. Schrag; $2,653,383 over three years

Both proposals were sponsored by the Alliance for Clinical Trials in Oncology Foundation.

Dr. Chen’s study has substantial potential to provide new knowledge that will benefit the three million prostate cancer survivors in the United States. The study seeks to identify the benefits (improved survival) and harms (more procedures, more treatment, side effects, and quality-of-life impact) from different surveillance frequencies—every three versus six versus 12 months. Dr. Chen hypothesizes that patients with a low risk of recurrence may experience more harm than benefit, while patients with a high risk of recurrence may have improved survival from frequent surveillance. The study aims to compare survival, procedures/tests, treatments, and side effects in prostate cancer survivors who are followed with alternative surveillance frequencies, and to compare quality-of-life outcomes. It is hoped that the study will inform patient decision-making and change clinical practice to improve patient outcomes. Click this link to learn more - http://www.pcori.org/research-results/2015/optimizing-effectiveness-routine-post-treatment-surveillance-prostate-cancer

Dr. Schrag’s study seeks to determine the effectiveness of low molecular weight heparin (LMWH)/warfarin versus direct oral anticoagulants (DOAC) anticoagulation for preventing recurrent deep venous thromboses (VTE). The study aims to recruit 750 patients with solid tumor from more than 50 centers and follow them for six months. The intervention strategy is DOAC therapy with edoxaban, apixaban, or rivaroxaban; the comparator is LMWH alone or with warfarin. Within each arm, patients can choose the agent they prefer, based on side effects, drug interactions, and such practical issues as co-pays. The trial compares these two strategies in terms of treatment: 1) benefits based on VTE recurrence; 2) harms based on bleeding rates; 3) burdens based on patients’ reports of their experiences; and 4) mortality rates, including deaths from VTE, bleeding, and cancer. Dr. Schrag hypothesizes that the benefits, harms, and burdens of DOAC treatment will be not inferior to, or better than, usual care with LMWH/warfarin among patients with cancer. The information gained will empower patients with cancer and physicians to make more informed choices about anticoagulation strategies to manage VTE. Click this link to learn more - http://www.pcori.org/research-results/2015/rivaroxaban-versus-low-molecular-weight-heparin-or-coumadin-treatment-venous

The studies were selected for PCORI funding through a highly competitive review process in which patients, clinicians, and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders, and their methodological rigor among other criteria. Awards to both Drs. Chen and Schrag have been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org or http://www.pcori.org/funding/opportunities.


* * * * * * * * * * * * *
For other articles in the October issue of Alliance E-News, see below.