Following New Wisdom

Experienced researchers sign on to guide ACRIN® and RTOG® cancer trials.following wisdom

The importance of outstanding scientific leadership in guiding clinical research that translates into clinical benefits for patients with cancer cannot be overstated. Two leaders, Daniel P. Barboriak, M.D., and Quynh-Thu Le, M.D., have recently begun guiding head, neck, and neurological trials at ACRIN® and RTOG®.

New ACRIN Committee Leadership

Daniel BarboriakDaniel P. Barboriak, M.D., professor of radiology and director of pediatric neuroradiology at Duke University Medical Center in Durham, N.C., has the expertise crucial to guiding multicenter research of imaging in cancers of the brain, head, and neck. As the Director of Pediatric Neuroradiology at Duke, Barboriak has more than 16 years of clinical experience as a senior member of the American Society of Neuroradiology. The focus of his research is on imaging evaluation of cancer therapeutics and neuro-oncology imaging.

Barboriak plans to use this experience, as well as his four years as a member of the ACRIN Head and Neck/Neurological Committee, to advance the evaluation of imaging techniques that could improve the characterization and staging of tumors and evaluation of therapy response. "I see the committee as an honest broker of the many imaging ideas posed by scientists for evaluating treatment of cancers of the brain, head, and neck, and determining which are most likely to have clinical benefits," offers Barboriak. "Assessment of an imaging test in a multicenter environment is a crucial step in determining whether it will be useful for the care of individual patients." Showing that an imaging test benefited patients in a multicenter trial often paves the way for more widespread acceptance of the technique, and for real changes in the practice of radiology.

“I see the committee as an honest broker of the many imaging ideas posed by scientists for evaluating treatment of cancers of the brain, head, and neck, and determining which are most likely to have clinical benefits.” — Daniel P. Barboriak, M.D.

Barboriak's approach to imaging clinical trials includes involving a broad range of imaging facilities, including community-based institutions that may lack the technological resources of academic centers. "We hope to not only promote advanced imaging applications, but also to increase the network of sites with experience in obtaining better structural images — for example, with T2-weighted thin-section methods and different ways of acquiring spoiled gradient recalled images," he explains.

Barboriak acknowledges the challenges involved with conducting trials with the most cutting-edge equipment. "The more advanced the technologies, the smaller the number of sites able to carry out the protocol, and not having many sites participating in a trial makes patient recruitment difficult," he notes. "Especially for trials involving large numbers of participants at various types of institutions, incorporating imaging acceptable to the patient is important in terms of number of additional research scans required and the length of scans," he says.

In addition, academic centers with more advanced imaging research capabilities prefer an imaging protocol, say, for a MRI brain scan for a suspected brain tumor, that differs from what is required for a specific clinical trial. "We need sites participating in ACRIN trials to strictly adhere to specified imaging parameters that might not be optimal from their perspective but are critical for comparing images across sites," explains Barboriak. "Image data from sites that are not comparable have minimal value. Ultimately, each trial has its own challenges, and we try to tailor what we're doing to the necessities of the trial. A major emphasis for us is to try to do the best study we can without adversely affecting patient recruitment."

Given the recent Eastern Cooperative Oncology Group (ECOG) and ACRIN merger (see "ACRIN's New Deal on page 10 of the September ACR Bulletin), Barboriak has been interacting with ECOG representatives, including Lawrence R. Kleinberg, M.D., from the Johns Hopkins University in Baltimore, chair of the ECOG Brain Tumor Working Group. "[Kleinberg and I] are discussing the integration of imaging science in studies of patient populations that have been the focus of ECOG research, such as patients with low-grade glioma," he notes. "This is a new direction for ACRIN, which has traditionally focused on trials in patients with high-grade gliomas such as glioblastoma. We look forward to further discussions about the science evolving through ECOG-ACRIN," elaborates Barboriak. Additionally, plans are underway to target research focused on metastatic disease — another new direction for the ACRIN committee.

With the broad scope of imaging research that head and neck cancer and brain cancer encompasses, Laurie Loevner, M.D., director of head and neck imaging at the Hospital of the University of Pennsylvania in Philadelphia, has been appointed to the newly created position of vice chair of the head and neck section of the committee. Loevner is also the principal investigator at the site for ACRIN 6885: A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients. "I am very excited that Dr. Loevner has joined the committee. She has an extensive background in head and neck imaging and will be an effective member of the ECOG-ACRIN team," says Barboriak. Loevner will work alongside her ECOG counterpart, Barbara Burtness, M.D., from Fox Chase Cancer Center, in Philadelphia. At the University of Pennsylvania, Loevner is overseeing the ACRIN 6885 trial investigating FDG-PET/CT for the staging of head and neck cancer.

RTOG Committee Adds Experience

Quynh LeIn January 2012, Quynh-Thu Le, M.D., became chair of the RTOG Head and Neck Cancer Committee. Le is professor and chair of the Department of Radiation Oncology at Stanford University in Palo Alto, Calif. Her association with RTOG clinical trials dates back to her experience as resident at the University of California, San Francisco, where she was mentored by longtime RTOG committee chair Karen K. Fu, M.D. Le has since gone on to lead single-center head and neck cancer clinical trials at Stanford University and to strongly support RTOG multicenter trials being conducted at that site.

“Dr. Le’s extensive biomarker research background will be invaluable in continuing to advance RTOG’s translational research efforts.” — Walter J. Curran Jr., M.D.

The identification and validation of biomarkers for prognosis in patients with head and neck cancer has long been a focus of Le's research. She is currently involved with clinical trials aimed at identifying novel proteins and secreted markers for tumor hypoxia in patients with head and neck cancer.

Because of her interest in determining response to specific chemotherapy and radiation therapy regimens in patients with head and neck cancer who test negative for human papillomavirus (HPV), Le is excited about participating in RTOG 3501, a trial led by Stuart Wong, M.D., from the Medical College of Wisconsin in Milwaukee, Wisc., and George Shenouda, Ph.D., M.B.B.Ch., from Montreal General Hospital in Montreal, Quebec. The primary goal of RTOG 3501 is to determine whether adding lapatinib (a dual EGFR and Her2 inhibitor) to concurrent cisplatin-based chemoradiation followed by maintenance lapatinib for one year would improve disease-free survival over concurrent chemoradiation alone in patients with HPV-negative, locally advanced head and neck cancer. Prior to research by RTOG and others has shown that patients whose head and neck cancer is HPV-negative have poorer outcomes than patient's whose cancer is HPV-positive.1 "As the first cooperative group study specifically designed to intensify treatment in this patient population with such a poor prognosis, this study has the potential to impact clinical care," says Le.

"Dr. Le's extensive biomarker research background will be invaluable in continuing to advance RTOG's translational research efforts," says Walter J. Curran Jr., M.D., RTOG group chair and executive director of the Winship Cancer Institute of Emory Institute in Atlanta. "As cancer research strives to develop more personalized treatment strategies, scientific leadership with experience in the design of clinical trials integrating biomarkers is critical, and we are very fortunate to have Dr. Le agree to lead the Head and Neck Cancer Committee."


ENDNOTES
1. Lowry D, Munger K. “Prognostic Implications of HPV in Oropharyngeal Cancer,” Editorial. N Engl J Med 2010;363(1):82–83.


By Nancy Fredericks, M.B.A., and Julie Catagnus, M.P.H., E.L.S.
Nancy Fredericks, M.B.A. (This email address is being protected from spambots. You need JavaScript enabled to view it.), is communications director, ACR Clinical Research Center.
Julie Catagnus, M.S.W., ELS, is a freelance writer.

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