Jun 29, 2016
By Shira Klapper, Senior Medical Writer/Editor
In 1995, Daniel F. Hayes, MD, FASCO, gathered with several other oncologists at a conference center in San Francisco to begin writing the first-ever ASCO guidelines on cancer treatment. He and his colleagues felt like pioneers scouting uncharted frontier. “I’ll never forget, that first hour or so, we just sat around looking at each other, [because] the field of clinical guidelines, what is now known as translational research, was so chaotic,” he said.
But the doctors got to work and imposed order onto chaos, ultimately producing the paper “Tumor Marker Utility Grading System: A Framework to Evaluate Clinical Utility of Tumor Markers.” A revision of the paper 10 years later included guidelines that came to be known as the Simon-Paik-Hayes Criteria. Today, Dr. Hayes’ work is recognized as having a lasting impact on the field of tumor biomarkers.
Twenty-one years after that first guidelines meeting, Dr. Hayes begins his term as the 2016-2017 President of ASCO, and it is certain that the leadership skills, vision, and research and clinical expertise he displayed in his pioneering work on guidelines will serve him well in this role.
Dr. Hayes is a Professor of Internal Medicine, the Stuart B. Padnos Professor of Breast Cancer Research, and the Clinical Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center, in Ann Arbor. Prior to joining the faculty at the University of Michigan, he held academic appointments at Harvard Medical School (1985-1996) and Georgetown University Medical Center (1996-2001).
A distinguished track and field athlete during his high school and college years, it is fitting to say that Dr. Hayes is taking the baton of leadership at a momentous time in ASCO’s history. This coming year, ASCO will carry out major patient-recruitment efforts for the first ASCO-sponsored clinical trial—the Targeted Agent and Profiling Utilization Registry (TAPUR) study—which began enrollment in March 2016 and intends to assess commercially available, targeted anticancer drugs for patients who have tried all other treatments.
This year will also see important developments for CancerLinQ™, ASCO’s cutting-edge health information technology (HIT) platform that will aggregate data and allow oncologists to learn from each of the millions of individual patients living with cancer. On the policy front, ASCO will continue to promote its Patient-Centered Oncology Payment: Payment Reform to Support Higher Quality, More Affordable Cancer Care (PCOP) model, to address the serious financial challenges facing oncology practices.
In addition to these projects, Dr. Hayes will also focus on two initiatives close to his heart: promoting ASCO’s efforts in value in cancer care, particularly as it relates to tumor biomarkers, and continuing to lead ASCO’s ongoing collaboration with the College of American Pathologists (CAP) to develop cancer care guidelines for low- and middle-income countries.
Immediate Past President Julie M. Vose, MD, MBA, FASCO, said that Dr. Hayes’s expertise in guideline development, global health, and clinical research make him an ideal leader to guide ASCO at this time.
“Dr. Hayes has had a long and fruitful career specializing in translational therapy for breast cancer as well as studying the clinical use of biomarkers and pharmacogenomics,” Dr. Vose said. “He and I have also been working jointly on a multiyear project, Best Practices in Clinical Research, to standardize and simplify the regulatory processes associated with clinical trials and allow patients more access to clinical trials in a timely manner. The next several years in oncology will be a time of change, with physician payment reform modifications, enhancement in quality improvement, and optimization of the value framework in oncology. Dan is well suited to tackle all of these issues.”
One of the most significant changes to occur at ASCO this year is the arrival of a new CEO, Clifford A. Hudis, MD, FACP. Dr. Hudis, who worked with Dr. Hayes when both were members of the Board of Directors, spoke of the strengths Dr. Hayes will bring to the Presidency.
“I was privileged to work with Dr. Hayes when I was President and then, as always, I could count on him to quickly see through to the heart of any matter under consideration. He has an incisive analytical wisdom that enables him to lead the group to quickly grasp the core concept under discussion as well as the key implications,” Dr. Hudis said. “In addition, Dr. Hayes has extensive technical and leadership experience across all of oncology, but especially in the development of biomarkers in the context of breast cancer treatment. The process of developing complex analyses and interpretation of study results, at which he excels, is quite similar to the way our Board must incorporate multifactorial considerations as they plan our future and make challenging decisions about our next steps.”
Dr. Hudis also noted that Dr. Hayes’ knowledge about a wide range of data sources is enormously valuable as ASCO begins to make CancerLinQ available to the oncology community.
Brotherly Advice, Great Mentors Led to Oncology Career
As a child in a small town in Indiana, Dr. Hayes was certain of one thing: When he grew up, he would be a basketball and track and field coach. During college, however, he realized that it would be hard to make a living as a coach. His brother, said Dr. Hayes, suggested a novel idea: “He said, ‘Since your main passions are teaching, why not consider medicine, where you’ll be able to work with people and train future generations of doctors?’”
Dr. Hayes took his brother’s advice and attended the Indiana University School of Medicine. There, he was assigned to the oncology ward, where he worked with the now-legendary oncologist Lawrence H. Einhorn, MD, FASCO. At that time, Dr. Einhorn was a young attending physician bent on curing testicular cancer with cisplatin-containing combination chemotherapy.
While working alongside Dr. Einhorn, Dr. Hayes was inspired to become an oncologist. Following graduation, Dr. Hayes entered residency at Parkland Memorial Hospital/University of Texas Southwestern Medical School.
Upon beginning his fellowship at the Sidney Farber Cancer Institute (now the Dana-Farber Cancer Institute), Dr. Hayes thought he would follow in Dr. Einhorn’s footsteps and specialize in testicular cancer, but Emil (Tom) Frei III, MD, another oncology luminary, had a different idea. He assigned Dr. Hayes to work in the lab of Donald W. Kufe, MD, who was trying to find a circulating antigen for breast cancer.
After a year in Dr. Kufe’s lab, Dr. Hayes wanted to learn more about breast cancer, so he walked down the hall to speak with I. Craig Henderson, MD, who ran one of the first multimodality cancer clinics in the United States.
That meeting set Dr. Hayes on his lifelong career path.
“Dr. Henderson said to me, ‘Why don’t you start working in the clinic since you’re doing lab work in breast cancer?’ I said, ‘Okay, I like that idea.’ And that’s how I got into the field of breast cancer,” Dr. Hayes recounted with characteristic good humor. “I owe a lot to the mentors who helped me along the way, including Dr. Einhorn, Dr. Frei, Dr. Kufe, George P. Canellos, MD, FASCO, [then Chief of Medical Oncology at Dana-Farber Cancer Institute], Robert J. Mayer, MD, FASCO [then Fellowship Director at Dana-Farber Cancer Institute], and especially Dr. Henderson.”
Following fellowship, Dr. Hayes went on to work at the Georgetown Lombardi Comprehensive Cancer Center. There, he was privileged to work with Marc E. Lippman, MD; the two still keep in close contact and collaborate on projects.
Reflecting on the many doctors who influenced his career, Dr. Hayes said, “There aren’t many oncologists who can match that line-up of great mentors!”
Translating Research Into Guidelines
Dr. Hayes’ work on biomarkers began in Dr. Kufe’s lab, where, as a fellow, he discovered a very high molecular-weight circulating antigen in several patients’ blood specimens; the antigen was soon shown to be the product of the MUC1 gene, and became the analyte with the CA15-3 assay, now widely used to monitor patients with metastatic breast cancer.
Dr. Hayes’ work has since been steeped in tumor biomarker research as well as other aspects of clinical and translational research. For the past 30 years, he has run a laboratory conducting translational research and, to date, has published more than 400 articles and edited six books on clinical and translational research and clinical care, mostly focused on breast cancer. In addition, as an ASCO volunteer since 1995, he has served on multiple committees focused on tumor biomarkers.
“I’m as proud of the systems for guidelines I helped set up as I am of the actual science I’ve done. Both of these, ultimately, serve the purpose of what we are trying to do: make things better for patients,” he said.
Dr. Hayes is particularly passionate about efforts to bring a value framework to the field of tumor biomarkers, citing an aphorism he coined to explain the state of the field: “A bad tumor marker is as bad as a bad drug.”
“What I’d love to see is that, as the field becomes more mature, we develop a conceptual framework to assess the value of tumor biomarkers—the same way ASCO did for cancer treatment options in its Value Framework initiative—and that the regulatory environment around tumor biomarkers becomes more consistent,” he explained.
These thoughts about value and tumor biomarkers coalesced into a paper Dr. Hayes wrote with colleagues in 2013, “Breaking a Vicious Cycle,” published in Science Translational Medicine. The article states that, “Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting from inconsistent regulatory standards and reimbursement, as well as insufficient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility.”
A Long History of ASCO Service
An ASCO member since 1986, Dr. Hayes has served on numerous committees. He was a two-term member of the Breast Cancer Track of the Scientific Program Committee, Chair of the Scientific Program Committee, Co-Chair of the ASCO-CAP Estrogen Receptor/Progesterone Receptor Expert Panel (and several other ASCO expert panels related to breast cancer), as well as the Journal of Clinical Oncology Editorial Board. From 2011-2014 he served on the ASCO Board of Directors. In 2007, he was presented with ASCO’s Gianni Bonadonna Breast Cancer Award and Lecture; in 2013, he was elected as a Fellow of ASCO (FASCO).
Dr. Hayes explained how he found himself, a bit unknowingly, holding his first leadership position within the Society: “In 2009, Douglas W. Blayney, MD, FASCO, then ASCO President, asked me to be Chair of the Scientific Program Committee for the Annual Meeting. I said, ‘Oh, I’m pretty busy,’ and he said, ‘Great! You start tomorrow.’ That was really a wonderful experience and led me to understand how ASCO had become, especially under the leadership of Allen S. Lichter, MD, FASCO [2006-2016 CEO], a highly professional organization with staff that are just outstanding.”
After Dr. Hayes’ term as Chair came to a close, Dr. Blayney encouraged him to run for the Board of Directors. “I was fortunate enough to be elected to the Board and had a great time serving. Frankly, when my 4-year term was up, I was sad it had ended!” he said. “I looked into running for President, and I was fortunate enough to win, and I feel very lucky for that. This last year, to prepare for the role of President, I’ve been drinking from a fire hose of information, learning about the many facets of ASCO and the multitude of incredible programs it offers.”
In addition to his involvement with ASCO, Dr. Hayes has served as Chair of the Breast Cancer Intergroup of North America’s Correlative Sciences Committee and Chair of the Southwest Oncology Group’s Breast Cancer Translational Medicine Committee. He is on the Union for International Cancer Control (UICC) TNM Expert Advisory Panel on Breast Tumors and the Early Breast Cancer Clinical Trials Collaborative Group (the Oxford Overview) Executive Committee. He is the breast cancer section editor for the online textbook UpToDate. He serves on the Susan G. Komen Scientific Advisory Board as a Komen Scholar, in addition to several other past and current leadership roles.
A Philosophy That Puts Patients First
Looking back at his career so far, Dr. Hayes says his proudest moments are when patients tell him they have enjoyed being in his care.
“Patients come to us from all walks of life and from all kinds of circumstances, and so many things have happened in their lives, struggles and challenges, and now, oh by the way, they have cancer. One of the privileges of working as an oncologist is that we get to learn so much about our patients’ lives and see them as a whole person, in addition to treating their cancer,” he said.
This patient-centered philosophy is also captured in ASCO’s vision statement: “A world where cancer is prevented or cured, and every survivor is healthy.”
“We are not just a trade union, serving members, but an organization with a larger goal in mind—to improve the lives of patients with cancer,” Dr. Hayes said. “Every decision we make on the Board, every program we launch is couched in the question, ‘Is this the best thing for our patients?’ That, ultimately, is our goal.”