A New Era in Patient-Centered Research: Supporting patient-directed clinical trials through the geriatric oncology therapy optimization (GOTO) program

August 30, 2022

With the support of Rising Tide Foundation for Clinical Cancer Research (RTFCCR), City of Hope, one of the largest cancer research and treatment organizations in the United States, will launch five coordinated, high-quality research studies specifically addressing the knowledge gaps linked to vulnerable older adults not being included in most cancer trials.

Lead investigator William Dale, MD, PhD, director of City of Hope’s Center for Cancer and Aging, has brought together experts from across the country to lead the RTFCCR’s geriatric oncology therapy optimization (GOTO) program — the first of its kind.  The GOTO program promises to be the next advance in the growing field of cancer and aging. 

“Cancer is primarily a disease of aging,” Dale said.  “The majority of cancer patients are older, with almost 60% of cancer cases occurring in patients over 65. Despite this, older adults remain vastly underrepresented in clinical cancer trials, and few clinical trials are designed specifically for this patient group. As a result, many oncologists – lacking evidence on the safety and efficacy of the treatment for this age group – are treating older adults based on evidence from younger, healthier patients.  The GOTO program addresses a crucial knowledge gap.”

Trials with overly strict inclusion criteria lack representation of older adults and, therefore, do not adequately reflect how innovative treatment options might affect older patients with cancer. Because of this evidence gap, solid guidance for treating older adults is still in its infancy. Fit older adults are often undertreated while vulnerable older adults – who often value quality of life over length of life – are too often overtreated with aggressive therapies that result in unnecessary toxicities. “Much better data is needed to answer these questions,” Dale said.

The largest organization of its kind in North America, the Cancer and Aging Research Group (CARG), founded by City of Hope, is partnering with RTFCCR on the CARG National Consortia for Patient-Centered Geriatric Oncology Trials. This collaboration leverages the infrastructure and expertise of CARG. With the patient partner group Stakeholders for Care in Oncology and Research for our Elders board (SCOREboard), this research program brings together five trials using the same geriatric assessment to evaluate interventions to optimize treatment decisions. SCOREboard is a well-established group of 10 cancer survivors who are over the age of 65 from across the country who have been engaged with the design of these studies from the beginning.

The investigative team is composed of national geriatric oncology experts from across the country, including project leads Mina S. Sedrak, MD, MS (Breast Cancer, City of Hope); Alicia Morgans, MD, MPH (Prostate Cancer, Dana-Farber Cancer Institute); Andrew Artz, MD, MS (Hematology, City of Hope); Supriya Mohile, MD, MS (Lung Cancer, University of Rochester); and Tanyanika Phillips, MD, MPH (City of Hope | Antelope Valley).  Together with patient partners Beverly Canin and Chuck O’Shea, co-chairs of ScoreBOARD, and CARG leaders Drs. Heidi Klepin, Supriya Mohile, and William Dale, these trials, all using the same CARG-designed geriatric assessment, will answer fundamental questions in the field. The partnership will create new infrastructure for the future conduct of cancer clinical trials, which is expected to pay dividends long into the future.

“These trials will work together in a new way, setting a new standard in the field of cancer and aging,” said Steven Rosen, MD, provost and chief scientific officer at City of Hope. “The trials demonstrate the crucial importance of having patient partners from the beginning, which could become a benchmark for the design of geriatric oncology trials.  We at City of Hope are delighted to be collaborating with RTFCCR in this crucial area of research.”

RTFCCR Founder and Chairman, Shawn Stephenson, noted his excitement at seeing the first patient-directed clinical trial for RTFCCR come to life at the recent grantee summit at ASCO in June, saying “It was wonderful to meet William, Supriya, Andrew,  Beverly and Chuck and to feel their passion for making a real difference in patients’ lives – especially in the area of geriatric oncology where we have identified a real need for clinical trials to provide better treatment options for patients.”

Patients are at the center of everything we do here at RTFCCR – which is why each trial in the CARG GOTO program has an active patient partner, who has been heavily involved in the creation, design, and implementation of this study from the beginning. By bringing together the world’s leading experts in geriatric oncology and patient advocates with “lived experience,” the results of this GOTO program have the potential to create a significant impact on patient lives while addressing a major challenge of caring for older adults.

More info about the GOTO program can be found here.