In a paper recently appearing in the Journal of Clinical Oncology, the European Organisation for Research and Treatment of Cancer (EORTC), the International Society of Geriatric Oncology (SIOG), and the Alliance for Clinical Trials in Oncology (Alliance) point out how changes in clinical trial designs are needed in order to understand how new treatments affect the elderly cancer patient population. The authors also address the advantages and disadvantages of specific clinical trial endpoints for elderly patients.
Appropriate endpoint selection is an essential aspect of assessing treatment strategies, and there are well-established endpoints for cancer clinical trials. However, these established endpoints might not be relevant for an elderly cancer patient population, because of competing risks of death, the potentially increased impact of therapy on global functioning, and quality of life. The EORTC, SIOG, and Alliance posit that efforts should be made to study treatments in the population where it will be used (thus also in old and in frail patients).
Dr. Hans Wildiers of the University Hospitals Leuven and lead author of the position paper says, “We recommend the use of randomized controlled trials when possible, and these clinical trials should include both fit as well as frail older individuals. Trials specifically for older cancer patients should be required if the standard therapy is different from that for younger patients. We also encourage trials comparing different treatment strategies, for example, therapy versus best supportive care.”
Dr. Ulrich Wedding of the Universitätsklinikum, Jena, and co-author of this paper says, “Randomized phase II or even single arm phase II trials in specific subsets of elderly patients could provide insight in the range of efficacy and toxicity in older populations. These would need to be confirmed in large phase III trials that might be difficult to perform due to such reasons as insufficient interest from sponsors and investors and recruiting sufficient numbers of patients.”
Hans Wildiers explains, “We do recognize that randomized trials cannot answer all questions, but large observational cohort studies or registries could provide additional insight. Comparable, uniform geriatric assessment should be integrated into future geriatric oncology clinical trials, and regulatory authorities should require evaluation of efficacy and safety of new drugs in older and frail patients.”
This work was supported by a donation from the Fondation Contre le Cancer from Belgium through the EORTC Charitable Trust.
About the EORTC
The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration.
Both multinational and multidisciplinary, the EORTC Network comprises more than 2,500 collaborators from all disciplines involved in cancer treatment and research in more than 300 hospitals in over 30 countries.
Through translational and clinical research, the EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices.
EORTC Headquarters, a unique pan European independent clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.
For more information about cancer in the elderly please contact: www.eortc.org/contact
About the Alliance for Clinical Trials in Cancer
The Alliance for Clinical Trials in Oncology is a national clinical trials network sponsored by the National Cancer Institute that consists of nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada. The Alliance is dedicated to developing and conducting clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as researching methods to alleviate side effects of cancer and cancer treatments.
To learn more about collaborating with the Alliance please visit: www.allianceforclinicaltrialsinoncology.org
About the International Society of Geriatric Oncology
The International Society of Geriatric Oncology, or Société Internationale d’Oncologie Gériatrique in French, hence the acronym SIOG, was founded in 2000 and was officially registered as a Not-for-profit organization under Swiss law in October 2012. SIOG is a multidisciplinary society, including physicians in the fields of oncology and geriatrics, and allied health professionals and has over 1000 members in more than 40 countries around the world.
The major risk factor for cancer is age, and with the aging of the world population, a major epidemiologic challenge is before us. For more information about SIOG please visit: www.siog.org
John Bean, PhD
EORTC Medical Science Writer