Given the expected direct cytotoxicity of chemotherapy, tumor shrinkage has been used as a proxy for anticancer activity since the early days of clinical cancer research. Despite the differing modes of action of some targeted and immunotherapeutic agents, tumor responses are still widely used in oncology, especially for proof-of-concept and phase II trials. For practical purposes, tumor responses are usually dichotomized for analysis, and the response rate is used as one of the indicators of treatment success in clinical trials.
Several guidelines for assessment of the response rate have been developed over the years, with the current Response Evaluation Criteria in Solid Tumors (RECIST) being widely used and periodically updated. However, tumor shrinkage can also be analyzed in other ways that capture the relative change from baseline in tumor measurements. Moreover, novel endpoints such as early tumor shrinkage, early objective tumor response, or the depth of response have been suggested as potential surrogates for overall survival in some settings.
In this webinar, we will provide an overview of the use of endpoints based on tumor measurements in cancer clinical trials. In particular, we review the definitions of the traditional and novel response-based endpoints, discussing their pros and cons. We will then present several examples, including results of our own work related, in particular, to modeling tumor-size changes and use of the depth of response as a surrogate for overall survival in colorectal cancer trials.
Tomasz Burzykowski, PhD, VP Research, International Drug Development Institute (IDDI)
Dr.Burzykowski has been working as Research Professor of Biostatistics/Bioinformatics at the Center for Statistics of Hasselt University since 2002. He held visiting professorship positions at the Karolinska Institute (Sweden), Warsaw University of Technology (Poland), and Medical University of Bialystok (Poland) and has been involved in interdisciplinary research in numerous biomedical studies and clinical trials.
Everardo Saad, MD, Medical Director, International Drug Development Institute (IDDI)
Dr. Saad has over 15 years of experience in Medical Oncology and clinical trial designs. He graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston. After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer patients
Who Should Attend?
Clinical trialists, statisticians, data managers, physicians, and other professionals involved in the design, conduct and analysis of clinical trials in oncology
International Drug Development Institute (IDDI) is an expert center in biostatistical and integrated eClinical services for pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology.
IDDI optimizes the clinical development of drugs, biologics and devices thanks to proven statistical expertise and operational excellence. Founded in 1991, IDDI has offices in Belgium, Boston (MA), Raleigh (NC) and San Francisco (CA).