Researchers from Fox Chase Cancer Center, Philadelphia PA report that cancer-focused clinical trials may be generating inaccurate trial results. Why? The nutritional status and body composition of advanced cancer patients participating in these trials may need further evaluation. The study has found that patients who are malnourished for example, may experience more adverse events from the investigational therapy, not to mention higher rates of hospitalization and lower response rates and overall shortened survival.
Recently reported in Oncology Nurse Advisor, the lead author of this study, Rishi Jain, MD, assistant professor, Department of Hematology/Oncology with Fox Chase Cancer Center, noted adverse outcomes are forecasted with patients dealing with malnutrition, and that the magnitude of this effect was alarming. He was quoted, “There was (an approximately) twofold increased risk of hospitalizations and severe side effects in those who were malnourished. Also, patients who were malnourished were only able to stay on the clinical trial study for half as long.”
Dr. Jain and colleagues recruited 100 patients (54% male, 46% female) between July 2016 and May 2017 and initiated baseline assessments of nutrition and exercise prior to any initiation of Phase I and II oncology clinical trials. Sixty of the patients were subjects in early-stage immunotherapeutic agent trials while 87 were entering Phase I trials. The median age of 60 (range 28-85) and a median follow-up of 306 days. The investigators utilized Kaplan-Meier curves with log-rank tests to compare duration on the study with overall survival (OS).
As reported by John Schieszer with Oncology Nurse Adviser, the study team found that those patients who were malnourished at the time of the study experienced increase side effect rates from the experimental therapy, as well as hospitalizations, lower overall response rates, and a shortened survival. Dr. Jain reported, “We were very surprised by the magnitude of the effect baseline malnutrition had on outcomes.”
Phase I and II clinical trials are incredibly important for sponsors (and investigators) to better understand future cancer therapies. Because of the influence of thee factors identified in this study, Dr. Jain emphasizes the importance of research sponsors to understand the exact reasons why malnutrition could interfere with the effectiveness of such novel treatments.
About Fox Chase Cancer Center
Fox Chase Cancer Center is an NCI-designated Comprehensive Cancer Center research facility and hospital located in the Fox Chase section of Philadelphia, PA. The center is part of Temple University Health System (TUHS) and specializes in the treatment and prevention of cancer. The center was formed in 1974 by the merger of the American Oncologic Hospital (the first cancer hospital in the US) and the Institute for Cancer Research, founded in 1927. It became part of TUHS in 2012.
Rishi Jain, MD, assistant professor, Department of Hematology/Oncology with Fox Chase Cancer Center
Call to Action: Dr. Jain’s team is presently researching ways to understand better how dietary habits may morph during cancer care. The researchers hope to identify new ways treatments work so they can prevent malnutrition in patients with advanced cancer, and hence not materially skew data from trials. Jain notes that there is an overall increased awareness of the importance and influence of the interactions between malnutrition, sarcopenia, and treatment-related outcomes and responses. Such factors are not systematically incorporated into therapeutic decision-making when planning clinical trials. Moreover, additional studies should further look into the impact of nutritional support in patients undergoing clinical trial therapy. TrialSite News will monitor any relevant and material results.