Researchers Suggest Current Methods for Reporting Toxicities in Cancer Clinical Trials are Falling Short

PLYMOUTH MEETING, Pa., Dec. 19, 2018 /PRNewswire/ -- New research from Europe, published in the December 2018 issue of JNCCN—Journal of the National Comprehensive Cancer Network, finds that quality-of-life for people with cancer is reduced by an accumulation of low-level toxicities just as much as it is from high-level adverse events. Additionally, patient-reported outcomes were more likely to reflect the impact on a patient's physical well-being than those reported by their doctor.

"Incorporating patient-reported toxicity into routine cancer care will help make sure people with cancer get high-quality care with better symptom detection and management," explained Claudia Schuurhuizen, MD, Amsterdam UMC Cancer Center Amsterdam. "These patient-reported outcomes appear to have a better correlation to patient quality-of-life. Our results also suggest that clinicians shouldn't lose sight of lower grade adverse events. We want physicians to be more aware of how addressing lower grade toxicities can be just as important as higher ones for optimizing physical health status."

Clinicians grade toxicity using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) on a five-point scale, with higher numbers being worse and grade three and four generally indicating a need for clinical action. For example, in the case of vomiting, grade 1 correlates to one-to-two episodes of vomiting in 24 hours; grade 2 would be three-to-five episodes; grade 3 means more than six episodes, requiring a feeding tube or hospitalization; and grade 4 would be life-threatening consequences that need urgent intervention.

For this study, the researchers looked at 184 patients who were enrolled in a multicenter phase III randomized trial for patients with metastatic castrate-naïve prostate cancer between October 2004 and December 2008¹. Each patient completed quality-of-life assessments before treatment, as well as at three and six months in. Separate toxicity data were reported by both the patients and their clinicians.

According to the results, the strongest impact on quality-of-life came from cumulative toxicities, regardless of the grade. The researchers also found that patient-reported toxicity scores were more associated with quality-of-life outcomes than clinician-reported scores.

"This study clearly demonstrates that patients self-report higher rates of toxicities when independently queried, compared with clinician-elicited toxicities during office visits," said Terry S. Langbaum, Administrative Director, The Comprehensive Transplant Center, Johns Hopkins, and Patient Advocate, NCCN Guidelines^® Panel for Survivorship. "This may be due to a reluctance, on the part of patients, to 'complain' to their clinicians in a face-to-face encounter, especially when the symptoms are sensitive, such as impact on sexual function. Additionally, the significant differences in reporting may be due to less thorough inquiry on the part of the clinicians, who may be rushed for time during visits. If a full understanding of the impact of toxicities on quality-of-life is the goal, this study demonstrates that patients can self-report and grade their toxicities more completely in a setting independent of the office visit than clinicians can during a clinical encounter."

Moving forward, the researchers would like to see reliable tools for assessing toxicity, particularly in patient-reported outcomes, used more frequently. They encourage the use of electronic data collection as one method for improving reporting rates and accuracy.

To read the entire study, visit JNCCN.org. Complimentary access to "Impact of Patient- and Clinician-Reported Cumulative Toxicity on Quality of Life in Patients With Metastatic Castration-Naïve Prostate Cancer" is available until March 10, 2019.

About JNCCN—Journal of the National Comprehensive Cancer Network
More than 25,000 oncologists and other cancer care professionals across the United States read JNCCN—Journal of the National Comprehensive Cancer Network. This peer-reviewed, indexed medical journal provides the latest information about best clinical practices, health services research, and translational medicine. JNCCN features updates on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®), review articles elaborating on guidelines recommendations, health services research, and case reports highlighting molecular insights in patient care. JNCCN is published by Harborside Press. Visit JNCCN.org. To inquire if you are eligible for a FREE subscription to JNCCN, visit http://www.nccn.org/jnccn/subscribe.asp. Follow JNCCN on Twitter @JNCCN.

About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network^® (NCCN^®) is a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. By defining and advancing high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers around the world.

The NCCN Member Institutions are: Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA; Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope National Medical Center, Duarte, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Comprehensive Cancer Center, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Rogel Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.org/patients. Media, visit NCCN.org/news. Follow NCCN on Twitter @NCCNnews and Facebook @National.Comprehensive.Cancer.Network.

¹ The Genito-Urinary Oncology Group (GETUG)-AFU 15 trial, which evaluated the efficacy and safety of docetaxel combined with androgen-deprivation therapy (ADT) compared to ADT alone.

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