Home Patient Reported Outcomes Oncology Sponsors Failing to Adequately Report Toxicities During Cancer Trials

Oncology Sponsors Failing to Adequately Report Toxicities During Cancer Trials


New research from Europe, published in the December 2018 issue of JNCCNJournal of the National Comprehensive Cancer Networkfinds 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 2008. 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.


Please enter your comment!
Please enter your name here

This site uses Akismet to reduce spam. Learn how your comment data is processed.