A study involving more than 1000 patients enrolled in randomized clinical trials has found that patient and physician assessment of treatment toxicities can vary greatly, and they are frequently under-reported by physicians.
Claire Snyder, MHS, PhD
A study involving more than 1000 patients enrolled in randomized clinical trials has found that patient and physician assessment of treatment toxicities can vary greatly, and they are frequently under-reported by physicians.
Researchers found that when compared to the patients’ reports, physicians’ under-reporting of all-grade toxicities ranged from 41% of the time for nausea, to 74% of the time for anorexia. Rates of under-reporting by clinicians were lower when involving patients who reported the most severe symptoms, ranging from 13% for vomiting to 50% for anorexia. In addition to anorexia and vomiting, researchers looked at four other toxicities associated with anticancer treatment and found that agreement between patients and physicians was low for all of them (Box).
The study is based on an analysis of patients enrolled in three trials conducted at 78 institutions in Italy and Canada. One trial included patients aged 65 to 79 years with early-stage breast cancer receiving adjuvant therapy with either a cyclophosphamide/methotrexate/fluorouracil regimen or docetaxel; the other two trials involved patients receiving first-line treatments for advanced non—small cell lung cancer, and the agents studied were gemcitabine/cisplatin regimens, rofecoxib, and erlotinib.
Toxicity* (any grade)
Reported by Neither Patient Nor Physician
Reported by Physician but Not Patient
Reported by Patient but Not Physician
Reported by Both Patient And Physician
Anorexia
383
28
505
174
Nausea
335
100
266
388
Vomiting
700
107
134
149
Constipation
501
32
384
170
Diarrhea
643
57
197
191
Hair Loss
519
15
360
192
*Range of evaluable patients for each toxicity (n = 1086-1090).
Three treatment cycles were used for the analysis, yielding 2482 evaluable cycles. The researchers coded toxicities according to the National Cancer Institute (NCI) Common Toxicity Criteria and the NCI’s Common Terminology Criteria for Adverse Events (CTCAE). In addition, after each treatment cycle, patients completed the European Organization for Research and Treatment of Cancer quality-of-life questionnaire that included toxicity-related symptom questions allowing for responses on a continuum from “not at all” to “very much.”
“This study adds to a body of literature comparing toxicity reporting between patients and clinicians,” noted Claire Snyder, MHS, PhD, president-elect of the International Society for Quality of Life Research, in a podcast accompanying publication of the study results in the Journal of Clinical Oncology.1
She added that other studies have also demonstrated the difference in perspectives between patients and clinicians but stressed that both perspectives provide valuable information:
“The importance of this study’s finding of differences in patient and clinician reporting of toxicities is not that one perspective is more accurate or in some way better than the other, but that the two perspectives provide complementary information.”
Snyder, an associate professor of medicine, oncology, and health policy and management at the Johns Hopkins Schools of Medicine and Public Health, said that these findings underscore the importance of capturing patient-reported outcomes (PROs) as part of toxicity reporting for clinical trials, but also the need to deploy systematic tools to obtain this information in routine practice where toxicity reporting faces similar obstacles.
Among these barriers, she and the study authors noted, is that physicians have a higher threshold for reporting toxicities and may attribute them to the disease rather than treatment. Another challenge could be inadequate patient—provider communication, with some patients “self-censuring” discussion of toxicities, believing that focusing on treatment benefit is more relevant than adverse events in these exchanges.
A number of tools have been developed to aid in the collection of information on toxicity and other PROs, said Snyder, including the NCI’s patient-reported outcomes version of the CTCAE (PRO-CTCAE),2 and she encouraged their greater utilization to integrate the patient voice both in research and practice.
References
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