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abstract
Purpose Information
about symptomatic toxicities of anticancer treatments is not based on
direct report by patients, but rather on
reports by clinicians in trials. Given the
potential for under-reporting, our aim was to compare reporting by
patients and
physicians of six toxicities (anorexia, nausea,
vomiting, constipation, diarrhea, and hair loss) within three randomized
trials.
Patients and Methods
In one trial, elderly patients with breast cancer received adjuvant
chemotherapy; in two trials, patients with advanced non–small-cell
lung cancer received first-line treatment.
Toxicity was prospectively collected by investigators (graded by
National Cancer
Institute Common Toxicity Criteria [version 2.0]
or Common Terminology Criteria for Adverse Events [version 3]). At the
end
of each cycle, patients completed the European
Organisation for Research and Treatment of Cancer quality-of-life
questionnaires,
including toxicity-related symptom items.
Possible answers were “not at all,” “a little,” “quite a bit,” and “very
much.”
Analysis was limited to the first three cycles.
For each toxicity, agreement between patients and physicians and
under-reporting
by physicians (ie, toxicity reported by patients
but not reported by physicians) were calculated.
Results Overall, 1,090
patients (2,482 cycles) were included. Agreement between patients and
physicians was low for all toxicities.
Toxicity rates reported by physicians were
always lower than those reported by patients. For patients who reported
toxicity
(any severity), under-reporting by physicians
ranged from 40.7% to 74.4%. Examining only patients who reported “very
much”
toxicity, under-reporting by physicians ranged
from 13.0% to 50.0%.
Conclusion Subjective
toxicities are at high risk of under-reporting by physicians, even when
prospectively collected within randomized
trials. This strongly supports the incorporation
of patient-reported outcomes into toxicity reporting in clinical
trials.
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