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Subjective toxicities associated with cancer treatment may be under-reported
The rate at which patients and physicians report subjective toxicities varies considerably, according to an analysis of data from three randomized studies.
The finding suggests there is a high risk that subjective toxicities will be under-reported — even in the context of clinical trials — and demonstrates the value of incorporating patient-reported outcomes into toxicity data, researchers wrote.
“There is a worldwide movement toward integrating and valuing patient-reported outcomes in cancer clinical research,” researcher Francesco Perrone, MD, PhD, of the clinical trials unit at Istituto Nazionale per lo Studio e la Cura dei Tumori in Italy, told HemOnc Today. “One of the things that patients can be asked to report by themselves is toxicity, particularly for symptoms that are subjective and not immediately visible by the doctors. Thanks to several prospective cancer clinical trials that we have done during the years, where the doctors evaluated toxicity and the patients [completed] quality-of-life questionnaires, we are in a privileged position to evaluate the relationship between patient and physician reporting of subjective toxicity.”
Perrone and colleagues evaluated data from 1,090 patients enrolled on one of three trials: the Elderly Breast Cancer–Docetaxel Adjuvant (ELDA) study, the Gemcitabine–Coxib (GECO) trial in non–small cell lung cancer, and the Tarceva or Chemotherapy (TORCH) trial in NSCLC.
Patients in all three trials completed the European Organization for Research and Treatment of Cancer Quality of Life questionnaire at the end of each treatment cycle. The survey queried patients about whether they had experienced the following six symptoms: anorexia, nausea, vomiting, constipation, diarrhea and hair loss. Response options were “not at all,” “a little,” “quite a bit” or “very much.”
Study researchers also prospectively collected toxicity data.
Overall, patients were more likely than physicians to report each of the six symptoms: anorexia (62.3% vs. 18.5%), nausea (60% vs. 44.8%), vomiting (26% vs. 23.5%), constipation (51% vs. 18.6%), diarrhea (35.7% vs. 22.8%) and hair loss (50.8% vs. 19.1%).
Using these data, researchers calculated the following rates at which physicians under-reported subjective toxicities: anorexia, 74.4%; vomiting, nausea, 40.7%; vomiting, 47.3%; constipation, 69.3%; diarrhea, 50.8%; and hair loss, 65.2%.
The rate at which physicians under-reported severe symptoms — or those patients reported experiencing “very much” — were as follows: 50% for anorexia, 25.8% for nausea, 13% for vomiting, 44.2% for constipation, 24.1% for diarrhea and 42.7% for hair loss.
“Patient-reported outcomes have to be integrated into cancer clinical trials because they are very important in defining tolerability of new treatments from the patients’ perspective,” Perrone said. “Patients should be empowered to directly report subjective side effects and be active in defining the tolerability of anticancer drugs.”
Work is underway to integrate novel tools into clinical trials that better assess patient side effects, Perrone said.
“It is clear that if we don’t provide tools that can capture directly from the patients their experience of subjective side effects, we can underestimate them and their impact,” Perrone said. “This consideration should increase the commitment of the oncological community to endorse the use of patient-reported outcomes instruments to measure toxicity like the PRO-CTCAE of the NCI-US, that are now being proposed and disseminated. Questions are directly posed to the patients and they respond independently of the doctors. We are working within the Italian PRO-CTCAE Study Group for doing the translation, validation and cross-cultural adaptation of this tool in Italian language.” –by Alexandra Todak
Francesco Perrone, MD, PhD, can be reached at Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale–IRCCS, Via Mariano Semmola, 80131, Napoli, Italy; e-mail: f.perrone@istitutotumori.na.it.
Disclosure: The researchers report consultant/advisory roles with and honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck and Pfizer.