• Massimo Di Maio, Ciro Gallo, Natasha B Leighl, Maria Carmela Piccirillo, Gennaro Daniele, Francesco Nuzzo, Cesare Gridelli, Vittorio Gebbia, Fortunato Ciardiello, Sabino De Placido, Anna Ceribelli, Adolfo G Favaretto, Andrea de Matteis, Ronald Feld, Charles Butts, Jane Bryce, Simona Signoriello, Alessandro Morabito, Gaetano Rocco, and Francesco Perrone.
• Massimo Di Maio, Maria Carmela Piccirillo, Gennaro Daniele, Francesco Nuzzo, Andrea de Matteis, Jane Bryce, Alessandro Morabito, Gaetano Rocco, and Francesco Perrone, Istituto Nazionale Tumori-Fondazione "G. Pascale" Istituto di Ricovero e Cura a Carattere Scientifico; Ciro Gallo, Fortunato Ciardiello, and Simona Signoriello, Second University; Sabino De Placido, Federico II University, Napoli; Cesare Gridelli, S.G. Moscati Hospital, Avellino; Vittorio Gebbia, Istituto La Maddalena, Palermo; Anna Ceribelli, Regina Elena National Cancer Institute, Roma; Adolfo G. Favaretto, Istituto Oncologico Veneto, Padova, Italy; Natasha B. Leighl and Ronald Feld, Princess Margaret Hospital/University Health Network, Toronto; and Charles Butts, Cross Cancer Institute, Edmonton, Alberta, Canada.
• J. Clin. Oncol. 2015 Mar 10;33(8):910-5.

PurposeInformation 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 MethodsIn 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.ResultsOverall, 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%.ConclusionSubjective 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.© 2015 by American Society of Clinical Oncology.

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