Cited by 497Cancer survivorship and carePharmacovigilance and Adverse Drug ReactionsCancer Treatment and Pharmacology

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Symptomatic Toxicities Experienced During Anticancer Treatment: Agreement Between Patient and Physician Reporting in Three Randomized Trials

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Di Maio, Massimo, Gallo, Ciro, Leighl, Natasha B., Piccirillo, Maria Carmela, Daniele, Gennaro, Nuzzo, Francesco, Gridelli, Cesare, Gebbia, Vittorio, Ciardiello, Fortunato, De Placido, Sabino, Ceribelli, Anna, Favaretto, Adolfo G., de Matteis, Andrea, Feld, Ronald, Butts, Charles, Bryce, Jane, Signoriello, Simona, Morabito, Alessandro, Rocco, Gaetano, Perrone, Francesco·2015·Journal of Clinical Oncology

DOI 10.1200/jco.2014.57.9334

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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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Authors: Di Maio, M., Gallo, C., Leighl, N. B., Piccirillo, M. C., Daniele, G., Nuzzo, F., Gridelli, C., Gebbia, V., Ciardiello, F., De Placido, S., Ceribelli, A., Favaretto, A. G., de Matteis, A., Feld, R., Butts, C., Bryce, J., Signoriello, S., Morabito, A., Rocco, G., & Perrone, F.
Affiliations: 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...
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
ORCID: Gallo, Ciro
Leighl, Natasha B.
Piccirillo, Maria Carmela
Daniele, Gennaro
Nuzzo, Francesco
Gridelli, Cesare
Gebbia, Vittorio
Ciardiello, Fortunato
Favaretto, Adolfo G.
Bryce, Jane
Signoriello, Simona
Morabito, Alessandro
Rocco, Gaetano
Perrone, Francesco
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2015-03-10
Volume: 33
Issue: 8
Pages: 910-915
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2014.57.9334
OpenAlex: W2156635540
Cited by: 497
References: 22
Citations by year: 2026: 33 · 2025: 40 · 2024: 51 · 2023: 42 · 2022: 50 · 2021: 51 · 2020: 49 · 2019: 42 · 2018: 40 · 2017: 38 · 2016: 38 · 2015: 22
FWCI: 20.09
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
Topics: Health Sciences › Medicine › Oncology › Cancer survivorship and care
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
Keywords: anticancer treatment, patient-physician agreement, underreporting, patient-reported outcomes, anorexia, nausea and vomiting, constipation, diarrhea, hair loss, adjuvant chemotherapy, breast cancer, non-small cell lung cancer, first-line therapy
MeSH terms: Adult, Aged, Aged, 80 and over, Anorexia, Antineoplastic Agents, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Constipation, Diarrhea, Europe, Female, Humans, Hypotrichosis, Lung Neoplasms, Male, Middle Aged, Nausea, Patient Participation, Physicians, Prospective Studies, Quality of Life, Surveys and Questionnaires, Vomiting, Reproducibility of Results, Treatment Outcome, Chemotherapy, Adjuvant

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