BACKGROUND: Toxicity, which is a key parameter in the evaluation of cancer treatments, can be underestimated by clinicians.
We investigated differences between patients and physicians in reporting adverse events of androgen deprivation therapy (ADT) with or without docetaxel in a multicentre phase III trial in non-castrate metastatic prostate cancer.
METHODS: The 385 patients included were invited to complete a 26-symptom questionnaire 3 and 6months after the start of treatment, among which eighteen symptoms were also assessed by physicians, reported in medical records and graded using the Common Toxicity Criteria of the National Cancer Institute. Positive and negative agreements as well as Kappa concordance coefficients were computed.
FINDINGS: Data were available for 220 and 165 patients at 3 and 6months respectively. Physicians systematically under-reported patients' symptoms. Positive agreement rates (at respectively 3 and 6months) for the five most commonly reported symptoms were: 61.0% and 64.3% hot flushes, 50.0% and 43.6% fatigue, 29.4% and 31.1% sexual dysfunction, 24.4% and 14.4% weigh gain/loss, 16.7% and 19.3% for joint/muscle pain. For symptoms most frequently reported as disturbing or very disturbing by patients, the clinicians' failure to report them ranged from 50.8% (hot flushes) to 89.5% (joint/muscle pain) at 3months, and from 48.2% (hot flushes) to 88.4% (joint/muscle pain) at 6months.
INTERPRETATION: Physicians often failed to report treatment-related symptoms, even the most common and disturbing ones. Patients' self-evaluation of toxicity should be used in clinical trials to improve the process of drug assessment in oncology.
Written by:
Gravis G, Marino P, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Théodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M, Fizazi K. Are you the author?
Medical Oncology, Institut Paoli-Calmettes, Marseille, France; Institut Paoli-Calmettes, Marseilles, France; Inserm, UMR 912 'Economic & Social Sciences, Health Systems & Societies (SESSTIM)', Aix-Marseille Université, IRD, Marseilles, France; Medical Oncology, Centre François Baclesse - CHU Côte de Nacre, Caen, France; Medical Oncology Department, Georges Pompidou Hospital and Rene Descartes University, Paris, France; Medical Oncology, Centre Hospitalier Les Oudairies, La Roche-sur-Yon, France; Biostatistic, Institut Paoli-Calmettes, Marseille, France; Radiotherapy Department, Clinique Pasteur, Toulouse, France; Department of Medical Oncology, Centre Paul Papin, Angers, France; Medical Oncology, Centre Alexis Vautrin, Vandoeuvre-les-nancy, France; Medical Oncology, Centre Eugène Marquis, Rennes, France; Medical Oncology, Centre René Gauducheau, Saint-Herblain, France; Medical Oncology, Hôpital Foch, Suresnes, France; Medical Oncology, Groupe Hospitalier Saint Joseph, Paris, France; Medical Oncology, Centre Antoine Lacassagne, Nice, France; Medical Oncology, Centre Val d'Aurelle-Paul Lamarque, Montpellier, France; Medical Oncology, Institut Claudius Régaud, Toulouse, France; Medical Oncology, Institut Curie, Paris, France; Medical Oncology, Centre Georges François Leclerc, Dijon, France; R&D UNICANCER, Paris cedex 13, France; Medical Oncology, Clinique Sainte Marguerite, Hyeres, France; Medical Oncology, Hôpital Layné, Mont de Marsan, France; Medical Oncology, Centre Hospitalier La Timone, Marseille, France; Medical Oncology, Centre Régional Hospitalier, Metz-Thionville, France; Medical Oncology, Hôpital Bretonneau, Tours, France; Medical Oncology, Centre Hospitalier Dupuytren, Limoges, France; Medical Oncology, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Bruxelles, Belgium; Medical Oncology, Centre Catherine de Sienne, Nantes, France; Medical Oncology, Hôpital Saint-André, Bordeaux, France; Medical Oncology, Clinique Saint-Jean Languedoc, Toulouse, France; Medical Oncology, Institut Jean Godinot, Reims, France; Medical Oncology, Clinique armoricaine de radiologie, Saint-Brieux, France; Medical Oncology, Hôpital Saint-Louis, Paris, France; Urology Department, Centre Hospitalier Universitaire Rangueil, Toulouse, France; Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.
Reference: Eur J Cancer. 2014 Jan 11. pii: S0959-8049(13)01030-7.
doi: 10.1016/j.ejca.2013.11.034
PubMed Abstract
PMID: 24424105
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