title: Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15).
abstract: 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 6 months 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.
  
  
  RESULTS
  Data were available for 220 and 165 patients at 3 and 6 months respectively. Physicians systematically under-reported patients' symptoms. Positive agreement rates (at respectively 3 and 6 months) 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 3 months, and from 48.2% (hot flushes) to 88.4% (joint/muscle pain) at 6 months.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, Astra-Zeneca, and Amgen.
authors.affiliation: Medical Oncology, Institut Paoli-Calmettes, Marseille, France. Electronic address: gravisg@ipc.unicancer.fr.
authors.forename: Gwenaelle
authors.initials: G
authors.lastname: Gravis
authors.affiliation: Institut Paoli-Calmettes, Marseilles, France; Inserm, UMR 912 'Economic & Social Sciences, Health Systems & Societies (SESSTIM)', Aix-Marseille Université, IRD, Marseilles, France.
authors.forename: Patricia
authors.initials: P
authors.lastname: Marino
authors.affiliation: Medical Oncology, Centre François Baclesse - CHU Côte de Nacre, Caen, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Joly
authors.affiliation: Medical Oncology Department, Georges Pompidou Hospital and Rene Descartes University, Paris, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Oudard
authors.affiliation: Medical Oncology, Centre Hospitalier Les Oudairies, La Roche-sur-Yon, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Priou
authors.affiliation: Biostatistic, Institut Paoli-Calmettes, Marseille, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Esterni
authors.affiliation: Radiotherapy Department, Clinique Pasteur, Toulouse, France.
authors.forename: Igor
authors.initials: I
authors.lastname: Latorzeff
authors.affiliation: Department of Medical Oncology, Centre Paul Papin, Angers, France.
authors.forename: Remy
authors.initials: R
authors.lastname: Delva
authors.affiliation: Medical Oncology, Centre Alexis Vautrin, Vandoeuvre-les-nancy, France.
authors.forename: Ivan
authors.initials: I
authors.lastname: Krakowski
authors.affiliation: Medical Oncology, Centre Eugène Marquis, Rennes, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Laguerre
authors.affiliation: Medical Oncology, Centre René Gauducheau, Saint-Herblain, France.
authors.forename: Fréderic
authors.initials: F
authors.lastname: Rolland
authors.affiliation: Medical Oncology, Hôpital Foch, Suresnes, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Théodore
authors.affiliation: Medical Oncology, Groupe Hospitalier Saint Joseph, Paris, France.
authors.forename: Gael
authors.initials: G
authors.lastname: Deplanque
authors.affiliation: Medical Oncology, Centre Antoine Lacassagne, Nice, France.
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Ferrero
authors.affiliation: Medical Oncology, Centre Val d'Aurelle-Paul Lamarque, Montpellier, France.
authors.forename: Damien
authors.initials: D
authors.lastname: Pouessel
authors.affiliation: Medical Oncology, Institut Claudius Régaud, Toulouse, France.
authors.forename: Loïc
authors.initials: L
authors.lastname: Mourey
authors.affiliation: Medical Oncology, Institut Curie, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Beuzeboc
authors.affiliation: Medical Oncology, Centre Georges François Leclerc, Dijon, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Zanetta
authors.affiliation: R&D UNICANCER, Paris cedex 13, France.
authors.forename: Muriel
authors.initials: M
authors.lastname: Habibian
authors.affiliation: Medical Oncology, Clinique Sainte Marguerite, Hyeres, France.
authors.forename: Jean François
authors.initials: JF
authors.lastname: Berdah
authors.affiliation: Medical Oncology, Hôpital Layné, Mont de Marsan, France.
authors.forename: Jerome
authors.initials: J
authors.lastname: Dauba
authors.affiliation: Medical Oncology, Centre Hospitalier La Timone, Marseille, France.
authors.forename: Marjorie
authors.initials: M
authors.lastname: Baciuchka
authors.affiliation: Medical Oncology, Centre Régional Hospitalier, Metz-Thionville, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Platini
authors.affiliation: Medical Oncology, Hôpital Bretonneau, Tours, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Linassier
authors.affiliation: Medical Oncology, Centre Hospitalier Dupuytren, Limoges, France.
authors.forename: Jean Luc
authors.initials: JL
authors.lastname: Labourey
authors.affiliation: Medical Oncology, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Bruxelles, Belgium.
authors.forename: Jean Pascal
authors.initials: JP
authors.lastname: Machiels
authors.affiliation: Medical Oncology, Centre Catherine de Sienne, Nantes, France.
authors.forename: Claude
authors.initials: C
authors.lastname: El Kouri
authors.affiliation: Medical Oncology, Hôpital Saint-André, Bordeaux, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Ravaud
authors.affiliation: Medical Oncology, Clinique Saint-Jean Languedoc, Toulouse, France.
authors.forename: Etienne
authors.initials: E
authors.lastname: Suc
authors.affiliation: Medical Oncology, Institut Jean Godinot, Reims, France.
authors.forename: Jean Christophe
authors.initials: JC
authors.lastname: Eymard
authors.affiliation: Medical Oncology, Clinique armoricaine de radiologie, Saint-Brieux, France.
authors.forename: Ali
authors.initials: A
authors.lastname: Hasbini
authors.affiliation: Medical Oncology, Hôpital Saint-Louis, Paris, France.
authors.forename: Guilhem
authors.initials: G
authors.lastname: Bousquet
authors.affiliation: Urology Department, Centre Hospitalier Universitaire Rangueil, Toulouse, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Soulie
authors.affiliation: Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.
authors.forename: Karim
authors.initials: K
authors.lastname: Fizazi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018771:Arthralgia / Q000139:chemically induced; D000077143:Docetaxel; D005221:Fatigue / Q000139:chemically induced; D019584:Hot Flashes / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D010817:Physician-Patient Relations; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D012647:Self-Assessment; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D015430:Weight Gain / Q000187:drug effects; D015431:Weight Loss / Q000187:drug effects
chemical_list: D000726:Androgen Antagonists; D043823:Taxoids; D000077143:Docetaxel
keywords: Docetaxel; Non-castrate; Patient reported outcome; Phase III; Prostate; Toxicity