title: A multicenter prospective observational study of the conformity of temozolomide prescriptions in France.
abstract: BACKGROUND
  Temozolomide (TMZ) is approved for the treatment of high-grade gliomas such as glioblastoma (GBM) multiforme and refractory anaplastic astrocytoma, but it is also used in indications not mentioned in the summary of product characteristics (SPC). The main objective of this study was to evaluate the conformity of TMZ prescriptions to the French SPC and prescription guidebook.
  
  
  METHODS
  We conducted a prospective observational study of all consecutive patients treated with TMZ in 21 French hospitals between September 2006 and February 2007, accounting for 39% of total TMZ consumption in France. The conformity of TMZ prescriptions was evaluated in terms of the indication, dosage, treatment duration, and combination with other treatments, with respect to the SPC and prescription guidebook.
  
  
  RESULTS
  We enrolled 831 patients (median age, 56 years) who received a total of 5982 TMZ treatment cycles. TMZ was mainly prescribed to patients with newly diagnosed GBM (384 patients), GBM in progression/relapse (28 patients), or anaplastic astrocytoma in progression/relapse (19 patients). Prescriptions conformed to the SPC in 51.9% of cases and to the prescription guidebook in 91.5% of cases. Global conformity with the SPC, in terms of the dosage, treatment duration, and combination with other treatments, was 62% for newly diagnosed GBM treated with radiotherapy plus TMZ, 72% for TMZ maintenance monotherapy, and 66% for GBM and anaplastic astrocytoma in progression/relapse.
  
  
  CONCLUSIONS
  In France, routine TMZ prescriptions conform to the SPC and practice guidebook. This is one of the largest studies of drug use in neuro-oncology in terms of the number of patients and cycles analyzed.
authors.affiliation: Department of Pharmacy, Pitié-Salpétrière Hospital, Paris, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Tilleul
authors.forename: Melanie
authors.initials: M
authors.lastname: Brignone
authors.forename: Yasmine
authors.initials: Y
authors.lastname: Hassani
authors.forename: Christelle
authors.initials: C
authors.lastname: Labrande
authors.forename: Stéphane
authors.initials: S
authors.lastname: Pedeboscq
authors.forename: Sophie
authors.initials: S
authors.lastname: Gensollen
authors.forename: Benedicte
authors.initials: B
authors.lastname: Lahille
authors.forename: Delphine
authors.initials: D
authors.lastname: Exinger
authors.forename: Valérie
authors.initials: V
authors.lastname: Bertholle
authors.forename: Martine
authors.initials: M
authors.lastname: Billard
authors.forename: Dominique
authors.initials: D
authors.lastname: Charlety
authors.forename: Danielle
authors.initials: D
authors.lastname: Prebay
authors.forename: Frederic
authors.initials: F
authors.lastname: Pinguet
authors.forename: Sophie
authors.initials: S
authors.lastname: Taillibert
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Cartalat
authors.forename: Olivier
authors.initials: O
authors.lastname: Chinot
authors.forename: Isabelle
authors.initials: I
authors.lastname: Borget
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004363:Drug Utilization; D005260:Female; D005602:France; D005910:Glioma / Q000188:drug therapy*; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use / Q000706:statistics & numerical data*; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D011446:Prospective Studies; D000077204:Temozolomide
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide