A multicenter prospective observational study of the conformity of temozolomide prescriptions in France

作者：Tilleul Patrick; Brignone Melanie; Hassani Yasmine; Labrande Christelle; Pedeboscq Stephane; Gensollen Sophie; Lahille Benedicte; Exinger Delphine; Bertholle Valerie; Billard Martine; Charlety Dominique; Prebay Danielle; Pinguet Frederic; Taillibert Sophie; Cartalat Stephanie; Chinot Olivier; Borget Isabelle^*

来源：Pharmacoepidemiology and Drug Safety, 2012, 21(8): 828-834.

DOI：10.1002/pds.3233

• brain tumor
• temozolomide
• glioma
• guidelines

Context 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. Conclusion/discussion 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.

• 出版日期2012-8