Bulletin du Cancer


Off label drug use in adult patients treated by anticancer chemotherapy Volume 92, issue 5, Mai 2005

Service de pharmacie stérilisation, Hôpitaux universitaires de Strasbourg, Hôpital Hautepierre, avenue Molière, 67000 Strasbourg

Off-label drug use is supposed to be widespread in chemotherapy but very few studies have determined its extent in clinical practice. This prospective study evaluates the proportion of off-label anticancer drug use in terms of indications in a French teaching hospital. Adult ambulatory patient prescriptions were analysed by pharmacists in the year 2002. Data concerning the type of cancer and the indication of the antitumor agent were collected and compared with the official Summary of Product Characteristics in France. In the year 2002, 6,168 chemotherapy cycles (prescriptions) were administered to 1,206 patients. Four hundred and fifteen (6,7%) prescriptions presented a drug used in an off-label manner. Off label prescriptions were common in patients with hormone-refractory prostate cancer (57,6% of the courses for this type of tumor) and in patients with bladder cancer (37,6%). No off-label use was observed in patients with colorectal cancer. The drugs most commonly used in an off-label indication were docetaxel (29,1% of the off label prescriptions) and oxaliplatin (23,6%). Overall, in our hospital, the proportion of off-label use of anticancer agents in terms of indications in adult patients appears low.