fotemustine shows antitumour activity in treatment-refractory paediatric brain tumours

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Inpharma 1361 - 26 Oct 2002 IV fotemustine * shows antitumour activity in treatment-refractory paediatric brain tumours, report researchers from Canada. This phase I study involved 16 paediatric patients aged < 21 years with recurrent/ resistant brain tumours who received IV fotemustine every 3 weeks at increasing dose levels starting at 100 mg/m 2 . ** Fifteen patients were evaluable; they received a total of 45 courses of fotemustine over a dose range of 100–175 mg/m 2 . The overall radiological response rate was 20%; a partial response was achieved by 1 patient with a radiation-induced undifferentiated brain sarcoma, and minor responses were seen in 2 patients with recurrent metastatic medulloblastoma and anaplastic ependymoma, respectively. The main observed toxicity was myelosuppression and the dose-limiting toxicity was grade 4 neutropenia and thrombocytopenia. The maximum tolerated dose was 150 mg/m 2 every 3 weeks. * Servier, Bender, Rontag; fotemustine has been launched in France, Argentina and Australia for the treatment of malignant melanoma ** The study was supported by Servier Research International, France. Hargrave DR, et al. Phase I study of fotemustine in pediatric patients with refractory brain tumors. Cancer 95: 1294-1301, 15 Sep 2002 800920542 1 Inpharma 26 Oct 2002 No. 1361 1173-8324/10/1361-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1361 - 26 Oct 2002

■ IV fotemustine* shows antitumour activity intreatment-refractory paediatric brain tumours, reportresearchers from Canada. This phase I study involved16 paediatric patients aged < 21 years with recurrent/resistant brain tumours who received IV fotemustineevery 3 weeks at increasing dose levels starting at 100mg/m2.** Fifteen patients were evaluable; theyreceived a total of 45 courses of fotemustine over adose range of 100–175 mg/m2. The overall radiologicalresponse rate was 20%; a partial response wasachieved by 1 patient with a radiation-inducedundifferentiated brain sarcoma, and minor responseswere seen in 2 patients with recurrent metastaticmedulloblastoma and anaplastic ependymoma,respectively. The main observed toxicity wasmyelosuppression and the dose-limiting toxicity wasgrade 4 neutropenia and thrombocytopenia. Themaximum tolerated dose was 150 mg/m2 every 3weeks.* Servier, Bender, Rontag; fotemustine has been launched inFrance, Argentina and Australia for the treatment of malignantmelanoma** The study was supported by Servier Research International,France.

Hargrave DR, et al. Phase I study of fotemustine in pediatric patients withrefractory brain tumors. Cancer 95: 1294-1301, 15 Sep 2002 800920542

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Inpharma 26 Oct 2002 No. 13611173-8324/10/1361-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved