Al's Comment:
This study says that of GBM patients using concurrent radiation and Temodar, 3% developed serious thrombocyopenia. In the Temodar package insert, it was reported that about 4% for adults, and 58% for kids have problems with platelets. This abstract did not mention the ages of the patients but the article said they were all adults. 19.6% that used the generic had thrombocytopenia. Big difference.
From this it is hard to tell which is better. I doubt there is a differencem but if there is and the generic causes more thrombocytopenia, the next question is which one worked better. More side effects might mean more potency but also might mean worse quality control.
I would like to take a quick survey of the readers. If you have ever used Temodar or the generic, please fill out this quick 3 question survey:
Posted on: 02/03/2020
. Fundam Clin Pharmacol. 2020 Jan 29. doi: 10.1111/fcp.12539. [Epub ahead of print]
Deleterious impact of a generic temozolomide formulation compared with brand-name product on the kinetic of platelet concentration and survival in newly diagnosed glioblastoma.
Fontanilles M1,2,3, Fontanilles A4, Massy N3, Rouvet J5, Pereira T3, Alexandru C2, Hanzen C6, Basuyau F5, Langlois O7, Clatot F1,2, Tennevet I2, Di Fiore F1,2,8, Joannides R3,9, Lamoureux F3,9.
Author information:
1. Normandie Univ, UNIROUEN, Inserm U1245, IRON group, Rouen University Hospital, Normandy Centre for Genomic and Personalized Medicine, F-76031, Rouen, France.
2. Department of Medical Oncology, Cancer Centre Henri Becquerel, F-76000, Rouen, France.
3. Department of Pharmacology, Rouen University Hospital, F-76031, Rouen, France.
4. Institut supérieur d'agriculture Rhône-Alpes, ISARA-Lyon, F-69007, Lyon.
5. Department of Pharmacy, Cancer Centre Henri Becquerel, F-76000, Rouen, France.
6. Department of Radiation Oncology and Medical Physics, Cancer Centre Henri Becquerel, F-76000, Rouen, France.
7. Department of Neurosurgery, Rouen University Hospital, F-76031, Rouen, France.
8. Department of Hepatogastroenterology, Rouen University Hospital, F-76031, Rouen, France.
9. Inserm U1096, Normandie Univ, UNIROUEN, Institute for Research and Innovation in Biomedicine, University of Rouen, Rouen, France.
Abstract
Chemo-induced thrombocytopenia is a limiting toxicity among patients receiving temozolomide (TMZ) as first-line treatment for glioblastoma. We aimed to compare early platelet concentration kinetics, hematological safety profile and impact on survival following the initiation of either the brand-name or a generic TMZ formulation. A retrospective trial was conducted in patients suffering from newly diagnosed glioblastoma. Patients were treated with TMZ at 75 mg/m2 per day during six weeks, concomitantly with radiotherapy. Platelet concentration was collected each week. Primary endpoint was to perform a linear mixed effect model of platelet concentration kinetic over weeks. 147 patients were included: 96 received the brand-name TMZ and 51 received a generic TMZ formulation. Exposition to the generic was a significant variable that negatively influenced the platelet kinetics in the radiotherapy and concomitant TMZ phase, p=0.02. Grade ≥3 chemo-induced thrombocytopenia was more frequent in the generic group: 19.6% [95% CI 8.7-30.5%] vs 3.1% [0-6.6%], p=0.001. Exposition to the generic formulation of TMZ led to increase early treatment discontinuation due to TMZ-induced thrombocytopenia and was a worsening independent prognostic factor on overall survival: adjusted HR 1.83 [1.21-2.8], p=0.031. These data suggest that exposition to a generic formulation of TMZ vs the brand-name product is associated with higher early platelet decrease leading to clinically relevant impacts on treatment schedule in glioblastoma. Further prospective trials are needed to confirm these results.
© 2020 Société Française de Pharmacologie et de Thérapeutique.
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