Lay Summary: Tarceva is a promising new drug for GBM.
There are a number of phase II trials of Tarceva. Researchers from the Cleveland Clinic Brain Tumor Institute have reported that Tarceva® (erlotinib) produced responses in more than 40% of patients with glioblastoma multiforme. These results were presented at the 29th European Society of Medical Oncology (ESMO) Congress held in Vienna, Austria, October 29 – November 3, 2004. Another phase II trial, evaluating efficacy and tolerability of gefitinib in 53 recurrent glioblastoma patients not selected for any biologic characteristic showed that the drug may have modest activity. Haas-Kogan et al. reported their experience in 41 glioma patients treated with erlotinib within a phase I study. Erlotinib was administered alone or in combination with the alkylating agent temozolomide. All of these studies showed activity comparable or better than other available options.
There are two phase II trials and a phase I trial as well as the orphan drug designation by the FDA.
Vogelbaum MA, Peereboom D, Stevens GH, et al. Phase II study of single agent therapy with the EGFR tyrosine kinase inhibitor erlotinib in recurrent glioblastoma multiforme. Proceedings from the 29th ESMO Congress, Vienna, Austria, October 29 – November 3, 2004; Annals of Oncology 2004;15, supplement 3:iii206, Abstract #783.
Rich JN, Reardon DA, Peery T, Dowell JM, Quinn JA, Penne KL, et al. Phase II trial of gefitinib in recurrent glioblastoma. J Clin Oncol 2004;22:133–42.
Haas-Kogan DA, Prados MD, Tihan T, Eberhard DA, Jelluma N, Arvold ND, et al. Epidermal growth factor receptor, protein kinase B/Akt, and glioma response to erlotinib. J Natl Cancer Inst 2005;97:880–7
- Fine HA. J Clin Oncol. 2004;doi:10.1200/JCO.2004.06.927.