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Phase II study of ZD1839 in patients with newly diagnosed grade 4 astrocytoma.


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)



Website: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-00915,00.asp

Posted on: 06/08/2004

Phase II study of ZD1839 in patients with newly diagnosed grade 4 astrocytoma.

Meeting: 2004 ASCO Annual Meeting
Category: Central Nervous System Tumors
SubCategory: CNS Tumors
Abstract No: 1505
Author(s): J. H. Uhm, K. V. Ballman, C. Giannini, J. C. Krauss, J. C. Buckner, D. James, B. W. Scheithauer, J. R. O'Fallon, K. A. Jaeckle; Mayo Clinic, Rochester, MN; St Joseph Mercy Hospital, Ann Arbor, MI

Abstract:
Background: Amplification of the EGFR represents one of the most frequent gene alterations in glioblastoma (GBM). In the current study, our objectives were to evaluate ZD1839 (Iressa), a potent EGFR inhibitor, in the treatment of adults with newly diagnosed GBM, and to correlate response with tumor EGFR status.

Methods: By the end of the study, 98 patients (96 evaluable) were accrued. All were newly diagnosed GBM patients who were radiographically stable/improved following radiation treatment (enrollment within in 5 weeks of radiation completion). No prior chemotherapy was permitted. EGFR amplification/mutation, as assessed by FISH and immunohistochemistry, was not required for treatment with ZD1839 but was studied when tissues were available. ZD1839 was administered at 500mg QD; for patients receiving dexamethasone and/or enzyme-inducing (CYP3A4) agents, dose was escalated to a maximum of 1000mg QD. Treatment cycles were repeated at 4-week intervals with tumor response assessed by brain MRI at 8-week intervals.

Results: Survival (calculated from time of initial surgery) at 1 year (primary endpoint) with ZD1839 was 54.2%, which was not statistically different compared to that of historical control population (48.9%, 3 previous phase III NCCTG studies of newly diagnosed GBM patients). Progression-free status at 1 year post-RT (13.3%) was also not statistically different to that of historical controls (16.1%). EGFR amplification, as assessed by FISH and immunohistochemistry, was not associated with survival or progression-free survival. Fatigue (41%), rash (62%), and loose stools (58%) constituted the most frequent adverse events, the majority of these being limited to Grade 1/2.

Conclusions: Modest activity of ZD1839 and other EGFR inhibitors have been previously suggested in relatively smaller studies with recurrent GBM. In our current study of nearly one hundred patients with newly diagnosed GBM, treatment with ZD1839 was not associated with significant improvement in overall- nor progression-free survival. Whether EGFR inhibitor therapy in combination with other treatments, such as concurrent radiation, will show synergy is being addressed in ongoing studies.



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