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Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 1518
© 2005 American Society of Clinical Oncology
Pre-radiation R115777 in patients with newly diagnosed glioblastoma multiforme and residual enhancing disease
R. A. Lustig,
T. Mikkelesen,
G. Lesser,
S. Grossman,
X. Ye,
S. Desideri,
J. Fisher,
J. Wright New Approaches to Brain Tumor Therapy Consortium
Univ of Pennsylvania Medcl Ctr, Philadelphia, PA; Henry Ford Hosp, Detroit, MI; Wake Forrest Univ, Winston-Salem, NC; Johns Hopkins Univ, Baltimore, MD; NABTT Central Office, Baltimore, MD; National Cancer Institute, Bethesda, MD
1518
Purpose The aim of this study was to evaluate response and survival following the administration of R115777 prior to and following radiation therapy in newly diagnosed patients with GBM who had residual contrast enhancing tumor. Methods: Following surgery, patients with residual contrast enhancing tumor were eligible for this study. Patients were stratified based on their usage or non-usage of EIACs. After informed consent was obtained, patients were started on oral R115777. Patients on EIACs received 600mg b.i.d and those not on EIACs received 300mg b.i.d. R115777 was given continuously for 3 weeks followed by a one week rest. MRIs were performed monthly to establish response. Patients with evidence of progression went to immediate radiation therapy. Progression was defined as a 25% increase in the volume of tumor on MRI or progressive neurologic symptoms not explained by medication or systemic disease. For patients completing 3 cycles of R115777, the drug was stopped and radiation started, 60 Gy in 6 weeks. After radiation non-progressing patients were to have R11577 restarted until progression. The primary endpoint of the study was overall survival. The secondary endpoints were response rate, progression free survival, and toxicity. Results: From August 28, 2003 until April 13, 2004, 28 patients were accrued into the study. The mean age was 59.6 years and the mean KPS 84.6 All patients had histologically confirmed glioblastoma. A total of 15 patients were on EIACs. Fifteeen patients remain alive with a maximum follow-up of 350 days. Progressive disease occurred quickly on this therapy: 12 pts (48%) in the first month, 9 pts (36%) in the 2nd month, and 3 pts (12%) in the 3rd month. Only 2 patients completed all 3 cycles of induction therapy and radiation. No patient achieved a CR or PR. One patient was off study due to toxicity. To date 14 of 28 patients have died with a median overall survival of 7.5 months. Conclusions: R115777 administered prior to radiation therapy in patients with newly diagnosed GBM with residual contrast enhancing disease did not result in any measurable responses. No significant toxicities were noted in this group of patients. These patients continue to be followed for survival.
No significant financial relationships to disclose.
Abstract presentation from the 2005 ASCO Annual Meeting
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