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MGI Pharma Summarizes Data Presented at the 2007 American Society,of Clinical Oncology (ASCO) Annual Meeting

ional multi-agent chemotherapy compared to those who received chemotherapy together with Gliadel Wafer were presented in a poster discussion on Monday June 4, 2007. Eighty-five patients with primary glioblastoma multiforme received surgery with

(n=36) or without (n=49) Gliadel implantation followed by radiotherapy and concurrent temozolomide (TMZ) plus one year of adjuvant rotational multi-agent chemotherapy (lomustine (CCNU), TMZ, and irinotecan), consisting of two cycles of each agent. After a median follow-up of

132 weeks, the group that received Gliadel had an extended median survival of 89.4 weeks (95% CI, 65.1- (Infinity)) compared to 72.7 weeks (95% CI, 57.7-84.3) for patients who did not receive Gliadel.

One- and 2- year survival rates were also increased with the addition of Gliadel (81% vs. 67% and 44% vs. 27%, respectively). A Cox proportional hazards model accounting for the effects of the Recursive Partitioning Analysis (RPA) class was performed, and the effect of Gliadel treatment on survival was found to approach significance (pless than 0.055). Adverse events were similar in patients treated with or without Gliadel and included thrombocytopenia, leukopenia, seizures, fatigue, and gastrointestinal.

Irofulven

Results of a Randomized Phase 2 Trial of Irofulven in Hormone Refractory Prostate Cancer (HRPC) Patients who Failed First-line Docetaxel Treatment

Updated results of a randomized, 3-arm phase 2 study of irofulven

+ prednisone +/- capecitabine compared to mitoxantrone + prednisone in

patients with HRPC were presented in a poster discussion on Saturday, June 2, 2007. A total of 137 patients with documented resistance to first-line treatment with docetaxel were stratified by presence or absence of disease related pain at study entry and assigned to treatment in a 2:2:1 manner (i.e. 4/5 patients received an irofulven-containing regimen). Although the study was not designed for a statistical compa
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