Abstract
In an effort to reduce hematological toxicity of a dose-intensive regimen (CPM 1200 mg/m2 & EDOX 75 mg/m2 every 14 days) given for 6 courses in patients with metastatic, inflammatory or N + > 5, patients received in a randomized parallel design 1 dose (arm A) (910 mg/m2) or 2 doses (arm B) 4 hours apart. This design aimed at giving the 2nd dose at the expected Cmax of phosphoramide mustard. This exploratory analysis concerns 6 pts and 30 cycles in each arm. No growth factor was allowed. Efficacy was estimated through blood-cell counts (G/1) at d14 (mean), as no recovery period was considered. WBC PLT C1 C2 C3 C4 C5 C6 C1 C2 C3 C4 C5 C6 A 1.2 2.1 1.5 2.4 .9 NA 293 262 384 155 154 NA B 1.6 1.2 1.9 .8 .9 NA 327 238 222 76 300 NA While incidence of emesis was similar, hypotension was observed in 15/30 cycles in arm B as compared to 0/30 in arm A. This preliminary analysis does not suggest increased efficacy of 2 doses of amifostine compared to 1 in patients receiving dose intensive CPM-EDOX while amifostine induced hypotension was observed more often in patients scheduled to receive 2 protective doses.
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