Lorusso, D., Ferrandina, G., Greffi, S., Gadducci, A., Pignata, S., Tateo, S. … Scambia, G. (2003). Phase III multicenter randomized trial of amifostine as cytoprotectant in first-line chemotherapy in ovarian cancer patients. Annals of Oncology, 14, 1086–1093.
Patients receiving carboplatin (area under the curve [AUC] 5 mg per minute/ml) and 175 mg/m2 paclitaxel were randomly assigned to receive 910 mg/m2 IV amifostine 30 minutes prior to carboplatin.
The study was conducted between April 1999 and July 2001.
This was a phase III, multicenter, randomized trial.
A significant difference was found in grade 3-4 mucositis (4.7% in the amifostine group versus 15.4% in the control group, p < 0.0001).