Cytoprotection of amifostine (A) in ovarian cancer patients receiving paclitaxel/carboplatin (PC) first line chemotherapy in a multicenter phase III trial

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5021 Background: The primary objectives of the study were to evaluate, if A can prevent or reduce the WHO grade of haematological and non haematological toxicities induced by PC and to determine if A enables to adhere to the planned chemotherapy regimen (interval and dosage). Methods: 89 patients with primary epithelial ovarian cancer FIGO Stage IC – IV were entered into this prospective randomised phase III trial between 1998 and 2/2002. In all patients first line chemotherapy of P 175 mg/m2 i.v. within 3 hours day 1 and C AUC 5 on day 2 was planned for 6 cycles. 44 patients were randomised to the A arm and received 740 mg/m2 A before P on day 1 and 740 mg/m2 before and 2 hours after C on day 2. 41 patients received chemotherapy only. Results: The planned number of 40 patients in each treatment arm was achieved with 85 eligible patients. This number was calculated to confirm a reduction of granulocytopenia by 50% and prevention of neurotoxicity difference in score increase by 2 units) in the A therapy arm. Grad 3 and 4 granulocytopenia developed in 52,3 % of the patients in the A arm and 71,8 % in the control group (one-sided chi-square test X2= 3,32; p=0,034). Neurotoxicity and all other toxicities were identical in both treatment arms. Only nausea and vomiting was significantly increased in the A therapy arm with 20,5% grade 3 and 4 versus 5,1% in the control arm (chi-square test X2=4,22; p= 0,04). Quality of life analysis showed a significant lower deterioration of the global health score in the A group (Wilcoxon test p=0,035). Treatment delay was not significantly different in both groups. Conclusions: A was able to reduce granulocytopenia and had a positive influence on global health score. According to neurotoxicity and other toxicities A did not prove efficacy. At present we cannot recommend A as standard cytoprotective agent in ovarian cancer patients treated with this PC chemotherapy. This study was supported by AESCA Austria and Bristol Myers Squibb Austria Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AESCA Bristol-Myers Squibb AESCA Austria; Bristol-Myers Squibb

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