; (±1.04) 19.1 (±1.58)
Hazard ratio
(95% Confidence Interval) .98 (.64, 1.4)
Survival (months)
Median (± 95% CI) 31.3 (28.3, 38.2) 31.8 (26.3, 39.8)
Mean (± Std error) 33.7 (±2.03) 34.3 (±2.04)
Hazard ratio
(95% Confidence Interval) .97 (.69, 1.32)
Indications and Usage for Amifostine
Amifostine for injection is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin based chemotherapy regimens is altered by Amifostine for injection. There are at present only limited data on the effects of Amifostine for injection on the efficacy of chemotherapy. Amifostine for injection should not be administered to patients in other settings where chemotherapy can produce a significant survival benefit except in the context of a clinical study (see WARNINGS).
Contraindications
Amifostine for injection is contraindicated in patients with known hypersensitivity to aminothiol compounds.
Warnings
1. Effectiveness of the Cytotoxic Regimen
Limited data are currently available regarding the preservation of antitumor efficacy when Amifostine is administered prior to cisplatin therapy in settings other than advanced ovarian cancer. Although some animal data suggest interference is possible, in most tumor models the antitumor effects of chemotherapy are not altered by Amifostine. Amifostine should not be used in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure (e.g., certain malignancies of germ cell origin), except in the context of a clinical study.
2. Hypotension
Patients who are hypotensive or in a state of dehydration should not receive Amifostine. Patients receiving Amifostine at doses recommended for chemotherapy should have antihypertensive therapy interrupted 24 hours preceding administration of Amifostine. Patients receiving Amifostine at doses recommended for chemotherapy who are taking antihypertensive therapy that cannot be stopped for 24 hours preceding Amifostine treatment, should not receive Amifostine.
Prior to Amifostine infusion patients should be adequately hydrated. During Amifostine infusion patients should be kept in a supine position. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated. It is important that the duration of the 910 mg/m2 infusion not exceed 15 minutes, as administration of Amifostine as a longer infusion is associated with a higher incidence of side effects. For infusion durations less than 5 minutes, blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated. If hypotension occurs, patients should be placed in the Trendelenburg position and be given an infusion of normal saline using a separate i.v. line. During and after Amifostine infusion, care should be taken to monitor the blood pressure of patients whose antihypertensive medication has been interrupted since hypertension may be exacerbated by discontinuation of antihypertensive medication and other causes such as i.v. hydration.
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