n at increased risk for significant nephrotoxicity), as well as in patients who lacked these risks. Selected analyses of the effects of Amifostine in reducing the cumulative renal toxicity of cisplatin in the randomized ovarian cancer study are provided in TABLES 1 and 2, below.
TABLE 1 Proportion of Patients with ≥40% Reduction in Calculated Creatinine Clearance* *
Creatinine clearance values were calculated using the Cockcroft-Gault formula, Nephron 1976; 16:31-41.
Amifostine+CP CP p-value
(2-sided)
All Patients 16/122 (13%) 36/120 (30%) 0.001
First Cohort 10/63 20/58 0.018
Second Cohort 6/59 16/62 0.026
Creatinine clearance values were calculated using the Cockcroft-Gault formula, Nephron 1976; 16:31-41.
Amifostine+CP CP p-value
(2-sided)
All Patients 16/122 (13%) 36/120 (30%) 0.001
First Cohort 10/63 20/58 0.018
Second Cohort 6/59 16/62 0.026
TABLE 2 NCI Toxicity Grades of Serum Magnesium Levels for Each Patient's Last Cycle of Therapy *
Based on 2-sided Mantel-Haenszel Chi-Square statistic.
NCI-CTC Grade:
(mEq/L) 0
>1.4 1
≤1.4 to >1.1 2
≤1.1 to >0.8 3
≤0.8 to >0.5 4
≤0.5 p-value*
All Patients
Amifostine+CP
CP 92
73 13
18 3
7 0
5 0
1 0.001
First Cohort
Amifostine+CP
CP 49
35 10
8 3
6 0
3 0
1 0.017
Second Cohort
Amifostine+CP
CP 43
38 3
10 0
1 0
2 0
0 0.012
Based on 2-sided Mantel-Haenszel Chi-Square statistic.
NCI-CTC Grade:
(mEq/L) 0
>1.4 1
≤1.4 to >1.1 2
≤1.1 to >0.8 3
≤0.8 to >0.5 4
≤0.5 p-value*
All Patients
Amifostine+CP
CP 92
73 13
18 3
7 0
5 0
1 0.001
First Cohort
Amifostine+CP
CP 49
35 10
8 3
6 0
3 0
1 0.017
Second Cohort
Amifostine+CP
CP 43
38 3
10 0
1 0
2 0
0 0.012
In the randomized ovarian cancer study, Amifostine had no detectable effect on the antitumor efficacy of cisplatin-cyclophosphamide chemotherapy. Objective response rates (including pathologically confirmed complete remission rates), time to progression, and survival duration were all similar in the Amifostine and control study groups. The table below summarizes the principal efficacy findings of the randomized ovarian cancer study.
TABLE 3 Comparison of Principal Efficacy Findings Amifostine +CP CP
Complete pathologic tumor response rate 21.3% 15.8%
Time to progression (months)
Median (± 95% CI) 15.8 (13.2, 25.1) 18.1 (12.5, 20.4)
Mean (± Std error) 19.8 |
