was firm [1:1.5 mg/dL), or severe hypomagnesemia. Subgroup analyses suggested that the effect of Amifostine was present in patients who had received nephrotoxic antibiotics, or who had preexisting diabetes or hypertension (and thus may have been 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 for Injection +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->1.1 2 1.1->0.8 3 0.8->0.5 4 0.5 p-value * All Patien ts Amifostine for Injection+CP CP 92 73 13 18 3 7 0 5 0 1 0.001 First Cohort Amifostine for Injection+CP CP 49 35 10 8 3 6 0 3 0 1 0.017 Second Cohort Amifostine for Injection+CP CP 43 38 3 10 0 1 0 2 0 0 0.012 In the randomized ovarian cancer study, Amifostine for Injection 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 for Injection +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 ( 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) Radiotherapy for Head and Neck Cancer. A randomized controlled trial of standard fractionated radiation (1.8 Gy - 2.0 Gy/day for 5 days/week for 5-7 weeks) with or without Amifostine for Injection, administered at 200 mg/m 2 as a 3 minute i.v. infusion 15-30 minutes prior to each fraction of radiation, was conducted in 315 patients with head and neck cancer. Patients were required to have at least 75% of both parotid glands in the radiation field. The incidence of Grade 2 or higher acute (90 days or less from start of radiation) and late xerostomia (9-12 months following radiation) as assessed by RTOG Acute and Late Morbidity Scoring Criteria, was significantly reduced in patients receiving Amifostine (TABLE 4). TABLE 4 Incidence of Grade 2 or Higher Xerostomia (RTOG criteria) * Based on the number of patients for whom actual data were available. Amifostine for Injection +RT RT p-value Acute ( 90 days from start of radiation) 51% (75/148) 78% (120/153) p] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer West-Ward Pharmaceuticals Drug Class Antineoplastic detoxifying agents Related Drugs antineoplastic detoxifying agents mesna , Mesnex , Ethyol Cancer carboplatin , fluorouracil , cyclophosphamide , Cytoxan , etoposide , Adriamycin , doxorubicin , vincristine , More... Non-Small Cell Lung Cancer Avastin , methotrexate , Taxol , Opdivo , cisplatin , Taxotere , Tarceva , Keytruda , More... Ovarian Cancer Avastin , carboplatin , Taxol , cisplatin , cyclophosphamide , paclitaxel , gemcitabine , Gemzar , More... Amifostine Rating No Reviews - Be the first! 10 /10 No Reviews - Be the first! 10 Rate it! beat back
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