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Randomized Controlled Trial
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Korean J Obstet Gynecol. 2001;44(11):1961-1967. Published online November 1, 2001.
- Amifostine Pretreatment for Protection against Cisplatin-based Combination Chemotherapy in Gynecologic Cancer Patients.
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Lynn Hwa Lee, Hyun Jun Jee, Hwa Kyung Jung, Yua Jung, Jung Ho Shin, Hee Suk Oh, Yong Kyun Park, Jun Young Hur, Soo Yong Chough, Ho Suk Saw
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Department of Obstetrics and Gynecology, Korea University School of Medicine, Seoul, Korea.
- Abstract
- OBJECTIVE
Amifostine (Ethyol(R)), an organic thiophosphate, has shown the ability to protect normal, but not neoplastic, tissues from the damaging effects of chemotherapy and radiotherapy in various kinds of cancers. This study was designed to determine ifostine could reduce the serious hematologic and nephrologic toxicities associated with cisplatin based combination chemotherapy in gynecologic cancer patients. PATIENTS AND METHODS: Forty patients who received cisplatin-based combination chemotherapy were randomized into two groups. They received chemotherapy with or without pretreatment of amifostine before each course. The occurrence of hematologic and renal toxicities were evaluated. Stastical analysis was done by independent t-test and Chi-square test. RESULTS: Hematologic toxicity was evaluated with nadir count of neutrophil and platelet. The nadir count of neutrophil was 2034.2+/-1199.20/microliter in group with pretreatment using amifostine vs 1070.85+/-472.66/microliter in control group (p<0.01). Platelet count was not statistically different. (p<0.16) Grade 3 neutropenia was observed in nine (45%) patients in pretreatment group vs four (20%) patients with control group (p<0.09). Grade 4 neutropenia occurred in one patient only in control group. Renal toxicity was evaluated by serum creatinine and creatinine clearance. Protracted serum creatinine elevation was not significant in both groups. (p<0.14) Reduction of creatinine clearance was less in patients with pretreatment (p<0.01). There were no significant side reactions in subjects using amifostine. CONCLUSION: Pretreatment with amifostine reduces the neutropenia and nephrotoxicity associated with cisplatin-based combination chemotherapy with gynecologic cancer patients.
Keywords :Amifostine;chemotherapy toxicity;gynecologic cancer;cytoprotectant;ethyol
