The Journal of the Association of Physicians of India · 2001
Effect of amifostine on toxicities associated with salvage combination chemotherapy.
Клиническое исследованиеКлиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Awasthy B S, Julka P K, Agarwal S, Nair O, Bhamrah R, Rath G K
Аннотация
PURPOSE: To determine the effect of amifostine on the safety and efficacy of chemotherapy in heavily pretreated patients and to study the side effects of amifostine delivered to patients receiving chemotherapy at a dose of 740 mg/m2.
MATERIAL AND METHODS: Thirty-two patients of histologically proven (recurrent) malignancy who had previously received > or = 6 cycles of chemotherapy and developed grade II or grade III toxicities during treatment with salvage chemotherapy were eligible. These patients were given Injection Amifostine 740 mg/m2 as a 15 min. i.v. infusion 30 min. prior to combination chemotherapy.
RESULTS: A total of 85 cycles were administered with amifostine and 46 cycles without amifostine. The side effects during amifostine infusion were hypotension (9.6% cycles), vomiting (20% cycles), somnolence (33% cycles), sneezing (8% cycles), and flushing (19% cycles). The chemotherapy toxicities were reduced from 47.7% to 30.6% for grade II and from 28% to 9.4% for grade III in case of gastrointestinal toxicity. Similarly there was improvement in the mean hemoglobin level from 8.2 gm% to 10.01 gm%, mean total leucocyte count from 2,280/mm3 to 3,600/mm3.
CONCLUSION: Amifostine has an excellent safety profile and is well tolerated by the patients. Pretreatment with Amifostine resulted in fewer treatment related delays and dose reduction resulting in better tolerance to salvage chemotherapy.
MATERIAL AND METHODS: Thirty-two patients of histologically proven (recurrent) malignancy who had previously received > or = 6 cycles of chemotherapy and developed grade II or grade III toxicities during treatment with salvage chemotherapy were eligible. These patients were given Injection Amifostine 740 mg/m2 as a 15 min. i.v. infusion 30 min. prior to combination chemotherapy.
RESULTS: A total of 85 cycles were administered with amifostine and 46 cycles without amifostine. The side effects during amifostine infusion were hypotension (9.6% cycles), vomiting (20% cycles), somnolence (33% cycles), sneezing (8% cycles), and flushing (19% cycles). The chemotherapy toxicities were reduced from 47.7% to 30.6% for grade II and from 28% to 9.4% for grade III in case of gastrointestinal toxicity. Similarly there was improvement in the mean hemoglobin level from 8.2 gm% to 10.01 gm%, mean total leucocyte count from 2,280/mm3 to 3,600/mm3.
CONCLUSION: Amifostine has an excellent safety profile and is well tolerated by the patients. Pretreatment with Amifostine resulted in fewer treatment related delays and dose reduction resulting in better tolerance to salvage chemotherapy.