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document
Prophylactic use of amifostine to prevent radiochemotherapy-induced mucositis and xerostomia in head-and-neck cancer . PURPOSE To determine the prophylactic properties of amifostine against acute and late toxicities from radiochemotherapy in patients with head-and-neck cancer . METHODS AND MATERIALS Fifty patients were randomized to receive conventional radiotherapy ( RT ) ( 2-Gy fractions , 5 days weekly , to a total of 60-74 Gy , depending on the tumor localization and TNM classification ) and carboplatin ( 90 mg/m ( 2 ) infusion once per week before RT ) . Amifostine ( 300 mg/m ( 2 ) ) was administered in the study group only 15-30 min before RT for 6-7.5 weeks . The primary study end point was the grading of acute and late nonhematologic toxicities ( mucositis , dysphagia , xerostomia ) induced by radiochemotherapy . Secondary end points included treatment duration , hematologic toxicity , and clinical outcome . RESULTS The treatment duration was significantly shorter in the amifostine-treated group ( p = 0.013 ) , because treatment interruptions were more frequent in the control group . Acute toxicities ( mucositis and dysphagia ) were less severe in the amifostine-treated group . By Week 3 , all in the control group experienced Grade 2 mucositis compared with only 9 % in the amifostine-treated group ( p < 0.0001 ) . By Week 5 , 52.2 % of the patients in the control group experienced Grade 4 mucositis compared with 4.5 % in the amifostine-treated group ( p = 0.0006 ) . Similar results were obtained for dysphagia . At 3 months of follow-up , only 27 % of patients in the study group experienced Grade 2 xerostomia compared with 73.9 % in the control group ( p = 0.0001 ) . Eighteen months after cessation of therapy , the proportion of patients with Grade 2 xerostomia was 4.5 % vs. 30.4 % for each respective treatment group ( p = 0.047 ) . Cytoprotection with amifostine did not affect treatment outcome , with 90.9 % complete responses in the amifostine-treated group compared with 78.3 % in the control group ( p = 0.414 ) . CONCLUSION Amifostine was effective in reducing mucositis and dysphagia resulting from radiochemotherapy in patients with head-and-neck cancer . Furthermore , amifostine reduced the severity of late xerostomia , a side effect of RT with long-lasting consequences . Amifostine treatment did not affect the clinical outcome .
8250
Intervention_Pharmacological
amifostine
8251
Intervention_Pharmacological
amifostine
8252
Intervention_Physical
conventional radiotherapy
8253
Intervention_Pharmacological
carboplatin
8254
Intervention_Pharmacological
Amifostine
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Intervention_Physical
radiochemotherapy
8256
Intervention_Pharmacological
Cytoprotection
8257
Intervention_Pharmacological
amifostine
8258
Intervention_Pharmacological
Amifostine
8259
Intervention_Pharmacological
amifostine
8260
Intervention_Pharmacological
Amifostine
8261
Outcome_Physical
grading of acute and late nonhematologic toxicities
8262
Outcome_Physical
mucositis
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Outcome_Physical
dysphagia
8264
Outcome_Physical
xerostomia
8265
Outcome_Physical
treatment duration
8266
Outcome_Physical
hematologic toxicity
8267
Outcome_Physical
clinical outcome
8268
Outcome_Other
treatment duration
8269
Outcome_Physical
Acute toxicities
8270
Outcome_Physical
mucositis
8271
Outcome_Physical
dysphagia
8272
Outcome_Physical
Grade 2 mucositis
8273
Outcome_Physical
dysphagia
8274
Outcome_Physical
Grade 2 xerostomia
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Outcome_Physical
proportion of patients with Grade 2 xerostomia