Abstract | PURPOSE: 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:
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Authors | Dosia Antonadou, Marizenia Pepelassi, Maria Synodinou, Maria Puglisi, Nicolas Throuvalas |
Journal | International journal of radiation oncology, biology, physics
(Int J Radiat Oncol Biol Phys)
Vol. 52
Issue 3
Pg. 739-47
(Mar 01 2002)
ISSN: 0360-3016 [Print] United States |
PMID | 11849797
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antineoplastic Agents
- Radiation-Protective Agents
- Carboplatin
- Amifostine
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Topics |
- Aged
- Amifostine
(therapeutic use)
- Antineoplastic Agents
(adverse effects)
- Carboplatin
(adverse effects)
- Carcinoma, Squamous Cell
(drug therapy, radiotherapy)
- Combined Modality Therapy
- Female
- Head and Neck Neoplasms
(drug therapy, radiotherapy)
- Humans
- Male
- Middle Aged
- Mouth Mucosa
(drug effects, radiation effects)
- Radiation Injuries
(complications, prevention & control)
- Radiation-Protective Agents
(therapeutic use)
- Stomatitis
(etiology, prevention & control)
- Xerostomia
(etiology, prevention & control)
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