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Sub-category:
Head and Neck Cancer
Category:
Head & Neck Cancer
Meeting:
2004 ASCO Annual Meeting
Session Type and Session Title:
Poster Discussion, Head and Neck Cancer
Abstract No:
5536
Citation:
Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 5536
Author(s):
D. M. Brizel, T. Wasserman; Duke University Medical Center, Durham, NC; Washington University, St. Louis, MO
Abstract:
Background: Amifostine (A, Ethyol) reduced radiotherapy (RT)-induced xerostomia without diminishing tumor control at 12 months in a prospective, randomized trial of patients receiving head and neck RT (Brizel et al, J Clin Oncol 2000;18:3339-45). The FDA approved A for protection against xerostomia based on that trial. We now evaluate follow-up data 12-24 months after RT to further assess both long-term radioprotective effects of A and tumor control. Methods: Adults with head and neck cancer who underwent once-daily fractionated RT for 5–7 weeks (total dose 50–70 Gy) received open-label intravenous A 200 mg/m2 15–30 minutes before each RT fraction (n=150) or no treatment before RT (control; C; n=153). Xerostomia, disease progression, and survival were assessed at 12, 18, and 24 months. Results: Minimum followup for all survivors is now 2 years. A continued to result in diminished xerostomia during the second year of follow-up (Table), based on incidence of RTOG Grade ≥2 xerostomia and proportion of patients with meaningful (>0.1 g) unstimulated saliva production. Patients reported less mouth dryness (P<.001) and greater mean benefit overall (P=.053) with A vs C on a Patient Benefit Questionnaire. Locoregional tumor control, progression-free survival, and overall survival were similar between groups (Table). Conclusions: Amifostine provides radioprotection from xerostomia that continues for at least 2 years without evidence of change in tumor control.
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Amifostine (n=153) vs Control (n=150)
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12 months
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18 months
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24 months
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P value
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Local Regional Control
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72% vs 71%
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61% vs 64%
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54% vs 58%
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.86
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Progression Free Survival
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75% vs 70%
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63% vs 63%
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56 vs 59%
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.91
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Survival
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89% vs 82%
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81% vs 73%
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72% vs 67%
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.14
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Grade ≥2 Xerostomia
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32% vs 56%
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29% vs 51%
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20% vs 36%
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.002
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Unstimulated Saliva ≥0.1 g
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70% vs 49%
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69% vs 60%
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76% vs 56%
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.01
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 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by D. M. Brizel:
Presentations by D. M. Brizel:
Educational Book Manuscripts by D. M. Brizel:
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