Abstract | PURPOSE: PATIENTS AND METHODS: In a phase II trial, standard radiotherapy was delivered in daily 2-Gy fractions to 70 Gy, or hyperfractionated radiotherapy was delivered in 1.25-Gy fractions twice daily to 72 Gy, over 7 weeks. Chemotherapy included cisplatin 20 mg/m(2) for 4 days and continuous-infusion fluorouracil 1,000 mg/m(2)/d for 4 days on weeks 1 and 5 of irradiation. Patients were randomly assigned 2:1 to palifermin 60 microg/kg or placebo once weekly for 10 doses. A follow-up trial evaluated long-term survival. RESULTS: CONCLUSION: Ten once-weekly doses of palifermin at 60 microg/kg were well tolerated. Most patients completed treatment, but palifermin did not reduce the morbidity of concurrent chemotherapy and radiotherapy. Future studies should evaluate higher palifermin doses with longer and more standardized assessment of acute mucositis.
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Authors | David M Brizel, Barbara A Murphy, David I Rosenthal, Kishan J Pandya, Stefan Glück, Herbert E Brizel, Ruby F Meredith, Dietmar Berger, Mon-Gy Chen, William Mendenhall |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 26
Issue 15
Pg. 2489-96
(May 20 2008)
ISSN: 1527-7755 [Electronic] United States |
PMID | 18487568
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Fibroblast Growth Factor 7
- Cisplatin
- Fluorouracil
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Squamous Cell
(drug therapy, radiotherapy, secondary, therapy)
- Cisplatin
(administration & dosage)
- Combined Modality Therapy
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Fibroblast Growth Factor 7
(therapeutic use)
- Fluorouracil
(administration & dosage)
- Head and Neck Neoplasms
(drug therapy, pathology, radiotherapy, therapy)
- Humans
- Male
- Middle Aged
- Mucositis
(etiology)
- Neoplasm Staging
- Prognosis
- Survival Rate
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