Phase III Randomized Trial of Amifostine as a Radioprotector in Head and Neck Cancer
Authors: Bhadrasain Vikram, David M. Brizel
Journal: Journal of Clinical Oncology (2001)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2001.19.4.1233 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 11181692 Phase III Randomized Trial of Amifostine as a Radioprotector in Head and Neck Cancer Bhadrasain VikramxBhadrasain VikramSearch for articles by this author David M. BrizelxDavid M. BrizelSearch for articles by this author Show More Albert Einstein College of Medicine, Montefiore Medical Center, New York, NYDuke University Medical Center, Durham, NC https://doi.org/10.1200/JCO.2001.19.4.1233 First Page Full Text PDF Figures and Tables © 2001 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse15022001In Reply:We appreciate the thoughtful comments from Dr Vikram. We also regret the fact that the appendices were inadvertently omitted during the publication process and this seems to be the source of his uncertainty. The Appendices were published in the December 15, 2000, issue of the Journal of Clinical Oncology.1 We used a more recent version of the Radiation Therapy Oncology Group (RTOG) criteria for acute salivary gland toxicity than that cited by Vikram. This scale is available for review on the RTOG Web site. According to these criteria, grade 1 acute xerostomia is mild dryness/slightly thickened saliva and slightly altered or metallic taste. Grade 2 is moderate to complete dryness, thick sticky saliva, and markedly altered taste. Of note, there is no grade 3 in the scoring system, and grade 4 is acute salivary gland necrosis. Consequently, we would argue that a reduction from grade 2 to grade 1 is in fact clinically significant. Vikram’s comments about the potential physician bias in an open-label trial are also well taken. It is reassuring, however, that the objective quantitation of salivary function greatly favored the patients who received amifostine, and these results were highly correlated with those patients being assessed as having less xerostomia. Finally, when the patients themselves assessed their symptoms after radiotherapy, those patients who received amifostine consistently indicated a better quality of life. This patient self-assessment has recently been published.2 In summary, the patients on this trial who received amifostine had less severe xerostomia as assessed by the physician, had objectively greater quantities of saliva production, and had improved quality of life on patient’s self-assessment. All of these results were strongly correlated with one another.REFERENCE1. Brizel DM, Wasserman TH, Henke M, et al: Phase III randomized trial of amifostine as a radioprotector in head and neck cancer. J Clin Oncol 18:: 3339,2000-3345, (published erratum appears in J Clin Oncol 18:4110-4111, 2000) Link, Google Scholar2. Wasserman TT, Mackowiak JI, Brizel DM, et al: Effective amifostine on patient assessed clinical benefit in irradiated head and neck cancer. Int J Radiat Oncol Biol Phys 48:: 1035,2000-1040, Crossref, Medline, Google Scholar