Open-Label, Long-Term Safety Study of Cevimeline in the Treatment of Postirradiation Xerostomia
- Radiological Associates of Sacramento, Sacramento, CA (United States)
- Ear, Nose and Throat Specialty Care of Minnesota, Minneapolis, MN (United States)
- Department of Head and Neck Surgery, University of Texas M. D. Anderson Cancer Center, Houston, TX (United States)
- Commonwealth Ear Nose and Throat, Louisville, KY (United States)
- Department of Radiation Oncology, University of Rochester Cancer Center, Rochester, NY (United States)
- Department of Radiation Oncology, Oregon Health and Science University, Portland, OR (United States)
- Bluestone Center for Clinical Research, New York University College of Dentistry, New York, NY (United States)
- Daiichi Pharmaceutical Corporation, Montvale, NJ (United States)
- Department of Radiation Oncology, University of Texas M. D. Anderson Cancer Center, Houston, TX (United States)
- Dana Farber Cancer Center, Harvard University, Boston, MA (United States)
Purpose: To assess the safety of long-term cevimeline treatment of radiation-induced xerostomia in patients with head-and-neck cancer; and to assess the efficacy of cevimeline in these patients. Methods and Materials: A total of 255 adults with head-and-neck cancer who had received more than 40 Gy of radiation 4 months or more before entry and had clinically significant salivary gland dysfunction received cevimeline hydrochloride 45 mg t.i.d. orally for 52 weeks. Adverse events (AEs), their severity, and their relationship to the study medication were assessed by each investigator. The efficacy assessment was based on subjects' global evaluation of oral dryness on a scale of 0 (none) to 3 (severe). Results: Overall, 175 subjects (68.6%) experienced expected treatment-related AEs, most mild to moderate. The most frequent was increased sweating (47.5%), followed by dyspepsia (9.4%), nausea (8.2%), and diarrhea (6.3%). Fifteen subjects (5.9%) experienced Grade 3 treatment-related AEs, of which the most frequent was increased sweating. Eighteen subjects (7.1%) reported at least one serious AE, and 45 subjects (17.6%) discontinued study medication because of an AE. The global efficacy evaluation at the last study visit showed that cevimeline improved dry mouth in most subjects (59.2%). Significant improvement was seen at each study visit in the mean change from baseline of the numeric global evaluation score (p < 0.0001). Conclusions: Cevimeline 45 mg t.i.d. was generally well tolerated over a period of 52 weeks in subjects with xerostomia secondary to radiotherapy for cancer in the head-and-neck region.
- OSTI ID:
- 21039655
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 69, Issue 5; Other Information: DOI: 10.1016/j.ijrobp.2007.05.024; PII: S0360-3016(07)00845-0; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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