Open-Label, Long-Term Safety Study of Cevimeline in the Treatment of Postirradiation Xerostomia

Mark S. Chambers, Christopher Uwe Jones, Merrill A. Biel, Randal S. Weber, Kenneth M. Hodge, Y. Chen, John Holland, Jonathan A. Ship, Robert Vitti, Ingrid Armstrong, Adam S. Garden, Robert Haddad

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1369-1376
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Volume69
Issue number5
DOIs
StatePublished - Dec 1 2007

Fingerprint

Xerostomia
safety
Safety
perspiration
Head and Neck Neoplasms
Sweating
cancer
evaluation
nausea
salivary glands
Therapeutics
Radiation Dosage
mouth
Dyspepsia
hydrochlorides
radiation
Salivary Glands
entry
Nausea
Mouth

Keywords

  • Cevimeline
  • Head-and-neck tumor
  • Pilocarpine
  • Radiation
  • Xerostomia

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation

Cite this

Open-Label, Long-Term Safety Study of Cevimeline in the Treatment of Postirradiation Xerostomia. / Chambers, Mark S.; Jones, Christopher Uwe; Biel, Merrill A.; Weber, Randal S.; Hodge, Kenneth M.; Chen, Y.; Holland, John; Ship, Jonathan A.; Vitti, Robert; Armstrong, Ingrid; Garden, Adam S.; Haddad, Robert.

In: International Journal of Radiation Oncology Biology Physics, Vol. 69, No. 5, 01.12.2007, p. 1369-1376.

Research output: Contribution to journalArticle

Chambers, MS, Jones, CU, Biel, MA, Weber, RS, Hodge, KM, Chen, Y, Holland, J, Ship, JA, Vitti, R, Armstrong, I, Garden, AS & Haddad, R 2007, 'Open-Label, Long-Term Safety Study of Cevimeline in the Treatment of Postirradiation Xerostomia', International Journal of Radiation Oncology Biology Physics, vol. 69, no. 5, pp. 1369-1376. https://doi.org/10.1016/j.ijrobp.2007.05.024
Chambers, Mark S. ; Jones, Christopher Uwe ; Biel, Merrill A. ; Weber, Randal S. ; Hodge, Kenneth M. ; Chen, Y. ; Holland, John ; Ship, Jonathan A. ; Vitti, Robert ; Armstrong, Ingrid ; Garden, Adam S. ; Haddad, Robert. / Open-Label, Long-Term Safety Study of Cevimeline in the Treatment of Postirradiation Xerostomia. In: International Journal of Radiation Oncology Biology Physics. 2007 ; Vol. 69, No. 5. pp. 1369-1376.
@article{f70b965820084e0e942f4906a8e406bf,
title = "Open-Label, Long-Term Safety Study of Cevimeline in the Treatment of Postirradiation Xerostomia",
abstract = "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.",
keywords = "Cevimeline, Head-and-neck tumor, Pilocarpine, Radiation, Xerostomia",
author = "Chambers, {Mark S.} and Jones, {Christopher Uwe} and Biel, {Merrill A.} and Weber, {Randal S.} and Hodge, {Kenneth M.} and Y. Chen and John Holland and Ship, {Jonathan A.} and Robert Vitti and Ingrid Armstrong and Garden, {Adam S.} and Robert Haddad",
year = "2007",
month = "12",
day = "1",
doi = "10.1016/j.ijrobp.2007.05.024",
language = "English (US)",
volume = "69",
pages = "1369--1376",
journal = "International Journal of Radiation Oncology Biology Physics",
issn = "0360-3016",
publisher = "Elsevier Inc.",
number = "5",

}

TY - JOUR

T1 - Open-Label, Long-Term Safety Study of Cevimeline in the Treatment of Postirradiation Xerostomia

AU - Chambers, Mark S.

AU - Jones, Christopher Uwe

AU - Biel, Merrill A.

AU - Weber, Randal S.

AU - Hodge, Kenneth M.

AU - Chen, Y.

AU - Holland, John

AU - Ship, Jonathan A.

AU - Vitti, Robert

AU - Armstrong, Ingrid

AU - Garden, Adam S.

AU - Haddad, Robert

PY - 2007/12/1

Y1 - 2007/12/1

N2 - 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.

AB - 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.

KW - Cevimeline

KW - Head-and-neck tumor

KW - Pilocarpine

KW - Radiation

KW - Xerostomia

UR - http://www.scopus.com/inward/record.url?scp=36248957651&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=36248957651&partnerID=8YFLogxK

U2 - 10.1016/j.ijrobp.2007.05.024

DO - 10.1016/j.ijrobp.2007.05.024

M3 - Article

C2 - 17855005

AN - SCOPUS:36248957651

VL - 69

SP - 1369

EP - 1376

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

SN - 0360-3016

IS - 5

ER -