PURPOSE: To study the efficacy and safety of cevimeline in two double-blind trials (Studies 003 and 004) enrolling patients with head and neck cancer in whom xerostomia developed afterradiotherapy. METHODS AND MATERIALS: Subjects were randomly assigned to receive cevimeline, 30 mg three times daily, or placebo for 12 weeks, with the possibility of dose escalation to 45 mg three times daily at 6 weeks. The primary efficacy endpoint was the patient's final global evaluation of oral dryness; change in unstimulated salivary flow was a secondary endpoint. RESULTS:Five hundred seventy subjects (284 in Study 003 and 286 in Study 004) were randomized. Significantly more cevimeline-treated subjects than placeborecipients (47.4% vs. 33.3%, p = 0.0162) in Study 003 reported improvement in dry mouth in the final global evaluation of oral dryness. No significant difference between groups in the final global evaluation was seen in Study 004, in which a high placebo response rate of 47.6% was observed. In both studies, cevimeline-treated subjects had significantly greater increases in the objective measure of unstimulated salivary flow than placeborecipients (p = 0.0093 [Study 003] and p = 0.0215 [Study 004]), whereas no significant differences in stimulated salivary flow were observed. The most frequent adverse event was increased sweating. CONCLUSION:Cevimeline was well tolerated by patients with xerostomia after radiotherapy for head and neck cancer, and oral administration of 30-45 mg of cevimeline three times daily increased unstimulated salivary flow.
RCT Entities:
PURPOSE: To study the efficacy and safety of cevimeline in two double-blind trials (Studies 003 and 004) enrolling patients with head and neck cancer in whom xerostomia developed after radiotherapy. METHODS AND MATERIALS: Subjects were randomly assigned to receive cevimeline, 30 mg three times daily, or placebo for 12 weeks, with the possibility of dose escalation to 45 mg three times daily at 6 weeks. The primary efficacy endpoint was the patient's final global evaluation of oral dryness; change in unstimulated salivary flow was a secondary endpoint. RESULTS: Five hundred seventy subjects (284 in Study 003 and 286 in Study 004) were randomized. Significantly more cevimeline-treated subjects than placebo recipients (47.4% vs. 33.3%, p = 0.0162) in Study 003 reported improvement in dry mouth in the final global evaluation of oral dryness. No significant difference between groups in the final global evaluation was seen in Study 004, in which a high placebo response rate of 47.6% was observed. In both studies, cevimeline-treated subjects had significantly greater increases in the objective measure of unstimulated salivary flow than placebo recipients (p = 0.0093 [Study 003] and p = 0.0215 [Study 004]), whereas no significant differences in stimulated salivary flow were observed. The most frequent adverse event was increased sweating. CONCLUSION:Cevimeline was well tolerated by patients with xerostomia after radiotherapy for head and neck cancer, and oral administration of 30-45 mg of cevimeline three times daily increased unstimulated salivary flow.
Authors: S B Jensen; A M L Pedersen; A Vissink; E Andersen; C G Brown; A N Davies; J Dutilh; J S Fulton; L Jankovic; N N F Lopes; A L S Mello; L V Muniz; C A Murdoch-Kinch; R G Nair; J J Napeñas; A Nogueira-Rodrigues; D Saunders; B Stirling; I von Bültzingslöwen; D S Weikel; L S Elting; F K L Spijkervet; M T Brennan Journal: Support Care Cancer Date: 2010-03-25 Impact factor: 3.603
Authors: Primož Strojan; Katherine A Hutcheson; Avraham Eisbruch; Jonathan J Beitler; Johannes A Langendijk; Anne W M Lee; June Corry; William M Mendenhall; Robert Smee; Alessandra Rinaldo; Alfio Ferlito Journal: Cancer Treat Rev Date: 2017-07-18 Impact factor: 12.111
Authors: David G Pfister; Barrie R Cassileth; Gary E Deng; K Simon Yeung; Jennifer S Lee; Donald Garrity; Angel Cronin; Nancy Lee; Dennis Kraus; Ashok R Shaha; Jatin Shah; Andrew J Vickers Journal: J Clin Oncol Date: 2010-04-20 Impact factor: 44.544
Authors: Y Ota; A Morito; K Fujisawa; M Nishida; H Hata; T Ueno; T Yurikusa; T Murata Journal: Eur J Cancer Care (Engl) Date: 2012-04-23 Impact factor: 2.520
Authors: Anju Gangadharan; Sung Eun Choi; Ahmed Hassan; Nehad M Ayoub; Gina Durante; Sakshi Balwani; Young Hee Kim; Andrew Pecora; Andre Goy; K Stephen Suh Journal: Oncotarget Date: 2017-04-04