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• W2018013333 abstract "The mouth is affected in 75% to 85% of patients with chronic graft-versus-host disease (cGVHD) after allogeneic hematopoietic cell transplantation and ranks second behind the skin in order of prevalence of organ involvement [1Flowers M.E.D. Parker P.M. Johnston L.J. et al.Comparison of chronic graft-versus-host disease after transplantation of peripheral blood stem cells versus bone marrow in allogeneic recipients long-term follow-up of a randomized trial.Blood. 2002; 100: 415-419Crossref PubMed Scopus (347) Google Scholar]. Labial salivary gland biopsies show evidence of immunologically mediated destruction with lymphocytic infiltration [2Schubert M.M. Sullivan K.M. Recognition, incidence, and management of oral graft-versus-host disease.NCI Monogr. 1990; 9: 135-143PubMed Google Scholar]. Patients with cGVHD of the mouth frequently have xerostomia, which can be a distressing condition causing taste alterations, difficulty with chewing and swallowing, and anorexia, all potentially contributing to nutritional deficits and undesired weight loss [3Rhodus N.L. Brown J. The association of xerostomia and inadequate intake in older adults.J Am Diet Assoc. 1990; 90: 1688-1692PubMed Google Scholar, 4Lenssen P. Sherry M.E. Cheney C.L. et al.Prevalence of nutrition-related problems among long-term survivors of allogeneic marrow transplantation.J Am Diet Assoc. 1990; 90: 835-842PubMed Google Scholar]. In addition, the oral mucosa becomes susceptible to infection by Candida albicans, and overgrowth of procariogenic bacteria accelerates dental decay [5Guggenheimer J. Moore P.A. Xerostomia etiology, recognition and treatment.J Am Dent Assoc. 2003; 134: 61-69Crossref PubMed Scopus (395) Google Scholar]. Xerostomia may have a greater effect for patients with cGVHD because of additional oral complications such as lichenoid and hyperkeratotic mucosal lesions, pseudomembranes, ulcers, and infections [6Lee S.J. Vogelsang G. Flowers M.E.D. Chronic graft-versus-host disease.Biol Blood Marrow Transplant. 2003; 9: 215-233Abstract Full Text Full Text PDF PubMed Scopus (670) Google Scholar]. The Ancillary and Supportive Care Working Group of the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in cGVHD has concluded that the procholinergic agents pilocarpine and cevimeline, which are approved for symptomatic treatment of xerostomia associated with Sjögren syndrome, can be considered optional therapy for cGVHD-associated xerostomia [7Couriel D. Carpenter P.A. Cutler C. et al.Ancillary therapy and supportive care of chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: V. Ancillary therapy and supportive care working group report.Biol Blood Marrow Transplant. 2006; 12: 375-396Abstract Full Text Full Text PDF PubMed Scopus (278) Google Scholar]. In a small open-label, uncontrolled study, treatment with pilocarpine significantly improved objective and subjective measurements of salivary function in 6 patients with cGVHD-related xerostomia [8Nagler R.M. Nagler A. Pilocarpine hydrochloride relieves xerostomia in chronic graft-versus-host disease a sialometrical study.Bone Marrow Transplant. 1999; 23: 1007-1011Crossref PubMed Scopus (55) Google Scholar]. The relative selectivity of cevimeline for the M1 and M3 muscarinic receptors [9Iwabuchi Y. Masuhara T. Sialagogic activities of SNI-2011 compared with those of pilocarpine and McN-A-343 in rat salivary glands identification of a potential therapeutic agent for treatment of Sjögren’s syndrome.Gen Pharmacol. 1994; 25: 123-129Crossref PubMed Scopus (55) Google Scholar] may make it a preferred agent for use in patients with cGVHD. Three patients at the Fred Hutchinson Cancer Research Center, Seattle, were enrolled in an open-label trial of cevimeline for cGVHD-associated xerostomia and completed treatment before the trial’s premature termination due to slow accrual. The primary outcome measurement was the patient’s final global evaluation of xerostomia as better, much better, worse, much worse, or unchanged after 10 weeks of treatment. Secondary outcome measurements included the patient’s evaluation of separate symptoms using a 100-mm visual analog scale and unstimulated salivary flow 1.5 to 2.5 hours after the administration of a dose of cevimeline. Cevimeline was given at a dosage of 15 mg 3 times a day for 2 weeks, then 30 mg 3 times a day, and then 45 mg 3 times a day for the final 4 weeks of the study, if no improvement and no dose-limiting toxicity were seen at the end of week 6. The experience of these 3 patients (Table 1), who each had persistent xerostomia symptoms despite an adequate trial of altered systemic or topical immunosuppressive therapy, indicates that cevimeline may be a useful ancillary therapy for xerostomia associated with cGVHD. All 3 patients reported improvement in the global evaluation of dry mouth, and 2 had increased unstimulated salivary flow after 10 weeks of treatment. In 1 patient, clinically significant and probably treatment-related adverse events developed on the last day of the 10-week study period. Symptoms of wheezing and eye discomfort may have been attributable to excessive systemic cholinergic effects at the highest dosage. No clinically significant abnormalities in vital signs, electrocardiograms, or laboratory values were detected during treatment with cevimeline.Table 1Characteristics and Responses of the 3 Study Participants⁎AML indicates acute myelogenous leukemia; AT, artificial tears; AZA, azathioprine; CSP, cyclosporine; DEXA, dexamethasone; MDS, myelodysplastic syndrome; P, prednisone; SIR, sirolimus; TAC, tacrolimus.DataCharacteristicsPatient 1Patient 2Patient 3GenderMaleMaleMaleDiagnosisMDSAMLAMLBaseline demographics Age at study entry (y)572547 Duration of cGVHD (mo)48412 Prior sites of cGVHDSkin, mouthSkin, eyes, mouthSkin, eyes, mouth, gut Oral mucosal exam ErythemaYesYesYes AtrophyYesYesYes Lichenoid striaeYesYesYes Hyperkeratotic plaquesYesNoYes Extensive dental cariesYesNoNo SalivaVisibly reducedScant and foamyVisibly reduced Prior therapies (duration) FirstP + CSP (6 wk)P + CSP (18 mo)P + CSP (12 mo) SecondP + CSP + oral AZA or DEXA rinses (6 mo)None (lost to follow-up for 2 y)P + CSP, oxycodone + paroxetine (4 mo) ThirdP + TAC + SIR (6 wk)CSP and AT (7 wk)NoneCevimeline therapy†Milligrams, oral, 3 times daily. Days 1-14151515 Days 15-42303030 Days 43-70304530Global xerostomia evaluation Day 14BetterNo changeBetter Day 42Much betterBetterBetter Day 70Much betterBetterMuch betterUnstimulated salivary flow (g)‡Amount of saliva collected over a period of 6 minutes. Baseline3.871.560.32 Day 146.661.510.95 Day 428.881.381.28 Day 7011.211.321.77Xerosis questionnaire (day 70) Ability to speak without drinking liquids improvedYesYesYes Fluid intake frequency decreasedYesNoNo Chewing improvedYesYesYes Swallowing improvedYesYesYes Broadened food choicesYes—— Decreased oral sensitivitiesYesYes— Decreased mouth soresYes—— Improved sleepYesUnchangedYes (but variable) Decreased use of ATYesYes—CommentsDry mouth recurred immediately after study ended; cevimeline was then resumed for another 2 yWheezing and eye discomfort at day 70 resolved when cevimeline stopped, but xerostomia recurredDry mouth recurred after study ended; patient was treated with a short course of oral DEXA rinses and resumed cevimeline for several months AML indicates acute myelogenous leukemia; AT, artificial tears; AZA, azathioprine; CSP, cyclosporine; DEXA, dexamethasone; MDS, myelodysplastic syndrome; P, prednisone; SIR, sirolimus; TAC, tacrolimus.† Milligrams, oral, 3 times daily.‡ Amount of saliva collected over a period of 6 minutes. Open table in a new tab The experience of these 3 patients confirms the potential benefit of cevimeline for treating cGVHD-associated xerostomia, and we recommend the standard approved dosage of 30 mg 3 times a day. Larger studies are warranted to confirm efficacy and safety in this population." @default.
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• W2018013333 title "Cevimeline Reduced Mouth Dryness and Increased Salivary Flow in Patients with Xerostomia Complicating Chronic Graft-versus-Host Disease" @default.
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