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

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

doi:10.1016/j.ijrobp.2007.05.024

Cited by 43 publications

(26 citation statements)

References 30 publications

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“…79,104,105 Cevimeline is a selective M3 muscarinic receptor acetylcholine analog that when administered orally at a dose of 30 mg given 3 times daily has been shown to increase nonstimulated salivary flow. 106,107 Both pilocarpine and cevimeline are contraindicated in patients with uncontrolled asthma, narrow angle glaucoma, and acute iritis, and caution should be taken in patients with gallbladder disease. 85 Bethanechol (25 mg, given 3 times a day) is a cholinergic stimulant that has been studied for salivary stimulation.…”

Section: Palliation and Supportive Care For Patients With Xerostomiamentioning

confidence: 99%

Oral complications of cancer and cancer therapy

Epstein

Thariat

Bensadoun

et al. 2012

CA A Cancer J Clinicians

411

356

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Answer questions and earn CME/CNEOral complications resulting from cancer and cancer therapies cause acute and late toxicities that may be underreported, underrecognized, and undertreated. Recent advances in cancer treatment have led to changes in the incidence, nature, and severity of oral complications. As the number of survivors increases, it is becoming increasingly recognized that the aggressive management of oral toxicities is needed to ensure optimal long‐term oral health and general well‐being. Advances in care have had an impact on previously recognized oral complications and are leading to newly recognized adverse effects. Here, the authors briefly review advances in cancer therapy, including recent advances in surgery, oral care, radiation therapy, hematopoietic cell transplantation, and medical oncology; describe how these advances affect oral health; and discuss the frequent and/or severe oral health complications associated with cancer and cancer treatment and their effect upon long‐term health. Although some of the acute oral toxicities of cancer therapies may be reduced, they remain essentially unavoidable. The significant impact of long‐term complications requires increased awareness and recognition to promote prevention and appropriate intervention. It is therefore important for the primary oncologist to be aware of these complications so that appropriate measures can be implemented in a timely manner. Prevention and management is best provided via multidisciplinary health care teams, which must be integrated and communicate effectively in order to provide the best patient care in a coordinated manner at the appropriate time. CA Cancer J Clin 2012. © 2012 American Cancer Society.

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Section: Palliation and Supportive Care For Patients With Xerostomiamentioning

confidence: 99%

Oral complications of cancer and cancer therapy

Epstein

Thariat

Bensadoun

et al. 2012

CA A Cancer J Clinicians

411

356

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“…This review includes two large studies concerning the use of cevimeline HCl in the treatment of post-radiation xerostomia in patients with head and neck cancer; one open label study and a randomized controlled trial [123,124]. In these studies, cevimeline HCl was generally well tolerated and oral administration of 30-45 mg three times daily for 52 weeks improved xerostomia (response rate 59% at the final visit) [124] and significantly increased unstimulated, but not stimulated, whole salivary flow rate [123]. About 70% experienced adverse effects, and most of them were mild to moderate [123].…”

Section: Cevimeline and Bethanecholmentioning

confidence: 99%

A systematic review of salivary gland hypofunction and xerostomia induced by cancer therapies: management strategies and economic impact

Jensen

Pedersen

Vissink

et al. 2010

Support Care Cancer

226

180

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There is evidence that salivary gland hypofunction and xerostomia induced by cancer therapies can be prevented or symptoms be minimized to some degree, depending on the type of cancer treatment. Management guideline recommendations are provided for IMRT, amifostine, muscarinic agonist stimulation, oral mucosal lubricants, acupuncture, and submandibular gland transfer. Fields of sparse literature identified included effects of gustatory and masticatory stimulation, specific oral mucosal lubricant formulas, submandibular gland transfer, acupuncture, hyperbaric oxygen treatment, management strategies in pediatric cancer populations, and the economic consequences of salivary gland hypofunction and xerostomia.

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“…The comorbidity associated with xerostomia severely limits patients' well-being and their prospect of continuing cancer treatment (Epstein et al, 2001;Bruce, 2004). Palliative relief of symptoms with artificial salivary substitutes and the use of prosecretory drugs, such as pilocarpine and cevimeline, have had limited success in treating xerostomia (Chambers et al, 2007b;Berk, 2008). The incorporation of salivary glandsparing radiation techniques and the use of radioprotective drug, Amifostine, have, to some measure, diminished the severity of xerostomia (Rudat et al, 2008), but the chronic functional deterioration of the gland remains a major concern.…”

Section: Introductionmentioning

confidence: 99%

Recombinant AAV9-TLK1B Administration Ameliorates Fractionated Radiation-Induced Xerostomia

Shanmugam

Dayton²,

Palaniyandi³

et al. 2013

Human Gene Therapy

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Salivary glands are highly susceptible to radiation, and patients with head and neck cancer treated with radiotherapy invariably suffer from its distressing side effect, salivary hypofunction. The reduction in saliva disrupts oral functions, and significantly impairs oral health. Previously, we demonstrated that adenoviralmediated expression of Tousled-like kinase 1B (TLK1B) in rat submandibular glands preserves salivary function after single-dose ionizing radiation. To achieve long-term transgene expression for protection of salivary gland function against fractionated radiation, this study examines the usefulness of recombinant adeno-associated viral vector for TLK1B delivery. Lactated Ringers or AAV2/9 with either TLK1B or GFP expression cassette were retroductally delivered to rat submandibular salivary glands (10 11 vg/gland), and animals were exposed, or not, to 20 Gy in eight fractions of 2.5 Gy/day. AAV2/9 transduced predominantly the ductal cells, including the convoluted granular tubules of the submandibular glands. Transgene expression after virus delivery could be detected within 5 weeks, and stable gene expression was observed till the end of study. Pilocarpine-stimulated saliva output measured at 8 weeks after completion of radiation demonstrated >10-fold reduction in salivary flow in saline-and AAV2/9-GFP-treated animals compared with the respective nonirradiated groups (90.8% and 92.5% reduction in salivary flow, respectively). Importantly, there was no decrease in stimulated salivary output after irradiation in animals that were pretreated with AAV2/9-TLK1B (121.5% increase in salivary flow; p < 0.01). Salivary gland histology was better preserved after irradiation in TLK1B-treated group, though not significantly, compared with control groups. Single preemptive delivery of AAV2/9-TLK1B averts salivary dysfunction resulting from fractionated radiation. Although AAV2/9 transduces mostly the ductal cells of the gland, their protection against radiation assists in preserving submandibular gland function. AAV2/9-TLK1B treatment could prove beneficial in attenuating xerostomia in patients with head and neck cancer undergoing radiotherapy.

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

Cited by 43 publications

References 30 publications

Oral complications of cancer and cancer therapy

Oral complications of cancer and cancer therapy

A systematic review of salivary gland hypofunction and xerostomia induced by cancer therapies: management strategies and economic impact

Recombinant AAV9-TLK1B Administration Ameliorates Fractionated Radiation-Induced Xerostomia

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