Stomatitis Prophylaxis During Everolimus (Afinitor®) Therapy

Written by: Matthew Schulz, RPh Rocky Mountain Cancer Centers
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Description of PQI: The purpose of this PQI is to identify patients initiating everolimus therapy and could benefit from stomatitis prophylaxis with a steroid mouthwash.

Background: Stomatitis is a significant complication associated with mTOR inhibition. In BOLERO-2 patients receiving everolimus/exemestane (EVE/EXE), all grade stomatitis was 67%; 33% Grade 2 and 8% Grade 3. The median time to Grade 2 or worse onset was 15.5 days. The incidence of new stomatitis (Grade ≥ 2) plateaued at 6 weeks. In a meta-analysis, 89% of first stomatitis events occurred within 8 weeks. Topical steroids are used to treat aphthous ulcers; anecdotal use of topical steroid prophylaxis has been reported. A trial entitled SWISH revealed prophylactic use of 0.5 mg/5 mL dexamethasone oral solution markedly decreased the incidence and severity of stomatitis in patients receiving EVE/EXE for metastatic breast cancer and should be considered a new standard of care in this setting.

PQI process: Upon receipt of a new prescription for everolimus:

  • Identify if the patient may be a candidate for steroid rinse
  • Contact the oncologist to obtain a prescription for mouthwash:
    • Dexamethasone 0.5mg/5ml solution – swish 10ml for 2 minutes and spit out QID for initial 8 weeks *Do not eat or drink for 1 hour post mouth rinse*
  • Follow up within 7 days of starting everolimus/steroid mouth rinse

Patient Centered Activities:

  • Provide Oral Chemotherapy Education (OCE) sheet
  • Encourage patients to use rinse on a scheduled regimen, four times per day
  • Brush teeth with soft or extra soft tooth brush
  • Advise patients to immediately report any signs or symptoms of mouth sore

Supplemental Information:





Stomatitis Grade (%)
BOLERO-2 (total)67342580
SWISH (at 8 weeks)19.817.42.400


  1. Rugo, HS, Seneviratne, L, Beck JT, et. Al. Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): a single-arm, phase 2 trial. The Lancet Oncology. Vol 18, Issue 5; 654-662, May 01, 2017 https://doi.org/10.1016/S1470-2045(17)30109-2.
  2. Baselga J, et Al. Everolimus in Postmenopausal Hormone-Receptor-Positive Advanced Breast Cancer (BOLERO-2). The New England Journal of Medicine. Vol 366, No 6; 520-529. February 9, 2012. https://www.nejm.org/doi/full/10.1056/nejmoa1109653.
Important notice: National Community Oncology Dispensing Association, Inc. (NCODA), has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional. This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented. NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.

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