No stomatitis occurred in 78.8% of the SWISH population, compared with 38.8% of the BOLERO-2 patients, Dr. 2 No patients using the mouthwash developed grade 3 or 4 stomatitis, whereas in BOLERO-2, grade 3 stomatitis occurred in 7.3%.
#SWISH AND SPIT TRIAL#
In patients who used the mouthwash, the incidence of grade ≥ 2 stomatitis by 8 weeks was 2.4%, compared with 27.4% in the BOLERO-2 trial and 33% over the entire BOLERO-2 study duration ( P <. In the study, 95% of patients used the mouthwash as instructed, and 70% continued it for 8 weeks or longer. At the completion of cycle 2 (day 56), patients could continue the mouthwash regimen for an additional 56 days, if desired. In the open-label phase II SWISH trial, 92 patients were instructed to use the mouthwash (10 mL containing 0.5 mg/5 mL of dexamethasone) to swish for 2 minutes, then spit, four times a day for 8 weeks. “Because mTOR stomatitis looks like aphthous ulcers, we sought to explore whether a steroid-based mouthwash would prevent this toxicity,” she explained. Rugo has been using the dental paste to treat the stomatitis that sometimes occurs with other drugs, such as palbociclib (Ibrance), she said. These ulcers often respond to steroid dental paste (topical triamcinolone). The basis for evaluating the dexamethasone mouthwash is the efficacy observed for topical steroids in idiopathic aphthous ulcers (ie, small shallow lesions on mucous membranes). A total of 33% were grade ≥ 2, and 8% were grade 3. Stomatitis is a frequent adverse event associated with mTOR (mammalian target of rapamycin) inhibition, observed in 67% of patients in the BOLERO-2 trial. 3 (For more on this presentation, see the August 10 issue of The ASCO Post.) At the Palliative Care in Oncology Symposium, she focused on the 8-week outcomes by 8 weeks, 89% of BOLERO-2 patients with stomatitis had experienced a first event. Rugo presented the main results of the SWISH trial, with outcomes spanning the duration of the study. 2Īt the 2016 Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology International Symposium on Supportive Care in Cancer in Adelaide, Australia, Dr.
1 The comparator was historical data from the BOLERO-2 trial. The SWISH trial sought to evaluate an alcohol-free, steroid mouthwash to prevent grade ≥ 2 stomatitis in patients with HER2-positive advanced breast cancer receiving everolimus/exemestane. Rugo said at the 2016 Palliative Care in Oncology Symposium. “This should be considered a new standard of oral care in this setting,” Dr. Rugo, MD, principal investigator of the SWISH trial and Director of Breast Oncology and Clinical Trials Education at the University of California Helen Diller Family Comprehensive Cancer Center, San Francisco. Dexamethasone mouth rinse should be given prophylactically to prevent stomatitis associated with everolimus (Afinitor)/exemestane in metastatic breast cancer, according to Hope S.
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