In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 26_suppl ( 2016-10-09), p. 189-189
Abstract:
189 Background: Stomatitis is a frequent adverse event (AE) associated with mTOR inhibition. In BOLERO-2 patients (pts) receiving EVE/EXE, all grade (Gr) stomatitis was 67%; 33% had Gr ≥ 2 and 8% Gr 3. Median time to ≥ Gr 2 onset was 15.5 days; incidence of new stomatitis (Gr ≥ 2) plateaued at 6 wks. In a meta-analysis, 89% of first stomatitis events occurred within 8 wks. Topical steroids are used to treat aphthous ulcers; anecdotal use as prophylaxis has been reported. Methods: Eligibility included PM women with HR+ MBC prescribed EVE/EXE. Treatment included EVE 10 mg and EXE 25 mg QD, with 10 mL of commercially available 0.5 mg/5 mL dexamethasone oral solution to swish x 2 min and spit QID for 8 wks starting day 1. Pts completed a daily adherence log, including an oral pain (range 0-10) and normalcy of diet score. The primary endpoint was to compare the incidence of Gr ≥ 2 stomatitis at 8 wks with BOLERO-2 results. Secondary endpoints included MW use by average times/day, EVE/EXE dose intensity, incidence of all Gr stomatitis and time to resolution to Gr ≤ 1. Results: 92 women were enrolled; 86 were evaluable for efficacy. Median age was 61 yrs (range 34-87); median dose intensity was 10 (range 3-10) and 25 mg (range 8-25) for EVE and EXE, respectively. 95% of pts used the MW 3-4 times/day (median MW use/day = 3.95, range 1.9-4). At 8 wks, the rate of ≥ Gr 2 stomatitis was 2.4% (2 pts) with a Gr 1 rate of 18.8%. A comparison of stomatitis incidence by grade between BOLERO-2 and SWISH is shown in the table. In the 75 patients with complete ECOG scores, 88% maintained/improved ECOG status. Mean pain scale score was 〈 1 at all visits; 88% of pts reported a normal diet at 8 wks. 13% discontinued EVE/EXE due to suspected related AEs (most common: rash, 2%; hyperglycemia, 2%; stomatitis, 2%; and pneumonitis, 1%). Conclusions: Prophylactic use of 0.5 mg/5 mL dexamethasone oral solution markedly decreases the incidence and severity of stomatitis in patients receiving EVE/EXE for MBC and should be considered a new standard of oral care in this setting. Clinical trial information: NCT02069093. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2016.34.26_suppl.189
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2016
detail.hit.zdb_id:
2005181-5
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