Download 2015 department of medicine research day

2015 DEPARTMENT OF MEDICINE RESEARCH DAY
Title of Poster: Prophylactic MuGard Mouth Wash to Prevent and Treat Stomatitis in
Patients Receiving Everolimus
Presenter: Parvin Peddi
Division: Hematology Oncology
☒Faculty ☐Fellow ☐Resident ☐Post-doc Research Fellow ☐Graduate Student ☐Medical Student ☐Other
Principal Investigator/Mentor: Parvin Peddi
Co-Investigators: Sara Hurvitz, Brad Adams, Diego Martinez
Thematic Poster Category: Clinical Observations and Clinical Trials
Abstract
Background: Everolimus combined with anti-estrogen therapy is a commonly used treatment for
metastatic hormone receptor positive breast cancer. While everolimus is generally well tolerated at the
dosage used (10mg daily), it has several well-known adverse effects. Of these effects, stomatitis
(mucositis) is the most common. In a large phase III trial of everolimus in patients with breast cancer,
stomatitis occurred in 56% of patients treated with combination of everolimus and exemestane, with
grade 3-4 in 8%. This study evaluates MuGard, a viscous polymer-based solution, as a prophylactic
measure to both prevent and treat everolimus induced mucositis.
Methods: This is an open-label phase II double-arm study, with half the patients randomized to
standard of care, which is no prophylactic measure, and the other half to prophylactic MuGard 4 times
a day started at time of everolimus therapy initiation. Patient population is women with metastatic or
locally recurrent unresectable breast cancer that is hormone receptor positive. They will be
concomitantly treated with everolimus and endocrine therapy.
Results: Study is currently ongoing. As of August 2015, 22 patients have been enrolled on the study,
with 11 in each arm. Primary objective is whether use of MuGard in participants being treated with
everolimus will reduce the rate of stomatitis. Secondary objectives are to compare symptoms from
mouth sores in patients receiving MuGard with those receiving best supportive care and to evaluate
the rate of everolimus dose adjustment or therapy discontinuation as a result of stomatitis in
participants treated with MuGard prophylaxis versus best supportive care. A total of 66 patients will be
needed for the study.