A single-arm, phase 2 study of steroid-containing mouthwash for the prevention of everolimus-associated stomatitis in multiple tumor types
| Autor: | Masaya Hattori, Masahiko Tachi, Masashi Andoh, Yasunari Mizuno, Kenichi Yoshimura, Hiroji Iwata, Sumitaka Hagiwara, Susumu Hijioka, Haruru Kotani, Naomi Gondo, Junichi Shimizu, Michiko Tatematsu, Yayoi Adachi, Akiyo Yoshimura, Masataka Sawaki |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Population Mouthwashes Phases of clinical research Neuroendocrine tumors Gastroenterology law.invention 03 medical and health sciences 0302 clinical medicine Breast cancer stomatognathic system Randomized controlled trial law Internal medicine Neoplasms Antineoplastic Combined Chemotherapy Protocols medicine Humans Everolimus Prospective Studies education Stomatitis Aged education.field_of_study business.industry Incidence (epidemiology) Hematology General Medicine Middle Aged medicine.disease Prognosis Androstadienes 030104 developmental biology Oncology 030220 oncology & carcinogenesis Quality of Life Surgery Female Steroids business medicine.drug |
| Zdroj: | International journal of clinical oncology. 24(10) |
| ISSN: | 1437-7772 |
| Popis: | Everolimus is a mammalian target of rapamycin inhibitor used in the treatment of multiple tumor types, and its most common toxicity, stomatitis, can affect patient quality of life. Recent studies in breast cancer have supported the efficacy of steroid mouthwash for the prevention of everolimus-associated stomatitis. However, a few studies have been reported to date, and none have examined this effect in other tumor types. This single-arm phase 2 study was designed to evaluate the efficacy of steroid-containing mouthwash for the prevention of stomatitis in patients with multiple tumor types receiving everolimus. The primary outcome was incidence of grade ≥ 2 stomatitis at 8 weeks of everolimus with steroid-containing mouthwash prophylaxis. We also assessed the stability of steroid-containing mouthwash components. Twenty-nine patients were evaluated, of which 76% had breast cancer and 24% had neuroendocrine tumors originating in the lung, gastrointestinal tract, pancreas, or of unknown primary origin. Grade ≥ 2 stomatitis incidence at 8 weeks was 28.1% (90% CI 16.2–46.1); the higher confidence limit exceeded the prespecified threshold of 30%. No patients developed grade ≥ 3 stomatitis. Most stomatitis occurred behind the oral cavity, with no lesions observed on the lips or floor of the mouth. Our findings did not support a prophylactic effect of steroid-containing mouthwash on everolimus-associated stomatitis. Given the needs of prevention of everolimus-associated stomatitis in various tumor types, further studies in a larger population using a randomized controlled trial design are, therefore, required to confirm the efficacy of steroid-containing mouthwash. |
| Databáze: | OpenAIRE |
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