Department of Breast Oncology, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
Department of Head and Neck Surgery, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
Int J Clin Oncol. 2019 Oct;24(10):1320-1327. doi: 10.1007/s10147-019-01476-0. Epub 2019 Jun 1.
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.
依维莫司是一种哺乳动物雷帕霉素靶蛋白抑制剂，用于治疗多种肿瘤类型，其最常见的毒性是口腔炎，会影响患者的生活质量。最近在乳腺癌中的研究支持使用类固醇漱口液预防依维莫司相关口腔炎的疗效。然而，迄今为止仅有少数研究报道，且均未在其他肿瘤类型中进行过相关研究。
这项单臂 2 期研究旨在评估含类固醇漱口液预防接受依维莫司治疗的多种肿瘤类型患者口腔炎的疗效。主要结局是在使用含类固醇漱口液预防的情况下，8 周时依维莫司相关口腔炎的发生率达到 2 级或更高级别。我们还评估了含类固醇漱口液成分的稳定性。
共评估了 29 例患者，其中 76%患有乳腺癌，24%患有起源于肺、胃肠道、胰腺或来源不明的神经内分泌肿瘤。8 周时 2 级或更高级别的口腔炎发生率为 28.1%（90%CI 16.2-46.1）；置信上限超过了预设的 30%阈值。无患者发生 3 级或更高级别的口腔炎。大多数口腔炎发生在口腔后部，唇部或口腔底部未观察到病变。
我们的研究结果并不支持含类固醇漱口液对依维莫司相关口腔炎的预防作用。鉴于各种肿瘤类型预防依维莫司相关口腔炎的需求，因此需要进行更大规模的人群、采用随机对照试验设计的进一步研究来证实含类固醇漱口液的疗效。
