Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Oral Oncol. 2014 Aug;50(8):765-9. doi: 10.1016/j.oraloncology.2014.06.001. Epub 2014 Jun 20.
We conducted a phase II multicenter study evaluating Caphosol in patients receiving head and neck radiation (H/N RT) +/- chemotherapy or biologic sensitizer.
MATERIALS/METHODS: The primary endpoint of the study tested the rate of functional mucositis (WHO grade > or equal to 2) with the hypothesis that <75% of patients would develop > or equal to 2 mucositis with Caphosol compared with a historical rate of >90%. New methods were applied with higher than historic rigor. 5 Institutions were included in this study: Moffitt Cancer Center (MCC), MD Anderson Cancer Center (MDACC), Duke University Cancer Center (DUCC), University of Florida (UF) and Temple University Cancer Center (TUCC). Caphosol was taken by patients at least 4 times a day and up to 10 times per day commencing with day 1 of RT and for a total duration of 8 weeks after completion of RT. Detailed questionnaires were completed weekly by patients and a unique algorithm was used to generate the WHO grade of mucositis.
98 Patients were enrolled in the study. 59/98 (60%) patients were evaluable for the primary endpoint giving us 80% power. All evaluable patients experienced WHO grade > or equal to 2 mucositis and the trial failed to reject the null hypothesis. > or equal to 2 mucositis rates at weeks 2, 4, 6, 11 and 15 were as follows: 45%, 90%, 98%, 71%, 50%.
We were unable to demonstrate that Caphosol significantly reduced WHO grade 2 or higher mucositis below a 90% historic rate. We are not surprised with this finding given our rigorous methodology in grading.
我们进行了一项 II 期多中心研究，评估 Caphosol 在接受头颈部放疗（H/N RT）+/-化疗或生物增敏剂的患者中的作用。
材料/方法：该研究的主要终点是功能性黏膜炎（WHO 分级≥2 级）的发生率，假设使用 Caphosol 的患者中≥2 级黏膜炎的发生率<75%，而历史发生率>90%。新方法的应用比历史数据更加严格。本研究纳入了 5 家机构：Moffitt 癌症中心（MCC）、MD 安德森癌症中心（MDACC）、杜克大学癌症中心（DUCC）、佛罗里达大学（UF）和天普大学癌症中心（TUCC）。Caphosol 于放疗第 1 天开始，每天至少服用 4 次，最多 10 次，持续 8 周。患者每周完成详细的问卷，使用独特的算法生成 WHO 分级的黏膜炎。
98 例患者入组本研究。98 例患者中有 59 例（60%）可评估主要终点，我们有 80%的效能。所有可评估患者均出现 WHO 分级≥2 级黏膜炎，试验未能拒绝无效假设。第 2、4、6、11 和 15 周时≥2 级黏膜炎的发生率如下：45%、90%、98%、71%、50%。
我们未能证明 Caphosol 能显著降低≥2 级黏膜炎的发生率，低于 90%的历史发生率。考虑到我们在分级方面严格的方法学，我们对这一发现并不感到惊讶。
