Kumagai Hozumi, Kusaba Hitoshi, Yamanaka Takeharu, Nio Kenta, Inadomi Kyoko, Takayoshi Kotoe, Ito Mamoru, Tamura Shingo, Makiyama Akitaka, Makiyama Chinatsu, Hirano Gen, Shibata Yoshihiro, Shirakawa Tsuyoshi, Mitsugi Kenji, Ariyama Hiroshi, Esaki Taito, Akashi Koichi, Baba Eishi
Department of Hematology, Oncology & Cardiovascular Medicine, Kyushu University Hospital, Maidashi, Higashi-ku Department of Medical Oncology, National Hospital Organization Kyushu Medical Center, Jigyohama, Chuo-ku, Fukuoka Department of Biostatistics, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Notame, Minami-ku, Fukuoka Department of Internal Medicine, Kyushu University Beppu Hospital, Tsurumibaru, Tsurumi, Beppu Department of Hematology and Oncology, Japan Community Health Care Organization Kyushu Hospital, Kishinoura, Yahatanishi-ku, Kitakyushu Department of Medical Oncology, Fukuoka Wajiro Hospital, Wajirogaoka, Higashi-ku Department of Medical Oncology, Hamanomachi Hospital, Nagahama, Chuo-ku Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University, Maidashi, Higashi-ku, Fukuoka, Japan.
Medicine (Baltimore). 2018 Jun;97(25):e11042. doi: 10.1097/MD.0000000000011042.
Combination therapy of fosaprepitant, dexamethasone (DEX) and a serotonin (5-HT3) receptor antagonist is a standard antiemetic prophylaxis for patients receiving highly emetogenic chemotherapy (HEC). However, the appropriate dose of DEX has not been established in Japan. This study determined the efficacy and safety of triplet antiemetic prophylaxis in Japanese patients receiving HEC when administered the same doses of DEX as those given in a previous international phase 3 study on this drug.
To assess the efficacy and safety of a sufficient dose of DEX (12 mg on day 1, 8 mg on day 2, 16 mg on days 3 and 4) in combination with intravenous fosaprepitant and granisetron, we prospectively examined patients receiving HEC including cisplatin (≥50 mg/m). The primary endpoint was to determine the percentage of patients who had achieved a complete response (CR), which was defined as no vomiting and no rescue therapy during the entire treatment course.
Between February 2013 and January 2015, 44 patients were enrolled with a median age of 65 years (range, 30-75). There were 34 males (77.3%) in the study. Most of the patients had upper gastrointestinal cancers. The CR rate during the treatment course was 70% (95% confidence interval [CI]: 55%-83%) in the overall phase and 91% (95% CI: 78%-97%) in the acute phase and 70% (95% CI: 55%-83%) in the delayed phase. Appreciable severe toxicities related to the antiemetic therapy were not observed.
These results suggest that a sufficient dose of DEX in combination with fosaprepitant and granisetron is optimal as an antiemetic prophylaxis for Japanese patients receiving HEC.
对于接受高致吐性化疗（HEC）的患者，磷丙泊酚二钠、地塞米松（DEX）和5-羟色胺（5-HT3）受体拮抗剂联合治疗是一种标准的止吐预防措施。然而，DEX在日本的合适剂量尚未确定。本研究确定了在日本接受HEC的患者中，给予与先前关于该药物的国际3期研究相同剂量的DEX时，三联止吐预防措施的疗效和安全性。
为了评估足量DEX（第1天12毫克，第2天8毫克，第3天和第4天16毫克）联合静脉注射磷丙泊酚二钠和格拉司琼的疗效和安全性，我们前瞻性地研究了接受包括顺铂（≥50毫克/平方米）在内的HEC的患者。主要终点是确定达到完全缓解（CR）的患者百分比，CR定义为在整个治疗过程中无呕吐且未进行救援治疗。
在2013年2月至2015年1月期间，纳入了44例患者，中位年龄为65岁（范围30-75岁）。研究中有34名男性（77.3%）。大多数患者患有上消化道癌症。在整个阶段，治疗过程中的CR率为70%（95%置信区间[CI]：55%-83%），急性期为91%（95%CI：78%-97%），延迟期为70%（95%CI：55%-83%）。未观察到与止吐治疗相关的明显严重毒性。
这些结果表明，足量DEX联合磷丙泊酚二钠和格拉司琼作为日本接受HEC患者的止吐预防措施是最佳的。
