Takeshima Nobuhiro, Matoda Maki, Abe Masakazu, Hirashima Yasuyuki, Kai Kentaro, Nasu Kaei, Takano Masashi, Furuya Kenichi, Sato Seiya, Itamochi Hiroaki, Tsubamoto Hiroshi, Hasegawa Kosei, Terao Kiminari, Otsuki Takeo, Kuritani Keiko, Ito Kimihiko
Department of Gynecology, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan,
Support Care Cancer. 2014 Nov;22(11):2891-8. doi: 10.1007/s00520-014-2280-6. Epub 2014 May 14.
Prevention of chemotherapy-induced nausea and vomiting (CINV) is crucial for maintaining the quality of life of cancer patients. Female patients have been underrepresented in previous clinical studies of aprepitant or palonosetron. We performed a prospective multicenter study to investigate the efficacy and safety of triple therapy comprising these two agents and dexamethasone in female cancer patients receiving chemotherapy that included cisplatin (≥ 50 mg/m(2)).
Aprepitant was administered at a dose of 125 mg before chemotherapy on day 1 and at 80 mg on days 2 and 3. Palonosetron (0.75 mg) was given before chemotherapy on day 1. Dexamethasone was administered at a dose of 9.9 mg before chemotherapy on day 1 and at 6.6 mg on days 2-4. The primary endpoint was the the proportion of patients with a complete response (CR no vomiting and no use of rescue medication) throughout the overall period (0-120 h post-chemotherapy).
Ninety-six women (median age 55 years) were enrolled. The overall CR rate was 54.2 %. CR was obtained during the acute phase (0-24 h post-chemotherapy) and the delayed phase (24-120 h post-chemotherapy) in 87.5 and 56.3 % of the patients, respectively. The most common adverse reactions were constipation and fatigue (reported by three patients each).
Exhibition of a favorable overall CR rate over existing two-drug combinations suggests that the triple therapy regimen used in the present study is effective and tolerable in patients with gynecological malignancies receiving cisplatin-based chemotherapy. Female patients may have a higher risk of developing CINV.
预防化疗引起的恶心和呕吐（CINV）对于维持癌症患者的生活质量至关重要。在以往关于阿瑞匹坦或帕洛诺司琼的临床研究中，女性患者的代表性不足。我们进行了一项前瞻性多中心研究，以调查这两种药物与地塞米松组成的三联疗法在接受含顺铂（≥50mg/m²）化疗的女性癌症患者中的疗效和安全性。
阿瑞匹坦在化疗前第1天给予125mg剂量，第2天和第3天给予80mg剂量。帕洛诺司琼（0.75mg）在化疗前第1天给予。地塞米松在化疗前第1天给予9.9mg剂量，第2 - 4天给予6.6mg剂量。主要终点是整个观察期（化疗后0 - 120小时）内完全缓解（CR，无呕吐且未使用解救药物）的患者比例。
96名女性（中位年龄55岁）入组。总体CR率为54.2%。分别有87.5%和56.3%的患者在急性期（化疗后0 - 24小时）和延迟期（化疗后24 - 120小时）获得CR。最常见的不良反应是便秘和疲劳（各有3名患者报告）。
与现有的两药联合方案相比，总体CR率良好，表明本研究中使用的三联疗法方案在接受以顺铂为基础化疗的妇科恶性肿瘤患者中有效且耐受性良好。女性患者发生CINV的风险可能更高。
