Yang Liu-Qing, Sun Xin-Chen, Qin Shu-Kui, Chen Ying-Xia, Zhang He-Long, Cheng Ying, Chen Zhen-Dong, Shi Jian-Hua, Wu Qiong, Bai Yu-Xian, Han Bao-Hui, Liu Wei, Ouyang Xue-Nong, Liu Ji-Wei, Zhang Zhi-Hui, Li Yong-Qiang, Xu Jian-Ming, Yu Shi-Ying
Department of Clinical Medicine, Nanjing Medical University, Nanjing 211166, China; Department of Medical Oncology, Nanjing Bayi Hospital, Nanjing 210002, China.
Department of Clinical Medicine, Nanjing Medical University, Nanjing 211166, China; Department of Radiotherapy, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.
Chin Clin Oncol. 2016 Dec;5(6):79. doi: 10.21037/cco.2016.12.04.
The granisetron transdermal delivery system (GTDS) has been demonstrated effectiveness in the control of chemotherapy-induced nausea and vomiting (CINV) in previous studies. This is the first phase III study to evaluate the efficacy and tolerability of GTDS in patients receiving moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) in China.
A total of 313 patients were randomized into the GTDS group (one transdermal granisetron patch, 7 days) or the oral granisetron group (granisetron oral 2 mg/day, ≥2 days). The primary endpoint was the percentage of patients achieving complete control (CC) from chemotherapy initiation until 24 h after final administration (PEEP). Chi-square test and Fisher's exact test were used for statistical analysis.
Two hundred eighty-one patients were included in the per protocol analysis. During PEEP, CC was achieved by 67 (47.52%) patients in the GTDS group and 83 (59.29%) patients in the oral granisetron group. There was no statistical significance between the groups (P=0.0559). However, the difference of the CC percentage mainly occurred on the first day of chemotherapy between the groups. The CC was 70.13% on day 1 in the GTDS group, which was significantly lower than that of 91.03% in the oral granisetron group in the full analysis set. In the following days of chemotherapy, the CC was similar between the groups. In terms of cisplatin-contained regimen and female, there was statistical significance between the groups. Both treatments were well tolerated and safe. The most common adverse event was constipation.
GTDS provided effective and well-tolerated control of CINV in Chinese patients, especially to non-cisplatin-contained regimen.
在先前的研究中，格拉司琼透皮给药系统（GTDS）已被证明在控制化疗引起的恶心和呕吐（CINV）方面有效。这是在中国进行的第一项评估GTDS在接受中度致吐性化疗（MEC）或高度致吐性化疗（HEC）患者中的疗效和耐受性的III期研究。
总共313例患者被随机分为GTDS组（一片格拉司琼透皮贴剂，7天）或口服格拉司琼组（口服格拉司琼2mg/天，≥2天）。主要终点是从化疗开始至最后一次给药后24小时（PEEP）达到完全控制（CC）的患者百分比。采用卡方检验和Fisher精确检验进行统计分析。
符合方案分析纳入281例患者。在PEEP期间，GTDS组67例（47.52%）患者达到CC，口服格拉司琼组83例（59.29%）患者达到CC。两组之间无统计学意义（P=0.0559）。然而，CC百分比的差异主要发生在化疗的第一天。在全分析集中，GTDS组第1天的CC为70.13%，显著低于口服格拉司琼组的91.03%。在化疗的后续日子里，两组之间的CC相似。在含顺铂方案和女性方面，两组之间有统计学意义。两种治疗耐受性良好且安全。最常见的不良事件是便秘。
GTDS在中国患者中对CINV提供了有效且耐受性良好的控制，尤其是对不含顺铂的方案。
