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Transdermal granisetron for the prevention of nausea and vomiting following moderately or highly emetogenic chemotherapy in Chinese patients: a randomized, double-blind, phase III study

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单位: [1]Nanjing Med Univ, Dept Clin Med, Nanjing 211166, Jiangsu, Peoples R China [2]Nanjing Bayi Hosp, Dept Med Oncol, Nanjing 210002, Jiangsu, Peoples R China [3]Nanjing Med Univ, Dept Radiotherapy, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China [4]Tangdu Hosp, Dept Med Oncol, Xian 710038, Peoples R China [5]Jilin Canc Hosp, Dept Med Oncol, Changchun 130012, Peoples R China [6]Anhui Med Univ, Dept Med Oncol, Affiliated Hosp 2, Hefei 230601, Peoples R China [7]Linyi Canc Hosp, Dept Med Oncol, Linyi 276002, Peoples R China [8]Bengbu Med Coll, Dept Med Oncol, Affiliated Hosp 1, Bengbu 233099, Peoples R China [9]Heilongjiang Prov Canc Hosp, Dept Med Oncol, Haerbin 150081, Peoples R China [10]Shanghai Chest Hosp, Dept Resp Med, Shanghai 200030, Peoples R China [11]Hebei Med Univ, Dept Med Oncol, Hosp 4, Shijiazhuang 050011, Peoples R China [12]Nanjing Mil Command, Dept Med Oncol, Fuzhou Gen Hosp, Fuzhou 350025, Peoples R China [13]Dalian Med Univ, Dept Med Oncol, Hosp 1, Dalian 116011, Peoples R China [14]Sichuan Prov Canc Hosp, Dept Med Oncol, Chengdu 610042, Peoples R China [15]Guangxi Med Univ, Dept Med Oncol, Canc Hosp, Nanning 530021, Peoples R China [16]PLA, Dept Med Oncol, Hosp 307, Beijing 100071, Peoples R China [17]Wuhan Tongji Hosp, Dept Med Oncol, Wuhan 430012, Peoples R China [18]300 Guangzhou St, Nanjing 210029, Jiangsu, Peoples R China [19]34,34 Biao,Yanggongjing St, Nanjing 210002, Jiangsu, Peoples R China
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关键词: Chemotherapy granisetron transdermal delivery system nausea vomiting

摘要:
Background: 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. Methods: 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. Results: 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. Conclusions: GTDS provided effective and well-tolerated control of CINV in Chinese patients, especially to non-cisplatin-contained regimen.

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大类 | 4 区 医学
小类 | 4 区 肿瘤学
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Q3 ONCOLOGY

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第一作者单位: [1]Nanjing Med Univ, Dept Clin Med, Nanjing 211166, Jiangsu, Peoples R China [2]Nanjing Bayi Hosp, Dept Med Oncol, Nanjing 210002, Jiangsu, Peoples R China
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通讯机构: [1]Nanjing Med Univ, Dept Clin Med, Nanjing 211166, Jiangsu, Peoples R China [3]Nanjing Med Univ, Dept Radiotherapy, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
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