title: 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.
abstract: 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.
authors.affiliation: Department of Clinical Medicine, Nanjing Medical University, Nanjing 211166, China; Department of Medical Oncology, Nanjing Bayi Hospital, Nanjing 210002, China.
authors.forename: Liu-Qing
authors.initials: LQ
authors.lastname: Yang
authors.affiliation: Department of Clinical Medicine, Nanjing Medical University, Nanjing 211166, China; Department of Radiotherapy, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China. qinsk@csco.org.cn.
authors.forename: Xin-Chen
authors.initials: XC
authors.lastname: Sun
authors.affiliation: Department of Medical Oncology, Nanjing Bayi Hospital, Nanjing 210002, China.
authors.forename: Shu-Kui
authors.initials: SK
authors.lastname: Qin
authors.affiliation: Department of Medical Oncology, Nanjing Bayi Hospital, Nanjing 210002, China.
authors.forename: Ying-Xia
authors.initials: YX
authors.lastname: Chen
authors.affiliation: Department of Medical Oncology, Tangdu Hospital, Xi'an 710038, China.
authors.forename: He-Long
authors.initials: HL
authors.lastname: Zhang
authors.affiliation: Department of Medical Oncology, Jilin Cancer Hospital, Changchun 130012, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Cheng
authors.affiliation: Department of Medical Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, China.
authors.forename: Zhen-Dong
authors.initials: ZD
authors.lastname: Chen
authors.affiliation: Department of Medical Oncology, Linyi Cancer Hospital, Linyi 276002, China.
authors.forename: Jian-Hua
authors.initials: JH
authors.lastname: Shi
authors.affiliation: Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233099, China.
authors.forename: Qiong
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Department of Medical Oncology, Heilongjiang Province Cancer Hospital, Ha'er'bin 150081, China.
authors.forename: Yu-Xian
authors.initials: YX
authors.lastname: Bai
authors.affiliation: Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai 200030, China.
authors.forename: Bao-Hui
authors.initials: BH
authors.lastname: Han
authors.affiliation: Department of Medical Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Liu
authors.affiliation: Department of Medical Oncology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou 350025, China.
authors.forename: Xue-Nong
authors.initials: XN
authors.lastname: Ouyang
authors.affiliation: Department of Medical Oncology, The First Hospital of Dalian Medical University, Dalian 116011, China.
authors.forename: Ji-Wei
authors.initials: JW
authors.lastname: Liu
authors.affiliation: Department of Medical Oncology, Sichuan Province Cancer Hospital, Chengdu 610042, China.
authors.forename: Zhi-Hui
authors.initials: ZH
authors.lastname: Zhang
authors.affiliation: Department of Medical Oncology, The Cancer Hospital of Guangxi Medical University, Nanning 530021, China.
authors.forename: Yong-Qiang
authors.initials: YQ
authors.lastname: Li
authors.affiliation: Department of Medical Oncology, The 307th Hospital of PLA, Beijing 100071, China.
authors.forename: Jian-Ming
authors.initials: JM
authors.lastname: Xu
authors.affiliation: Department of Medical Oncology, Wuhan Tongji Hospital, Wuhan 430012, China.
authors.forename: Shi-Ying
authors.initials: SY
authors.lastname: Yu
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D017829:Granisetron / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000188:drug therapy / Q000517:prevention & control*; D014839:Vomiting / Q000188:drug therapy / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D017829:Granisetron
keywords: Chemotherapy; granisetron transdermal delivery system; nausea; vomiting