title: A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients.
abstract: BACKGROUND
  The granisetron transdermal system (GTS) showed non-inferior efficacy to oral granisetron to control chemotherapy-induced nausea and vomiting (CINV) during multiday chemotherapy. We compared the efficacy and safety of GTS with that of intravenous and oral granisetron in Korean patients receiving moderately emetogenic chemotherapy (MEC).
  
  
  METHODS
  A total of 276 patients were randomized into GTS (n = 139, one patch on days 1-4) or control group (n = 137, intravenous on day 1 and oral on days 2-4). The primary endpoint was the percentage of patients achieving complete response (CR) from chemotherapy initiation until 24 h after the final administration.
  
  
  RESULTS
  Out of 234 patients (112 in GTS and 122 in control group) included in the per protocol analysis, 97.9 % had gastrointestinal cancer and 76.9 % received 3-day chemotherapy. The GTS showed non-inferior efficacy achieving CR in 75.0 % of the patients; 74.6 % of the patients in the control group achieved CR (95 % confidence interval -10.73 to 11.55 %). The CR rate did not change after subgroup analyses by sex, age, and chemotherapy naivety and analysis per day and overall days of treatment. The GTS group showed sustained CR from day 1 to day 4. Patients' satisfaction, assessed using Functional Living Index-Emesis (FLI-E), showed no difference. Both treatments were well tolerated and safe.
  
  
  CONCLUSIONS
  The GTS showed non-inferior efficacy to intravenous and oral granisetron. The safety, tolerability, and FLI-E scores of the GTS were comparable to those of control group. The GTS offers a convenient alternative option for relieving CINV in patients receiving MEC.
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil Songpa-gu, Seoul, 138-736, South Korea.
authors.forename: Jeong Eun
authors.initials: JE
authors.lastname: Kim
authors.forename: Yong Sang
authors.initials: YS
authors.lastname: Hong
authors.forename: Jae-Lyun
authors.initials: JL
authors.lastname: Lee
authors.forename: Kyu-Pyo
authors.initials: KP
authors.lastname: Kim
authors.forename: Seong Joon
authors.initials: SJ
authors.lastname: Park
authors.forename: Sun Jin
authors.initials: SJ
authors.lastname: Sym
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Ahn
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Kim
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D017829:Granisetron / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D009369:Neoplasms / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012074:Remission Induction; D056910:Republic of Korea; D012449:Safety; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D002166:Camptothecin; D002945:Cisplatin; D005472:Fluorouracil; D017829:Granisetron; D002955:Leucovorin; D009944:Organoplatinum Compounds