Kim, J.E., Hong, Y.S., Lee, J.L., Kim, K.P., Park, S.J., Sym, S.J., . . . Kim, T.W. (2015). 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. Supportive Care in Cancer, 23, 1769–1677.

To determine the efficacy (as measured by complete response [CR]) of the granisetron transdermal system (GTS) compared to IV and oral granisetron in managing chemotherapy-induced nausea and vomiting (CINV) in Korean patients receiving moderately emetogenic chemotherapy (MEC)

Adult patients with cancer (aged 20 years or greater) assigned to receive the first cycle of a MEC regimen (according to National Comprehensive Cancer Network guidelines) in three hospitals in Korea were eligible to participate. Patients were randomly assigned to receive either GTS or IV/PO granisetron. In the GTS group, patches were applied 24–48 hours prior to chemotherapy and left in place for four days. In the control group, patients received 3 mg IV granisetron day 1 and 1 mg of oral granisetron every 12 hours on days 2 and 3. All patients received 10 mg of IV decadron on day 1. Patients recorded daily in diaries and rated nausea and vomiting on four- and five-point scales. Quality of life was assessed using the Functional Living Index-Emesis (FLI-E). The primary endpoint was the percentage of patients achieving complete response from beginning of chemotherapy until after the final administration from the PPS group.

• N = 263
• MEDIAN AGE = 56 years
• MALES: 62.4%, FEMALES: 37.6%
• KEY DISEASE CHARACTERISTICS: 97.9% had gastrointestinal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group score ≤ 2; life expectancy of ≥ 3 months; receiving a three-day course of MEC; 77% receiving either FOLFOX or FOLFIRI; exclusion criteria included all other sources of nausea and vomiting including opioids for pain

• SITE: Multi-site    
• SETTING TYPE: Multiple settings  
• LOCATION: Three hospitals in South Korea

• PHASE OF CARE: Active antitumor treatment

Randomized, active controlled, open-label, prospective, multicenter trial

The primary efficacy endpoint was CR for the entire regimen, and the secondary endpoint was daily complete response. Patients kept daily diaries, and the Functional Living Index-Emesis (FLI-E) was used to measure patient satisfaction. Efficacy was assessed using a noninferiority model with a noninferiority margin of 15% as determined by a previous comparison research of serotonin antagonists.

GTS showed noninferior efficacy to intravenous and oral granisetron. The safety, tolerability, and FLI-E scores of the GTS were comparable to those of the control group. GTS offers a convenient alternative option for relieving CINV in patients receiving MEC.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Findings not generalizable

Because the results of this trial suggest GTS is no-inferior to IV or oral granisetron it offers a convenient alternative for relieving CINV in patients receiving MEC. GTS should be considered for patients with gastrointestinal malignancies who are at an even greater risk of having issues with nausea, abdominal pain, or malabsorption, especially male patients.