Granisetron is in a class of drugs known as serotonin 5-HT3 receptor antagonists. It works by blocking serotonin activity in the chemoreceptor trigger zone. Granisetron is taken by mouth as a tablet or solution to prevent CINV.
Granisetron may also be administered as a transdermal patch, which is a newer formulation of the drug.
Recommended for Practice
Research Evidence Summaries
Boccia, R.V., Gordan, L.N., Clark, G., Howell, J.D., & Grunberg, S.M. (2010). Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: A randomized, double-blind, phase III study. Supportive Care in Cancer, 19, 1609–1617.doi: 10.1007/s00520-010-0990-y
To compare the efficacy and tolerability of the granisetron transdermal delivery system (GTDS) to daily oral granisetron for the control of chemotherapy-induced nausea and vomiting (CINV)
Intervention Characteristics/Basic Study Process:
Patients were randomized to oral (2 mg per day for 3–5 days) or transdermal (one GTDS patch over 7 days) granisetron before receiving multiday chemotherapy. Patients received placebo capsules or capsules according to group assignment. Corticosteroids and rescue medications were given at the discretion of the investigator. Patients were followed for 14 days after chemotherapy.
- The study consisted of 582 participants.
- The mean age of participants in the GTDS group was 54 years (SD = 13 years). The mean age of participants in the oral granisetron group was 55 years (SD = 14 years).
- In the GTDS group, 52% of patients were female and 48% were male. In the oral granisetron group, 51% were female and 49% were male.
- Diagnoses were not provided.
- Patients were receiving the first cycle of a new multiday moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimen.
The study was conducted at multiple sites in Europe, the United States, Mexico, and India.
This was a randomized, double-blind, controlled trial.
Patients recorded the following in diaries daily.
- Vomiting, presence and severity, on a five-point scale ranging from 1 = none and 5 = very severe.
- Nausea, presence and severity, on a four-point scale ranging from 1 = none and 4 = severe.
Complete control (CC) was defined as no vomiting or retching, no more than mild nausea, and no use of rescue medication from the first administration until 24 hours after the last administration of chemotherapy.
- GTDS was not inferior to oral granisetron in CC.
- The percentage of patients achieving complete response (CR) or total control (TC) was not significantly different.
- Time to failure and time to treatment CC failure were similar.
- In patients receiving three- and five-day chemotherapy regimens, CC and CR were similar between the GTDS and oral granisetron groups.
- The GTDS group reported more constipation, and the oral granisetron group reported more headaches.
- In the experimental group, 65% of patients achieved CR with oral graniestron, and, in the control group, 60% of patients achieved CR with oral granisetron.
The GTDS provided effective, well-tolerated control of CINV associated with moderately or highly emetogenic, multiday chemotherapy.
- Diagnoses were not reported.
- No information was provided or subgroup analysis done on the use of dexamethasone or rescue medications.
- No differentiation or analysis was provided regarding acute versus delayed nausea or between those receiving MEC or HEC.
- No neurokinin 1 (NK1) receptor antagonists were used.
GTDS could be an option for CINV from multiday chemotherapy regimens. Further research to determine the role of this approach within an overall antiemetic regimen is warranted.
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.doi: 10.1007/s00520-014-2507-6
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)
Intervention Characteristics/Basic Study Process:
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 and Clinical Applications:
- 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.
Tuca, A. (2010). Use of granisetron transdermal system in the prevention of chemotherapy-induced nausea and vomiting: a review. Cancer Management and Research, 2, 1–12.
To evaluate the antiemetic efficacy of transdermal granisetron in chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and highly emetogenic chemotherapy
- This article describes two clinical trials. The first, which was a phase II study, consisted of 210 patients with cancer. The second, which was a phase III study, consisted of 641 patients with cancer.
- Ages, gender, and key disease characteristics were not specified.
This was a multisite study conducted in the inpatient setting. The phase II trial was conducted in Germany. The phase III trial was conducted in nine countries.
Phase of Care and Clinical Applications:
All patients were in active treatment. Clinical applications of these studies are late effects and survivorship.
- The first clinical trial was a double-blind, double-dummy, randomized, multicenter study.
- The second trial was a randomized, active control, double-blind, double-dummy, parallel group, multicenter, multinational study.
In the first trial, patients used a Likert-type scale and visual analog scale (VAS) to measure CINV.
- No statistically significant differences were found in severity of nausea and vomiting, number of emetic episodes, or patient satisfaction between the two trial groups.
- Constipation was more common in patients treated with the granisetron patch compared with patients who were treated with oral granisetron.
Transdermal granisetron is effective and safe in controlling acute emesis induced by chemotherapy with moderate and high emetogenic potential; its efficacy and safety are fully comparable with those of oral granisetron.
Age, gender, cancer type, and stage were not mentioned.
The transdermal route may bring more comfort to patients. The patch is simple to apply and is maintained throughout chemotherapy without skin problems in most patients. The use of transdermal patch can avoid one of the many venous manipulations necessary in chemotherapy. Also, patches could be helpful in patients with swallowing problems. Nurses need to consider obstacles, including cost and insurance coverage, when selecting antiemetics.