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. 

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)

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.