Seol, Y.M., Kim, H.J., Choi, Y.J., Lee, E.M., Kim, Y.S., Oh, S.Y., . . . Chung, J.S. (2016). Transdermal granisetron versus palonosetron for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: A multicenter, randomized, open-label, cross-over, active-controlled, and phase IV study. Supportive Care in Cancer, 24, 945–952. 

To compare the efficacy and tolerability of the granisetron transdermal delivery system (GTDS) to palonosetron for the control of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC)

Eligible patients were randomized to either the granisetron group (GP) or palonosetron group (PG). The GP group received transdermal granisetron (one patch, seven days) for the first chemotherapy cycle and palonosetron (IV 0.25 mg/day, one day) for the second chemotherapy before receiving MEC in two consecutive cycles. The PG received palonosetron for cycle 1 and granisetron for cycle 2. Granisetron was applied 24–48 hours prior to the start of chemotherapy in both groups and left in place for seven days. IV injection of palonosetron 0.25 mg was given 30 minutes prior to chemotherapy on day 1. Both groups received dexamethasone (IV 10 mg) within 30 minutes before chemotherapy on day 1. All subjects were followed for a total of 15 days. Patient diaries were used to record the following: emetic episodes, use of rescue medications, patch adhesion, and severity of nausea (which was evaluated daily until day 4) by the CTCAE. Adverse events and vital signs were also recorded.

• N =188   
• AGE = 29–83 years
• MALES: 59.3% GP, 65% PG  
• FEMALES: 40.7% GP, 35% PG
• CURRENT TREATMENT: Chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Receiving MEC combining 5-fluorouracil/leucovorin with Irinotecan (FOLFIRI) or oxaliplatin (FOLFOX) in two consecutive chemotherapy cycles

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Korea

PHASE OF CARE: Active antitumor treatment

Multicenter, randomized, open-label, cross-over, active-controlled, phase IV study

• Complete response in acute and delayed phases—no emesis and no use of rescue medication
• Functional Living Index-Emesis (FLI-E)

The GTDS cycles showed noninferiority to palonosetron cycles during the acute phase. Complete responses were achieved by 75% of patients in the GTDS cycles and 80% in the palonosetron cycles. There was no significant difference in complete response rate of acute phase after the first cycle and the second cycle between the GP group and PG group (p = 0.405, p = 0.074).  Similar proportions of compete response were noted during the overall period of 0–72 hours. In both groups, small portions of patients had severe nausea during the acute phase (3 of 175 in the GTDS cycle and 1 of 175 of the palonosetron cycle). Satisfaction scores were measured by FLI-E and were equal in both groups for patients in the PG group, but in the GP group, patients' scores were lower in the palonosetron cycle versus GTDS. There were no differences in adverse events between the groups.

This study demonstrated that the granisetron transdermal delivery system is noninferior to palonosetron for relieving CINV in patients receiving MEC. Patients' satisfaction was higher with the GTDS than with palonosetron.

The GTDS is noninferior to palonosetron for patients receiving MEC. This may be a valuable option for patients who are unable to swallow pills or who have impaired absorption.