Yonemura, M., Katsumata, N., Hashimoto, H., Satake, S., Kaneko, M., Kobayashi, Y., … Hojo, T. (2009). Randomized controlled study comparing two doses of intravenous granisetron (1 and 3 mg) for acute chemotherapy-induced nausea and vomiting in cancer patients: A non-inferiority trial. Japanese Journal of Clinical Oncology, 3, 443–448. 

To assess the noninferiority of 1 mg granisetron injection to 3 mg granisetron injection for the treatment of acute chemotherapy-induced nausea and vomiting (CINV)

Patients were randomly assigned to two treatment arms. All patients also received dexamethasone. Researchers asked the patients directly or via phone if they experienced any emetic events within 24–36 hours following the start of administration of highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Patients recorded their symptoms, along with use of rescue antiemetics, for six days on diary cards, which were collected at each visit.

• The sample consisted of 182 participants.
• Median age was 56 years, with a range of 23–80 years.
• The sample was 96% female and 4% male.
• Participants were patients with cancer who were scheduled to undergo chemotherapy and were stratified into the high- or moderate-emetic risk groups for CINV according to the American Society for Clinical Oncology (ASCO) guidelines for antiemetic treatment.
• The most commonly reported primary cancers were breast (n = 94), gynecologic (n = 64), primary unknown (n = 16), urothelial (n = 4), and sarcoma (n = 3). 

The setting was a single site in Tokyo, Japan.

Study participants were in active treatment.

This was a single-blind, randomized parallel group trial.

• Episodes of nausea were recorded by the patients on diary cards, along with the severity of the episodes according to the following 4-point scale: 0 = none (no nausea), 1 = mild (able to take meals as usual), 2 = moderate (reduced intake of food), and 3 = severe (unable to take either food or water).
• Patients also recorded any type or doses of antiemetic agents (i.e., rescue medications).
• Adverse events were evaluated based on the Common Terminology Criteria for Adverse Events (CTAE v3.0, Japanese version).

• Complete protection was achieved in 78% of the patients in the 1-mg group and 81% of the 3-mg group.
• The one-sided test did not reveal noninferiority of either dose of granisetron to the other at the 5% significance level.
• No significant differences were found between the groups for rate of complete response.

The rate of complete protection from nausea and vomiting was similar in both the 1-mg and 3-mg granisetron groups.

Nausea was measured as ability or inability to take meals as usual, rather than the symptom of nausea.

Granisetron dosed at 1 mg is appropriate for treatment of acute CINV in patients with cancer.