New drug formulation for the treatment of nausea and vomiting due to chemotherapy

This study looked at the effectiveness of a new granisetron (Sustol) formulation for the treatment of nausea and vomiting during breast cancer treatment. The study concluded that the new formulation effectively prevented nausea and vomiting over 4 chemotherapy cycles in breast cancer patients.

A known side effect of chemotherapy is nausea and vomiting. However with appropriate treatments this can be prevented. Nausea and vomiting after chemotherapy can be acute (occurring within 24 hours after receiving the chemotherapy) or it can be delayed (occurring many hours after chemotherapy).

Granisetron is a drug used to treat acute nausea and vomiting. Palonosetron (Aloxi) is a drug used to treat delayed nausea and vomiting. A new formulation of granisetron, called APF530 is being investigated. Unlike the original formulation, it may also be able to treat the delayed nausea and vomiting associated with chemotherapy.

The study included 423 breast cancer patients. The patients were randomized during their first chemotherapy cycle to receive either APF530 or the standard palonosetron. During cycles 2 and 4 of chemotherapy all of the patients received APF530, at either a 250mg dose or a 500mg dose.  The study measured the complete response rates to the drug (complete response means that there was no vomiting).

The complete response rate for acute nausea and vomiting in cycle 1 was 71% to 77% (depending on type of chemotherapy) for those treated with APF530 and around 66% to 68% for those treated with palonosetron. The complete response rate for delayed nausea and vomiting in cycle 1 was 46% to 63%for those treated with APF530 and 52% for those treated with palonosetron. These small differences were not significant.  There were also no significant differences in the complete response rates between the two doses of APF530 in cycles 2 and 4.

The current study concluded that the new formulation, APF530 effectively prevented nausea and vomiting over 4 chemotherapy cycles in breast cancer patients.  

This study was sponsored by Heron Therapeutics, the manufacturers of granisetron.