Schwartzberg, L., Morrow, G., Balu, S., Craver, C., Gayle, J., & Cox, D. (2011). Chemotherapy-induced nausea and vomiting and antiemetic prophylaxis with palonosetron versus other 5-HT(3) receptor antagonists in patients with cancer treated with low emetogenic chemotherapy in a hospital outpatient setting in the United States. Current Medical Research and Opinion, 27(8), 1613–1622.

To compare the incidence of chemotherapy-induced nausea and vomiting (CINV) among patients with cancer receiving low emetogenic chemotherapy (LEC) when given an antiemetic prophylaxis treatment of palonosetron versus other 5-HT₃ receptor antagonists. 

Using the Premier Perspective database, medical records were reviewed to identify patients with cancer who began LEC between the dates of 4/1/2007 and 3/31/2009. The medical records were then examined to determine the type of prophylactic antiemetic therapy prescribed and the patients were divided into two groups: patients prescribed palonosetron and patients prescribed other 5-HT₃ receptor antagonists (ondansetron, granisetron, or dolasetron). For the time period encompassing either the first eight cycles of chemotherapy or the first six months of treatment (whichever occurred first), the medical records were examined to determine the rate of acute and delayed CINV events, CINV-related rescue medications used, and CINV-related admissions that occurred during the study follow-up period. Acute events were defined as occurring on day one of a chemotherapy cycle, and delayed events were defined as occurring on days two through seven of a chemotherapy cycle. Outcomes were compared for those patients who were prescribed palonosetron as antiemetic prophylaxis versus those who were prescribed other 5-HT₃ receptor antagonists as antiemetic prophylaxis.

A total of 2,439 patients were included in the study.

Mean age was 66.3 years (SD = 12.6 years).

The sample was 54.2% male and 45.8% female.

Cancer diagnoses were lung, gynecological, head and neck, noncolon gastrointestinal, breast, urinary tract, and other or unknown.

All patients were beginning LEC and receiving palonosetron or other 5-HT₃ receptor antagonists as antiemetic prophylaxis.

This was a multisite, inpatient and outpatient review of data from more than 600 hospitals from across the United States.

Patients were undergoing the active treatment phase of care.

This was a nonexperimental, retrospective, longitudinal, observational study.

• Medical records were reviewed to identify any documented events of emesis, nausea, or volume depletion that occurred.
• Medical records were reviewed to identify any documented rescue medications used to treat established nausea or emesis.
• Medical records were reviewed to identify any documented hospitalizations due to nausea, emesis, volume depletion, dehydration, or hypovolemia.

Patients receiving palonosetron experienced significantly fewer CINV events (nausea, vomiting, volume depletion) (p < 0.0001), used significantly fewer antiemetic rescue medications (p < 0.0001), and were emergently/urgently admitted to the hospital significantly fewer times (p < 0.0001) than patients taking other 5-HT₃ antagonists.

Among patients with cancer receiving LEC, palonosetron may offer more relief from CINV compared to that offered by older-generation 5-HT₃ antagonists.

This was a retrospective study that compared palonosetron against a pool of other 5-HT₃ antagonists, with no random assignment to antiemetic medication. This makes it difficult to attribute the study results to the effects of the target “intervention” (palonosetron) and not to other factors.

Palonosetron is a newer 5-HT₃ antagonist with different receptor-binding characteristics and a longer half-life than older-generation 5-HT₃ antagonists. It may offer more relief from the effects of CINV compared to standard prophylactic emetic therapy. However, one important issue that was noted was that, with LEC, delayed nausea and vomiting was more of an issue than acute. Current guidelines suggest antiemetics that address only nausea and vomiting that occur in the acute phase. Palonosetron could replace older generation 5-HT₃ antagonists as standard prophylactic antiemetic therapy, but more research is needed.