Blazer, M., Phillips, G., Reardon, J., Efries, D., Smith, Y., Weatherby, L., … Bekaii-Saab, T. (2012). Antiemetic control with palonosetron in patients with gastrointestinal cancer receiving a fluoropyrimidine-based regimen in addition to either irinotecan or oxaliplatin: a retrospective study. Oncology, 83, 135–140.

To evaluate the use of palonosetron compared to ondansetron for the complete control of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic oxaliplatin or irinotecan plus a fluoropyrimidine regimen

Patient charts were reviewed for time periods before the use of palonosetron and after use of palonosetron. Prior to use of palonosetron, ondaansetron was given in combination with 12 mg oral dexamethasone 30 minutes prior to chemotherapy on day 1 of each regimen.  In the post palonosetron group, palonosetron was used instead of ondansetron.  In the setting of grade 1 or more vomiting or grade 2 nausea, aprepitant was added to the regimen. Nurses graded nausea and vomiting during chemotherapy administration.

• The study consisted of 305 participants.
• The majority of patients (73%) were more than 50 years old.
• The sample was 53% male and 47% female.
• Patients had been diagnosed with gastrointestinal cancers.
• In early-stage disease, more patients had received oxaliplatin. The highest percentage of patients in this study had metastatic colorectal cancer.

This was a single-site study conducted in both the inpatient and outpatient settings of a Midwest (Ohio) Academic medical center.

• All patients were in active treatment.
• This study has application to palliative care.

This study was a retrospective review of patients’ medical records.

• Failure of the prophylactic antiemetic was considered the primary endpoint in both groups. Failure was defined as vomiting at grade 1 or more or nausea at grade 2 or more. 
• The Common Terminology Criteria for Adverse Events, version 3, was used for grading.

With the use of palononsetron, the incidence of CINV failure was 28.4% versus 50.3% with the use of ondansetron (p < 0.001) regardless of the agent used (oxaliplatin or irinotecan).

The findings of this study support the use of palonosetron in regimens that include oxaliplatin or irinotecan plus either 5-FU or capecitabine. The study reported that the use of palononsetron resulted in a statistically significant reduction in the risk of CINV.

• A risk of bias exists because assignment was not random.
• Unintended interventions or applicable interventions that would influence results were not described.
• Measurement and methods were not well described.
• Antiemetic failure in the acute setting versus the delayed setting was not distinguished.

Although the National Comprehensive Cancer Network (NCCN) Guidelines for Antiemesis state that, for moderately emetogenic chemotherapy, a 5-HT₃ antagonist and dexamethasone should be used to prevent CINV, this study showed that, for regimens with oxaliplatin or irinotecan and either 5-FU or capecitabine, the 5-HT₃ of choice may be palononsetron. What is unknown is whether the use of palononsetron is equally as effective in reducing CINV using other moderately emetogenic chemotherapeutic regimens.