Kaushal, J., Gupta, M.C., Kaushal, V., Bhutani, G., Dhankar, R., Atri, R., & Verma, S. (2010). Clinical evaluation of two antiemetic combinations palonosetron dexamethasone versus ondansetron dexamethasone in chemotherapy of head and neck cancer. Singapore Medical Journal, 51(11), 871–875.
To compare the antiemetic effectiveness of palonosetron plus dexamethasone (PD) versus ondansetron plus dexamethasone (OD) for patients with head and neck cancer receiving moderately emetogenic chemotherapy (MEC)
Patients with head and neck cancer who were receiving a standardized MEC regimen (60 mg/m² IV docetaxel, 300 mg/m² IV carboplatin, and 600 mg/m² IV 5-flurouracil) were randomly assigned to one of two groups. During the first cycle of chemotherapy, group one received palonosetron plus dexamethasone (PD) as antiemetic prophylaxis therapy and group two received ondansetron plus dexamethasone (OD) as antiemetic prophylaxis therapy. For the second cycle, the groups crossed over and group one received OD as antiemetic prophylaxis therapy and group two received PD as antiemetic prophylaxis therapy. The efficacy of the antiemetic prophylaxis medication combinations was evaluated at each of the two cycles of chemotherapy by recording the intensity of nausea and the frequency of vomiting. These outcome variables were evaluated during three phases of treatment: the acute phase beginning at chemotherapy administration and ending 24 hours after, the delayed phase beginning 24 hours after chemotherapy administration and ending five days after, and overall for the five days following chemotherapy administration.
The study was conducted at a single outpatient site at a large medical center in India.
All patients were in active treatment.
The study used a randomized, crossover design.
Patients recorded each instance of emesis over the five-day, post-chemotherapy period and the intensity of their nausea using a four-point, descriptive ordinal scale ranging from no nausea to severe nausea.
No significant differences were found between groups for any of the study outcomes (emesis frequency and nausea intensity) in any of the treatment phases (acute phase, delayed phase, and overall).
No difference was found in antiemetogenic efficacy between the PD and OD groups.
The study sample was small with fewer than 100 patients.
As a second-generation 5-HT3 antagonist, palonosetron, may be more effective in preventing and reducing chemotherapy-induced nausea. Some studies have demonstrated that palonosetron is more effective at reducing chemotherapy-induced nausea and vomiting (CINV), while other studies, such as this one, have not. More research must be done before any formulary changes can be proposed.