Lorusso, V., Spedicato, A., Petrucelli, L., Saracino, V., Giampaglia, M., & Perrone, T. (2009). Single dose of palonosetron plus dexamethasone to control nausea, vomiting and to warrant an adequate food intake in patients treated with highly emetogenic chemotherapy (HEC): Preliminary results. Supportive Care in Cancer, 17, 1469–1473.

To evaluate the efficacy of a single-dose palonosetron plus dexamethasone to control emesis in patients receiving highly emetogenic chemotherapy (HEC) and to measure any reduction of calories consumption related to CINV

At baseline, nutritional evaluation subjective global assessment and assessment of appetite were done. Patients received a single bolus of 250 mcg palonosetron plus a single dose of 20 mg dexamethasone 30 minutes prior to chemotherapy. Subjects recorded emesis, nausea, use of rescue medication, and food intake in daily diaries. Amount of food intake was quantified with the aid of pictures of standard portions.

• The study consisted of 35 patients.
• Mean age was 56 years, with a range of 48–67 years.
• The majority of patients were female (82.9%).
• Diagnoses were solid tumors (soft tissue sarcoma, cervix, bladder, lung, and breast).
• Of those patients receiving HEC, 88.6% were chemotherapy naïve, 28.6% were receiving cisplatin-based regimens, and 71.4% were on ifosfamide-epirubicin regimens.
• At baseline, 82.9% of patients were evaluated as well-nourished.

The study was conducted at a single site.

All patients were in active treatment.

This was a prospective trial (noncomparative, single-arm study).

• Patient diaries were used to record the time of each emesis and each dose of rescue medication, as well as the start and stop times of nausea and food intake. 
• Subjective global assessment of complete response (CR) was no vomiting and no rescue therapy. Complete control was defined as no more than mild nausea.
• Appetite was rated on a visual analog scale (VAS).

• CR was achieved in 85.7% of patients, and CC was achieved in 82.9% of patients in the acute phase.
• During the delayed phase, 82.9% achieved CR and 77.1% achieved CC.
• Overall, 80% achieved CR and 77.1% achieved CC. Even in patients with CC, the presence of residual nausea, although it was rated as mild, significantly decreased calorie intake during the acute and delayed phases (r² = 0.77, p < 0.0001).

Palonosetron was able to prevent both acute and delayed vomiting and nausea in most patients treated with HEC. A strong, significant relationship was found between the presence of nausea and lower caloric intake.

• The sample consisted of fewer than 100 patients.
• No control group was included. This reported provided only preliminary results.
• Aprepitant was not employed as an antiemetic for HEC.
• Patient compliance with the diary was not discussed.
• Caloric intake can only be considered an estimation based on the method of measurement.

• Even mild nausea has a negative effect on caloric intake, and, for those with severe nausea, intake may be diminished drastically.
• Findings support the observation that palonosetron is useful in the prevention of CINV in patients receiving HEC.