Karthaus, M., Tibor, C., Lorusso, V., Singh-Arora, R., Filippov, A., Rizzi, G., . . . Grunberg, S.M. (2015). Efficacy and safety of oral palonosetron compared with IV palonosetron administered with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with solid tumors receiving cisplatin-based highly emetogenic chemotherapy (HEC). Supportive Care in Cancer, 23, 2917–2923. 

To compare the safety and efficacy of oral and intravenous palonosetron when used to prevent chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based chemotherapy

On day 1 of chemotherapy, subjects were given either 0.50 mg oral palonosetron or 0.25 mg IV palonosetron in addition to oral dexamethasone at 20 mg on day 1 followed by 8 mg orally as needed on days 2–4. The use of rescue medication was considered a treatment failure. Metoclopramide tablets were available, the use of other 5HT3s was discouraged, and the use of palonosetron was not allowed. 

• N = 738  
• MEAN AGE = 58 years
• MALES: 59%, FEMALES: 41%
• KEY DISEASE CHARACTERISTICS: 87% white and 13% Asian; primary cancer diagnoses were 47% lung, 23% other, 18% head and neck, and 7% gastric; 51% had primary disease; 46% had metastatic disease; 3% local recurrence
• OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria included: age ≥ 18 years old; histologically or cytologically confirmed malignant solid tumor; Eastern Cooperative Oncology Group performance status of 0–2; and adequate hepatic, renal, and hematologic function. Exclusion criteria included the inability to receive moderately or highly emetogenic chemotherapy on days 2–5 following cisplatin or radiation therapy to the abdomen or pelvis within one week prior to day 1.

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: United States, Latin America, Europe, Asia, and the Commonwealth of Independent States

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, double-blinded, double-dummy, parallel-group, stratified study

• Impact on quality of life was measured by the modified Function Living Index-Emesis (FLIE).
• Safety assessments included a physical examination, vital signs, electrocardiogram, laboratory analysis, and reports of adverse events.

The acute phase complete response (CR) rate was 89% in the oral palonosetron group and 86% in the IV group. The CR rate in the delayed phase was 76% for oral versus 75% for IV palonosetron. There was no difference in the percentage of patients with no emesis in the delayed (79% oral versus 78% IV) and overall phases (76% oral versus 73% IV). There was no overall statistical difference in nausea and the use of rescue medication between the oral and IV groups in the acute, delayed, and overall study phases. Study drug treatment-emergent adverse events were rare (3.2% oral versus 6.5% IV).

IV palonosetron was not superior to oral palonosetron in preventing CINV from platinum-based highly emetogenic chemotherapy. Both routes had similar efficacy in the acute, delayed, and overall phases. 

Oral 0.50 mg and IV 0.25 mg palonosetron were effective in preventing CINV in highly emetogenic chemotherapy regimens containing cisplatin without increasing the risk of adverse events. The availability of oral antiemetics provides opportunities to decrease the amount of time patients spend in the clinic receiving IV premedications. This may decrease the cost of treatment because of the decrease in chair time.