Hamada, S., Hinotsu, S., Kawai, K., Yamada, S., Narita, S., Kamba, T., . . . Kawakami, K. (2014). Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy. Supportive Care in Cancer, 22(8), 2161–2166. 

To determine the efficacy and safety of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor (TGCT)

Male patients being treated with cisplatin-based therapy for TGCT received a three-drug antiemetic regimen. The antiemetic therapy consisted of palonosetron 0.75 mg on day 1; aprepitant 125 mg on day 1 and 80 mg on days 2–5; and dexamethasone 12 mg on day 1 and 9 mg on days 2–8. Patients were given a diary to complete from 0–216 hours after the start of chemotherapy for a maximum of three consecutive chemotherapy courses.

• N = 30  
• MEAN AGE = 33.9 years
• MALES: 100%
• KEY DISEASE CHARACTERISTICS: TGCT, chemotherapy-naive
• OTHER KEY SAMPLE CHARACTERISTICS: All patients receiving a five-day, cisplatin-containing treatment regimen

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Nine hospitals in Japan

• PHASE OF CARE: Active antitumor treatment

Open-label, single-arm, multi-center prospective trial

Patients were given a diary to record nausea and vomiting events. The severity of the nausea was graded using the Common Terminology Criteria for Adverse Events (CTCAE).

This three-drug regimen resulted in a 90% complete response (CR) rate in the first course of therapy. In the second and third courses of treatment, CR rates of 82.1% and 78.3 %, respectively, were achieved. No vomiting was reported in the first course of treatment. There were six episodes of vomiting reported by three different patients during the second course of treatment in the delayed phase. One patient reported two episodes of vomiting in the acute phase, and an additional patient reported three episodes in the delayed phase of the third course.

This three-drug regimen is effective in controlling nausea and vomiting in this patient population. There is still data needed to better identify the appropriate dose and duration of dexamethasone and to determine the efficacy and tolerability of the regimen when using palonosetron 0.25 mg versus the 0.75 mg that was used in this study.

• Small sample (< 30)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Different approved dose of palonosetron in Japan versus United States limits the applicability of the findings.

This small study provides continued evidence regarding the efficacy and tolerability of this three-drug combination approach with five-day cisplatin regimens. There is still data needed about the appropriate duration and dose of dexamethasone in this approach. A higher dose of palonosetron was used. There will need to be future studies assess the 0.25 mg dose used in the United States.