Ito, F., & Furukawa, N. (2017). Effectiveness of antiemetic triplet therapy with aprepitant, palonosetron, and dexamethasone for gynecologic cancer patients receiving carboplatin and paclitaxel: A prospective single-arm study. Supportive Care in Cancer, 25, 1941–1945.

The purpose of this study was to evaluate the efficacy of triplet therapy aprepitant, palonosetron, and dexamethasone in patients receiving carboplatin and paclitaxel (CP) for gynecologic malignancy.

Seventy patients with gynecologic cancer receiving CP were enrolled into a prospective single-arm study with APR (125 mg on day 1, 80 mg on days 2–3), PALO (0.75 mg), and DEX (20 mg) before initiating chemotherapy. The primary endpoint was delayed complete response (CR) rate (i.e., no vomiting and no rescue) at 24–120 hours after chemotherapy administration.

• N = 70   
• AGE: Median age = 57 (range = 37-80) 
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Gynecologic cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy-naïve women aged 20 years or older with a confirmed diagnosis of gynecologic malignancy; scheduled to receive CP; Eastern Cooperative Oncology Group performance status of 0–1 and adequate organ function

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Nara Medical University, Japan

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care

Single-arm phase II

• MASCC Antiemetic Tool was used to evaluate the efficacy of the antiemetic used 
• The primary endpoint was the complete response (CR) rate (no emetic episodes, no rescue medication) in the delayed phase for the first cycle
• The secondary endpoints were CR rates in the acute and overall phases; complete control (CC) rates (no significant nausea, no rescue medication) in the acute, delayed, and overall phases;
• Total control (TC) rates (no emetic episodes, no rescue medication, and no nausea) in the acute, delayed, and overall phases; and adverse events.“Acute” was defined as up to 24 hours after the administration of CP, and “delayed” was defined as the 24–120 hours after administration. 
• No significant nausea was defined as a MASCC Antiemetic Tool score of 3 or lower.

• Seventy patients were enrolled as planned, and all were eligible .
• Delayed CR rate was 97.1% (68/70). CR rates in the acute and overall phases were 100% (70/70) and 97.1% (68/70), respectively. CC rates in the acute, delayed, and overall phases were 98.6% (69/70), 1.4% (64/70), and 91.4% (64/70), respectively. TC rates in the acute, delayed, and overall phases were70% (49/70), 87.1% (61/70), and 65.7% (46/70), respectively.
• Proportions of the incidence of adverse events were 42.5 and 2.5% of constipation grades 1 and 2 (17/40 and 1/40), respectively, and 5% of insomnia grade 1 (2/40). No grade 3 or 4 events were observed.
• In the univariate logistic analysis, there were no significant factors associated with the delayed CR rate.
• Only the factor of age 50 years and younger tended to be associated with a poor delayed CR rate (p = 0.096).

Adding APR to PALO and DEX combination therapy may be promising for patients with gynecologic cancer receiving CP. A phase III study comparing APR, PALO, and DEX to PALO and DEX should be conducted in order to determine if APR in addition to PALO and DEX is efficacious for female patients receiving CP.

• Small sample (< 100)
• Intervention expensive, impractical, or training needs

Encourage more studies to better determine the efficiency of APR in addition to PALO and DEX in this patient population.