Bubalo, J.S., Herrington, J.D., Takemoto, M., Willman, P., Edwards, M.S., Williams, C., . . . Lopez, C.D. (2018). Phase II open label pilot trial of aprepitant and palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic FOLFOX chemotherapy for the treatment of colorectal cancer. Supportive Care in Cancer, 26, 1273–1279.

To determine the efficacy of aprepitant added to standard antiemetic therapy for the control of CINV in patients with colorectal cancer receiving FOLFOX (fluorouracil, oxaliplatin, and leucovorin) chemotherapy.

Patients with colorectal cancer receiving FOLFOX chemotherapy were given standard antiemetic therapy (palonosetron 0.25 mg IV on day 1, dexamethasone 12 mg PO day 1, dexamethasone 8 mg PO day 2-4) plus aprepitant 125 mg PO day 1 and 80 mg PO day 2 and day 3 after chemotherapy. No comparison group.

• N: 50   
• AGE: Mean age = 57 years, range = 27-80
• MALES: 47%  
• FEMALES: 53%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Colorectal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy naïve, life expectancy greater than four months, ECOG < 2

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: USA

PHASE OF CARE: Active anti-tumor treatment

One-group pre-/post-test design

Complete response (no emesis or rescue medications used), major response (no emesis but nauseated with or without rescue medication use), treatment failure (emesis within five days of chemotherapy using daily diary recording emetic events, nausea (0-100 mm visual analog scale), rescue medication use, as well as appetite and nutritional intake.

Overall CINV remained low throughout the chemotherapy cycles (CR = 74%, major response = 23%, failure = 4%). Appetite and nutritional status did not significantly change throughout treatment. Few adverse events were reported (diarrhea, 13.6%, fatigue, 12.6%, and neutropenia, 11%).

Aprepitant added to standard antiemetic therapy results in low CINV and has few adverse events. This regimen appears to be safe and effective for prevention of CINV in patients with colorectal cancer receiving FOLFOX. However, without a comparison group it is unclear if this antiemetic regimen is equal to or better than standard antiemetic therapy.

• Small sample (< 100)
• Risk of bias (no control group)

Aprepitant added to standard antiemetic therapy is safe and effective for preventing CINV in patients with colorectal cancer receiving FOLFOX, but may or may not be an improvement over standard antiemetic therapy alone.