Oyama, K., Fushida, S., Kaji, M., Takeda, T., Kinami, S., Hirono, Y., . . . Ohta, T. (2013). Aprepitant plus granisetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients with gastric cancer treated with S-1 plus cisplatin. Journal of Gastroenterology, 48, 1234–1241.

Evaluate the efficacy of new antiemetic combination (aprepitant, granisetron, and dexamethasone) in gastric cancer patients’ receiving chemotherapy regimen (cisplatin 60 mg/m² and 5-flourouracil analog (S-1) 80 mg/m²) in day 1, aprepitant and dexa on day 2 and 3, and dexa on day 4.

S-1 (80 mg/m²) orally x 2 x 3 weeks of a five-week cycle. Cisplatin 60 mg/m² IV on day 8 of each cycle. Antiemetic regimen: aprepitant 125 mg 1 hour before cisplatin plus dexamethasone 9.9 mg IV plus granisetron 3 mg IV 30 minutes before cisplatin infusion on day 1, oral aprepitant 80 mg x 1 & oral dexamethasone 8 mg bid on days 2 and 3, and oral dexamethasone 8 mg bid on day 4. Observations of the patients done 0-120 hours.

• N = 53   
• AGE: Median = 65 years
• MALES: 90.6%  
• FEMALES: 9.4%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Gastric cancer, chemotherapy naïve, receiving cisplatin and S-1 
• OTHER KEY SAMPLE CHARACTERISTICS: ECOG performance status of 0-2, not experienced ANV 24 hours before chemotherapy, did not received radiotherapy to the abdomen or pelvis before 1 week, no CNS metastasis, with other medical condition that can induce a risk for vomiting

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: 17 institutions of the digestive disease support organization; Japan

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Elder care

Prospective observational non-comparative study

Patient self-report of number and timing of any episodes of vomiting or retching; the degree of nausea using a four-point categorical scale (0, none; 1, mild; 2, moderate; 3, severe, use of rescue therapy (frequency and timing), and change in the amount of diet intake, and completed the Functional Living Index-Emesis (FLIE) questionnaire daily on days 1-5. Safety was assessed by physical examination, toxicity used NCI-CTCAE, version 4.

88.7, 98.1, and 88.7 % achieved complete response (CR) (no emesis, and no rescue antiemetics) in the overall, acute, and delayed phases, respectively. While 67.9, 96.2, and 67.9 % achieved complete protection (CR + no significant nausea). Half of the patients had anorexia, FLIE indicated 79.5% of the patients reported minimal or no impact of CINV on QOL. About half of the patients had some degree of anorexia. 30% of the patients reported decrease volume of diet intake to half and 10% could not consume any food during the delayed phase. Antiemetics therapy was well-tolerated.

Addition of aprepitant to standard antiemetic therapy was effective in patients with gastric cancer undergoing treatment with cisplatin and S-1.

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

CINV incidence with highly emetogenic chemotherapy is a challenge. A combination of a recommended JSCO guidelines of aprepitant, granisetron, and dexamethasone was well tolerated and very effective in preventing CINV for patients with gastric cancer receiving cisplatin.