Tsukahara, K., Nakamura, K., Motohashi, R., Sato, H., Endo, M., Katsube, Y., . . . Suzuki, M. (2014). Antiemetic therapy of fosaprepitant, palonosetron, and dexamethasone combined with cisplatin-based chemotherapy for head and neck carcinomas. Acta Oto-Laryngologica, 134, 1198–1204. 

To determine the effects of triple-drug therapy on chemotherapy-induced nausea and vomiting (CINV) in patients with head and neck cancer

Thirty men received 53 cycles of chemotherapy, and 11 women 18 cycles of chemotherapy consisting of cisplatin, docetaxel, and ​5-fluorouracil. Patients received concomitant radiation therapy except in the induction phase. Prior to each cycle, patients received fosaprepitant at 150 mg/kg, palonosetron at 0.75 mg/kg, and dexamethasone at 10 mg/kg. They also received dexamethasone at 6.6 mg/kg daily for three days after chemotherapy. Each patient received a diary to record their experiences of nausea and vomiting with each cycle.

• N = 41
• MEAN AGE = 59 years (range = 31–75 years)
• MALES: 73%, FEMALES: 27%
• KEY DISEASE CHARACTERISTICS: Head and neck cancers including laryngeal, oral cavity, nasopharyngeal, mesopharyngeal, and hypopharyngeal among others
• OTHER KEY SAMPLE CHARACTERISTICS: Patients received cisplatin-based regimens.

• SITE: Not stated
• SETTING TYPE: Not specified    
• LOCATION: Tokyo Medical University Hachioji Medical Center in Japan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care and palliative care 

Prospective, quantitative, nonrandomized, nonblinded trial

• A 0–100 mm Visual Analog Scale (VAS) was used to measure nausea (0 = no nausea, ≥ 0 and < 30 = slight nausea, ≥ 30 and < 70 = moderate nausea, ≥ 70 and < 100 = severe nausea, and 100 = very severe nausea).
• Patient diary with multiple choice questions
• Acute phase was day of administration
• The delayed phase was day of administration to day 5

A complete response (CR) was defined as no vomiting and no rescue therapy. In the overall phase, 69% (49 of 71) of courses achieved CR. The rate of no vomiting in the overall phase was 90.1%. Nausea in acute phase was reported as no nausea or slight nausea in 91.5% of patients. 87.3% of patients experienced no changes in or slightly reduced food intake, and 85.9% of patients reported good or relatively good general condition in the acute phase. In the delayed phase, no nausea to slight nausea was reported in 56.3% of patients, and 43.7% reported no changes in or slightly reduced food intake. 53.5% reported good to relatively good general condition.

In the overall phase, the majority of patients achieved a CR and reported no nausea or slight nausea. More patients experienced some nausea during the delayed phase than during the overall phase.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Measurement validity/reliability questionable 
• Findings not generalizable
• Questionable protocol fidelity
• Other limitations/explanation: The diary used to measure outcomes was not validated as a research tool. The findings were not generalizable because of the variation in cisplatin dosing, postoperative status of patients, and doses of radiotherapy.

Triple-drug therapy should be considered during prophylaxis for CINV in patients with head and neck cancer receiving chemotherapy. Although the majority of patients experienced CR during the overall phase, more patients experienced nausea in the delayed phase. Additional interventions to prevent and treat CINV in the delayed phase may be necessary.