Miyata, Y., Yakushijin, K., Inui, Y., Imamura, Y., Goto, H., Mizutani, Y., . . . Murayama, T. (2016). A prospective study of the antiemetic effect of palonosetron in malignant lymphoma patients treated with the CHOP regimen. International Journal of Hematology, 104, 682–691. 

To determine the impact of palonosetron on chemotherapy-induced nausea and vomiting (CINV) in patients with lymphoma receiving CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone or prednisolone) chemotherapy

This single-arm study evaluated palonosetron in patients with lymphoma. Patients received 0.75 mg palonosetron as an IVP 30 minutes prior to chemotherapy. No antiemetics were allowed within 48 hours prior to treatment. Patient were further restricted from taking any antiemetics unless they experienced symptoms of CINV for 168 hours after treatment. There is no mention of other antiemetics that were used. It is unclear if the data were collected beyond one cycle. Patients were chemotherapy naïve but could have received rituximab.

• N = 54/50   
• AGE = 23–75 years
• MALES: 46%, FEMALES: 54%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Non-Hodgkin lymphoma  
• OTHER KEY SAMPLE CHARACTERISTICS: Stage of disease, alcohol use, smoking, motion sickness, morning sickness, previous radiation

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

PHASE OF CARE: Active antitumor treatment

Single-arm study conducted at five hospitals

Patients maintained an assessment diary from 0–168 hours after chemotherapy. Questionnaires also assessed drinking history, motion sickness, pregnancy history, and emesis during pregnancy. The primary end point was the occurrence rate of nausea, vomiting, and anorexia, which were measured using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Secondary end points evaluated these symptoms during the acute and delayed phases of CINV, as well as frequency of rescue medication use. The patients’ physicians scored the CTCAE based on the patients' diary.

Four patients became ineligible because of steroid administration dosing and new central nervous system metastasis. Overall occurrence of nausea and anorexia of any grade for the overall phase was 56% for nausea, 62% for anorexia, and 12% for vomiting. Six patients experienced vomiting. Half of these patients experienced vomiting after completion of the five days of steroids (part of the chemotherapy regimen). Patient characteristics were evaluated using univariate analysis, which did not show any association between patient parameters and nausea or vomiting in the overall phase. Anorexia, however, was significantly associated with both sex (p < 0.001) and drinking history (p < 0.001).

Females were more likely to experience anorexia, and should be considered for NK-1 inhibitors. There was an association of nausea in the acute phase leading to the development of delayed anorexia. Clinicians should also be more attentive to development of CINV in the delayed phase after 120 hours.

• 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)
• Findings not generalizable
• Provider scoring diaries, with possible prejudice

Nurses need to consider delayed CINV in CHOP chemotherapy, particularly after patients have completed the steroid component of their treatment.