Nishimura, J., Satoh, T., Fukunaga, M., Takemoto, H., Nakata, K., Ide, Y., . . . Multi-center Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO). (2015). Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy (SENRI trial): A multicentre, randomised, controlled phase 3 trial. European Journal of Cancer, 51, 1274–1282.
DOI Link
Study Purpose
To evaluate the efficacy of aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) for in patients with colorectal cancer receiving oxaliplatin
Intervention Characteristics/Basic Study Process
CYCLE 1
Patients in the aprepitant group received:
Day 1: 125 mg PO aprepitant, 5-HT3 receptor antagonist IV, 6.6 mg dexamethasone
Days 2 and 3: 80 mg PO aprepitant, 2 mg dexamethasone BID
Patients in the fosaprepitant group received:
Day 1: 150 mg fosaprepitant IV, 5-HT3 receptor antagonist, 6.6 mg dexamethasone
Day 2: 2 mg PO dexamethasone BID
Day 3: 4 mg PO dexamethasone BID
Patients in the control group received:
Day 1: 5-HT3 receptor antagonist IV, 9.9 mg dexamethasone
CYCLE 2
All patients were in the aprepitant or fosaprepitant groups
Sample Characteristics
-
N = 413 for full analysis set; however, because of either refusal of chemotherapy (10 patients) or ineligibility on review, only 370 patients were evaluated for the first cycle protocol set. The number lowered further to 338 for second cycle protocol set because of deletion of oxaliplatin from the chemotherapy regimen or lack of data (i.e., not recording in the patient diary).
-
MEAN AGE = 64.2 years
-
MALES: 61%, FEMALES: 39%
-
CURRENT TREATMENT: Chemotherapy
-
KEY DISEASE CHARACTERISTICS: Colorectal cancer
-
OTHER KEY SAMPLE CHARACTERISTICS: Oxaliplatin-based chemotherapy, adults
Setting
-
SITE: Multisite
-
SETTING TYPE: Hospitals
-
LOCATION: Japan
Phase of Care and Clinical Applications
PHASE OF CARE: Active anti-tumor treatment
Study Design
This was a double-blind, randomized, placebo-controlled trial.
Measurement Instruments/Methods
Patients used a diary on days 1–6 to record the use of rescue antiemetics, severity of nausea, and episodes of vomiting. The severity of nausea was recorded on a four-grade scale. Tolerability, or other adverse effects, were monitored through laboratory tests and a physical examination.
Results
Patients in the aprepitant group had significantly higher rates of no vomiting than patients in the control group overall (relative risk [RR] = 1.14, 95% confidence interval [CI] [1.07, 1.23], p < 0.0001). Analyses of the acute and delayed phases also demonstrated significantly higher rates of no vomiting or patients in the aprepitant group when compared to the control group (acute phase: RR = 1.02, 95% CI [1.01, 1.06], p = 0.013; delayed phase: RR = 1.13, 95% CI [1.06, 1.21], p = 0.0003). In the acute phase, no nausea, no significant nausea, complete response, and complete protection were not significantly different in the aprepitant group compared to the control group. In the delayed phase, patients in the aprepitant group had higher percentages of no significant nausea (RR = 1.09, 95% CI [1, 1.1], p = 0.047), complete response (RR = 1.13, 95% CI [1.02, 1.25], p = 0.02), and complete protection (RR = 1.15, 95% CI [1.02, 1.3], p = 0.02).
Conclusions
For patients receiving oxaliplatin for the treatment of colorectal cancer, CINV prophylaxis with aprepitant or fosaprepitant significantly reduced the rate of vomiting in the acute and delayed phases and significantly reduced the rate of nausea in the delayed phase.
Nursing Implications
Aprepritant and fosaprepitant are safe and effective for the prevention of CINV in patients with colorectal cancer who receive oxaliplatin.