Effectiveness Not Established

Risk Model-Based CINV Prophylaxis

for Chemotherapy-Induced Nausea and Vomiting—Adult

Risk model based chemotherapy-induced nausea and vomiting (CINV) prophylaxis is the provision of an antiemetic regimen based on a combination of patient-centered factors as well as treatment factors for the determination of CINV risk. Individual risk scores for acute and delayed CINV are calculated according to predictors identified, including younger age, history of motion or morning sickness, low daily alcohol consumptions, patient expectation of having CINV, emesis in previous chemotherapy cycles, and receiving platinum- or anthracycline-based chemotherapy. Patients at low risk by the model were given prophylaxis for a moderately emetic regimen, and patients at high risk received prophylaxis recommended for highly emetic regimens.

Clemons, M., Bouganim, N., Smith, S., Mazzarello, S., Vandermeer, L., Segal, R., . . . Dranitsaris, G. (2016). Risk model-guided antiemetic prophylaxis vs physician's choice in patients receiving chemotherapy for early-stage breast cancer: A randomized clinical trial. JAMA Oncology, 2, 225–231. doi:10.1001/jamaoncol.2015.3730

Research Evidence Summaries

Clemons, M., Bouganim, N., Smith, S., Mazzarello, S., Vandermeer, L., Segal, R., . . . Dranitsaris, G. (2016). Risk model-guided antiemetic prophylaxis vs physician's choice in patients receiving chemotherapy for early-stage breast cancer: A randomized clinical trial. JAMA Oncology, 2, 225–231. 

Study Purpose

To test the clinical utility of a chemotherapy-induced nausea and vomiting (CINV) risk model to improve patient outcomes compared to usual care

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the risk model group (RMG) or physician choice group (PCG) (control). Those in the RMG group had acute and delayed emetic risk scores calculated prior to each cycle of chemotherapy. Patients with low risk (acute risk score < 7, delayed score ≤ 16) received dexamethasone and ondansetron regimens. Those at high risk by the models were given triplet antiemetics according to highly emetogenic chemotherapy (HEC) guidelines. Patients assigned to the PCG were given whatever regimen their oncologist decided upon. Patients rated their control of nausea and vomiting on a 4-point Likert-type scale, and need for intravenous fluids was recorded. Patients were contacted by phone on days 1 and 5 after chemotherapy.

Sample Characteristics

  • N = 312   
  • MEAN AGE = 53.6 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving either four cycles of AC (doxorubicin and cyclophosphamide) or three cycles of FEC (5-fluorouracil, epirubicin, and cyclophosphamide) or FAC (5-fluorouracil, doxorubicin, and cyclophosphamide). A total of 1,184 cycles were included in the study.
  • OTHER KEY SAMPLE CHARACTERISTICS: The groups were similar in terms of cancer stage, history of motion sickness, alcohol intake history, and comorbid conditions.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized controlled trial (RCT)

Measurement Instruments/Methods

  • 4-point Likert-type scales for nausea and vomiting
  • 4-point scale for severity of IV fluid need from none to requiring hospitalization
  • Functional Living Index-Emesis (FLIE)

Results

In cycle 1, 94.1% in the PCG group and 15.6% in the RMG group were given 5-HT3 and dexamethasone prophylaxis, and 81.2% in the RMG group and 4.1% of controls were given triple drug regimens. In the RMG group, 90% received aprepitant by cycle 4 and 40% had olanzapine added to cycles 3 and 4. In the control group, aprepitant was added to about 25% of cycles 2–4. Significantly fewer patients in the RMG group required prochlorperazine (p = 0.02) or methotrimeprazine (p = 0.001) for rescue. No differences existed in the need for IV fluids between groups. In both the acute and delayed phases, significantly more patients in the RMG group reported no vomiting and no nausea (p < 0.001). FLIE scores were consistently better in the RMG group, but differences from control patients were not statistically significant.

Conclusions

The use of the emetic risk model for prophylaxis decision making was shown to be more effective than physician antiemetic choice for the prevention of both acute and delayed CINV.

Limitations

  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • Likert-type scales used were not previously tested.

Nursing Implications

The findings support the use of emesis risk prediction in treatment decision making for antiemetic prophylaxis. Nurses can advocate for the consideration of emetic risk and the appropriate prescription of antiemetics for patients with breast cancer receiving chemotherapy.

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Dranitsaris, G., Mazzarello, S., Smith, S., Vandermeer, L., Bouganim, N., & Clemons, M. (2016). Measuring the impact of guideline-based antiemetic therapy on nausea and vomiting control in breast cancer patients with multiple risk factors. Supportive Care in Cancer, 24, 1563–1569. 

Study Purpose

The purpose of this study was to determine if guideline-based antiemetic therapy would improve chemotherapy-induced nausea and vomiting (CINV) in patients with multiple risk factors for CINV

Intervention Characteristics/Basic Study Process

Patients were randomized to the risk model-guided antiemetic therapy group or a physician’s choice antiemetic group. All patients in the physician’s choice group received antiemetics at a dose and frequency chosen by the physician. Patients in the risk model-guided antiemetic therapy group were stratified into low-risk or high-risk categories based on a risk model developed in a previous study.
 
Low-risk patients (level 0) received the following.
Day 1: 10 mg dexamethasone IV and 8 mg ondansetron by mouth (PO) prior to chemotherapy and 4 mg dexamethasone PO and 8 mg ondansetron PO eight hours after chemotherapy
Days 2 and 3: 4 mg dexamethasone PO two times a day (BID) and 8 mg ondansetron PO BID
 
High-risk patients (level 1) received the following.
Day 1: 12 mg dexamethasone IV, 8 mg ondansetron PO, and 25 mg aprepitant PO prior to chemotherapy, and 8 mg ondansetron eight hours after chemotherapy
Days 2 and 3: 80 mg aprepitant PO daily
 
Additional dexamethasone and olanzapine 2.5 mg daily for seven days were added to subsequent cycles for patients with poorly controlled CINV (levels 2 and 3).

Sample Characteristics

  • N = 152 
  • AGE RANGE = 26–76 years
  • MEDIAN AGE = 54 years
  • MALES (%): Not provided, FEMALES (%): Not provided
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Early-stage breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Anthracycline-based chemotherapy

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized controlled trial (RCT)

Measurement Instruments/Methods

  • The Functional Living Index-Emesis (FLIE) was used to measure the impact of CINV on the patients' quality of life. This assessment was given to patients on day 5.
  • Patients used a diary daily to record the frequency, intensity, and duration of CINV. This diary was used for the first five days post administration of chemotherapy. The research nurse called the patient on days 1 and 5.

Results

In the first 24 hours post chemotherapy, the proportion of patients in each risk level who experienced vomiting was similar; however, acute nausea was more common in the high-risk patients, with patients in levels 1–3 being 2–4 times more likely to experience nausea than patients in level 0. Delayed vomiting was similar among the different levels of patients, but delayed nausea was more common in higher risk patients. The highest risk patients (level 3) were eight times more likely to experience delayed nausea than the lowest risk patients (level 0) (odds ratio [OR] = 8, p < 0.001). Delayed nausea was highest after the cycle 1 of chemotherapy.
 
Quality of life related to vomiting was similar in patients from each risk level, but quality of life related to nausea was significantly different between risk levels when compared to level 0 (level 1: p = 0.023, level 2: p = 0.007, level 3: p = 0.005).

Conclusions

Patients from all risk levels had similar rates of acute and delayed vomiting; however, acute and delayed nausea remained higher in the high-risk patients.

Limitations

  • Findings not generalizable
  • No report of comparison of outcomes across study groups

Nursing Implications

By assessing patient risk factors for CINV and prescribing antiemetic therapy based on patient risk stratification, acute and delayed vomiting may be managed; however, acute and delayed nausea remained significantly higher in the highest risk patients.

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