Tamura, K., Aiba, K., Saeki, T., Nakanishi, Y., Kamura, T., Baba, H., . . . CINV Study Group of Japan. (2015). Testing the effectiveness of antiemetic guidelines: Results of a prospective registry by the CINV Study Group of Japan. International Journal of Clinical Oncology, 20, 855–865.

DOI Link

Study Purpose

  • Studied the incidence of CINV in Japan, also evaluating risk factors and acute versus delayed CINV
  • Assessed staff estimation of incidence of CINV

Intervention Characteristics/Basic Study Process

Patients were provided with seven-day diaries before the start of therapy with either highly emetogenic or moderately emetogenic chemotherapy. The patient must be receiving this type of therapy for the first time. Recording of digestive symptoms including severity of nausea, oral intake, and vomiting were measured using a visual analog scale. Investigators/colleagues recorded background information including date of birth, treatment history, use of anxiolytics, and use of opioids. Other risk factors including alcohol use, history of motion sickness or morning sickness, performance status, chemotherapy regimen, and clinical lab reports were collected in a case report, corresponding to the patient’s diary.

Sample Characteristics

  • N: 2,068 registered, 1,939 patients evaluated with case reports  
  • AGE: 19-87 years, with a mean of 62 years
  • MALES: 45.7%  
  • FEMALES: 54.3%
  • CURRENT TREATMENT: Chemotherapy, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Stage II, 20.6%; III, 24.2%; IV, 34.5%; PS-ECOG), 0, 70.8%; 1, 26.3%; 2, 2.5%; 3, 0.3%; 4, 0.1%. Cancer type: breast, hematologic, gynecologic, lung, gastric, colorectal, esophageal, HCC, other gastrointestinal. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Multiple types of chemotherapy

Setting

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

Phase of Care and Clinical Applications

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

Study Design

This was a multicenter prospective cohort study, including university hospitals, cancer centers, and cancer treatment centers. One hundred eight institutions throughout Japan participated.

Measurement Instruments/Methods

Diaries and visual analog scales have long been utilized in CINV research, although several other instruments are available and reliable. Descriptive statistics were used as were univariate analysis and multivariate analysis (Wald's test) to evaluate risk factors for both acute and delayed nausea, and acute and vomiting. Fisher’s exact test was used to measure differences of occurrence between risk factors and HEC, MEC types of chemotherapy. There was no mention how providers gauged emetogenic risk for the patients, so it was difficult to tell if this was using a reliable instrument.

Results

Multiple cancers and multiple chemotherapy regimens were evaluated. Acute nausea and vomiting with HEC was 20.8% and 5.7%; with MEC, it was 6.7% and 1.7%, respectively. There was a high incidence of delayed nausea, 49.4% with HEC, and 41.7% with MEC. Delayed vomiting was low at 11.2% with HEC and 15.9% with MEC, which was notably higher; however, if the patient received a three-drug antiemetic regimen, it was then significantly lower. Motion sickness was associated with a higher risk for acute nausea, with men being more susceptible than women. A history of morning sickness was also a risk factor in women. HEC was associated with the highest risk in both genders. Prophylactic use of  three drug regimens was associated with reduced risk in men. Risk factor analysis also revealed that women were more susceptible to CINV in every aspect. Estimation of CINV by providers overestimated emetogenic risk.

Conclusions

A high compliance with guidelines was associated with a decreased incidence of CINV, particularly in the MEC group receiving three drugs. The authors recommend to study CINV for at least seven days. Mechanisms of acute CINV require further study to develop newer agents to target this symptom

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • Other limitations/explanation: Sample was too expansive with multiple disease states, all stages of disease and various chemotherapies. Inclusion criteria with previous treatments could be problematic. Lack of consistent chemotherapy regimens makes generalizing results difficult.

Nursing Implications

Implications for nurses indicates that knowledge and adherence to guidelines assist in managing CINV. As nurses, we must be advocates for patients, and ensure that the patient receives the best supportive care to prevent CINV and avoid breakthrough symptoms. Nurses should be aware of ONS guidelines to guide their practice.