Takeshima, N., Matoda, M., Abe, M., Hirashima, Y., Kai, K., Nasu, K., . . . Ito, K. (2014). Efficacy and safety of triple therapy with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy for gynecological cancer: KCOG-G1003 phase II trial. Supportive Care in Cancer, 22(11), 2891–2898.

DOI Link

Study Purpose

To evaluate the efficacy of the triple therapy of aprepitant, palonosetron, and dexamethasone in patients with gynecological cancer receiving highly emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

Women with gynecological cancer who were receiving highly emetogenic chemotherapy received 125 mg PO aprepitant before chemotherapy on day 1 and 80 mg on days 2 and 3, 0.75 mg of IV palonosetron before chemotherapy on day 1, and 9.9 mg of PO/IV dexamethasone before chemotherapy on day 1 and at 6.6 mg on days 2–4. The primary aim was to evaluate the number of patients with a complete response (CR) overall, which was defined as no vomiting and no use of rescue medication during the entire study period (0–120 hours postchemotherapy). The secondary aims were (1) to evaluate CR in the acute (0–24 hours postchemotherapy) and delayed (24–120 hours postchemotherapy) phases of treatment and (2) to evaluate complete protection (CP) defined as no vomiting, no rescue therapy, and no significant nausea overall and during the acute and delayed phases of treatment.

Sample Characteristics

N = 96
MEDIAN AGE = 55 years (range = 32–75 years)
FEMALES: 100%
KEY DISEASE CHARACTERISTICS: Gynecologic cancer
OTHER KEY SAMPLE CHARACTERISTICS: Patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 50 mg/m².

Setting

SITE: Multi-site
SETTING TYPE: Outpatient
LOCATION: Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, multi-center study

Measurement Instruments/Methods

No information was provided on the measurement of nausea and vomiting. A Visual Analog Scale (VAS) may have been used, although this was not expressly stated and the range and timing of administration of the VAS was undefined.

Results

For the primary aim, overall CR rate was 54.2 %. For the secondary aim, evaluating the number of patients with CR in the acute and delayed phases of treatment, CR was 87.5% in the acute phase of treatment and 56.3% in the delayed phase of treatment. For the secondary aim evaluating CP overall and during the acute and delayed phases of treatment, CP overall was 44.8%, CP during the acute phase of treatment was 82.3%, and CP during the delayed phase of treatment was 45.8%.

Conclusions

The combination of aprepitant, palonosetron, and dexamethasone showed similar CR and CP rates when compared to existing two-drug combinations (e.g., a first-generation 5-HT3 receptor antagonist plus dexamethasone). These results would indicate that the triple therapy is a safe and effective method to manage chemotherapy-induced nausea and vomiting (CINV) in patients with gynecological malignancies receiving cisplatin-based chemotherapy.

Limitations

Small sample (< 100)
Risk of bias (no control group)
Measurement/methods not well described
Measurement validity/reliability questionable
Findings not generalizable
Other limitations/explanation: No information was provided as to how the authors assessed nausea and vomiting, and as such we cannot know how valid or reliable the method of assessment was. The findings are only applicable to Japanese gynecological patients at this stage until further testing can take place in a more diverse sample.

Nursing Implications

CINV is often difficult to control and is especially prevalent in female patients. The combination of aprepitant, palonosetron, and dexamethasone has comparable rates of CR and CP when compared to other antiemetic regimens; however, the population used in this study has been shown to be at greater risk for severe CINV. This should be a recommended antiemetic regimen for gynecological patients receiving highly emetogenic chemotherapy.