Jordan, K., Jahn, F., Jahn, P., Behlendorf, T., Stein, A., Ruessel, J., … Schmoll, H. J. (2011). The NK-1 receptor-antagonist aprepitant in high-dose chemotherapy (high-dose melphalan and high-dose T-ICE: Paclitaxel, ifosfamide, carboplatin, etoposide): Efficacy and safety of a triple antiemetic combination. Bone Marrow Transplantation, 46(6), 784–789.
DOI Link
Study Purpose
To assess the role of an neurokinin 1 (NK1) antagonist in antimetic protection in combination with granisetron and dexamethasone in patients receiving high-dose chemotherapy (HDC)
Intervention Characteristics/Basic Study Process
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Patient undergoing multiple days of HDC received granisetron, dexamethasone, and aprepitant during chemotherapy and two days after the completion of chemotherapy.
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Patients were receiving two HDC regimens for at least two days.
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Melphalan, 70 mg – 100 mg/m2, days 1-4, followed by peripheral blood stem cell translant (PBSCT)
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Paclitaxel, carboplatin, etoposide, and ifosfamide
Sample Characteristics
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This study consisted of 64 patients.
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Patient mean age was 42.3 with a range of 21–67. The percentage of patients younger than age 35 was 18%.
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The study consisted of 52 male patients (81.2%) and 12 female patients (18.8%).
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Patients had been diagnosed with multiple myeloma (MM) (32.8%), thymic cancinoma (6.3%), testicular cancer (35.9%), sarcoma (23.4%), and unknown primary (1.6%).
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Additionally, 9.4% of patients had received previous gastrointestinal (GI) surgery, 7.8% had a history of alcohol abuse, 7.8% had a history of loss of appetite, 6.3% had preexisting nausea, 1.6% had preexisting dizziness, and 14.1% had anxiety.
Setting
This study was conducted at a single site at a university hospital in Halle, Germany.
Phase of Care and Clinical Applications
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All patients were in active treatment.
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The study has clinical application for elderly care.
Study Design
This was a nonrandomized, single-center, observational trial.
Measurement Instruments/Methods
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Complete response (CR) was defined as no vomiting and no use of rescue medications in the overall phase (days 1 until 5 days postchemotherapy).
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Nausea and vomiting were recorded daily on a special documentary chart. All adverse events were recorded to evaluate the tolerability and were graded according to the common terminology criteria.
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All other drugs administered to the patient during the study were recorded.
Results
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For the overall evaluation phase, the primary endpoint of CR was achieved with 40 (63%) patients.
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For the acute phase (during days of HDC), CR was achieved in 53 patients (83%).
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For the delayed phase (days 1 through 5 after the end of HDC) CR was seen in 45 patients (70%).
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Acute nausea was observed in 13 patients (20%), delayed nausea in 24 patients (24%), and overall nausea in 30 patients (47%).
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At the day of retransfusion of stem cells (second day of delayed phase in all HDC groups), the CR rate was 84% and the rate of nausea was 19%.
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The authors concluded that randomized studies may be necessary to add aprepitant to guidelines.
Conclusions
The study demonstrated a good toxicity profile with the addition of aprepitant to the standard antiemetic regimen, with improvement in the prevention of chemotherapy-induced nausea and vomiting (CINV) during multiday, high-dose regimens.
Limitations
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The study had a small sample with fewer than 100 patients.
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Tools or scales used to measure nausea were not reported.
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A description of how vomiting and nausea were recorded on the special documentation form was not included.
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The authors did not describe how the nurses were trained to use the form and whether it was only recorded by registered nurses.
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Methodological limitations exist with comparing the results with those only from the current literature.
Nursing Implications
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The addition of aprepitant to standard antiemetic regimens during multiday HDC administration provides additional protection for both acute and delayed CINV.
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The possible reaction between aprepitant and Ifosfamide was within the reported range of induced encephalopathy (26%, range = 10%–30%).