Jordan, K., Kinitz, I., Voigt, W., Behlendorf, T., Wolf, H., & Schmoll, H. (2009). Safety and efficacy of a triple antiemetic combination with the NK-1 antagonist aprepitant in highly and moderately emetogenic multiple-day chemotherapy. European Journal of Cancer, 45, 1184–1187.
DOI Link
Study Purpose
To determine the role of an neurokinin 1 (NK1) antagonist in multiple-day chemotherapy, in addition to standard of a 5-HT3 receptor antagonists and dexamethasone
Intervention Characteristics/Basic Study Process
Oral aprepitant 125 mg was given 1 hour before chemotherapy on day 1 and 80 mg oral aprepitant was given daily during chemotherapy and for 2 days after completion of the treatment course. Patients also received 1 mg IV granisetron and 8 mg IV dexamethasone daily prior to chemotherapy. Use and choice of rescue medication was at the discretion of the physician.
Sample Characteristics
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The study reported on 78 participants.
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Mean age was 40, with a range of 18–71 years.
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The sample was 18% female and 82% male.
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The most frequent diagnoses were germ cell cancer and sarcoma. Other diagnoses were myeloma, lymphoma, and thymus cancer.
Setting
The setting was a single site in Germany.
Phase of Care and Clinical Applications
Patients were in active treatment.
Study Design
The study design was a prospective trial.
Measurement Instruments/Methods
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The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for toxicity assessment was used with nausea rated as yes or no.
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Complete response (CR) was defined as no nausea or vomiting and no use of rescue medication.
Results
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65.8% had CR in the acute phase.
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68.4% had CR in the delayed phase.
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57.9% had CR in the overall phase.
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Preexisting nausea (p < 0.05), pretreatment anxiety (p = 0.0001), and patients with brain metastases (p = 0.04) were associated with lower CR rates.
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No patients discontinued because of adverse events.
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Most common events were hiccups (7.7%), diarrhea, and constipation.
Conclusions
Aprepitant appears to be well-tolerated. CR rates were only slightly above those commonly seen with 5-HT3 receptor antagonists and dexamethasone.
Limitations
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No control comparison or blinding with associated risk of bias was used.
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Methods of nausea and vomiting measurement were not clearly stated.
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Use of rescue medications was not stated.
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Definition of nausea as a single yes or no measure is questionable.
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Timing of measures was not stated.
Nursing Implications
Further well-defined research to fully evaluate multiple drug chemotherapy-induced nausea and vomiting regimens is warranted.