Methods
acute myocardial infarction, nausea or vomiting, nausea, appetite increase, alcoholism, dementia, vomiting, hypersensitivity, malignant disease
ACUTE MYOCARDIAL INFARCTION, DIABETES MELLITUS, CENTRAL NERVOUS SYSTEM DISEASE, CARDIAC ARRHYTHMIA, CONGESTIVE HEART FAILURE, ONCOLOGY, SEIZURE DISORDER, HYPERSENSITIVITY, MALIGNANT DISEASE
Alliance A221602 was a prospective double-blind, ­placebo-controlled clinical trial. Eligible patients for this trial were required to have a malignant disease for which highly emetogenic chemotherapy was prescribed. Patients entered on this trial could not have received any previous chemotherapy, must have been at least 18 years old, and must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better. They could not have had nausea or vomiting in the 24 hours prior to trial registration, a known diagnosis of dementia, a positive pregnancy test, or significant nonmalignant central nervous system disease such as a seizure disorder. In addition, they could not have been receiving treatment with an antipsychotic agent such as olanzapine, risperidone, quetiapine, clozapine, butyrophenone, or a phenothiazine, in the 30 days prior to registration. Also, they could not have received amifostine or quinolone antibiotic therapy within 7 days prior to registration. No radiotherapy was allowed within 7 days prior to registration or planned for 1 week after the initial planned dose of chemotherapy. Patients could not have had chronic alcoholism, a known hypersensitivity to olanzapine, an uncontrolled cardiac arrhythmia, uncontrolled congestive heart failure, an acute myocardial infarction within the previous 6 months, or a history of uncontrolled diabetes mellitus. Adequate renal and liver function was required.Patients participating in the current trial received intravenous highly emetogenic chemotherapy defined as either (1) cisplatin, given on a single day, at a dose of ≥70 mg/mPatients were randomized at a 1:1 ratio to receive an NK-1 receptor antagonist (intravenous [IV] fosaprepitant 150 mg or aprepitant 130 mg), on day one or a corresponding placebo, in a double-blinded manner. Patients were stratified according to gender, their chemotherapy regimen, and the specific 5-HTPatients in both arms were scheduled to receive (1) a 5-HTPatients completed a questionnaire at baseline and then daily for 5 days after chemotherapy that inquired about (1) nausea (on a 0-10 numerical analog scale that asked about their worse nausea from “no nausea at all” to “nausea as bad as it can be”; (2) any undesired sedation trouble that they had over the past 24 hours; and (3) any undesired appetite increase that they had over the prior 24 hours.Patients completed questionnaires daily for 5 days after chemotherapy that also asked them to note, over the prior 24 hours, how much nausea they had, how much vomiting that they had (none, once, twice, or more than twice) and the “number of extra nausea/vomiting pills taken because you developed nausea/vomiting” (none, one, 2, or more than 2).Nurse phone calls were also made daily for 5 days after chemotherapy to inquire about the same questions indicated above, to encourage the patients to complete their questionnaires, and to address any patient inquiries.When patients returned for a second cycle of the same chemotherapy, they were encouraged to continue treatment with their initially assigned antiemetic agents for an additional 3 chemotherapy cycles. Those choosing to continue on the protocol were unblinded, given they had completed and submitted all required questionnaires for their first cycle of treatment, and no placebo medication was given. Patients were asked to complete the same questionnaires on the same schedule that was used on the first cycle.