80 PART TWO | CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING and dexamethasone did not significantly improve CR rates during the acute, delayed, and overall phase among previously untreated patients receivingMEC, although a clear benefit of olanzapine was observed in the management of vomiting and quality of life. Because data on the efficacy of olanzapine are limited, more studies are needed to evaluate the efficacy of olanzapine against delayed CINV, and delayed nausea in particular, in patients treated with MEC. The present study has some limitations. First, 42 patients were eliminated from the full analysis set, because these subjects did not complete study assessments, despite planned telephone calls on day 2 by research personnel to ensure adherence to the study protocol. Complement of study assessments was essential to perform the efficacy and safety analyses in this study. Failure to include these subjects in the full analysis set may have reduced statistical power and efficiency of the study. However, after taking observed data into account, there were no systematic differences between participants with complete data as compared to those with missing data. Second, when this study was conducted, carboplatin was considered as a moderately emetogenic agent. Ultimately, 38 patients receiving carboplatin-based chemotherapy (evenly distributed across treatment groups) were included in the efficacy and safety analyses. Recently, carboplatin area under the curve (AUC) ≥4 mg/mL/minute has been reclassified as highly emetogenic chemotherapy [13, 14]. Consequently, these patients would no longer have been able to participate in this study, but should have received a three-drug antiemetic regimen including a NK1 receptor antagonist according to updated antiemetic guidelines [13, 14]. Third, the modified FLIE questionnaire with a 5-day recall period was not only completed on day 6 post-chemotherapy (in accordance with the validation study [24], but also on day 2 post-chemotherapy in order to obtain additional data on the impact of acute CINV on the patients’ daily lives. It should be mentioned that the FLIE has not been validated for use on day 2, which may have affected the reliability of the questionnaire responses. Fourth, a large majority of patients were diagnosed with colorectal cancer (85.7%) and treated with oxaliplatin-based chemotherapy (81.5%). Therefore, the results of this study add information on the control of delayed CINV caused by oxaliplatin-based MEC in particular. It is difficult to generalize the results to other MEC regimens. A possible explanation for this overrepresentation of oxaliplatin is that only chemotherapy-naïve patients were eligible in the present study, and many MEC agents other than oxaliplatin (e.g. irinotecan, carboplatin AUC <4 mg/mL/minute, monotherapy doxorubicin or cyclophosphamide <1500 mg/m2) are rarely used as first-line chemotherapeutic agents. Fifth, the present study was designed to assess the control rates of delayed CINV after the first course of MEC. The noninferiority of DEX-sparing strategies after repeated MEC cycles should be determined in future studies. Finally, although baseline characteristics were similar between treatment groups, we did not perform subgroup analyses categorized by individual patient factors that are well known to contribute to emetic risk, such as younger age, female sex, history of morning sickness, anxiety, and expectations of nausea or vomiting [37, 38].
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