Niels Neymark1, Ralph Crott. 1. EORTC Health Economics Unit, Brussels, Belgium. neymark@skynet.be
Abstract
OBJECTIVE: It is a current hypothesis that chemotherapy-induced nausea and vomiting (CINV) may ultimately impede the clinical success of cancer treatments by hindering patients' adherence to the optimal treatment schedule. The aim of this study is to examine clinical trial data retrospectively for possible evidence of such a detrimental impact of CINV. PATIENTS AND METHODS: Data from three recent European Organization for Research and Treatment of Cancer (EORTC) trials of highly emetogenic cisplatin-based chemotherapy in diverse patient populations were analyzed retrospectively for incidence and possible impact of CINV. Data on the incidence of emesis are presented as simple descriptive analyses, while the hypothetical impact of CINV on clinical outcomes and on the patients' length of hospital stays is analyzed by means of multivariate regression analysis techniques to control for confounding variables. MAIN RESULTS: Between 42 and 59% of the patients in the trials experienced at least one episode of nausea of NCIC grade 2 or worse, while the incidence of vomiting of similar grade was between 31 and 58%. Only in one of the trials could the determinants of the adherence to protocol therapy be assessed, statistically significant variables were the severity of emesis (p < 0.0001) and other toxicities combined (p < 0.019). In turn, a Cox regression showed adherence to protocol therapy and other toxicities as the only statistically significant determinants of overall survival. CONCLUSIONS: This study has shown a discernible detrimental impact of CINV on patients' adherence to protocol therapy and, indirectly, on survival in one of the three trials examined. Further studies are required to substantiate this finding.
OBJECTIVE: It is a current hypothesis that chemotherapy-induced nausea and vomiting (CINV) may ultimately impede the clinical success of cancer treatments by hindering patients' adherence to the optimal treatment schedule. The aim of this study is to examine clinical trial data retrospectively for possible evidence of such a detrimental impact of CINV. PATIENTS AND METHODS: Data from three recent European Organization for Research and Treatment of Cancer (EORTC) trials of highly emetogenic cisplatin-based chemotherapy in diverse patient populations were analyzed retrospectively for incidence and possible impact of CINV. Data on the incidence of emesis are presented as simple descriptive analyses, while the hypothetical impact of CINV on clinical outcomes and on the patients' length of hospital stays is analyzed by means of multivariate regression analysis techniques to control for confounding variables. MAIN RESULTS: Between 42 and 59% of the patients in the trials experienced at least one episode of nausea of NCIC grade 2 or worse, while the incidence of vomiting of similar grade was between 31 and 58%. Only in one of the trials could the determinants of the adherence to protocol therapy be assessed, statistically significant variables were the severity of emesis (p < 0.0001) and other toxicities combined (p < 0.019). In turn, a Cox regression showed adherence to protocol therapy and other toxicities as the only statistically significant determinants of overall survival. CONCLUSIONS: This study has shown a discernible detrimental impact of CINV on patients' adherence to protocol therapy and, indirectly, on survival in one of the three trials examined. Further studies are required to substantiate this finding.
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