title: Impact of emesis on clinical and economic outcomes of cancer therapy with highly emetogenic chemotherapy regimens: a retrospective analysis of three clinical trials.
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.
  
  
  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.
  
  
  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.
authors.affiliation: EORTC Health Economics Unit, Brussels, Belgium. neymark@skynet.be
authors.forename: Niels
authors.initials: N
authors.lastname: Neymark
authors.forename: Ralph
authors.initials: R
authors.lastname: Crott
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002945:Cisplatin / Q000009:adverse effects* / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D005060:Europe / Q000453:epidemiology; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000191:economics; D010349:Patient Compliance / Q000523:psychology*; D012189:Retrospective Studies; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced* / Q000191:economics / Q000523:psychology
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin