Predictors of toxicity-related hospitalization in four randomized studies of 5-fluorouracil-based chemotherapy in metastatic colorectal cancer
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To evaluate the predictors of toxicity-related hospitalization associated with various chemotherapy regimens among metastatic colorectal cancer patients
This pooled analysis includes patient-level datasets from four randomized clinical studies (NCT00272051; NCT00305188; NCT00115765; NCT00364013). Through univariate and multivariate logistic regression analyses, factors predicting the development of serious adverse events, fatal adverse events, and toxicity-related hospitalizations were determined.
A total of 2533 patients were included in the current study. A total of 1010 patients (39.9%) experienced one or more episodes of serious adverse events. These include 914 patients (36.1%) who were hospitalized at least once and 148 patients (5.8%) who suffered from a fatal adverse event. Within multivariate logistic regression analysis, older age (P < 0.001), higher ECOG score (P < 0.001), bevacizumab-containing chemotherapy (P < 0.001), and panitumumab-containing chemotherapy (P < 0.001) were predictive of hospitalization. Similarly, older age (P < 0.001), higher ECOG score (P < 0.001), and panitumumab-containing chemotherapy (P = 0.003) were predictive of fatal adverse events in multivariate logistic regression analysis. Moreover, in a multivariate Cox regression analysis, hospitalization was predictive of worse overall survival (P < 0.001) and progression-free survival (P < 0.001).
Older age, poorer performance status, and bevacizumab- and panitumumab-containing regimens are associated with a higher risk of hospitalization. Moreover, hospitalization is predictive of worse overall and progression-free survival.
Keywords5-fluorouracil Serious adverse events Fatal adverse events Hospitalization Colorectal cancer
This publication is based on research using information obtained from www.projectdatasphere.org.
Compliance with ethical standards
Informed consent was obtained from all participants included in the study.
All procedures performed were in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Conflict of interest
The authors declare that they have no conflict of interest.
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