Pediatric cancer patients in clinical trials of sepsis: Factors that predispose to sepsis and stratify outcome

Objective: To delineate the factors that predispose pediatric oncology and hematopoietic stem cell transplant (HSCT) patients to sepsis and to identify factors that stratify their outcome. Data source: Peer-reviewed literature available via MEDLINE search. Study selection: All types of study. Conclusions: Pediatric oncology patients account for a relatively high proportion of severe sepsis in children. Available data suggest that outcomes among the non-HSCT oncology population are not substantially different from that of the general population. Data suggest that children with cancer (non-HSCT) who survive their septic episode will have a high probability of 6-month survival. In light of these findings, pediatric oncology patients are an important source of potential candidates for clinical trials of sepsis. In addition, HSCT patients seem to have significantly worse outcomes from sepsis than the non-HSCT oncology population, and thus, their participation in clinical trials is needed. However, in view of these worse outcomes, it is important to stratify the randomization for this population and to ensure that studies are adequately powered to assess outcomes in this subgroup.