Exploring the effect of differing centre hydration and anti-emetic policies on acute gastrointestinal and renal toxicities in the De-ESCALaTE trial.

Abstract

Background: The De-ESCALaTE trial confirmed the superiority of cisplatin over cetuximab in combination with radiotherapy for the treatment of low risk HPV+ oropharyngeal cancer (HPV + OPC). However, there were concerns about certain toxicities with the use of cisplatin, in particular nausea, vomiting, dehydration and renal toxicities.

Methods: The De-ESCALaTE trial collected data on several centre level policies on hydration and anti-emetic use. Univariable and backwards stepwise multivariable logistic regression models were used to model the association between centre level policy variables and severe adverse events (SAEs) of interest and severe (grade 3-5) acute toxicities of interest. In addition, the predictive performance of each model was assessed.

Results: Centre level policies including the use of a triple anti-emetics regimen pre and post chemotherapy, increased volumes of IV fluids given before and during cisplatin chemotherapy as well as oral fluids advised post chemotherapy, were all associated with a reduced odds of SAEs of interest. Only a policy to give diuretics was associated with a reduction of severe (grade 3-5) acute toxicities of interest.

Conclusions: For centres with HPV + OPC patients undergoing chemoradiation, we recommend the use of specific hydration and anti-emetic policies to reduce the rates of relevant SAEs and severe acute toxicities.