Ruby M. van Stein

Evaluation of external validity of the OVHIPEC‐1 trial in a real‐world population

AbstractObjectiveThe OVHIPEC‐1 trial (Phase III randomised clinical trial for stage III ovarian carcinoma randomising between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy) showed improved survival when interval cytoreductive surgery (CRS) was combined with hyperthermic intraperitoneal chemotherapy in patients with stage III epithelial ovarian cancer (EOC). The authors compared the control arm of the trial with a real‐world population treated in the Netherlands during the same period to explore generalizability of the trial results.MethodsFor this nationwide comparative cohort study, all patients with EOC undergoing interval CRS between 2007 and 2016 were identified from the Netherlands Cancer Registry if they fulfilled the eligibility criteria of OVHIPEC‐1 (n = 1376). Patient and treatment characteristics, and overall survival (OS) were compared between trial and real‐world populations.ResultsAge, comorbidity, BRCA status, histologic subtype, and residual disease were similar in trial and real‐world patients. Trial patients had a better performance status, higher socioeconomic status, and underwent bowel surgery more often. In a real‐world setting, patients more often received more than six cycles. The difference in OS between the trial and the real‐world populations was not statistically significant (unadjusted hazard ratio, 1.09 [95% confidence interval, 0.87–1.37]; P = 0.44).ConclusionDespite differences in patient characteristics, OS of patients treated in the control arm of OVHIPEC‐1 was similar to patients treated outside the trial. The trial population accurately represents real‐world patients with stage III EOC undergoing interval CRS in terms of outcome.

Is routine admission to a critical care setting following hyperthermic intraperitoneal chemotherapy for ovarian cancer necessary?

Hyperthermic intraperitoneal chemotherapy (HIPEC) is increasingly being used in patients with stage III ovarian cancer undergoing interval cytoreductive surgery (CRS). It is uncertain whether routine postoperative admission to a critical care setting after CRS-HIPEC is necessary. This study aims to estimate the incidence of patients requiring critical care, and to create a prediction model to identify patients who may forego admission to a critical care setting. We analyzed 154 patients with primary ovarian cancer undergoing interval CRS-HIPEC at two Dutch centers between 2007 and 2021. Patients were routinely admitted to a critical care setting for 12-24 h. Patients that received critical support as defined by pre-specified definitions were retrospectively identified. Logistic regression analysis with backward selection was used to predict the need for critical care and the model was validated using bootstrapping. Thirty-eight percent of patients received postoperative critical care, consisting mainly of hemodynamic interventions. Independent predictors of critical care were blood loss, norepinephrine dose during surgery, and age (bootstrapped AUC = 0.76). Using a probability cut-off of 20%, one-third of patients are defined as low-risk for requiring critical care, with a negative predictive value of 0.88. The majority of patients,primarily undergoing low to intermediate complexity surgeries, did not receive critical care interventions after CRS-HIPEC. Selective admission to a critical care setting may be warranted and its feasibility and safety needs to be evaluated prospectively. Our prediction model can help identify patients in whom admission to a critical care setting may be omitted. Hospital costs and burden on critical care units will benefit from patient selection.