Evaluation of external validity of the OVHIPEC-1 trial in a real-world population.
Ruby M van SteinK SikorskaM A van der AaG S SonkeW J van Drielnull nullPublished in: International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics (2022)
Age, 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 real-world setting, patients received more often >6 cycles. The difference in OS between trial and real-world population was not statistically significant (unadjusted HR 1.09; 95% CI, 0.87-1.37;P=0.44).Conclusion Despite 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 stage III EOC patients undergoing interval CRS in terms of outcome.