Health Related Quality of Life after Interval Cytoreductive Surgery with or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients with Stage III Ovarian Cancer

Abstract

Background: The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer. We evaluated the effect of HIPEC on patient's health-related quality of life (HRQoL) in the OVHIPEC trial. Methods: OVHIPEC was a multicentre, open-label, randomized phase III trial for patients with stage III epithelial ovarian cancer. Patients were randomly assigned (1:1) to receive interval CRS with or without HIPEC with cisplatin. HRQoL was assessed using the EORTC QLQ-C30, and the ovarian cancer (QLQ-OV28) and colorectal cancer (QLQ-CR38) modules. HRQoL was assessed at baseline, after surgery, following the last cycle of chemotherapy, and every three months thereafter until a maximum of two years after randomization. HRQoL was a secondary endpoint of the OVHIPEC trial, with the prespecified focus on the QLQ-C30 summary score and symptom scales for fatigue, neuropathy and gastro-intestinal symptoms. HRQoL data were analysed using linear and non-linear mixed effect models, with time from randomization in weeks as temporal variable. Findings: From April 2007 through April 2016, 245 patients were randomized. One-hundred-ninety-seven patients (80%) completed at least one questionnaire. No significant difference in QLQ-C30 summary scores was observed between the study arms over time (p-values for linear and non-linear growth: p>0·133). The pattern over time for the symptom scales for fatigue, neuropathy and gastro-intestinal symptoms did not significantly differ between treatment arms. Interpretation: The addition of HIPEC to interval CRS does not negatively impact HRQoL in patients with stage III ovarian cancer who are treated with interval CRS. These HRQoL results, together with the improvement in recurrence-free and overall survival, support the viability of HIPEC as an important treatment option in this patient population. Clinical Trial Number: ClinicalTrials.gov number, NCT00426257; EudraCT number2006-003466-34 Funding Statement: This HRQoL study was performed without funding. The OVHIPEC trial was funded by the Dutch Cancer Society, NKI 2006-4176 Declaration of Interests: The authors declare no conflicts of interest. Ethics Approval Statement: The local ethical committees of all participating centres approved the study protocol. All participating patients provided written informed consent and agreed to complete questionnaires as part of their consent.