Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer

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DOI

  • S. N. Koole, Center for Gynecologic Oncology Amsterdam, The Netherlands Cancer Institute
  • ,
  • J. M. Kieffer, The Netherlands Cancer Institute
  • ,
  • K.Sikorska, The Netherlands Cancer Institute
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  • J. H. Schagen van Leeuwen, St Antonius Hospital Nieuwegein
  • ,
  • H. W.R. Schreuder, UMC Utrecht Cancer Center
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  • R. H. Hermans, Catharina Hospital
  • ,
  • I. H. de Hingh, Catharina Hospital, The Dutch Peritoneal Oncology Group
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  • J. van der Velden, Center for Gynecologic Oncology Amsterdam, Amsterdam UMC - University of Amsterdam
  • ,
  • H. J. Arts, University Medical Center Groningen
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  • M. A.P.C. van Ham, Radboud University Nijmegen Medical Centre
  • ,
  • A. G. Aalbers, The Dutch Peritoneal Oncology Group, The Netherlands Cancer Institute
  • ,
  • V. J. Verwaal
  • ,
  • K. K. Van de Vijver, Ghent University Hospital, Ghent
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  • G. S. Sonke, Center for Gynecologic Oncology Amsterdam, The Netherlands Cancer Institute
  • ,
  • W. J. van Driel, Center for Gynecologic Oncology Amsterdam, Dutch Gynecological Oncology Group, The Netherlands Cancer Institute
  • ,
  • N. K. Aaronson, The Netherlands Cancer Institute

Introduction: The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improves recurrence-free (RFS) and overall survival (OS) 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. Materials and methods: OVHIPEC was a multicentre, open-label, randomized phase III trial for patients with stage III 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 (QLQ-OV28) and colorectal cancer (QLQ-CR38) modules. HRQoL questionnaires were administered at baseline, after surgery, after end of treatment, and every three months thereafter. HRQoL was a secondary endpoint, with the prespecified focus on the QLQ-C30 summary score and symptom scores on fatigue, neuropathy and gastro-intestinal symptoms. HRQoL was analysed using linear and non-linear mixed effect models. Results: In total, 245 patients were randomized. One-hundred-ninety-seven patients (80%) completed at least one questionnaire. No significant difference over time in the QLQ-C30 summary scores was observed between the study arms (p-values for linear and non-linear growth: p > 0.133). The pattern over time for fatigue, neuropathy and gastro-intestinal symptoms did not significantly differ between treatment arms. Conclusion: 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 due to the extent of disease. These HRQoL results, together with the improvement in RFS and OS, support the viability of HIPEC as an important treatment option in this patient population. ClinicalTrials.gov number: NCT00426257. EudraCT number: 2006-003466-34.

OriginalsprogEngelsk
TidsskriftEuropean Journal of Surgical Oncology
Vol/bind47
Nummer1
Sider (fra-til)101-107
Antal sider7
ISSN0748-7983
DOI
StatusUdgivet - jan. 2021

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