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

S N Koole; J M Kieffer; K Sikorska; J H Schagen van Leeuwen; H W R Schreuder; R H Hermans; I H de Hingh; J van der Velden; H J Arts; M A P C van Ham; A G Aalbers; V J Verwaal; K K Van de Vijver; G S Sonke; W J van Driel; N K Aaronson

doi:10.1016/j.ejso.2019.05.006

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

Eur J Surg Oncol. 2021 Jan;47(1):101-107. doi: 10.1016/j.ejso.2019.05.006. Epub 2019 May 13.

Authors

S N Koole¹, J M Kieffer², K Sikorska³, J H Schagen van Leeuwen⁴, H W R Schreuder⁵, R H Hermans⁶, I H de Hingh⁷, J van der Velden⁸, H J Arts⁹, M A P C van Ham¹⁰, A G Aalbers¹¹, V J Verwaal¹², K K Van de Vijver¹³, G S Sonke¹⁴, W J van Driel¹⁵, N K Aaronson¹⁶

Affiliations

¹ Department of Gynecology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands.
² Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
³ Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
⁴ Department of Obstetrics & Gynecology, Sint Antonius Hospital, Nieuwegein, the Netherlands.
⁵ Department of Gynecological Oncology, UMC Utrecht Cancer Center, Utrecht, the Netherlands.
⁶ Department of Gynecology and Obstetrics, Catharina Hospital, Eindhoven, the Netherlands.
⁷ Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands; The Dutch Peritoneal Oncology Group, the Netherlands.
⁸ Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands; Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Amsterdam, the Netherlands.
⁹ Department of Gynecological Oncology, University Medical Center Groningen, Groningen, the Netherlands.
¹⁰ Department of Gynecological Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.
¹¹ The Dutch Peritoneal Oncology Group, the Netherlands; Department of Surgical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
¹² Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
¹³ Department of Pathology, University Hospital Ghent, Ghent, Belgium.
¹⁴ Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands.
¹⁵ Department of Gynecology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands; Dutch Gynecological Oncology Group, the Netherlands.
¹⁶ Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: [email protected].

PMID: 31128948
DOI: 10.1016/j.ejso.2019.05.006

Abstract

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.

Keywords: Health-related quality of life (HRQoL); Hyperthermic intraperitoneal chemotherapy (HIPEC); Ovarian cancer.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Belgium
Carboplatin / administration & dosage
Combined Modality Therapy
Cytoreduction Surgical Procedures*
Female
Humans
Hyperthermic Intraperitoneal Chemotherapy*
Middle Aged
Neoplasm Staging
Netherlands
Ovarian Neoplasms / pathology
Ovarian Neoplasms / therapy*
Paclitaxel / administration & dosage
Quality of Life*
Surveys and Questionnaires

Substances

Carboplatin
Paclitaxel

Associated data

ClinicalTrials.gov/NCT00426257