S N Koole1, J M Kieffer2, J H Schagen van Leeuwen3, H W R Schreuder4, R H Hermans5, I H de Hingh6, J van der Velden7, H J Arts8, M A P C van Ham9, A G Aalbers10, V J Verwaal11, K K Van de Vijver12, G S Sonke13, W J van Driel14, N K Aaronson15. 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 Obstetrics & Gynecology, Sint Antonius Hospital, Nieuwegein, the Netherlands. 4. Department of Gynecological Oncology, UMC Utrecht Cancer Center, Utrecht, the Netherlands. 5. Department of Gynecology and Obstetrics, Catharina Hospital, Eindhoven, the Netherlands. 6. Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands; The Dutch Peritoneal Oncology Group, the Netherlands. 7. Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands; Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Amsterdam, the Netherlands. 8. Department of Gynecological Oncology, University Medical Center Groningen, Groningen, the Netherlands. 9. Department of Gynecological Oncology, Radboud University Medical Center, Nijmegen, the Netherlands. 10. The Dutch Peritoneal Oncology Group, the Netherlands; Department of Surgical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. 11. Department of Surgery, Aarhus University Hospital, Aarhus, Denmark. 12. Department of Pathology, University Hospital Ghent, Ghent, Belgium. 13. Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands. 14. Department of Gynecology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands; Dutch Gynecological Oncology Group, the Netherlands. 15. Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: n.aaronson@nki.nl.
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.
RCT Entities:
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.
Authors: Michel Adamina; Maxime Warlaumont; Martin D Berger; Silvio Däster; Raphaël Delaloye; Antonia Digklia; Beat Gloor; Ralph Fritsch; Dieter Koeberle; Thibaud Koessler; Kuno Lehmann; Phaedra Müller; Ralph Peterli; Frédéric Ris; Thomas Steffen; Christian Stefan Weisshaupt; Martin Hübner Journal: Cancers (Basel) Date: 2022-09-01 Impact factor: 6.575