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; null 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

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

Research output: Contribution to journal › Review article › peer-review

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.

Original language	English
Pages (from-to)	101-107
Number of pages	7
Journal	European Journal of Surgical Oncology
Volume	47
Issue number	1
Early online date	13 May 2019
DOIs	https://doi.org/10.1016/j.ejso.2019.05.006
Publication status	Published - Jan 2021

Keywords

Health-related quality of life (HRQoL)
Hyperthermic intraperitoneal chemotherapy (HIPEC)
Ovarian cancer

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10.1016/j.ejso.2019.05.006

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Koole, S. N., Kieffer, J. M., K Sikorska, Schagen van Leeuwen, J. H., Schreuder, H. W. R., Hermans, R. H., de Hingh, I. H., van der Velden, J., Arts, H. J., van Ham, M. A. P. C., Aalbers, A. G., Verwaal, V. J., Van de Vijver, K. K., Sonke, G. S., van Driel, W. J., & Aaronson, N. K. (2021). Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer. European Journal of Surgical Oncology, 47(1), 101-107. https://doi.org/10.1016/j.ejso.2019.05.006

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

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",

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

note = "Funding Information: The OVHIPEC trial was supported by the Dutch Cancer Society (grant number NKI 2006-4176). We would like to thank the following individuals for contributing patients and for data collection for this study: R van Ginkel (University Medical Centre Groningen, Groningen, the Netherlands), K Havenga (University Medical Centre Groningen, Groningen, the Netherlands), A Reyners (University Medical Centre Groningen, Groningen, the Netherlands), A de Jong (Radboud University Medical Centre, Nijmegen, the Netherlands), L Massuger (Radboud University Medical Centre, Nijmegen, the Netherlands), P Ottevanger (Radboud University Medical Centre, Nijmegen, the Netherlands), P Witteveen (UMC Utrecht Cancer Centre, Utrecht, the Netherlands), M Hermans (Sint Antonius Hospital, Nieuwegein, the Netherlands), M Los (Sint Antonius Hospital, Nieuwegein, the Netherlands), M Wiezer (Sint Antonius Hospital, Nieuwegein, the Netherlands), C van Dam (Sint Antonius Hospital, Nieuwegein, the Netherlands), F Kosterman (Academic Medical Centre, Amsterdam, the Netherlands), P Tanis (Academic Medical Centre, Amsterdam, the Netherlands), A Westermann (Academic Medical Centre, Amsterdam, the Netherlands), Y Boomgaard (Catharina Hospital Eindhoven, Eindhoven, the Netherlands), D van Loosdrecht (Catharina Hospital Eindhoven, Eindhoven, the Netherlands), R Lembrechts (University Hospital Antwerp, Antwerpen, Belgium), P van Dam (University Hospital Antwerp, Antwerpen, Belgium), P Vuylsteke (University Hospital Centre, University Catholique de Louvain Namur, Louvain, Belgium). We would like to thank the following individuals for data collection and data management: A Torres (The Netherlands Cancer Institute, Amsterdam, the Netherlands), J Kant (The Netherlands Cancer Institute, Amsterdam, the Netherlands), L Pronk (The Netherlands Cancer Institute, Amsterdam, the Netherlands), D Baars (The Netherlands Cancer Institute, Amsterdam, the Netherlands). We thank The Netherlands Comprehensive Cancer Organization (IKNL) for performing local data management. Funding Information: The OVHIPEC trial was supported by the Dutch Cancer Society (grant number NKI 2006-4176 ). Publisher Copyright: {\textcopyright} 2019 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology",

year = "2021",

month = jan,

doi = "10.1016/j.ejso.2019.05.006",

language = "English",

volume = "47",

pages = "101--107",

journal = "European Journal of Surgical Oncology",

issn = "0748-7983",

publisher = "W.B. Saunders Ltd",

number = "1",

}

Koole, SN, Kieffer, JM, K Sikorska, Schagen van Leeuwen, JH, Schreuder, HWR, Hermans, RH, de Hingh, IH, van der Velden, J, Arts, HJ, van Ham, MAPC, Aalbers, AG, Verwaal, VJ, Van de Vijver, KK, Sonke, GS, van Driel, WJ & Aaronson, NK 2021, 'Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer', European Journal of Surgical Oncology, vol. 47, no. 1, pp. 101-107. https://doi.org/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. / Koole, S N; Kieffer, J M; K Sikorska et al.
In: European Journal of Surgical Oncology, Vol. 47, No. 1, 01.2021, p. 101-107.

Research output: Contribution to journal › Review article › peer-review

TY - JOUR

T1 - Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer

AU - Koole, S N

AU - Kieffer, J M

AU - K Sikorska, null

AU - Schagen van Leeuwen, J H

AU - Schreuder, H W R

AU - Hermans, R H

AU - de Hingh, I H

AU - van der Velden, J

AU - Arts, H J

AU - van Ham, M A P C

AU - Aalbers, A G

AU - Verwaal, V J

AU - Van de Vijver, K K

AU - Sonke, G S

AU - van Driel, W J

AU - Aaronson, N K

N1 - Funding Information: The OVHIPEC trial was supported by the Dutch Cancer Society (grant number NKI 2006-4176). We would like to thank the following individuals for contributing patients and for data collection for this study: R van Ginkel (University Medical Centre Groningen, Groningen, the Netherlands), K Havenga (University Medical Centre Groningen, Groningen, the Netherlands), A Reyners (University Medical Centre Groningen, Groningen, the Netherlands), A de Jong (Radboud University Medical Centre, Nijmegen, the Netherlands), L Massuger (Radboud University Medical Centre, Nijmegen, the Netherlands), P Ottevanger (Radboud University Medical Centre, Nijmegen, the Netherlands), P Witteveen (UMC Utrecht Cancer Centre, Utrecht, the Netherlands), M Hermans (Sint Antonius Hospital, Nieuwegein, the Netherlands), M Los (Sint Antonius Hospital, Nieuwegein, the Netherlands), M Wiezer (Sint Antonius Hospital, Nieuwegein, the Netherlands), C van Dam (Sint Antonius Hospital, Nieuwegein, the Netherlands), F Kosterman (Academic Medical Centre, Amsterdam, the Netherlands), P Tanis (Academic Medical Centre, Amsterdam, the Netherlands), A Westermann (Academic Medical Centre, Amsterdam, the Netherlands), Y Boomgaard (Catharina Hospital Eindhoven, Eindhoven, the Netherlands), D van Loosdrecht (Catharina Hospital Eindhoven, Eindhoven, the Netherlands), R Lembrechts (University Hospital Antwerp, Antwerpen, Belgium), P van Dam (University Hospital Antwerp, Antwerpen, Belgium), P Vuylsteke (University Hospital Centre, University Catholique de Louvain Namur, Louvain, Belgium). We would like to thank the following individuals for data collection and data management: A Torres (The Netherlands Cancer Institute, Amsterdam, the Netherlands), J Kant (The Netherlands Cancer Institute, Amsterdam, the Netherlands), L Pronk (The Netherlands Cancer Institute, Amsterdam, the Netherlands), D Baars (The Netherlands Cancer Institute, Amsterdam, the Netherlands). We thank The Netherlands Comprehensive Cancer Organization (IKNL) for performing local data management. Funding Information: The OVHIPEC trial was supported by the Dutch Cancer Society (grant number NKI 2006-4176 ). Publisher Copyright: © 2019 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology

PY - 2021/1

Y1 - 2021/1

N2 - 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.

AB - 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.

KW - Health-related quality of life (HRQoL)

KW - Hyperthermic intraperitoneal chemotherapy (HIPEC)

KW - Ovarian cancer

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U2 - 10.1016/j.ejso.2019.05.006

DO - 10.1016/j.ejso.2019.05.006

M3 - Review article

C2 - 31128948

SN - 0748-7983

VL - 47

SP - 101

EP - 107

JO - European Journal of Surgical Oncology

JF - European Journal of Surgical Oncology

IS - 1

ER -

Koole SN, Kieffer JM, K Sikorska, Schagen van Leeuwen JH, Schreuder HWR, Hermans RH et al. Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer. European Journal of Surgical Oncology. 2021 Jan;47(1):101-107. Epub 2019 May 13. 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

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