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; 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.

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

Mark

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. and van Ham, M. A.P.C. , et al. (2021) In European Journal of Surgical Oncology 47(1). p.101-107

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,... (More); 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.
(Less)

Please use this url to cite or link to this publication: https://lup.lub.lu.se/record/a51114ec-44d7-4838-84a0-f4c83122d6a8

author

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. and van Ham, M. A.P.C. , et al. (More)

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. ^LU ; Van de Vijver, K. K. ; Sonke, G. S. ; van Driel, W. J. and Aaronson, N. K. (Less)

publishing date

2021

type

Contribution to journal

publication status

published

keywords

in

European Journal of Surgical Oncology

volume

47

issue

1

pages

101 - 107

publisher

Elsevier

external identifiers

pmid:31128948
scopus:85065865300

ISSN

0748-7983

DOI

10.1016/j.ejso.2019.05.006

language

English

LU publication?

no

additional info

id

a51114ec-44d7-4838-84a0-f4c83122d6a8

date added to LUP

2022-03-31 12:43:55

date last changed

2024-04-13 12:21:04

@article{a51114ec-44d7-4838-84a0-f4c83122d6a8,
  abstract     = {{<p>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 &gt; 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.</p>}},
  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.}},
  issn         = {{0748-7983}},
  keywords     = {{Health-related quality of life (HRQoL); Hyperthermic intraperitoneal chemotherapy (HIPEC); Ovarian cancer}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{101--107}},
  publisher    = {{Elsevier}},
  series       = {{European Journal of Surgical Oncology}},
  title        = {{Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer}},
  url          = {{http://dx.doi.org/10.1016/j.ejso.2019.05.006}},
  doi          = {{10.1016/j.ejso.2019.05.006}},
  volume       = {{47}},
  year         = {{2021}},
}

Lund University Publications

LUND UNIVERSITY LIBRARIES

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