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Gynaecological cancers

4535 - Health-related quality of life after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for stage III ovarian cancer: results of the phase III OVHIPEC study

Date

09 Sep 2017

Session

Gynaecological cancers

Presenters

Simone Koole

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

S. Koole1, W. van Driel1, J. Kieffer2, K. Sikorska3, J. Schagen van Leeuwen4, H. Schreuder5, R. Hermans6, I. de Hingh7, J. van der Velden8, H. Arts9, L. Massuger10, A. Aalbers11, V. Verwaal12, K. Van de Vijver13, N. Aaronson2, G. Sonke14

Author affiliations

  • 1 Department Of Gynaecology, Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL), 1066 CX - Amsterdam/NL
  • 2 Division Of Psychosocial Research And Epidemiology, Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL), 1006 BE - Amsterdam/NL
  • 3 Department Of Statistics, Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL), 1006 BE - Amsterdam/NL
  • 4 Department Of Obstetrics & Gynaecology, Sint Antonius Hospital Nieuwegein, Nieuwegein/NL
  • 5 Department Of Gynaecological Oncology, University Medical Center Utrecht, Utrecht/NL
  • 6 Department Of Gynaecology And Obstetrics, Catharina Hospital Eindhoven, Eindhoven/NL
  • 7 Department Of Surgery, Catharina Hospital Eindhoven, Eindhoven/NL
  • 8 Department Of Gynaecology And Obstetrics, Amsterdam Medical Center, Amsterdam/NL
  • 9 Department Of Gynaecological Oncology, University Medical Centre Groningen, Groningen/NL
  • 10 Department Of Gynaecological Oncology, Radboud University Medical Center, Nijmegen/NL
  • 11 Department Of Surgical Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL), 1066 CX - Amsterdam/NL
  • 12 Department Of Surgery, Aarhus University Hospital, Aarhus/DK
  • 13 Department Of Pathology, Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL), 1006 BE - Amsterdam/NL
  • 14 Department Of Medical Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL), 1066CX - Amsterdam/NL
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Resources

Abstract 4535

Background

In the OVHIPEC study (NCT00426257), the addition of HIPEC to interval cytoreductive surgery (CRS) significantly improved recurrence-free (HR 0.66, 95% CI 0.50-0.87) and overall survival (HR 0.67, 95% CI 0.48-0.94) in patients with stage III ovarian cancer. We report the results of the health-related quality of life (HRQOL) analysis of patients in the OVHIPEC study.

Methods

Patients who had at least stable disease after 3 cycles of carboplatin and paclitaxel were randomly assigned to receive interval CRS with (n = 122) or without (n = 123) HIPEC using cisplatin. Patients in both arms received 3 additional cycles of carboplatin/paclitaxel post-operatively. HRQOL was assessed using the EORTC core questionnaire (the QLQ-C30) and the ovarian and colorectal cancer modules (QLQ-OV28 and QLQ-CR38). HRQOL assessments were planned at least 2 weeks prior to surgery, after surgery, following the 6th chemotherapy cycle, and every three months thereafter until a maximum of two years of follow-up. HRQOL data were analysed using a mixed effect model. Current preliminary results pertain to the QLQ-C30 summary score, and the fatigue, neuropathy, micturition and gastrointestinal symptom scale scores for up to 1 year of follow-up or time of recurrence.

Results

Of 245 randomized patients, 201 (82%) had at least one evaluable HRQOL assessment (93 for CRS arm, 108 for CRS+HIPEC arm). A linear mixed effects analysis indicated a significant group difference in QLQ-C30 summary scores over time (p = 0.047). The CRS group had modest improvement in overall HRQOL over time, while the CRS+HIPEC group remained largely unchanged. In both arms, the overall HRQOL scores were relatively high, both at baseline and during follow-up. No significant group differences over time were observed for fatigue, neuropathy, micturition or gastrointestinal symptoms.

Conclusions

Preliminary results indicate that patients in this trial had relatively high overall HRQOL scores, that tended to improve more over time in the CRS arm compared to the CRS+HIPEC arm. Future analyses will yield additional information about the specific patterns of HRQOL and symptom effects over the course of the trial.

Clinical trial identification

NCT00426257

Legal entity responsible for the study

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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