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Ovarian cancer
280 Improvement of complete cytoreduction for advanced-stage ovarian cancer with adjuvant use of the PlasmaJet Device. Results of a RCT
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  1. G Nieuwenhuyzen-de Boer1,2,
  2. W Hofhuis3,
  3. N Reesink-Peters4,
  4. S Willemsen5,
  5. IA Boere6,
  6. IG Schoots7,
  7. J Piek8,
  8. L Hofman2,
  9. J Beltman9,
  10. WJ Van Driel10,
  11. HMJ Werner11,
  12. M Dorman12,
  13. L Haans13,
  14. A Baalbergen14,
  15. AMLDVan Haaften-de Jong15,
  16. I Nedelcu16,
  17. PC Ewing-Graham17 and
  18. HJ Van Beekhuizen1
  1. 1Erasmus University Medical Center, Gynaecologic Oncology, Rotterdam, Netherlands
  2. 2Albert Schweitzer Hospital, Gynaecology, Dordrecht, Netherlands
  3. 3Franciscus Gasthuis and Vlietland, Gynaecology, Rotterdam, Netherlands
  4. 4MST, Gynaecology, Enschede, Netherlands
  5. 5Erasmus University Medical Center, Epidemiology and Statistics, Rotterdam, Netherlands
  6. 6Erasmus University Medical Center, Medical Oncology, Rotterdam, Netherlands
  7. 7Erasmus University Medical Center, Radiology and Nuclear Medicine, Rotterdam, Netherlands
  8. 8Catharina Ziekenhuis, Gynaecologic Oncology, Eindhoven, Netherlands
  9. 9Leiden University Medical Center (LUMC), Gynaecologic Oncology, Leiden, Netherlands
  10. 10The Netherlands Cancer Institute (NKI), Gynaecologic Oncology, Amsterdam, Netherlands
  11. 11Academic Hospital Maastricht, Gynaecologic Oncology, Maastricht, Netherlands
  12. 12Bravis Hospital, Gynaecology, Bergen op Zoom, Netherlands
  13. 13HMC Antoniushove, Gynaecology, Leidschendam, Netherlands
  14. 14Reinier de Graaf Gasthuis, Gynaecology, Delft, Netherlands
  15. 15Haga Hospital (Leyweg), Gynaecology, Den Haag, Netherlands
  16. 16Groene Hart Hospital, Gynaecology, Gouda, Netherlands
  17. 17Erasmus University Medical Center, Pathology, Rotterdam, Netherlands

Abstract

Results of the PlaComOv-study, a randomized, controlled trial in the Netherlands

Introduction/Background*The most important prognostic factor for patients with advanced-stage ovarian cancer is complete cytoreductive surgery (CRS). Standard surgical treatment with electrosurgery cannot always result in complete CRS, especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of the PlasmaJet® Device will help increase the complete cytoreduction rate.

Methodology 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were assigned to either surgery with PlasmaJet (intervention) or without PlasmaJet (control group).

Primary outcome was the percentage of complete CRS. Secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30 day-morbidity and quality of life (QoL).

Result(s)*Complete CRS was achieved in 119 patients (75.8%) of the intervention group and in 115 patients (67.6%) of the control group (P=0.131).

A per-protocol analysis was performed in which data of 27 patients with unresectable disease were excluded, considering that the aim of the study was to examine the effectiveness of the use of the PlasmaJet in achieving CRS. Complete CRS was obtained in 85.6% in the intervention group and in 71.5% in the control group (absolute difference 14.1%, 95% confidence interval [CI], 0.047 to 0.230; P=0.005).

The number of colostomies was lower in the intervention group (6.5% versus 12.7%) but did not differ significantly (P=0.169). Patient-reported QoL six months after surgery differed between groups in favor of PlasmaJet surgery (95% CI, 0.455 to 8.350; P=0.029). Other secondary outcomes did not differ significantly.

Conclusion*The adjuvant use of the PlasmaJet during CRS for advanced stage ovarian cancer resulted in a significant higher proportion of complete CRS in patients with resectable disease and a higher QoL six months after surgery. (Funded by ZonMw, Trial Register NL62035.078.17.)

https://doi.org/10.1136/ijgc-2021-ESGO.375

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