Abstract
Introduction
In 2021, 1238 Dutch women were diagnosed with ovarian cancer. More than 75% of these women were diagnosed with an advanced stage disease: metastases were found throughout the whole abdominal cavity (FIGO stage III) or even outside the abdominal cavity (FIGO stage IV).
The survival gain for women with advanced stage ovarian cancer (≥FIGO stage IIB) is mainly found in women in whom complete cytoreductive surgery (CRS) can be achieved. This means that all visible tumor in the abdomen is removed. In recent years, it became increasingly clear that there are large differences in overall survival between those women in whom all disease could be removed and those in whom minimal disease (less than 1 cm) remained after surgery. Therefore, surgical teams are committed to removing all disease in every woman, even from difficult sites and precarious surfaces such as the bowel, the small bowel and the diaphragm.
Methods
A multicenter randomized trial was designed, the PlaComOv study. 'PlaComOv' is an acronym for 'Will the use of the PLAsmaJet® device improve the rate of COMplete cytoreductive surgery for advanced-stage OVarian cancer?' The primary objective of the PlaComOv study was to assess the efficacy and safety of the PlasmaJet. Secondary outcomes were the impact on tissue damage, cost and quality-of-life.
Results
327 women with advanced stage epithelial ovarian cancer were included for the PlaComOv study between February 2018 and September 2020. Of these women, 157 were randomized into the intervention group and 170 into the control group. Randomization involved stratification for suspected ovarian cancer versus proven ovarian cancer, primary versus interval CRS, presence versus absence of peritoneal carcinomatosis on CT scan, and whether or not hyperthermic intraperitoneal chemotherapy (HIPEC) was administered. For patients in the intervention group, the surgeon could decide whether or not to use the PlasmaJet during surgery.
The intention-to-treat analysis showed that 75.8% of the patients in the intervention group underwent complete CRS compared to 67.6% of the patients in the control group (p=0.131).
The per-protocol analysis showed the surgical outcome of the patients who actually underwent CRS. In addition to excluding 27 patients who did not undergo CRS, 3 patients were excluded because of protocol violation: those patients underwent surgery in which the PlasmaJet was used while they were included in the control group. In the per-protocol analysis, complete cytoreductive surgery was achieved in 85.6% of the intervention group compared to 71.5% in the control group (p=0.005).
A sub-analysis for patients with peritoneal carcinomatosis (≥50 lesions on the diaphragm, peritoneum and/or mesentery) showed that the use of the PlasmaJet improved the surgical outcome: complete CRS was achieved in 72.2% in the intervention group versus 51.5% in the control group (p=0.034).
No differences were found between the two groups in terms of operative time or blood loss. Postoperatively, the number of complications, re-laparotomies or readmissions did not appear to be significantly different between the two groups.
In a series of 106 histological samples from 17 patients who underwent interval CRS, the mean depth of tissue damage was found to be smaller in tissue treated with the PlasmaJet (0.15 mm) than in tissue treated with electrocoagulation (0.33 mm) (p<0.001).
All healthcare costs for the patients included in the PlaComOv study were analyzed. These costs comprised the healthcare costs of patients with advanced stage ovarian cancer from diagnosis and treatment until six weeks after the last chemotherapy. The mean total health care costs for patients treated with the PlasmaJet were significantly higher than those for patients treated with conventional CRS (€19,414 versus €18,165, p=0.017).
285 patients (87%) completed the questionnaires about Quality-of-Life (QoL), and two years postoperatively, 172 patients (77%) out of 224 living patients completed the questionnaires.
QoL decreased postoperatively but increased after six months to the same QoL level as before surgery. Higher QoL was reported in several domains by patients treated in the intervention group. Twelve months after surgery, patients in the intervention group rated their QoL higher than patients in the control group (p=0.005). Two years after surgery, this difference in QoL was no longer significant.
Conclusions
The use of the PlasmaJet increased the probability of complete CRS, especially in patients with a large number of peritoneal lesions without a higher complication rate.
Long term results as a cost-effectiveness analysis, the progression free survival and overall survival have to be waited.
In 2021, 1238 Dutch women were diagnosed with ovarian cancer. More than 75% of these women were diagnosed with an advanced stage disease: metastases were found throughout the whole abdominal cavity (FIGO stage III) or even outside the abdominal cavity (FIGO stage IV).
The survival gain for women with advanced stage ovarian cancer (≥FIGO stage IIB) is mainly found in women in whom complete cytoreductive surgery (CRS) can be achieved. This means that all visible tumor in the abdomen is removed. In recent years, it became increasingly clear that there are large differences in overall survival between those women in whom all disease could be removed and those in whom minimal disease (less than 1 cm) remained after surgery. Therefore, surgical teams are committed to removing all disease in every woman, even from difficult sites and precarious surfaces such as the bowel, the small bowel and the diaphragm.
Methods
A multicenter randomized trial was designed, the PlaComOv study. 'PlaComOv' is an acronym for 'Will the use of the PLAsmaJet® device improve the rate of COMplete cytoreductive surgery for advanced-stage OVarian cancer?' The primary objective of the PlaComOv study was to assess the efficacy and safety of the PlasmaJet. Secondary outcomes were the impact on tissue damage, cost and quality-of-life.
Results
327 women with advanced stage epithelial ovarian cancer were included for the PlaComOv study between February 2018 and September 2020. Of these women, 157 were randomized into the intervention group and 170 into the control group. Randomization involved stratification for suspected ovarian cancer versus proven ovarian cancer, primary versus interval CRS, presence versus absence of peritoneal carcinomatosis on CT scan, and whether or not hyperthermic intraperitoneal chemotherapy (HIPEC) was administered. For patients in the intervention group, the surgeon could decide whether or not to use the PlasmaJet during surgery.
The intention-to-treat analysis showed that 75.8% of the patients in the intervention group underwent complete CRS compared to 67.6% of the patients in the control group (p=0.131).
The per-protocol analysis showed the surgical outcome of the patients who actually underwent CRS. In addition to excluding 27 patients who did not undergo CRS, 3 patients were excluded because of protocol violation: those patients underwent surgery in which the PlasmaJet was used while they were included in the control group. In the per-protocol analysis, complete cytoreductive surgery was achieved in 85.6% of the intervention group compared to 71.5% in the control group (p=0.005).
A sub-analysis for patients with peritoneal carcinomatosis (≥50 lesions on the diaphragm, peritoneum and/or mesentery) showed that the use of the PlasmaJet improved the surgical outcome: complete CRS was achieved in 72.2% in the intervention group versus 51.5% in the control group (p=0.034).
No differences were found between the two groups in terms of operative time or blood loss. Postoperatively, the number of complications, re-laparotomies or readmissions did not appear to be significantly different between the two groups.
In a series of 106 histological samples from 17 patients who underwent interval CRS, the mean depth of tissue damage was found to be smaller in tissue treated with the PlasmaJet (0.15 mm) than in tissue treated with electrocoagulation (0.33 mm) (p<0.001).
All healthcare costs for the patients included in the PlaComOv study were analyzed. These costs comprised the healthcare costs of patients with advanced stage ovarian cancer from diagnosis and treatment until six weeks after the last chemotherapy. The mean total health care costs for patients treated with the PlasmaJet were significantly higher than those for patients treated with conventional CRS (€19,414 versus €18,165, p=0.017).
285 patients (87%) completed the questionnaires about Quality-of-Life (QoL), and two years postoperatively, 172 patients (77%) out of 224 living patients completed the questionnaires.
QoL decreased postoperatively but increased after six months to the same QoL level as before surgery. Higher QoL was reported in several domains by patients treated in the intervention group. Twelve months after surgery, patients in the intervention group rated their QoL higher than patients in the control group (p=0.005). Two years after surgery, this difference in QoL was no longer significant.
Conclusions
The use of the PlasmaJet increased the probability of complete CRS, especially in patients with a large number of peritoneal lesions without a higher complication rate.
Long term results as a cost-effectiveness analysis, the progression free survival and overall survival have to be waited.
| Original language | English |
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| Award date | 19 Sept 2023 |
| Place of Publication | Rotterdam |
| Print ISBNs | 978-94-6483-199-3 |
| Publication status | Published - 19 Sept 2023 |
Bibliographical note
Financial support for the publication of this thesis was kindly provided by:Van Braak Accountants; Department of Gynecologic Oncology, Erasmus MC; Department of Obstetrics & Gynecology, Albert Schweitzer Hospital; Medical Dynamics; Plasma Surgical.
