MedicalResearch.com Interview with:
Dr. W.J. van Driel
Antoni van Leeuwenhoek
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Our study reports on the results of a randomized phase 3 study in patients with FIGO stage III ovarian cancer who were ineligible for primary cytoreductive surgery and therefore treated with neo-adjuvant chemotherapy and interval cytoreductive surgery. Following optimal or complete cytoreductive surgery another 3 cycles of chemotherapy were given. During the interval cytoreductive surgery patients were randomized between surgery alone or surgery + HIPEC. During hyperthermic intraperitoneal administration of chemotherapy (HIPEC) the abdomen is perfused with cisplatin to expose any remaining minimal or microscopic disease to a high dose of heated chemotherapy.
The main findings are that the addition of HIPEC to interval cytoreductive surgery resulted in longer recurrence-free survival and overall survival than surgery alone and the addition of HIPEC did not result in higher rates of side effects.
MedicalResearch.com: What should readers take away from your report?
Response: The take-home message is that adding HIPEC to interval cytoreductive surgery is an important treatment option in patients with stage III ovarian carcinoma.
HIPEC improves recurrence-free survival and overall survival with 3.5 and 12 months, respectively, and is well tolerated in this situation.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Cost-effectiveness analyses, detailed quality-of-life analyses, and biomarker studies of the present study are underway. Our next study will investigate the effect of HIPEC added to primary cytoreductive surgery for advanced ovarian cancer. In addition, data on the comparative efficacy of HIPEC versus regular intraperitoneal chemotherapy or the combination is lacking.
MedicalResearch.com: Is there anything else you would like to add?
Response: With respect to the stoma’s we would like to point out the following. Only a minority of patients undergoing HIPEC are left with a colostomy/ileostomy. Of the 245 patients in this study 59 patients underwent surgery of the large bowel (30 in the surgery group and 29 in the surgery+HIPEC group). Of these patients, 13 in the surgery only group had a stoma and 21 of the patients in the surgery + HIPEC group had a stoma (11% and 17% of the total group). There is no evidence from the literature or from our study that the rate of anastomotic leakage is higher after HIPEC. Therefore, the reason for a stoma may well have been out of precaution. Whether a colostomy is justified should be something to discuss with the patient before the surgical procedure. Usually this is always subject of discussion in preparation for procedures like this.
As for the costs, amongst the extended theatre time and the costs associated with HIPEC itself we don’s anticipate any other costs. For the postoperative period the most important thing is that patients are regularly observed. For the study, this was scheduled on ICU but since we did not note an increase in complications with HIPEC, medium care or regular wards should be sufficient. The added costs of the observed 10% survival gain at 5 years surely compares favourably to the costs of expensive new drugs, which often do not deliver any overall survival benefit.
We have no disclosures
Willemien J. van Driel, M.D., Ph.D., Simone N. Koole, M.D., Karolina Sikorska, Ph.D., Jules H. Schagen van Leeuwen, M.D., Ph.D., Henk W.R. Schreuder, M.D., Ph.D., Ralph H.M. Hermans, M.D., Ph.D., Ignace H.J.T. de Hingh, M.D., Ph.D., Jacobus van der Velden, M.D., Ph.D., Henriëtte J. Arts, M.D., Ph.D., Leon F.A.G. Massuger, M.D., Ph.D., Arend G.J. Aalbers, M.D., Victor J. Verwaal, M.D., Ph.D., Jacobien M. Kieffer, Ph.D., Koen K. Van de Vijver, M.D., Ph.D., Harm van Tinteren, Ph.D., Neil K. Aaronson, Ph.D., and Gabe S. Sonke, M.D., Ph.D.
January 18, 2018
N Engl J Med 2018; 378:230-240
MedicalResearch.com is not a forum for the exchange of personal medical information, advice or the promotion of self-destructive behavior (e.g., eating disorders, suicide). While you may freely discuss your troubles, you should not look to the Website for information or advice on such topics. Instead, we recommend that you talk in person with a trusted medical professional.
The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.