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“Adding HIPEC to interval debulking improved both recurrence free survival and overall survival without increasing morbidity,” said van Driel.
The addition of hyperthermic intraperitoneal chemotherapy (HIPEC), also known as a hot chemotherapy bath, improved survival rates by 10 percent in women with stage 3 epithelial ovarian cancer according to study results published in New England Journal of Medicine.
Patients with newly diagnosed advanced-stage ovarian cancer are often treated with cytoreductive surgery and systemic chemotherapy. Patients either start with an operation followed by six courses of chemotherapy, or primary debulking, or they are given three courses of chemotherapy before surgery and three more courses after, also known as interval debulking.
With these treatment options, only one-third of patients are still alive after five years, according to a Netherlands Cancer Institute press release.
Therefore, researchers in the Netherlands investigated whether the addition of HIPEC to interval debulking would improve outcomes among patients who were receiving neoadjuvant chemotherapy as treatment for stage 3 epithelial ovarian cancer.
“Ten years ago, we wanted to find out what the effect was of HIPEC for patients with ovarian carcinoma,” lead author Willemien J. van Driel, M.D., Ph.D., from the Department of Gynecology at the Netherlands Cancer Institute in Amsterdam, said in an interview with CURE. “We had the results of the colon HIPEC trial which were positive, and we had the results of the Armstrong trial who showed a longer survival for patients receiving postoperative intraperitoneal chemotherapy.”
In a multicenter, open-label, phase 3 trial, the researchers randomly assigned 245 patients to undergo interval debulking either with or without administration of HIPEC with cisplatin. Three additional cycles of carboplatin and paclitaxel were administered postoperatively.
The researchers specifically looked at recurrence-free survival, as well as overall survival (OS) and safety.
Events of disease recurrence or death occurred in 110 of the 123 patients who underwent surgery without HIPEC and in 99 of the 122 patients who had surgery plus HIPEC.
Patients treated with hot chemotherapy bath experienced longer recurrence-free survival (14.2 months) compared with patients who did not (10.7 months).
After a follow-up of 4.7 years, 76 patients in the control arm (62 percent) and 61 patients who received HIPEC (50 percent) died. The group of patients who received hot chemotherapy bath also experienced longer OS compared with the control arm (45.7 months vs. 33.9 months).
“Adding HIPEC to interval debulking improved both recurrence free survival and overall survival without increasing morbidity,” said van Driel.
There was no difference in adverse events (AEs) among groups, and HIPEC appeared well-tolerated.
As a result of the study, the guidelines committee for gynecological oncology in the Netherlands will be discussing whether to add HIPEC as a standard of care. However, van Driel noted oncology staff will need to be trained because this is a complicated procedure.
“In the Netherlands we are in the process of adjusting the guidelines at this point,” she added. “Once the literature search supports the result of the trial we will want to implement it as standard of care. It will be difficult to repeat this trial with this number of patients and the results are convincing.”