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Adding hyperthermic intraperitoneal chemotherapy to surgery did not improve progression-free survival in platinum-sensitive recurrent ovarian cancer.
Among patients with platinum-sensitive peritoneal recurrent epithelial ovarian cancer undergoing secondary cytoreductive surgery (SCS), the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to complete or nearly complete primary SCS did not demonstrate a benefit in terms of progression-free survival (PFS) compared to primary SCS alone, according to study findings published in the Journal of Clinical Oncology.
These findings suggest that HIPEC should not be used in women with platinum sensitive recurrent ovarian cancer who are undergoing SCS without neoadjuvant therapy, according to study authors.
After a median follow-up of 83 months, the median PFS rate was 23 months for patients undergoing SCS alone and 25 months for those undergoing CSC with HIPEC. The probability of postrecurrence survival (PRS) at five years was 61.6% in patients undergoing SCS alone and 75.9% for those undergoing SCS with HIPEC.
In addition, out of 167 patients, 135 had a recurrence and 72 died for any cause.
Progression-free survival (PFS): time without the disease worsening.
Postrecurrence survival (PRS): time after the cancer returns.
Hyperthermic intraperitoneal chemotherapy (HIPEC): heated chemotherapy targeted towards the abdomen.
Cytoreductive surgery (SCS): surgery to remove cancer.
This open-label, randomized phase 3 study did not meet its primary endpoint; however, the median PFS was exceptionally long in both SCS alone and SCS with HIPEC treatment groups.
“This value is longer than expected, especially considering that only a small rate of women [24 patients, 14.4%] received maintenance treatment,” study authors wrote.
Regarding safety, the incidence rate of postoperative side effects of any severity was similar between each treatment group, and there was no extra reported toxicity related to HIPEC. Specifically, 40 patients (23.9%) developed at least one early postoperative event of any grade, and two (1.2%) required reinterventions. No difference between the two groups was noted.
Furthermore, grade 3 (severe) or 4 (life-threatening) side effects were reported in six patients (7.1%) in the surgery alone group and 10 patients (12.2%) in the surgery with HIPEC. No deaths within 30 and 90 days from surgery were observed in both groups. Late postoperative complications were observed in seven patients (8.2%) in surgery alone and five patients (6.1%) in SCS with HIPEC. Grade 3 or 4 side effects also caused two delays in chemotherapy administration for each group, and eight chemotherapy dose reductions in each group. Seven patients (8.2%) undergoing surgery alone, and five patients (6.1%) undergoing surgery with HIPEC experienced late postoperative complications.
Eligible patients included those with a platinum-free interval of six months or more recurrence from epithelial ovarian, fallopian tube or peritoneal cancer. Patients also had to be referred for SCS if the disease was located in the abdominal cavity, with or without extraperitoneal spread and considered completely resectable during surgery. Patients who were excluded included those with ascites, recurrences other than primary or with an estimated life expectancy of four weeks or less.
Out of 167 patients, 82 received HIPEC and 85 did not. For patients undergoing surgery with HIPEC, 75 milligrams per square meter of HIPEC with cisplatin was administered for 60 minutes at 41.5 degrees Celsius and at the end of surgery.
The primary end goal of this study was PFS, and the secondary end goals were PRS and the safety profile of each treatment group.
“In conclusion, we observed no additional benefit in PFS in patients with platinum-sensitive recurrent [ovarian cancer], treated with SCS plus platinum-based HIPEC compared with complete SCS alone. No extra toxicity related to HIPEC was reported,” study authors concluded.
Reference:
“Hyperthermic Intraperitoneal Chemotherapy in Platinum-Sensitive Recurrent Ovarian Cancer: A Randomized Trial on Survival Evaluation (HORSE; MITO-18),” By Dr. Anna Fagotti et al. Journal of Clinical Oncology.
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