Long-Term HRQOL Remains Unimpaired With HIPEC Plus Cytoreductive Surgery in Newly Diagnosed Ovarian Cancer

Administration of hyperthermic intraperitoneal chemotherapy (HIPEC) with cytoreductive surgery did not have a negative impact on health-related quality of life (HRQOL) compared with cytoreductive surgery alone in patients with newly diagnosed ovarian cancer, according to findings from a phase 2 trial (NCT02124421) presented at The Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer.

All patients who participated in the study completed a FACT-O Questionnaire preoperatively. Investigators did not report any significant differences in baseline scores and response rates were similar between groups through the follow-up period. Moreover, investigators observed a decrease in HRQOL directly following surgery, although it returned to baseline levels between 6 to 12 months.

The negative HRQOL impact was not long-term, even after adjusting for age and tumor burden.

“We concluded that HIPEC in this particular study did not negatively affect QOL in patients after cytoreductive surgery for ovarian cancer done in primary setting,” according to Vadim Gushchin, MD, a surgical oncologist and director of the HIPEC Program at Mercy Medical Center in Baltimore, Maryland, during a presentation on the findings. “Most likely, the explanation is that the surgical trauma is so significant [following cytoreductive surgery] that HIPEC does not matter, that is one explanation.”

The study investigators set out to determine HRQOL in a population of patients with primary ovarian cancer with peritoneal metastases who enrolled in a randomized phase 2 study and underwent treatment with cytoreductive surgery and HIPEC.

Treatment was provided at a single, high-volume peritoneal surface malignancy center, and cytoreductive surgery was performed by a combination of gynecologic and surgical oncologists. In the treatment arm (n = 16), patients received cytoreductive surgery and HIPEC followed by 6 cycles of intravenous carboplatin and paclitaxel. The control group (n = 16) underwent cytoreductive surgery with intraperitoneal port placement followed by the same chemotherapy backbone delivered either intravenously or through the port.

“Rightly so gynecologic, oncologists are worried about the QOL of patients,” Gushchin said. “Patients actually call this operation ‘the mother of all the surgeries.’ … The surgery [is like] a shark bite; you have to recover for a long time. However, multiple studies from the Netherlands, Brazil, Spain, and Korea did not show that patients do worse with HRQOL, irrespective of the HIPEC in this setting.”

The primary end points were complications and toxicities and secondary end points included survival and HRQOL.

Complete cytoreductive surgery was defined as residual disease of less than 2.5 mm. Surgical complications were considered major if they were 90-day Clavien-Dindo grade 3/4. Additionally, tumor burden was determined with peritoneal cancer index.

Follow-up took place 2 to 6 weeks after being discharged, every 3 months for up to 2 years, and every 6 months until year 5.

The FACT-O Questionnaire had 5 subscales: physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and ovarian cancer concerns. The scoring was based on FACT-O score and trial outcome index (TOI). The TOI, which consists of physical wellbeing, functional wellbeing, and ovarian cancer concerns, is widely used and validated, according to Gushchin. Moreover, it is an independent prognostic factor for patients with ovarian cancer; changes in its values are indicative of clinical significance.

All patients who were included in the analysis had underwent full cytoreductive surgery. Cohorts were balanced based on age, primary tumor site and tumor burden.

The median patient age at the time of surgery was 59.5 years in the HIPEC group vs 65.0 years in the control group. Additionally, most patients had tubo-ovarian as the primary disease site (81.2% vs 75.0%, respectively) and underwent bowel resection (87.7% vs 87.7%). Patients across both arms had undergone a median of 5 major organ resections.

In terms of other patient variables, all patients achieved a preoperative response. The preoperative FACT-O mean was 109.5±15.4 in the HIPEC group vs 108.4±22.6 in the control group and the mean TOI was 70.0±13.0 vs 68.9±18.2, respectively. The 24-month response rate was 50.0% compared with 31.3% in each respective group.

The 24-month FACT-O mean was 125.2±20.8 vs 120.6±29.1 in the experimental and control groups, respectively. Additionally, the 24-month mean FACT-O in each respective group was 125.2±20.8 vs 120.6±29.1 and the 24-month mean TOI was 83.2±12.9 vs 79.2±20.0.

Gushchin also emphasized that further research efforts assessing quality of life are underway: “We are currently in the process of coming up with another patient QOL index that brings the perspectives of patients, caregivers, and health care providers to assess what actually happens to patients after HIPEC.”

Reference

Felipe L, Zuniga F, Sardi A, et al. HRQOL after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy is not different than cytoreductive surgery alone in primary ovarian cancer patients. Annual Meeting on Women’s Cancer; March 25-28; Tampa, Florida.