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March 29, 2021
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Paclitaxel-cisplatin combination extends PFS in advanced epithelial ovarian cancer

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The addition of paclitaxel to cisplatin in a hyperthermic intraperitoneal chemotherapy regimen doubled PFS among women with advanced epithelial ovarian cancer undergoing interval debulking surgery, study results showed.

“Treatments to improve oncologic outcomes are urgently needed for women with advanced ovarian cancer, so we were both surprised and excited to see such a positive outcome in women treated with the combination of paclitaxel/cisplatin,” Laura M. Chambers, DO, a fellow in the division of gynecologic oncology at Cleveland Clinic, told Healio after presenting the findings during the virtual Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.

Paclitaxel-cisplatin combination extends PFS in advanced epithelial ovarian cancer

Data were derived from Chambers LM, et al. Abstract 11583. Presented at: Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (virtual meeting); March 19-25, 2021.

The single-institution cohort study included data of 75 women with stage III or stage IV, high-grade epithelial ovarian cancer treated at Cleveland Clinic from 2017 to 2020. All women underwent interval debulking surgery with hypothermic intraperitoneal chemotherapy, administered at the primary surgeon’s discretion, and had at least 6 months of follow-up.

Women received hyperthermic intraperitoneal chemotherapy with either cisplatin dosed at 80 mg/m2 to 100 mg/m2 for 90 minutes (n = 42), or paclitaxel dosed at 135 mg/m2 to 175 mg/m2 for 90 minutes plus cisplatin dosed 80 mg/m2 to 100 mg/m2 for 45 minutes (n = 33), in a perfusate of normal saline at 41°C to 43°C for 90 minutes.

Women in the cisplatin-alone and paclitaxel-cisplatin combination groups had similar demographic characteristics, including mean age (64.7 years vs. 62.6 years), race (white, 87.8% vs. 93.9%; Black, 4.9% vs. 6.1%), medical comorbidities and American Society of Anesthesiologists score. Most had stage III disease (64.3% vs. 78.7%) and serous histology (100% vs. 93.9%).

Researchers analyzed PFS, defined as months from hypothermic intraperitoneal chemotherapy to the date of recurrence, and perioperative outcomes among the women.

Results, stratified by treatment regiment, showed PFS of 22.2 months in the paclitaxel-cisplatin group vs. 11 months in the cisplatin-alone group (HR = 0.41; 95% CI, 0.2-0.83) and 1-year RFS of 82.9% (95% CI, 69.3-96.6) vs. 36.7% (95% CI, 18.4-55.1).

"A combination of paclitaxel-cisplatin is associated with improved progression-free survival compared with cisplatin alone, which has been previously studied in randomized clinical trials,” Chambers said. “[Further], the addition of paclitaxel to cisplatin was not associated with worse perioperative outcomes or toxicity.”

The cisplatin-only group had a longer operative time than the combination group (6.1 hours vs. 5.3 hours), but researchers observed no significant differences in surgical procedures performed, including small bowel (9.5% vs. 9.1%) and large bowel resection (23.8% vs. 18.1%); postoperative adverse events as measured by the Accordion Severity Grading System (none, 42.9% vs. 42.4%; mild, 21.4% vs. 27.3%; moderate, 23.8% vs. 15.2%; severe, 9.5% vs. 15.2%; fatal, 2.4% vs. 0%); and need for intraoperative blood transfusion (42.9% vs. 57.6%) and intraoperative pressor support (71.4% vs. 81.8%).

Chambers acknowledged the study’s limitations, including lack of randomization, possible selection bias, limited follow-up of 15.7 months and use of data from a single-institution registry. However, she said that it was the first to compare cisplatin alone with the combination of paclitaxel and cisplatin for these women.

Further research is needed to validate the findings in larger cohorts and determine the effect of hypothermic intraperitoneal chemotherapy on OS, she added.

“We believe that clinicians should consider the use of combination of paclitaxel with cisplatin during hyperthermic intraperitoneal chemotherapy in women with advanced ovarian cancer undergoing interval debulking,” Chambers said.