Hyperthermic intraperitoneal chemotherapy may benefit some women with ovarian cancer
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Adding hyperthermic intraperitoneal chemotherapy to cytoreductive surgery did not significantly prolong PFS or OS among women with advanced epithelial ovarian cancer, according to a single-blind, randomized study in JAMA Surgery.
However, results of a subgroup analysis showed the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery after neoadjuvant chemotherapy did reduce rates of disease recurrence and mortality among women with primary stage III or stage IV epithelial ovarian cancer, researchers wrote.
“Hyperthermic intraperitoneal chemotherapy could be performed safely after maximal cytoreductive surgery, including left colon surgery, without any delay in the initiation of adjuvant chemotherapy,” Myong Cheol Lim, MD, PhD, chief scientist in the gynecologic cancer branch at the Center for Gynecologic Cancer at National Cancer Center in South Korea, and colleagues wrote.
“The survival benefit of HIPEC immediately after primary cytoreductive surgery has not been identified in this trial and needs to be further investigated in future clinical trials,” they added.
Background and methodology
Lim and colleagues pursued the research because ovarian cancer has the highest mortality rate among gynecologic malignant tumors and insufficient data exist on the survival benefit of HIPEC in women with advanced epithelial ovarian cancer who underwent primary or interval cytoreductive surgery.
The analysis included 184 women with stage 3 or stage 4 ovarian cancer with residual tumor size less than 1 cm treated at two institutions in South Korea from March 2, 2010, to Jan. 22, 2016. Researchers randomly assigned women 1:1 to HIPEC (n = 92; median age, 52 years; interquartile range [IQR], 46-59.5) or a control group (n = 92; median age, 53.5 years; IQR, 47.5-61).
Intraoperative HIPEC consisted of 75 mg/m2 of cisplatin perfused using a closed technique with a target temperature of 41.5 °C for 90 minutes.
PFS served as the primary endpoint; key secondary endpoints included OS and adverse events.
Key findings
After the last day of follow-up (Jan. 10, 2020), with median follow-up of 69.4 months (IQR, 54.4-86.3), results showed median PFS of 18.8 months (IQR, 13-43.2) in the control group and 19.8 months (IQR, 13.7-55.4) in the HIPEC group. Additionally, researchers reported median OS of 61.3 months in the control group (IQR, 34.3 months to not reported) and 69.5 months in the HIPEC group (IQR, 45.6 months to not reported).
In the subgroup of women who underwent interval cytoreductive surgery after neoadjuvant chemotherapy, Lim and colleagues reported median PFS of 15.4 months (IQR, 10.6-21.1 months) in the control group and 17.4 months (IQR, 13.8-31.5 months) in the HIPEC group (HR for disease progression or death = 0.6; 95% CI, 0.37-0.99); and median OS of 48.2 months (IQR, 33.8-61.3 months) vs. 61.8 months (IQR, 46.7 months to not reported; HR = 0.53; 95% CI, 0.29-0.96).
In the subgroup of primary cytoreductive surgery, the control group had numerically longer median PFS (29.7 months; IQR, 17.2-90.1) than the HIPEC group (23.9 months; IQR, 12.3-71.5), as well as longer median OS (not reached vs. 71.3 months; IQR, 45.6 to not reported).
Researchers reported no unresolved serious HIPEC-related adverse events in either group.
Implications
The results highlight “the critical need for well-designed studies of HIPEC in epithelial ovarian cancer,” wrote Stephanie L. Wethington, MD, MSc, Deborah K. Armstrong, MD, and Fabian M. Johnston, MD, MHS, all of The Johns Hopkins University School of Medicine, in an accompanying editorial.
“The studies must carefully define the patient population and enrollment process, including criteria for primary debulking surgery or neoadjuvant chemotherapy and [interval cytoreductive surgery] and balancing stage, grade and histologic type. The HIPEC procedure must specify the drug, volume of irrigation [and] time to dwell, as well as supportive approaches used,” Wethington, Armstrong and Johnston wrote.
Additionally, “data on toxic effects must be reported fully to address concerns regarding the toxic effects of HIPEC and tolerability of subsequent chemotherapy,” they wrote.
References:
Lim CL, et al. JAMA Surg. 2022;doi:10.1001/jamasurg.2022.0143.
Wethington SL, et al. JAMA Surg. 2022;doi:10.1001/jamasurg.2022.0156.
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