A phase III clinical study observed that patients with advanced ovarian cancer, when treated with neoadjuvant systemic chemotherapy, cytoreductive surgery, and hyperthermic intraperitoneal chemotherapy, showed improved overall survival and disease-free survival.
The efficacy of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has been demonstrated in multiple malignancies. Its prognostic benefit was recently tested in patients with advanced ovarian cancer.
A single-centre, randomised, phase III prospective study enrolled 71 patients (all diagnosed with ovarian cancer and treated with neoadjuvant systemic chemotherapy [NACT]) and divided them into two treatment groups. The patients received either CRS alone (control group; n=36) or CRS+HIPEC (experimental group, n=35) along with 75 mg/m2 cisplatin for 60 min at 42°C. The study’s primary endpoint was disease-free survival (DFS), whereas secondary endpoints included overall survival (OS), morbidity, and quality of life (QoL).
During a median follow-up of 32 months, a prolonged median DFS was observed in the experimental group versus the control group (18 versus 12 months, HR [95%-CI]: 0.12 [0.02-0.89]; p=0.038). Additionally, the median OS was also longer in the experimental group than the control group (52 versus 45 months). Adverse events of any grade (1 to 5) were observed in 37 patients (52.1%) with a mortality rate of 2.8% (control group) and 2.9% (experimental group, p>0.05). Neither of the treatments had any meaningful impact on the QoL in the dimensions evaluated.
The phase III clinical study demonstrated that the treatment of advanced ovarian cancer patients with NACT, CRS and HIPEC improved DFS and OS. However, no changes in postoperative morbidity, mortality, or QoL evaluation were observed.