Abstract
PURPOSE: Hyperthermic intraperitoneal chemotherapy (HIPEC) has been considered a promising treatment option for advanced or recurrent ovarian cancer, but there is no clear evidence based on randomized controlled trials to advocate this approach as a standard therapy. In this study, we aim to present the early outcomes and insights after an interim analysis of a pioneering clinical trial in Brazil. METHODS: This study was a cross-sectional analysis of early data from our ongoing clinical trial - an open-label, double-center, single-arm trial on the safety and efficacy of using HIPEC for advanced ovarian cancer (ClinicalTrials.gov: NCT02249013). A fast-track recovery strategy was also applied to improve patient outcomes. RESULTS: Nine patients with stage IIIB (n=1) or IIIC (n=8) epithelial malignancies were enrolled until February 2017. The median (range) serum CA125 level at diagnosis was 692 (223.7-6550) U/mL. The median number of preoperative cycles of intravenous (i.v.) chemotherapy was 3 (2-4), resulting in peritoneal cancer index scores of 9 (3-18) at the time of HIPEC. Time of restarting i.v. chemotherapy was 37 (33-50) days with all patients completing 6 cycles as planned. The median operation time was 395 (235-760) minutes, the length of hospital stay was 4 (3-10) days, and all the patients left the ICU on the morning after the procedure. Two patients experienced no postoperative complications, whereas 91% of the complications were minor G1/G2 events. Preliminary assessment also suggested no impairment of the patient's quality of life. CONCLUSION: Our comprehensive protocol might represent a promising all-in-one approach for advanced ovarian cancer. The patient recruitment for this trial is ongoing.