Ovarian cancer is the leading cause of death due to gynecological tumors in the female population. Despite optimal first-line treatment, including cytoreduction and platinum-based systemic chemotherapy, recurrences are frequent. The use of hyperthermic intraperitoneal chemotherapy (HIPEC) has been criticized, especially because of the lack of randomized controlled trials (RCTs) with convincing results to support the use of HIPEC in patients with ovarian cancer with peritoneal dissemination. In 2018, the clinical trial published by Van Driel et al. reported improved outcomes in favor of HIPEC treatment with cisplatin. In this study, we conducted a national survey within the Spanish group of peritoneal surgical oncology (Grupo Español de Cirugía Oncológica Peritoneal, GECOP) to explore the impact of the results of this RCT on clinical practice. A total of 33 groups completed the survey. Routine clinical practice was not changed in 28 of the 33 groups (85%) based on the results of the Van Driel trial. Despite the results of this RCT, most groups considered that more RCTs are needed and that, in the future, HIPEC may become the standard of care. In conclusion, the results from RCTs evaluating HIPEC treatment in patients with ovarian cancer has not been transferred to clinical practice.
10 March 2022 in Clinical and Translational Oncology
Backgroud: Ovarian cancer is the deadliest gynecologic malignancy, with most patients presenting with peritoneal dissemination at diagnosis. Complete cytoreduction and sensitivity to platinum-based systemic chemotherapy remain the most significant prognostic factors. However, even after optimal first-line management, over half of patients relapse due to residual microscopic disease. Intraperitoneal chemotherapy aims to target this component, with normothermic intraperitoneal chemotherapy long-term (NIPEC-LT) and hyperthermic intraperitoneal chemotherapy (HIPEC) being the most studied approaches. While NIPEC-LT has demonstrated improved survival in select trials, concerns regarding toxicity and catheter-related complications have limited its adoption as standard care. Conversely, HIPEC has shown survival benefits, particularly in patients undergoing interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy, leading to its inclusion in clinical guidelines. However, HIPEC is administered as a single intraoperative treatment, limiting its prolonged effect. Objectives and Method: This study investigates the combination of HIPEC and postoperative NIPEC-LT in the BICOV-1 trial, a prospective, non-randomized phase I study evaluating the feasibility, safety, and oncologic outcomes. The primary objective is to assess the treatment completion rates and morbidity. The secondary endpoints include disease-free survival (DFS), overall survival (OS), and quality-of-life measures. Combining HIPEC and NIPEC-LT is a rational approach, as both have shown independent benefits and do not overlap in toxicity. HIPEC-induced biological changes may enhance the effectiveness of subsequent intraperitoneal chemotherapy. This trial will provide essential data for future phase II/III studies assessing the role of intensified intraperitoneal treatment in ovarian cancer management.
Background: This study aimed to analyze the morbidity, mortality, and survival outcomes in patients with peritoneal surface malignancies who were initially considered candidates for cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) but were found to have unresectable disease, resulting in nontherapeutic exploratory laparotomy. Patients and Methods: We evaluated data from our referral center for the treatment of peritoneal surface malignancies between January 2008 and December 2022. Adverse events following nontherapeutic laparotomy were classified using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Results: Among a cohort of 486 patients with peritoneal surface malignancies initially considered candidates for CRS + HIPEC, 46 cases (9.4%) were aborted due to the disease being deemed unresectable during exploratory laparotomy. The primary reasons for unresectability included extensive disease spread, observed in 28 patients, with massive small intestine involvement detected in 13 of these cases. The median duration of surgery was 90 min (range: 60–180 min). Postoperative complications occurred in 10 patients (22%), with a mortality rate of 4.3% (2 patients). Survival was significantly lower in patients who did not receive adjuvant systemic chemotherapy with palliative intent (4 months vs. 15 months, p < 0.01). Conclusions: Exploratory laparotomy in patients with peritoneal surface malignancies considered for CRS with HIPEC carries a substantial risk of complications. Improved preoperative staging using advanced technologies such as radiomics and laparoscopy is expected to reduce the number of patients undergoing nontherapeutic laparotomy.