González-Gil Alida, Gil-Gómez Elena, Olivares-Ripoll Vicente, Cerezuela Fernández de Palencia Álvaro, Martínez-García Jerónimo, Sánchez-Martínez Domingo, Guijarro-Campillo Alberto Rafael, Cascales-Campos Pedro Antonio
Peritoneal Carcinomatosis and Sarcomas Unit, Department of Surgery, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, 30120 Murcia, Spain.
Department of Surgery, University of Murcia, 30100 Murcia, Spain.
Cancers (Basel). 2025 Jun 12;17(12):1957. doi: 10.3390/cancers17121957.
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. : 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.
卵巢癌是最致命的妇科恶性肿瘤，大多数患者在诊断时已出现腹膜播散。完全细胞减灭术和对铂类全身化疗的敏感性仍然是最重要的预后因素。然而，即使经过最佳的一线治疗，仍有超过一半的患者因残留微小病灶而复发。腹腔内化疗旨在针对这一成分，常温腹腔内长期化疗（NIPEC-LT）和热腹腔内化疗（HIPEC）是研究最多的方法。虽然NIPEC-LT在某些试验中已显示出生存改善，但对毒性和导管相关并发症的担忧限制了其作为标准治疗方法的采用。相反，HIPEC已显示出生存益处，特别是在新辅助化疗后接受间隔细胞减灭术（iCRS）的患者中，这导致其被纳入临床指南。然而，HIPEC作为一种单一的术中治疗方法，限制了其长期效果。本研究在BICOV-1试验中研究了HIPEC与术后NIPEC-LT的联合应用，这是一项前瞻性、非随机的I期研究，评估可行性、安全性和肿瘤学结果。主要目标是评估治疗完成率和发病率。次要终点包括无病生存期（DFS）、总生存期（OS）和生活质量指标。将HIPEC和NIPEC-LT联合应用是一种合理的方法，因为两者都已显示出独立的益处且毒性不重叠。HIPEC诱导的生物学变化可能会增强后续腹腔内化疗的有效性。该试验将为未来评估强化腹腔内治疗在卵巢癌管理中的作用的II/III期研究提供重要数据。
