Cascales Campos Pedro Antonio1, González Gil Alida2,3, Gil Gómez Elena1, González Sánchez Rocío1, Martínez García Jerónimo4, Alonso Romero José Luis4, Nieto Díaz Aníbal5, Barceló Valcárcel Francisco5, Gómez Ruiz Álvaro Jesús1, Ramírez Romero Pablo1, Gil Martínez José1. 1. Departamento de Cirugía. Unidad de Cirugía Oncológica Peritoneal, Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Murcia, Spain. 2. Departamento de Cirugía. Unidad de Cirugía Oncológica Peritoneal, Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Murcia, Spain. alidagonzalezgil@gmail.com. 3. Servicio de Cirugía y Aparato Digestivo- Hospital Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Ctra. Madrid-Cartagena s/n, 30120, El Palmar, Murcia, Spain. alidagonzalezgil@gmail.com. 4. Departamento de Oncología, Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Murcia, Spain. 5. Departamento de Ginecología y Obstetricia, Unidad de Ginecología Oncológica. Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Murcia, Spain.
Abstract
BACKGROUND: Cytoreductive surgery (CRS) and administration of hyperthermic intraperitoneal chemotherapy (HIPEC) have shown their efficacy in multiple malignancies and also could offer a prognostic benefit for patients with advanced ovarian cancer. METHODS: A prospective, single-center, parallel-group, randomized phase 3 clinical trial analyzed patients with a diagnosis of carcinomatosis from ovarian cancer treated with neoadjuvant systemic chemotherapy (NACT). In this trial, 71 patients were randomized to receive CRS alone (36 patients) or CRS with HIPEC (35 patients) using cisplatin (75 mg/m2 for 60 min at 42 °C). The primary end point was disease-free survival (DFS). Overall survival (OS), morbidity, and quality of life (QoL) were the secondary end points. RESULTS: During a median follow-up period of 32 months, the median DFS was 12 months in the control group (CRS) and 18 months in the experimental group (CRS and HIPEC). The findings showed HIPEC to be an independent protective factor against the development of recurrence (hazard ratio [HR], 0.12, 95 % confidence interval [CI], 0.02-0.89; p = 0.038). The median OS was 45 months in the control group and 52 months in the experimental group. The respective morbidity rates for any grade (1 to 5) were respectively 58.3 % and 45.7 % (p > 0.05), with a mortality rates of 2.8 % and 2.9 % (p > 0.05). In the dimensions evaluated, CRS with or without HIPEC had no impact on QoL. CONCLUSIONS: For patients who had advanced ovarian cancer treated with NACT, CRS and HIPEC was associated with better DFS and OS, but without a difference in postoperative morbidity, mortality, or in the QoL evaluation.
BACKGROUND: Cytoreductive surgery (CRS) and administration of hyperthermic intraperitoneal chemotherapy (HIPEC) have shown their efficacy in multiple malignancies and also could offer a prognostic benefit for patients with advanced ovarian cancer. METHODS: A prospective, single-center, parallel-group, randomized phase 3 clinical trial analyzed patients with a diagnosis of carcinomatosis from ovarian cancer treated with neoadjuvant systemic chemotherapy (NACT). In this trial, 71 patients were randomized to receive CRS alone (36 patients) or CRS with HIPEC (35 patients) using cisplatin (75 mg/m2 for 60 min at 42 °C). The primary end point was disease-free survival (DFS). Overall survival (OS), morbidity, and quality of life (QoL) were the secondary end points. RESULTS: During a median follow-up period of 32 months, the median DFS was 12 months in the control group (CRS) and 18 months in the experimental group (CRS and HIPEC). The findings showed HIPEC to be an independent protective factor against the development of recurrence (hazard ratio [HR], 0.12, 95 % confidence interval [CI], 0.02-0.89; p = 0.038). The median OS was 45 months in the control group and 52 months in the experimental group. The respective morbidity rates for any grade (1 to 5) were respectively 58.3 % and 45.7 % (p > 0.05), with a mortality rates of 2.8 % and 2.9 % (p > 0.05). In the dimensions evaluated, CRS with or without HIPEC had no impact on QoL. CONCLUSIONS: For patients who had advanced ovarian cancer treated with NACT, CRS and HIPEC was associated with better DFS and OS, but without a difference in postoperative morbidity, mortality, or in the QoL evaluation.
Authors: Angela Casado-Adam; Lidia Rodriguez-Ortiz; Sebastian Rufian-Peña; Cristobal Muñoz-Casares; Teresa Caro-Cuenca; Rosa Ortega-Salas; Maria Auxiliadora Fernandez-Peralbo; Maria Dolores Luque-de-Castro; Juan M Sanchez-Hidalgo; Cesar Hervas-Martinez; Antonio Romero-Ruiz; Javier Briceño; Álvaro Arjona-Sánchez Journal: J Clin Med Date: 2022-09-29 Impact factor: 4.964