| Autor: |
Villarejo Campos P; Department of Surgery, Fundación Jiménez Díaz University Hospital, Avda. Reyes Católicos, 2, 28040 Madrid, Spain.; Department of Surgery, Universidad Autónoma de Madrid, C/Arzobispo Morcillo s/n, 28034 Madrid, Spain., Sánchez García S; Department of Surgery, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, Spain., Amo-Salas M; Department of Mathematics, University of Castilla-La Mancha, Camino de Moledores, s/n, 13071 Ciudad Real, Spain., García Santos E; Department of Surgery, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, Spain., López de la Manzanara C; Department of Gynaecology, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, Spain., Alberca A; Department of Surgery, General University Hospital of Jaén, 23007 Jaén, Spain., Padilla-Valverde D; Department of Surgery, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, Spain., Redondo Calvo FJ; Department of Anaesthesia, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, Spain., Martín J; Department of Surgery, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, Spain. |
| Abstrakt: |
Multidisciplinary strategies have transformed the management of advanced ovarian cancer. We aimed to evaluate the effectiveness of paclitaxel in hyperthermic intraperitoneal chemotherapy (HIPEC) following surgical cytoreduction for ovarian peritoneal metastases in a randomized phase III trial conducted between August 2012 and December 2019. Seventy-six patients were randomized to either the HIPEC or no HIPEC group. Although median values for the primary endpoints (recurrence-free survival (RFS) and overall survival (OS)) revealed superior outcomes for the HIPEC (RFS: 23 months, OS: 48 months) over the control group (RFS: 19 months, OS: 46 months), these differences were not statistically significant ( p = 0.22 and p = 0.579). Notably, the HIPEC group demonstrated significantly higher 5-year OS and 3-year RFS rates (47.2% and 47.5%) compared to patients without HIPEC (34.5% and 21.3%). Stratification according to Peritoneal Surface Disease Severity Score (PSDSS) showed improved OS and RFS for patients with lower PSDSS (I-II) in the HIPEC-treated group ( p = 0.033 and p = 0.042, respectively). The Clavien-Dindo classification of adverse event grades revealed no significant differences between HIPEC and controls ( p = 0.482). While overall results were not statistically significant, our long-term follow-up emphasized the potential benefit of HIPEC-associated cytoreduction with paclitaxel, particularly in selected ovarian cancer patients with lower PSDSS indices. |
