Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA)
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 conduc...
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-01-01
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| Series: | Current Oncology |
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| Online Access: | https://www.mdpi.com/1718-7729/31/2/48 |
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| author | Pedro Villarejo Campos Susana Sánchez García Mariano Amo-Salas Esther García Santos Carlos López de la Manzanara Ana Alberca David Padilla-Valverde Francisco Javier Redondo Calvo Jesús Martín |
| author_facet | Pedro Villarejo Campos Susana Sánchez García Mariano Amo-Salas Esther García Santos Carlos López de la Manzanara Ana Alberca David Padilla-Valverde Francisco Javier Redondo Calvo Jesús Martín |
| author_sort | Pedro Villarejo Campos |
| collection | DOAJ |
| description | 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 (<i>p</i> = 0.22 and <i>p</i> = 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 (<i>p</i> = 0.033 and <i>p</i> = 0.042, respectively). The Clavien–Dindo classification of adverse event grades revealed no significant differences between HIPEC and controls (<i>p</i> = 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. |
| first_indexed | 2024-03-07T22:36:12Z |
| format | Article |
| id | doaj.art-0f70cf46e86e4bc8a41b35065c64fc55 |
| institution | Directory Open Access Journal |
| issn | 1198-0052 1718-7729 |
| language | English |
| last_indexed | 2024-03-07T22:36:12Z |
| publishDate | 2024-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj.art-0f70cf46e86e4bc8a41b35065c64fc552024-02-23T15:13:22ZengMDPI AGCurrent Oncology1198-00521718-77292024-01-0131266067110.3390/curroncol31020048Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA)Pedro Villarejo Campos0Susana Sánchez García1Mariano Amo-Salas2Esther García Santos3Carlos López de la Manzanara4Ana Alberca5David Padilla-Valverde6Francisco Javier Redondo Calvo7Jesús Martín8Department of Surgery, Fundación Jiménez Díaz University Hospital, Avda. Reyes Católicos, 2, 28040 Madrid, SpainDepartment of Surgery, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, SpainDepartment of Mathematics, University of Castilla-La Mancha, Camino de Moledores, s/n, 13071 Ciudad Real, SpainDepartment of Surgery, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, SpainDepartment of Gynaecology, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, SpainDepartment of Surgery, General University Hospital of Jaén, 23007 Jaén, SpainDepartment of Surgery, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, SpainDepartment of Anaesthesia, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, SpainDepartment of Surgery, General University Hospital of Ciudad Real, C/Obispo Rafael Torija, s/n, 13005 Ciudad Real, SpainMultidisciplinary 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 (<i>p</i> = 0.22 and <i>p</i> = 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 (<i>p</i> = 0.033 and <i>p</i> = 0.042, respectively). The Clavien–Dindo classification of adverse event grades revealed no significant differences between HIPEC and controls (<i>p</i> = 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.https://www.mdpi.com/1718-7729/31/2/48advanced or recurrent ovarian cancerHIPECpaclitaxelcytoreductionperitoneal metastasesperitoneal surface disease severity score |
| spellingShingle | Pedro Villarejo Campos Susana Sánchez García Mariano Amo-Salas Esther García Santos Carlos López de la Manzanara Ana Alberca David Padilla-Valverde Francisco Javier Redondo Calvo Jesús Martín Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA) Current Oncology advanced or recurrent ovarian cancer HIPEC paclitaxel cytoreduction peritoneal metastases peritoneal surface disease severity score |
| title | Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA) |
| title_full | Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA) |
| title_fullStr | Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA) |
| title_full_unstemmed | Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA) |
| title_short | Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA) |
| title_sort | paclitaxel as hipec drug after surgical cytoreduction for ovarian peritoneal metastases a randomized phase iii clinical trial hipecova |
| topic | advanced or recurrent ovarian cancer HIPEC paclitaxel cytoreduction peritoneal metastases peritoneal surface disease severity score |
| url | https://www.mdpi.com/1718-7729/31/2/48 |
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