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Cytoreductive surgery with or without HIPEC After neoadjuvant chemotherapy in ovarian cancer: a phase 3 clinical trial

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dc.contributor.authorCascales Campos, Pedro Antonio
dc.contributor.authorGonzález Gil, Alida
dc.contributor.authorGil Gómez, Elena
dc.contributor.authorGonzález Sánchez, Rocío
dc.contributor.authorMartínez García, Jerónimo
dc.contributor.authorAlonso-Romero, José Luis
dc.contributor.authorNieto Díaz, Aníbal
dc.contributor.authorBarceló Valcárcel, Francisco
dc.contributor.authorGómez Ruiz, Álvaro Jesús
dc.contributor.authorRamírez Romero, Pablo
dc.contributor.authorGil Martínez, José
dc.contributor.departmentMedicina
dc.date.accessioned2024-11-05T12:15:38Z
dc.date.available2024-11-05T12:15:38Z
dc.date.issued2021-11-23
dc.description© Society of Surgical Oncology 2021. This document is the Published version of a Published Work that appeared in final form in Annals of Surgical Oncology. To access the final edited and published work see https://doi.org/10.1245/s10434-021-11087-7
dc.description.abstractBackground. 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.es
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dc.identifier.citationAnn Surg Oncol (2022) 29:2617–2625
dc.identifier.doihttps://doi.org/10.1245/s10434-021-11087-7
dc.identifier.issnPrint: 1068-9265
dc.identifier.issnElectronic: 1534-4681
dc.identifier.urihttp://hdl.handle.net/10201/146020
dc.languageenges
dc.publisherSpringer
dc.relationThis study was funded by the Dirección General de Farmacia y Productos Sanitarios (Ministerio Español de Sanidad, Política Social e Igualdad)es
dc.relation.publisherversionhttps://link.springer.com/article/10.1245/s10434-021-11087-7
dc.rights.accessRightsinfo:eu-repo/semantics/restrictedAccess
dc.titleCytoreductive surgery with or without HIPEC After neoadjuvant chemotherapy in ovarian cancer: a phase 3 clinical triales
dc.typeinfo:eu-repo/semantics/articlees
dspace.entity.typePublicationes
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