Publication: Cytoreductive surgery with or without HIPEC After neoadjuvant chemotherapy in ovarian cancer: a phase 3 clinical trial
Authors
Cascales Campos, Pedro Antonio ; González Gil, Alida ; Gil Gómez, Elena ; González Sánchez, Rocío ; Martínez García, Jerónimo ; Alonso-Romero, José Luis ; Nieto Díaz, Aníbal ; Barceló Valcárcel, Francisco ; Gómez Ruiz, Álvaro Jesús ; Ramírez Romero, Pablo ; Gil Martínez, José
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Publisher
Springer
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DOI
https://doi.org/10.1245/s10434-021-11087-7
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info:eu-repo/semantics/article
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
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.
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Citation
Ann Surg Oncol (2022) 29:2617–2625
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