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Cytoreductive Surgery With or Without HIPEC After Neoadjuvant Chemotherapy in Ovarian Cancer: A Phase 3 Clinical Trial

  • Peritoneal Surface Malignancy
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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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Acknowledgment

This study was funded by the Dirección General de Farmacia y Productos Sanitarios (Ministerio Español de Sanidad, Política Social e Igualdad)

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Author notes

  1. Cascales Campos Pedro Antonio and González Gil Alida have equally contributed to the work

Authors and Affiliations

  1. Departamento de Cirugía. Unidad de Cirugía Oncológica Peritoneal, Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Murcia, Spain

    Cascales Campos Pedro Antonio MD, PHD, González Gil Alida MD, PHD, Gil Gómez Elena MD, PHD, González Sánchez Rocío PHD, Gómez Ruiz Álvaro Jesús MD, PHD, Ramírez Romero Pablo MD, PHD & Gil Martínez José MD, PHD

  2. Departamento de Oncología, Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Murcia, Spain

    Martínez García Jerónimo MD, PHD & Alonso Romero José Luis MD, PHD

  3. Departamento de Ginecología y Obstetricia, Unidad de Ginecología Oncológica. Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Murcia, Spain

    Nieto Díaz Aníbal MD, PHD & Barceló Valcárcel Francisco MD, PHD

  4. Servicio de Cirugía y Aparato Digestivo- Hospital Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Ctra. Madrid-Cartagena s/n, 30120, El Palmar, Murcia, Spain

    González Gil Alida MD, PHD

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  1. Cascales Campos Pedro Antonio MD, PHD
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Correspondence to González Gil Alida MD, PHD.

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Antonio, C.C.P., Alida, G.G., Elena, G.G. et al. Cytoreductive Surgery With or Without HIPEC After Neoadjuvant Chemotherapy in Ovarian Cancer: A Phase 3 Clinical Trial. Ann Surg Oncol 29, 2617–2625 (2022). https://doi.org/10.1245/s10434-021-11087-7

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