A phase 2 trial of short-course Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) at interval cytoreductive surgery (iCRS) for advanced ovarian cancer.

Thales Paulo Batista,Cristiano Souza Leão,Levon Badiglian Filho,Rodrigo Tancredi,Ronaldo Lúcio Costa Rangel,Bruno José Queiroz Sarmento,Vandré Cabral Gomes Carneiro,André Lopes

doi:10.1590/0100-6991e-20223135

Abstract

to report the final analysis of a phase 2 trial assessing the efficacy and safety of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with advanced epithelial ovarian cancer (EOC). this was an open-label, multicenter, single-arm trial of HIPEC in patients with advanced EOC who underwent interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy (NACT). HIPEC was performed as a concentration-based regimen of platinum-based chemotherapy for 30 minutes. Primary endpoint was the rate of disease progression occurring at nine months following iCRS plus HIPEC (PD9). Secondary endpoints were postoperative complications, time to start adjuvant chemotherapy, length of hospital and ICU stay, quality of life (QoL) over treatment, and ultimately 2-year progression-free survival (PFS) and overall survival (OS). Analysis was by intention-to-treat with final database lock for survival outcomes on February 23, 2021. fifteen patients with stage III EOC were enrolled between February 2015 and July 2019, in four centers. The intention to treat PD9 was 6.7%. With a median follow-up of 33 months (IQR, 24.3-46.5), the median PFS was 18.1 months and corresponding 2-year rates of PFS and OS was 33.3% and 93.3%, respectively. Three patients (20%) experienced graded III complications. Median length of hospital and ICU stay was 5 (IQR, 4-6.5) and 1 (IQR, 1-1) days, respectively. Time to restart systemic chemotherapy was 39 (IQR, 35-49.3) days and no significant difference over time in QoL was observed. we demonstrate preliminary efficacy and safety of short-course HIPEC in patient with advanced EOC.

Highlights

Ovarian tends cancer is a peritoneal-borne disease that to disseminate early into the peritoneal cavity and to be diagnosed at advanced stages in most patients
Patients with advanced epithelial ovarian cancer (EOC) treated with neoadjuvant chemotherapy (NACT) due to high tumor load at diagnosis were referred to interval cytoreductive surgery (iCRS), and they were assessed to participate in this study if had at least stable disease up to 4 cycles of systemic chemotherapy
Patients Characteristic Between February 2015 and July 2019, 43 women were assessed for eligibility (n=43) and 15 met the inclusion criteria and underwent Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) during iCRS in four of the six recruiting centers

Summary

Introduction

Ovarian tends cancer is a peritoneal-borne disease that to disseminate early into the peritoneal cavity and to be diagnosed at advanced stages in most patients. The rationale of HIPEC is based on the enhancement of cytotoxicity by hyperthermia for some anticancer medications and the pharmacokinetic advantages of intraperitoneal chemotherapy, whereas hyperthermia can reduce the mechanisms of cellular resistance to platins and induce an efficient anticancer immune response via exposure of cell surface heat shock proteins[2-6]. This technique is delivered only during the operation, avoiding the need for implantation of peritoneal access devices and reducing catheter-related morbidity[7]. A shorter time of perfusion may add benefits in terms of perioperative complications[14]

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