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World J Obstet Gynecol. Nov 10, 2013; 2(4): 124-128
Published online Nov 10, 2013. doi: 10.5317/wjog.v2.i4.124
Criticalities in randomized controlled trials on HIPEC for ovarian cancer
Federico Coccolini, Luca Ansaloni, Davide Corbella, Marco Lotti, Olivier Glehen
Federico Coccolini, Luca Ansaloni, Marco Lotti, General Surgery Dept., Papa Giovanni XXIII Hospital, 24128 Bergamo, Italy
Davide Corbella, Department of Anesthesiology, Papa Giovanni XXIII Hospital, 24128 Bergamo, Italy
Olivier Glehen, Department of Surgical Oncology, Centre Hospitalier Lyon Sud, 69495 Pierre-Bénite, France
Author contributions: Coccolini F contributed to the study design, literature analysis and paper writing; Corbella D and Lotti M contributed to the literature research, literature analysis and manuscript approval; Ansaloni L and Glehen O contributed equally to the final manuscript editing and approval.
Correspondence to: Federico Coccolini, MD, General Surgery Dept., Papa Giovanni XXIII Hospital, P.zza OMS 1, 24128 Bergamo, Italy. federico.coccolini@gmail.com
Telephone: +39-35-2696464 Fax: +39-35-2674963
Received: December 13, 2012
Revised: January 11, 2013
Accepted: March 23, 2013
Published online: November 10, 2013
Abstract

Since the 1990s, many oncological surgery groups around the world started to apply hyperthermic intra-peritoneal chemotherapy (HIPEC) to the different peritoneal spread cancers. The rationale of the application of HIPEC after surgery is to complete the cytoreductive procedure. This combined treatment has now been successfully applied to many different intra-abdominal neoplasms. However, the treatment of peritoneal surface malignancies and the administration of HIPEC still lack high graded evidence data, especially in ovarian cancer. Experimental data exists about every step of the treatment of peritoneal spread ovarian cancer but unfortunately they have not yet been translated into phase III clinical randomized trials. Moreover, treatment protocols differ between different centers. A systematic review of published randomized trial protocols was performed. HIPEC techniques are miscellaneous and not yet standardized. Well structured phase III randomized trials among specialized centers are needed to investigate the efficacy of this therapeutic approach, as well as technical details that may contribute to the standardization of the procedure and limit morbidity and mortality. In particular, new criteria are mandatory to uniformly stage the disease, to objectively evaluate the extension of cytoreduction and consequently the residual disease, to decide the best method of performing hyperthermia and to perfuse drugs. Moreover, pharmacokinetic and pharmacodynamic studies are urgently needed to assess the best type and dose of anticancer drugs.

Keywords: Randomized trial, Ovarian cancer, Hyperthermic intra-peritoneal chemotherapy, Hyperthermia

Core tip: Hyperthermic intra-peritoneal chemotherapy techniques are miscellaneous and not yet standardized. Well structured phase III randomized trials among specialized centers are necessary to investigate the efficacy of this therapeutic approach, as well as technical details that may contribute to the standardization of the procedure and limit morbidity and mortality.