Criticalities in randomized controlled trials on HIPEC for ovarian cancer

Since the 1990 s, many oncological surgery groups around the world started to apply hyperthermic intraperitoneal 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 investi-gate the effi cacy 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.