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In Reply:

Department of Surgery, The Netherlands Cancer Institute, Amsterdam, Netherlands

The comments in the letters to the editor are well taken. We agree with both writers that our study could not answer the question of whether adding hyperthermic, intraperitoneal chemotherapy to cytoreduction is better than cytoreduction alone. To answer this question, an appropriate study design would, indeed, be a randomized trial comparing cytoreduction alone with cytoreduction plus hyperthermic intraperitoneal chemotherapy.

At the current state of art in the treatment of carcinomatosis, neither cytoreduction alone nor hyperthermia plus chemotherapy is common practice or a proven treatment. This means that a study design comparing single elements of the treatment would be a comparison of two new therapies and would not answer the question whether either treatment is better than the regular treatment. At this moment, the gold standard in the treatment of peritoneal carcinomatosis has not yet been established. In practice, most patients affected by peritoneal carcinomatosis face a therapeutic nihilism and do not undergo major treatments. In this perspective, a novel therapy like cytoreduction with hyperthermic intraperitoneal chemotherapy should be compared with a nihilistic treatment regime, as being the standard.

Now that our randomized trial has been completed, the question of which element of the combined treatment is effective becomes relevant, as suggested in both letters. The design proposed in the first letter is an excellent suggestion. In such a study, cytoreduction plus hyperthermic intraperitoneal chemotherapy is seen as standard treatment. Therefore, this would be a noninferiority study design. A study of this nature is currently being prepared.

The suggestions in the second letter could follow if the oncoming trial will prove a benefit of hyperthermic intraperitoneal chemotherapy after cytoreduction. This trial would compare cytoreduction plus hyperthermic intraperitoneal chemotherapy, with cytoreduction plus intraperitoneal chemotherapy without hyperthermia.

Our randomized trial showed a survival benefit of cytoreduction plus hyperthermic intraperitoneal in patients affected by peritoneal carcinomatosis of colorectal origin. The value of any other new therapies should be tested either with the standard therapy or with cytoreduction plus hyperthermic intraperitoneal chemotherapy in a phase III setting. Only in this way we will be able to determinate which treatment or combination of treatments is optimal.

Author's Disclosures of Potential Conflicts of Interest

The author indicated no potential conflicts of interest.

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