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Journal of Clinical Oncology, Vol 22, No 8 (April 15), 2004: pp. 1527 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.99.263
Intraperitoneal Hyperthermic Chemotherapy As Treatment of Peritoneal Carcinomatosis of Colorectal CancerThe University of Texas M.D. Anderson Cancer Center, Houston, TX To the Editor: Verwaal et al1 are to be congratulated for their efforts to evaluate in a phase III randomized trial the clinical utility of "aggressive surgical cytoreduction" followed by hyperthermic intraperitoneal chemotherapy (HIPEC) as a management strategy for peritoneal carcinomatosis resulting from a colorectal malignancy. Unfortunately, a major conceptual flaw in the study's design prevents any meaningful conclusions to be drawn from the results of this otherwise interesting study. The investigators elected to compare a strategy that combined aggressive surgery with HIPEC versus standard intravenous chemotherapy plus palliative surgery (if necessary). However, if the aim of the study was to evaluate the highly experimental, complex, costly, and potentially very morbid regional chemotherapy strategy, this trial has failed to address this important question. A more appropriate trial design would have been to randomly assign patients with peritoneal carcinomatosis to aggressive surgical cytoreduction with or without HIPEC. With the present study design, the demonstrated survival benefit may have been due principally, if not totally, to the extensive surgery, with the regional chemotherapy only adding toxicity. The favorable impact on survival associated with an attempt at "interval surgical cytoreduction" (without the subsequent administration of intraperitoneal chemotherapy) has been documented in ovarian cancer,2 and the major influence of the volume of residual disease on survival has been clearly shown in the current study (median survival of 20 months v 5 months for patients with "limited" versus "extensive" residual cancer, respectively). As appropriately noted by the authors: "... it cannot be excluded that the observed effect was exclusively or mainly caused by the aggressive cytoreduction alone." In sum, this study fails to provide any support for the routine (as opposed to investigative) use of HIPEC in this clinical setting. It is hoped that these investigators will follow their important initial efforts with a phase III randomized trial that directly addresses the unique contribution (if any) of the regional chemotherapy component of this intensive management strategy. Author's Disclosures of Potential Conflicts of Interest The author indicated no potential conflicts of interest. REFERENCES
1. Verwaal VJ, van Ruth S, de Bree E, et al: Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol 21:3737-3743, 2003
2. Van der Burg MEL, Van Lent M, Buyse M, et al: The effect of debulking surgery after induction chemotherapy on the prognosis in advanced epithelial ovarian cancer. N Engl J Med 332:629-634, 1995
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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