Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC): 5-Year Results of a Randomized Multicenter Trial

Author(s): Emma Sophia Zwanenburg, MD^1,2; Charlotte El Klaver, MD, PhD^1,2; Daniel D. Wisselink, MD^1,2; Cornelis J.A. Punt, MD, PhD³; P. Snaebjornsson, MD, PhD^4,5; Johannes Crezee, MD, PhD^2,6; Arend G.J. Aalbers, MD, PhD¹; Alexandra R.M. Brandt-Kerkhof, MD7; Andre J.A. Bremers, MD, PhD⁸; Pim J.W.A. Burger, MD, PhD⁹; Hans F.J. Fabry, MD¹⁰; Floris T.J. Ferenschild, MD, PhD¹¹; Sebastiaan Festen, MD, PhD¹²; Wilhemina M.U. van Grevenstein, MD, PhD¹³; Patrick H.J. Hemmer, MD, PhD¹⁴; Ignace H.J.T. de Hingh, MD, PhD⁸; Niels F.M. Kok, MD, PhD⁹; M. Kusters, MD, PhD^1,2; G.D. Musters, MD, PhD^1,2; Lotte Schoonderwoerd, MD¹⁰; J.B. Tuynman, MD, PhD^2,11; Anthony W.H. van de Ven, MD, PhD¹²; Henderik L. van Westreenen, MD, PhD¹³; M.J. Wiezer, MD, PhD¹⁴; David D.E. Zimmerman, MD, PhD¹⁵; Annette van Zweeden, MD¹⁶; Marcel G.W. Dijkgraaf, MD, PhD^17,18; Pieter J. Tanis, MD, PhD^1,2,7

Source: https://doi.org/10.1200/JCO.22.02644

Dr. Anjan Patel's Thoughts

Negative study for the use of HIPEC in the adjuvant setting of high-risk or locally advanced colorectal cancers, including those with perforation and peritoneal invasion. HIPEC doesn’t seem to reduce the risk of peritoneal recurrence after potentially curative resection.

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

Whether adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) might prevent peritoneal metastases after curative surgery for high-risk colon cancer is an ongoing debate. This study aimed to determine 5-year oncologic outcomes of the randomized multicenter COLOPEC trial, which included patients with clinical or pathologic T4N0-2M0 or perforated colon cancer and randomly assigned (1:1) to either adjuvant systemic chemotherapy and HIPEC (n = 100) or adjuvant systemic chemotherapy alone (n = 102). HIPEC was performed using a one-time administration of oxaliplatin (460 mg/m2, 30 minutes, 42°C, concurrent fluorouracil/leucovorin intravenously), either simultaneously (9%) or within 5-8 weeks (91%) after primary tumor resection. Outcomes were analyzed according to the intention-to-treat principle. Long-term data were available of all 202 patients included in the COLOPEC trial, with a median follow-up of 59 months (IQR, 54.5-64.5). No significant difference was found in 5-year overall survival rate between patients assigned to adjuvant HIPEC followed by systemic chemotherapy or only adjuvant systemic chemotherapy (69.6% v 70.9%, log-rank; P = .692). Five-year peritoneal metastases rates were 63.9% and 63.2% (P = .907) and 5-year disease-free survival was 55.7% and 52.3% (log-rank; P = .875), respectively. No differences in quality-of-life outcomes were found. Our findings implicate that adjuvant HIPEC should still be performed in trial setting only.

Author Affiliations

¹Amsterdam UMC Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; ²Cancer Center Amsterdam, Treatment and Quality of Life, Amsterdam, the Netherlands; ³UMC Utrecht, Department of Epidemiology, Julius Center for Health Sciences and Primary Care, Utrecht, the Netherlands; ⁴Netherlands Cancer Institute, Department of Pathology, Amsterdam, the Netherlands; ⁵Faculty of Medicine, University of Iceland, Reykjavik, Iceland; ⁶Amsterdam UMC Location University of Amsterdam, Department of Radiation Oncology, Amsterdam, the Netherlands; ⁷Erasmus Medical Center, Department of Oncological and Gastrointestinal Surgery, Rotterdam, the Netherlands; ⁸Radboud University Medical Center, Department of Surgery, Nijmegen, the Netherlands; ⁹Catharina Hospital, Department of Surgery, Eindhoven, the Netherlands; ¹⁰Bravis Hospital, Department of Surgery, Roosendaal, the Netherlands; ¹¹Maashospital Pantein, Department of Surgery, Beugen, the Netherlands; ¹²Department of Surgery, Onze Lieve Vrouwen Gasthuis, Amsterdam, the Netherlands; ¹³University Medical Center Utrecht, Department of Surgery, Utrecht, the Netherlands; ¹⁴University Medical Center Groningen, Department of Surgery, Groningen, the Netherlands; ^9Netherlands Cancer Institute, Department of Surgery, Amsterdam, the Netherlands; ¹⁰Bernhoven Hospital, Department of Surgery, Uden, the Netherlands; ¹¹Amsterdam UMC Location Free University, Department of Surgery, Amsterdam, the Netherlands; ¹²Flevo Hospital, Department of Surgery, Almere, the Netherlands; ¹³Isala Hospital, Department of Surgery, Zwolle, the Netherlands; ¹⁴St Antonius Hospital, Department of Surgery, Nieuwegein, the Netherlands; ¹⁵Elisabeth-Tweesteden Hospital, Department of Surgery, Tilburg, the Netherlands; ¹⁶Amstelland Hospital, Department of Internal Medicine, Amstelveen, the Netherlands; ¹⁷Amsterdam UMC Location University of Amsterdam, Department of Epidemiology and Data Science, Amsterdam, the Netherlands; ¹⁸Amsterdam Public Health, Methodology, Amsterdam, the Netherlands

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Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC): 5-Year Results of a Randomized Multicenter Trial

Dr. Anjan Patel's Thoughts

ABSTRACT

Author Affiliations

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