Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC) : 5-Year Results of a Randomized Multicenter Trial
(2024) In Journal of clinical oncology : official journal of the American Society of Clinical Oncology 42(2). p.140-145- 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... (More)
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.
(Less)
- author
- contributor
- Verwaal, Vic LU
- author collaboration
- publishing date
- 2024-01-10
- type
- Contribution to journal
- publication status
- published
- keywords
- Humans, Hyperthermic Intraperitoneal Chemotherapy, Colorectal Neoplasms/drug therapy, Peritoneal Neoplasms/drug therapy, Hyperthermia, Induced/methods, Colonic Neoplasms/drug therapy, Chemotherapy, Adjuvant/methods, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Combined Modality Therapy, Cytoreduction Surgical Procedures
- in
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- volume
- 42
- issue
- 2
- pages
- 140 - 145
- publisher
- Lippincott Williams & Wilkins
- external identifiers
-
- pmid:37922442
- ISSN
- 0732-183X
- DOI
- 10.1200/JCO.22.02644
- language
- English
- LU publication?
- no
- id
- 067783c9-e35e-488d-b4b0-90a2741d078b
- date added to LUP
- 2025-11-26 09:28:48
- date last changed
- 2025-11-26 10:35:00
@article{067783c9-e35e-488d-b4b0-90a2741d078b,
abstract = {{<p>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.</p>}},
author = {{Zwanenburg, Emma Sophia and El Klaver, Charlotte and Wisselink, Daniel D and Punt, Cornelis J A and Snaebjornsson, P and Crezee, Johannes and Aalbers, Arend G J and Brandt-Kerkhof, Alexandra R M and Bremers, Andre J A and Burger, Pim J W A and Fabry, Hans F J and Ferenschild, Floris T J and Festen, Sebastiaan and van Grevenstein, Wilhemina M U and Hemmer, Patrick H J and de Hingh, Ignace H J T and Kok, Niels F M and Kusters, M and Musters, G D and Schoonderwoerd, Lotte and Tuynman, J B and van de Ven, Anthony W H and van Westreenen, Henderik L and Wiezer, M J and Zimmerman, David D E and van Zweeden, Annette and Dijkgraaf, Marcel G W and Tanis, Pieter J}},
issn = {{0732-183X}},
keywords = {{Humans; Hyperthermic Intraperitoneal Chemotherapy; Colorectal Neoplasms/drug therapy; Peritoneal Neoplasms/drug therapy; Hyperthermia, Induced/methods; Colonic Neoplasms/drug therapy; Chemotherapy, Adjuvant/methods; Antineoplastic Combined Chemotherapy Protocols/therapeutic use; Combined Modality Therapy; Cytoreduction Surgical Procedures}},
language = {{eng}},
month = {{01}},
number = {{2}},
pages = {{140--145}},
publisher = {{Lippincott Williams & Wilkins}},
series = {{Journal of clinical oncology : official journal of the American Society of Clinical Oncology}},
title = {{Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC) : 5-Year Results of a Randomized Multicenter Trial}},
url = {{http://dx.doi.org/10.1200/JCO.22.02644}},
doi = {{10.1200/JCO.22.02644}},
volume = {{42}},
year = {{2024}},
}