Intensified follow-up in colorectal cancer patients using frequent Carcino-Embryonic Antigen (CEA) measurements and CEA-triggered imaging: Results of the randomized "CEAwatch" trial

C J Verberne¹, Z Zhan², E van den Heuvel³, I Grossmann⁴, P M Doornbos⁵, K Havenga⁶, E Manusama⁷, J Klaase⁸, H C J van der Mijle⁹, B Lamme¹⁰, K Bosscha¹¹, P Baas¹², B van Ooijen¹³, G Nieuwenhuijzen¹⁴, A Marinelli¹⁵, E van der Zaag¹⁶, D Wasowicz¹⁷, G H de Bock¹⁸, T Wiggers¹⁹

Affiliations

¹ Department of Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: c.j.verberne@umcg.nl.
² Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: z.zhan01@umcg.nl.
³ Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: e.r.v.d.heuvel@tue.nl.
⁴ Department of Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: irenegrossmann@me.com.
⁵ Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
⁶ Department of Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
⁷ Department of Surgery, Medical Center Leeuwarden, Henri Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands. Electronic address: e.r.manusama@znb.nl.
⁸ Department of Surgery, Medical Spectrum Twente, Haaksbergerstraat 55, 7513 ER, Enschede, The Netherlands. Electronic address: j.klaase@mst.nl.
⁹ Department of Surgery, Nij Smellinghe Hospital, Compagnonsplein 1, 9202 NN, Drachten, The Netherlands. Electronic address: h.mijle@nijsmellinghe.nl.
¹⁰ Department of Surgery, Albert Schweitzer Hospital, Albert Schweitzerplaats 25, 3318 AT, Dordrecht, The Netherlands. Electronic address: b.lamme@asz.nl.
¹¹ Department of Surgery, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223 GZ, Den Bosch, The Netherlands. Electronic address: k.bosscha@jbz.nl.
¹² Department of Surgery, Martini Hospital, Van Swietenplein 1, 9728 NT, Groningen, The Netherlands. Electronic address: p.c.baas@mzh.nl.
¹³ Department of Surgery, Meander Medical Center, Maatweg 3, 3813 TZ, Amersfoort, The Netherlands. Electronic address: b.van.ooijen@meandermc.nl.
¹⁴ Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. Electronic address: grard.nieuwehuijzen@catharinaziekenhuis.nl.
¹⁵ Department of Surgery, Medical Center Haaglanden, Postbus 432, 2501 CK, Den Haag, The Netherlands. Electronic address: andreas.marinelli@mch.nl.
¹⁶ Department of Surgery, Gelre Hospital, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn, The Netherlands. Electronic address: e.van.der.zaag@gelre.nl.
¹⁷ Department of Surgery, Elisabeth Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands. Electronic address: d.wasowicz@elisabeth.nl.
¹⁸ Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: g.h.de.bock@umcg.nl.
¹⁹ Department of Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: t.wiggers@umcg.nl.

PMID: 26184850
DOI: 10.1016/j.ejso.2015.06.008

Free article

Randomized Controlled Trial

Intensified follow-up in colorectal cancer patients using frequent Carcino-Embryonic Antigen (CEA) measurements and CEA-triggered imaging: Results of the randomized "CEAwatch" trial

C J Verberne et al. Eur J Surg Oncol. 2015 Sep.

Free article

. 2015 Sep;41(9):1188-96.

doi: 10.1016/j.ejso.2015.06.008. Epub 2015 Jun 30.

Authors

Affiliations

¹ Department of Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: c.j.verberne@umcg.nl.
² Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: z.zhan01@umcg.nl.
³ Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: e.r.v.d.heuvel@tue.nl.
⁴ Department of Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: irenegrossmann@me.com.
⁵ Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
⁶ Department of Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
⁷ Department of Surgery, Medical Center Leeuwarden, Henri Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands. Electronic address: e.r.manusama@znb.nl.
⁸ Department of Surgery, Medical Spectrum Twente, Haaksbergerstraat 55, 7513 ER, Enschede, The Netherlands. Electronic address: j.klaase@mst.nl.
⁹ Department of Surgery, Nij Smellinghe Hospital, Compagnonsplein 1, 9202 NN, Drachten, The Netherlands. Electronic address: h.mijle@nijsmellinghe.nl.
¹⁰ Department of Surgery, Albert Schweitzer Hospital, Albert Schweitzerplaats 25, 3318 AT, Dordrecht, The Netherlands. Electronic address: b.lamme@asz.nl.
¹¹ Department of Surgery, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223 GZ, Den Bosch, The Netherlands. Electronic address: k.bosscha@jbz.nl.
¹² Department of Surgery, Martini Hospital, Van Swietenplein 1, 9728 NT, Groningen, The Netherlands. Electronic address: p.c.baas@mzh.nl.
¹³ Department of Surgery, Meander Medical Center, Maatweg 3, 3813 TZ, Amersfoort, The Netherlands. Electronic address: b.van.ooijen@meandermc.nl.
¹⁴ Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. Electronic address: grard.nieuwehuijzen@catharinaziekenhuis.nl.
¹⁵ Department of Surgery, Medical Center Haaglanden, Postbus 432, 2501 CK, Den Haag, The Netherlands. Electronic address: andreas.marinelli@mch.nl.
¹⁶ Department of Surgery, Gelre Hospital, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn, The Netherlands. Electronic address: e.van.der.zaag@gelre.nl.
¹⁷ Department of Surgery, Elisabeth Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands. Electronic address: d.wasowicz@elisabeth.nl.
¹⁸ Department of Epidemiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: g.h.de.bock@umcg.nl.
¹⁹ Department of Surgery, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Electronic address: t.wiggers@umcg.nl.

PMID: 26184850
DOI: 10.1016/j.ejso.2015.06.008

Abstract

Aim: The value of frequent Carcino-Embryonic Antigen (CEA) measurements and CEA-triggered imaging for detecting recurrent disease in colorectal cancer (CRC) patients was investigated in search for an evidence-based follow-up protocol.

Methods: This is a randomized-controlled multicenter prospective study using a stepped-wedge cluster design. From October 2010 to October 2012, surgically treated non-metastasized CRC patients in follow-up were followed in eleven hospitals. Clusters of hospitals sequentially changed their usual follow-up care into an intensified follow-up schedule consisting of CEA measurements every two months, with imaging in case of two CEA rises. The primary outcome measures were the proportion of recurrences that could be treated with curative intent, recurrences with definitive curative treatment outcome, and the time to detection of recurrent disease.

Results: 3223 patients were included; 243 recurrences were detected (7.5%). A higher proportion of recurrences was detected in the intervention protocol compared to the control protocol (OR = 1.80; 95%-CI: 1.33-2.50; p = 0.0004). The proportion of recurrences that could be treated with curative intent was higher in the intervention protocol (OR = 2.84; 95%-CI: 1.38-5.86; p = 0.0048) and the proportion of recurrences with definitive curative treatment outcome was also higher (OR = 3.12, 95%-CI: 1.25-6.02, p-value: 0.0145). The time to detection of recurrent disease was significantly shorter in the intensified follow-up protocol (HR = 1.45; 95%-CI: 1.08-1.95; p = 0.013).

Conclusion: The CEAwatch protocol detects recurrent disease after colorectal cancer earlier, in a phase that a significantly higher proportion of recurrences can be treated with curative intent.

Keywords: CEA; Colorectal cancer; Follow-up; Stepped-wedge cluster randomized trial (SW-RCT).

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Comment in

Is there a survival benefit from increased intensity of CEA monitoring after primary resection of colorectal cancer?
Treasure T, Macbeth F. Treasure T, et al. Eur J Surg Oncol. 2016 Feb;42(2):312-3. doi: 10.1016/j.ejso.2015.10.008. Epub 2015 Nov 2. Eur J Surg Oncol. 2016. PMID: 26560023 No abstract available.
Reply to: Is there survival benefit from increased intensity for CEA monitoring after primary resection of colorectal cancer?
Verberne CJ, Wiggers T. Verberne CJ, et al. Eur J Surg Oncol. 2016 Feb;42(2):314. doi: 10.1016/j.ejso.2015.10.007. Epub 2015 Nov 5. Eur J Surg Oncol. 2016. PMID: 26585466 No abstract available.

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Intensified follow-up in colorectal cancer patients using frequent Carcino-Embryonic Antigen (CEA) measurements and CEA-triggered imaging: Results of the randomized "CEAwatch" trial

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Intensified follow-up in colorectal cancer patients using frequent Carcino-Embryonic Antigen (CEA) measurements and CEA-triggered imaging: Results of the randomized "CEAwatch" trial

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