Rapid responses are electronic comments to the editor. They enable our users
to debate issues raised in articles published on bmj.com. A rapid response
is first posted online. If you need the URL (web address) of an individual
response, simply click on the response headline and copy the URL from the
browser window. A proportion of responses will, after editing, be published
online and in the print journal as letters, which are indexed in PubMed.
Rapid responses are not indexed in PubMed and they are not journal articles.
The BMJ reserves the right to remove responses which are being
wilfully misrepresented as published articles or when it is brought to our
attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not
including references and author details. We will no longer post responses
that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
We share the concern expressed by Anna de Vries and colleagues about bias in outcome reporting.[1] In the context of antidepressant trials and Study 329, De Vries and colleagues note ‘…negative trials were reported as positive, often because of outcome reporting bias’. Changing the reported outcome is a slippery slope, not confined to pharma, leading towards misleading claims.
CEASL, another recovered trial,[2-4] found that it was possible with intensive monitoring to bring forward in time the diagnosis of metastatic colorectal cancer following potentially curative surgery. The purpose of such monitoring is to improve survival among those whose cancer reappears after resection of the primary. The FACS trial of intensified follow-up was set up with the primary outcome being survival. By the time of publication this had changed to ‘surgery with curative intent’ and a positive result was reported.[5] In fact there were more deaths in the intensively monitored groups despite earlier detection (18.2% vs 15.9%, N=301 and 901. P=0.69) perhaps revealing, in the absence of survival benefit, some harm due to treatment. The larger CEAwatch trial (N=5604) followed suit using the phrase ‘curative treatment’ eleven times and ‘curative intent’ ten times while not providing any survival data. [6]
Neither lung nor liver metastasectomy has yet been shown to provide a survival benefit.[7;8] From basic principles, cure by piecemeal removal of blood borne disseminated cancer is improbable and cannot be assumed.[9] The PulMiCC trial has been funded by Cancer Research UK to run for a further five years to discover the true effect of pulmonary metastasectomy on survival in advanced colorectal cancer and it will be re-launched at the National Cancer Research Institute Conference in Liverpool on 1st November 2015.
Reference List
1 de Vries YA, Turner EH, Roest AM: Retraction of biased journal articles. BMJ 2015;351:h5497.
2 Treasure T, Monson K, Fiorentino F, Russell C: The CEA Second-Look Trial: a randomised controlled trial of carcinoembryonic antigen prompted reoperation for recurrent colorectal cancer. BMJ Open 2014;4:e004385.
3 Treasure T, Monson K, Fiorentino F, Russell C: Operating to remove recurrent colorectal cancer: have we got it right? BMJ 2014;348:g2085.
4 Godlee F: Colorectal cancer: a cautionary tale. BMJ DOI: 10.1136/bmj.g3311 (Published 15 May 2014).
5 Primrose JN, Perera R, Gray A, Rose P, Fuller A, Corkhill A, George S, Mant D: Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: the FACS randomized clinical trial. JAMA 2014;311:263-270.
6 Verberne CJ, Zhan Z, van den Heuvel E, Grossmann I, Doornbos PM, Havenga K, Manusama E, Klaase J, van der Mijle HC, Lamme B, Bosscha K, Baas P, van OB, Nieuwenhuijzen G, Marinelli A, van der Zaag E, Wasowicz D, de Bock GH, Wiggers T: Intensified follow-up in colorectal cancer patients using frequent Carcino-Embryonic Antigen (CEA) measurements and CEA-triggered imaging: Results of the randomized "CEAwatch" trial. Eur J Surg Oncol 2015;41:1188-1196.
7 Treasure T, Utley M, Hunt I: When professional opinion is not enough: surgical resection of pulmonary metastases. BMJ 2007;334:831-832.
8 Treasure T, Milosevic M, Fiorentino F, Macbeth F: Pulmonary metastasectomy: what is the practice and where is the evidence for effectiveness? Thorax 2014;69:946-949.
9 Treasure T, Brew-Graves C, Fallowfield L, Farewell V, Golesworthy T, Leonard P, Monson K, Russell C: The need to determine whether lung metastasectomy improves survival in advanced colorectal cancer. BMJ 2014;348:g4085.
Re: Retraction of biased journal articles
We share the concern expressed by Anna de Vries and colleagues about bias in outcome reporting.[1] In the context of antidepressant trials and Study 329, De Vries and colleagues note ‘…negative trials were reported as positive, often because of outcome reporting bias’. Changing the reported outcome is a slippery slope, not confined to pharma, leading towards misleading claims.
CEASL, another recovered trial,[2-4] found that it was possible with intensive monitoring to bring forward in time the diagnosis of metastatic colorectal cancer following potentially curative surgery. The purpose of such monitoring is to improve survival among those whose cancer reappears after resection of the primary. The FACS trial of intensified follow-up was set up with the primary outcome being survival. By the time of publication this had changed to ‘surgery with curative intent’ and a positive result was reported.[5] In fact there were more deaths in the intensively monitored groups despite earlier detection (18.2% vs 15.9%, N=301 and 901. P=0.69) perhaps revealing, in the absence of survival benefit, some harm due to treatment. The larger CEAwatch trial (N=5604) followed suit using the phrase ‘curative treatment’ eleven times and ‘curative intent’ ten times while not providing any survival data. [6]
Neither lung nor liver metastasectomy has yet been shown to provide a survival benefit.[7;8] From basic principles, cure by piecemeal removal of blood borne disseminated cancer is improbable and cannot be assumed.[9] The PulMiCC trial has been funded by Cancer Research UK to run for a further five years to discover the true effect of pulmonary metastasectomy on survival in advanced colorectal cancer and it will be re-launched at the National Cancer Research Institute Conference in Liverpool on 1st November 2015.
Reference List
1 de Vries YA, Turner EH, Roest AM: Retraction of biased journal articles. BMJ 2015;351:h5497.
2 Treasure T, Monson K, Fiorentino F, Russell C: The CEA Second-Look Trial: a randomised controlled trial of carcinoembryonic antigen prompted reoperation for recurrent colorectal cancer. BMJ Open 2014;4:e004385.
3 Treasure T, Monson K, Fiorentino F, Russell C: Operating to remove recurrent colorectal cancer: have we got it right? BMJ 2014;348:g2085.
4 Godlee F: Colorectal cancer: a cautionary tale. BMJ DOI: 10.1136/bmj.g3311 (Published 15 May 2014).
5 Primrose JN, Perera R, Gray A, Rose P, Fuller A, Corkhill A, George S, Mant D: Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: the FACS randomized clinical trial. JAMA 2014;311:263-270.
6 Verberne CJ, Zhan Z, van den Heuvel E, Grossmann I, Doornbos PM, Havenga K, Manusama E, Klaase J, van der Mijle HC, Lamme B, Bosscha K, Baas P, van OB, Nieuwenhuijzen G, Marinelli A, van der Zaag E, Wasowicz D, de Bock GH, Wiggers T: Intensified follow-up in colorectal cancer patients using frequent Carcino-Embryonic Antigen (CEA) measurements and CEA-triggered imaging: Results of the randomized "CEAwatch" trial. Eur J Surg Oncol 2015;41:1188-1196.
7 Treasure T, Utley M, Hunt I: When professional opinion is not enough: surgical resection of pulmonary metastases. BMJ 2007;334:831-832.
8 Treasure T, Milosevic M, Fiorentino F, Macbeth F: Pulmonary metastasectomy: what is the practice and where is the evidence for effectiveness? Thorax 2014;69:946-949.
9 Treasure T, Brew-Graves C, Fallowfield L, Farewell V, Golesworthy T, Leonard P, Monson K, Russell C: The need to determine whether lung metastasectomy improves survival in advanced colorectal cancer. BMJ 2014;348:g4085.
Competing interests: No competing interests