[Rapid response] Re: colorectal cancer: summary of NICE guidance

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Pulmonary metastasectomy: limits to credibility

Lung metastases are a common site of spread for many malignant tumours. Pulmonary metastasectomy has been practiced for many years for sarcomas and is now becoming increasingly frequently advocated for patients with many other tumours, especially colorectal cancer. In this article we argue that this procedure is one framed by therapeutic opportunity and not supported by strong evidence. It is potentially harmful and may not be effective. Our argument is based on several important issues: (I) the vagueness of the concept of “oligometastases” and its biological implausibility; (II) the flaws in the often-cited observational evidence, especially selection bias; (III) the lack of any reliable randomised trial evidence of improved survival but evidence of harm; (IV) the failure of strategies to detect metastases earlier to influence overall survival. The introduction of stereotactic radiotherapy and image-guided thermal ablation have made the urge to treat lung metastases stronger but without any good evidence to justify their use. We acknowledge the problems of carrying out randomised trials when there is a clear lack of equipoise in the clinical teams involved but believe that there is an ethical need to do so. Many patients are probably being given false hope of cure or prolonged survival but are at risk of harm from pulmonary metastasectomy or ablation. It is possible that a few patients may benefit but without better evidence we do not know which, if any, do

Controlled trial data casts doubt on the supposed benefit of lung metastasectomy. Comment on Chandra et al. The colorectal cancer tumor microenvironment and its impact on liver and lung metastasis. Cancers 2021, 13, 6206

We read with interest the comprehensive review by Chandra et al. [...

Reply to ‘Comment on “The myth of pulmonary metastasectomy’”

We thank Zellweger and Gonzalez for their comments on our article about pulmonary metastasectomy.1 We agree with much of what they say about the need for multidisciplinary management and the importance of ruling out other diagnoses such as primary lung cancer, but we need to correct several misunderstandings. The results of all 93 randomised patients in PulMiCC have now been published in an updated report,2 which confirms the lack of a significant survival difference (hazard ratio (HR) 0.93 (95% confidence interval (CI): 0.56,1.56)) and median survivals of 3.5 and 3.8 years for intervention and control patients, respectively. Although the numbers randomised were small, the trial has sufficient power to make it highly improbable that the 5-year survival rate in unoperated patients is <5%, as is so widely believed

The full cohort of 512 patients and the nested controlled trial in 93 patients in the Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) study raise doubts about the effective size at present claimed

A comparison of the relative merits of video-assisted pulmonary metastasectomy versus thoracotomy is predicated on the assumption that removal of asymptomatic lung metastases favourably influences survival and that it does so by a large degree. Recently published but long-awaited evidence from a prospective cohort study and a randomised trial of Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) challenges that assumption

The Average Body Surface Area of Adult Cancer Patients in the UK: A Multicentre Retrospective Study

The majority of chemotherapy drugs are dosed based on body surface area (BSA). No standard BSA values for patients being treated in the United Kingdom are available on which to base dose and cost calculations. We therefore retrospectively assessed the BSA of patients receiving chemotherapy treatment at three oncology centres in the UK between 1st January 2005 and 31st December 2005

From “getting things right” to “getting things right now”: Developing COVID-19 guidance under time pressure and knowledge uncertainty

Background - At the start of the COVID-19 pandemic, guidance was needed more than ever to direct frontline healthcare and national containment strategies. Rigorous guidance based on robust research was compromised by the emergence of the pandemic and the urgency of need for guidance. Rather than aiming to “get guidance right”, guidance developers needed to “get guidance right now”. Aim - To examine how guidance developers have responded to the need for credible guidance at the start of the COVID-19 pandemic. Methods - An exploratory mixed-methods study was conducted among guidance developers. A web-based survey and follow-up interviews were used to examine the most pertinent challenges in developing COVID-19 guidance, strategies used to address these, and perspectives on the implications of the COVID-19 pandemic on future guidance development. Results - The survey was completed by 46 guidance developers. Survey findings showed that conventional methods of guidance development were largely unsuited for COVID-19 guidance, with 80% (n = 37) of respondents resorting to other methods. From the survey and five follow-up interviews, two themes were identified to bolster the credibility of guidance in a setting of extreme uncertainty: (1) strengthening end-user involvement and (2) conjoining evidence review and recommendation formulation. 70% (n = 32) of survey respondents foresaw possible changes in future guidance production, most notably shortening development time, by reconsidering how to balance between rigour and speed for different types of questions. Conclusion - “Getting guidance right” and “getting guidance right now” are not opposites, rather uncertainties are always part of guidance development and require guidance developers to balance scientific robustness with usability, acceptability, adequacy and contingency. This crisis points to the need to acknowledge uncertainties of scientific evidence more explicitly and points to mechanisms to live with such uncertainty, thus extending guidance development methods and processes more widely