RECIST (Response Evaluation Criteria in Solid Tumours) were first published in 2000 and are used by investigators in phase II and phase III clinical trials of new anti-cancer drugs as a way of measuring the efficacy of the treatment. Tumour shrinkage (objective response) and time to the development of disease progression are both important endpoints in trials, and, increasingly in recent years, trials have been using time to progression (or progression-free survival) as their main endpoint on which to base conclusions about the efficacy of a drug.
The new RECIST (RECIST 1.1 to distinguish them from the original RECIST) answer some of the questions and issues that have arisen since 2000 as a result of changing methodologies and available treatments.
Professor Jaap Verweij (Erasmus University Medical Centre, The Netherlands), the EJC’s clinical oncology editor and a co-editor of the special issue on RECIST, said: “This special issue is very important for the cancer community as the updated criteria will affect all clinicians who are running clinical cancer trials. RECIST 1.1 describes a standard approach to solid tumour measurement and definitions for objective assessment of change in tumour size for use in adult clinical trials.”
Co-editor, Professor Elizabeth Eisenhauer (National Cancer Institute of Cancer, Ontario, Canada), stressed that the goal of developing RECIST 1.1 was to improve the consistency and standardisation of trials. “Drug development and clinical cancer research is a global enterprise. The more consistent we are in describing what we have seen, and in using the same measures and endpoints, the more reliably we are able to interpret the results from a variety of sources,” she said.
Key changes in RECIST 1.1 that will simplify, optimise and standardise the assessment of tumour burden in clinical trials are as follows:
•A reduction in the number of lesions to be assessed for response from a maximum of ten to five, and from five to a maximum of two per organ;
•New guidance on making robust measurements of lymph node involvement;
•Confirmation of response is required for trials with objective response as a primary endpoint, but is no longer required for randomised studies, since the control arm of these studies provides appropriate means for interpreting results of the experimental arm;
•The definition of disease progression has been refined so that it not only includes a 20% increase in the size of the lesion, but also a 5 mm absolute increase as well, so that changes of just a few mms in very small tumours, which may be within the range of measurement error, are not unnecessarily described as disease progression;
•Guidance on imaging, including its use in the detection of new lesions and the interpretation of FDG-PET scan assessment.
Prof Eisenhauer stressed that the recommendations are evidence-based: “They are grounded in the literature and where such information didn’t exist – as was the case in some areas – we set about generating the evidence to guide and support the changes. The EORTC Data Centre, under the leadership of Jan Bogaerts and Patrick Therasse (co-authors of RECIST 1.1), undertook to create a warehouse of data from clinical trials of solid tumours from both industry and cooperative groups. We were able to test the recommendations on these data to look at the impact of proposed changes and decide whether the evidence supported the change or not.”
The database consisted of over 6500 patients with more than 18000 target lesions, and was used to investigate the impact of a variety of questions, such as the number of lesions needing to be measured. “Our consequent recommendation that the number of lesions measured should be reduced from ten to five will have a big implication for the workload in clinical trials and we found that it will have no impact on described study outcomes,” said Prof Eisenhauer. “This change can be made without any loss of information.”
Professors Verweij, Eisenhauer and Therasse (who is also co-editor of the special issue and now based at GlaxoSmithKline Biologicals, Rixensart, Belgium) say that in the future it would be desirable to incorporate the use of modern functional imaging techniques in assessing benefit to treatment. “Although there are many exciting developments in this field, none of these techniques was considered as ready to substitute for anatomical endpoint assessment in clinical trials yet, since their use….awaits validation in large datasets and their availability in trial centres is limited,” they write in their introduction to the special issue. A discussion paper in the issue describes the process and the level of evidence that would be needed before functional imaging could be used in addition to, or instead of, anatomical imaging in clinical trials.
Professor Alexander M.M. Eggermont, president of ECCO (the European CanCer Organisation), welcomed the publication of RECIST 1.1. “This is an important and timely publication for all clinicians working in cancer clinical trials. I’m particularly pleased that some of the amendments will contribute to lessening the workload on trial investigators. This revision of the RECIST guidelines will enable researchers to work smarter and more effectively so that, ultimately, patients will benefit from improved treatments reaching them sooner.”Notes:
The European Journal of Cancer is the official journal of ECCO – the European CanCer Organisation.
ECCO – the European CanCer Organisation – exists to uphold the right of all European cancer patients to the best possible treatment and care and to promote interaction between all organisations involved in cancer research, education, treatment and care at the European level.
Emma Mason | alfa
Millions through license revenues
27.04.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn
New High-Performance Center Translational Medical Engineering
26.04.2017 | Fraunhofer ITEM
More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.
Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...
Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.
"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...
The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.
Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...
The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...
Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.
Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...
28.04.2017 | Event News
20.04.2017 | Event News
18.04.2017 | Event News
28.04.2017 | Medical Engineering
28.04.2017 | Earth Sciences
28.04.2017 | Life Sciences