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International criteria for measurement of tumour response

International criteria for measurement of tumour response Cancer Imaging (2001) 2, 31–39 Multidisciplinary Symposium — Monitoring Response to Treatment Tuesday 16 October 2001, 10.40–13.00 International criteria for measurement of tumour response L Ollivier*, A R Padhani† and J Lecle ` re‡ *Department of Radiology, Institut Curie, 26 rue d’Ulm, 75248 Paris, France; †The Paul Strickland Scanner Centre, Mount Vernon Hospital, Northwood, UK; and ‡Department of Radiology, Institut Gustave Roussy, rue Camille Desmoulins, 94805, Villejuif, France Efficacy of anti-cancer agents in clinical trials is mainly European Organization for Research and Treatment of determined on the basis of objective response rate. The Cancer (EORTC) have proposed a new set of tumour response evaluation criteria introduced by the World response criteria (Response Evaluation Criteria in Solid Health Organization (WHO) have been reviewed, and a Tumours : RECIST) designed to replace existing WHO [3] new set of response criteria proposed by the Response criteria . Evaluation Criteria in Solid Tumors (RECIST) Group. These simplified guidelines are still based on the change of the tumour size under treatment, but introduce the use of unidimensional measurement, and of new methods of WHO criteria assessing tumour lesions. Tumour size is determined by measurement of the ‘tumour area’ by multiplication of the largest diameter of the tumour by the greatest perpendicular diameter and, when multiple lesions are present, by the sum of Introduction the products of the perpendicular diameters. Complete Overall survival and objective response rates are the response is defined as the disappearance of all known usual parameters used to assess response to treatment in disease, determined by two observations not less than 4 cancer patients. Overall survival is the gold standard but weeks apart. Partial response is defined as a decrease of the delay necessary to obtain this parameter is too 50% or more in the size of the lesions and progressive long: physicians need to determine rapidly whether the disease as a 25% or more increase in the size of one or agent demonstrates encouraging results or not, in order more measurable lesions, or the appearance of new to adjust therapy. In contrast to survival, objective lesions. response is more difficult to assess because it is highly dependent on the quality of radiological tumour measurements. Because of the cost and toxicity of treat- ments, a rigorous evaluation of their efficacy is neces- Reasons for response rate variability sary, as well as evaluation of the toxicity. Many factors interfere with response evaluation, such as the quality A French group (the Research Group in Clinical and reproducibility of the imaging examinations, the Evaluation: GREC) studied the impact of an evaluation choice of targets and the investigator’s objectivity. committee on patients’ overall response status in a large [4] International rules for measurement of therapeutic multicentre trial in oncology . It identified reasons for response were progressively established during the disagreements between investigators and the evaluation 1970s. The WHO (World Health Organization) cri- committee. Overall tumour responses were reduced by [1] [2] teria published by Miller in 1981 have been widely 23% by the review evaluation committee. Reasons for adopted and remain the standard method of reporting major disagreements included errors in tumour measure- tumour response to treatment. Recently, members of ments, errors in selection of measurable targets. Pitfalls the National Cancer Institute (NCI), of the National such as tumour necrosis, intercurrent diseases, and Cancer Institute Canada (NCI Canada) and of the radiologic technical problems were highlighted. The 1470-7330/01/010031 + 09  2001 International Cancer Imaging Society 32 Multidisciplinary Symposium — monitoring response to treatment group recommended that an independent evaluation reflect the activity of anti-cancer agents. Metabolic committee should review all therapeutic trial results. and physiological changes antecede size changes, some tumours show little change in volume and may [6] also enlarge under treatment . Modern imaging technologies, particularly positron emission tomography RECIST [7] (PET) allow functional assessment of tumour metab- These new criteria support the simplification of response olism. Tumour neovascularity can be precisely assessed evaluation through the use of unidimensional measure- using Doppler ultrasound with contrast agent, enhanced [8,9] ments and the sum of the longest diameters instead of dynamic CT and dynamic MRI . However, these the conventional method using two measurements and techniques are not yet validated and cannot be widely the sum of the products. used for tumour response assessment in clinical trials. It is important to note that the RECIST criteria still rely on size change of lesions to make response assess- ment. The guidelines introduce the use of computed Conclusion tomography (CT) and magnetic resonance imaging (MRI). Technical recommendations are provided for the The end-points of phase II drug trials remain objective use of CT, concerning the slice thickness, the use of tumour response. Oncological radiologists must con- contrast media, image filming, etc. Ultrasound should tinue to describe objective changes in tumour size, using not be used to measure tumour lesions or as a possible simple, standardized international guidelines but have to alternative to clinical measurements for superficial develop new tools that may provide additional indi- palpable lesions. RECIST response criteria are linked to cators not only reflecting changes in tumour volume, but the WHO criteria by the relationship between change in also demonstrating changes in tumour metabolism. diameter, product and volume. Partial response which was defined as a 50% decrease using WHO criteria (tumour area) becomes 30% with the new criteria (diam- eter) and the disease progression becomes a 20% increase Key points (tumour diameter) instead of 25% (tumour area). This (1) Guidelines for tumour response evaluation relationship was chosen partially to allow comparison unidimensional measurements. with response rates obtained using WHO criteria, (2) Methods of assessing tumour size. particularly in historical trials. For the moment, the RECIST guidelines are based on retrospective statistical evaluation of measurements obtained in clinical trials. References [1] WHO Handbook for Reporting Results of Cancer Treatment. Assessment of tumour response Geneva: World Health Organisation Offset Publication, 1979: Objective tumour shrinkage is widely used in everyday [2] Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting clinical practice to estimate the benefit of anti-cancer results of cancer treatment. Cancer 1981; 47: 207–14. treatments. According to the RECIST criteria, a per- [3] Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines centage change in tumour size of about 20% or 30% to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205–16. from baseline is necessary to determine a progression or [4] Thiesse Ph, Ollivier L, Di Stefano-Louineau D et al. for the a partial response while measurements on CT images Groupe Franc ¸ais d’Immunothe ´rapie of the Fe ´de ´ration with electronic calipers provide a precision of more than Nationale des Centres de Lutte Contre le Cancer. Response 1 mm. Ultrasound examinations should not be used in rate accuracy in oncology trials: reasons for interobserver clinical trials to measure tumour regression or pro- variability. J Clin Oncol 1997; 12: 3507–14. [5] Lassau N, Spatz A, Avril MA et al. Value of high-frequency gression of lesions that are not superficial and palpable. US for the pre-operative assessment of skin tumors. Radio- However, high frequency probes allow extremely Graphics 1997; 17: 1559–65. accurate measurements of cutaneous or sub-cutaneous [6] Mac Vicar D, Husband JE. Assessment of response following lesions closer to the histological than the clinical treatment for malignant disease. Br J Radiol 1997; 70: S41– [5] S49. measurements . Cross-sectional imaging permits 3- [7] Smith TA. FDG uptake, tumour characteristics and response dimensional measurements (3-D) and 3-D image display to therapy: a review. Nucl Med Commun 1998; 19: 97–105. and each technique provides information about tumour [8] Miles KA, Hayball MP, Dixon AK. Functional images of volume. While state-of-the-art imaging machines can hepatic perfusion obtained with dynamic CT. Radiology 1993; acquire such information these techniques are not yet 188: 405–11. widely available. Furthermore, standardization and [9] Padhani AR. Dynamic contrast-enhanced MRI studies in human tumours. Br J Radiol 1999; 72: 427–31. simplification of methodology are desirable and it is not [10] Padhani AR. Are current tumour response criteria relevant sure that increased precision of measurement of tumour for the 21st century? Br J Radiol 2000; 73: 1031–3. volume is an important goal in clinical trials. Decreasing tumour size is recognized as the major The digital object identifier for this article is: 10.1102/ indicator of tumour response, but other factors may 1470-7330.2001.017 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Cancer Imaging Springer Journals

International criteria for measurement of tumour response

Ollivier, L.; Padhani, A.; Leclère, J.
Cancer Imaging , Volume 2 (1) – May 5, 2015
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Springer Journals
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Copyright © 2001 by International Cancer Imaging Society
Subject
Medicine & Public Health; Imaging / Radiology; Cancer Research; Oncology
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1470-7330
DOI
10.1102/1470-7330.2001.017
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Abstract

Cancer Imaging (2001) 2, 31–39 Multidisciplinary Symposium — Monitoring Response to Treatment Tuesday 16 October 2001, 10.40–13.00 International criteria for measurement of tumour response L Ollivier*, A R Padhani† and J Lecle ` re‡ *Department of Radiology, Institut Curie, 26 rue d’Ulm, 75248 Paris, France; †The Paul Strickland Scanner Centre, Mount Vernon Hospital, Northwood, UK; and ‡Department of Radiology, Institut Gustave Roussy, rue Camille Desmoulins, 94805, Villejuif, France Efficacy of anti-cancer agents in clinical trials is mainly European Organization for Research and Treatment of determined on the basis of objective response rate. The Cancer (EORTC) have proposed a new set of tumour response evaluation criteria introduced by the World response criteria (Response Evaluation Criteria in Solid Health Organization (WHO) have been reviewed, and a Tumours : RECIST) designed to replace existing WHO [3] new set of response criteria proposed by the Response criteria . Evaluation Criteria in Solid Tumors (RECIST) Group. These simplified guidelines are still based on the change of the tumour size under treatment, but introduce the use of unidimensional measurement, and of new methods of WHO criteria assessing tumour lesions. Tumour size is determined by measurement of the ‘tumour area’ by multiplication of the largest diameter of the tumour by the greatest perpendicular diameter and, when multiple lesions are present, by the sum of Introduction the products of the perpendicular diameters. Complete Overall survival and objective response rates are the response is defined as the disappearance of all known usual parameters used to assess response to treatment in disease, determined by two observations not less than 4 cancer patients. Overall survival is the gold standard but weeks apart. Partial response is defined as a decrease of the delay necessary to obtain this parameter is too 50% or more in the size of the lesions and progressive long: physicians need to determine rapidly whether the disease as a 25% or more increase in the size of one or agent demonstrates encouraging results or not, in order more measurable lesions, or the appearance of new to adjust therapy. In contrast to survival, objective lesions. response is more difficult to assess because it is highly dependent on the quality of radiological tumour measurements. Because of the cost and toxicity of treat- ments, a rigorous evaluation of their efficacy is neces- Reasons for response rate variability sary, as well as evaluation of the toxicity. Many factors interfere with response evaluation, such as the quality A French group (the Research Group in Clinical and reproducibility of the imaging examinations, the Evaluation: GREC) studied the impact of an evaluation choice of targets and the investigator’s objectivity. committee on patients’ overall response status in a large [4] International rules for measurement of therapeutic multicentre trial in oncology . It identified reasons for response were progressively established during the disagreements between investigators and the evaluation 1970s. The WHO (World Health Organization) cri- committee. Overall tumour responses were reduced by [1] [2] teria published by Miller in 1981 have been widely 23% by the review evaluation committee. Reasons for adopted and remain the standard method of reporting major disagreements included errors in tumour measure- tumour response to treatment. Recently, members of ments, errors in selection of measurable targets. Pitfalls the National Cancer Institute (NCI), of the National such as tumour necrosis, intercurrent diseases, and Cancer Institute Canada (NCI Canada) and of the radiologic technical problems were highlighted. The 1470-7330/01/010031 + 09  2001 International Cancer Imaging Society 32 Multidisciplinary Symposium — monitoring response to treatment group recommended that an independent evaluation reflect the activity of anti-cancer agents. Metabolic committee should review all therapeutic trial results. and physiological changes antecede size changes, some tumours show little change in volume and may [6] also enlarge under treatment . Modern imaging technologies, particularly positron emission tomography RECIST [7] (PET) allow functional assessment of tumour metab- These new criteria support the simplification of response olism. Tumour neovascularity can be precisely assessed evaluation through the use of unidimensional measure- using Doppler ultrasound with contrast agent, enhanced [8,9] ments and the sum of the longest diameters instead of dynamic CT and dynamic MRI . However, these the conventional method using two measurements and techniques are not yet validated and cannot be widely the sum of the products. used for tumour response assessment in clinical trials. It is important to note that the RECIST criteria still rely on size change of lesions to make response assess- ment. The guidelines introduce the use of computed Conclusion tomography (CT) and magnetic resonance imaging (MRI). Technical recommendations are provided for the The end-points of phase II drug trials remain objective use of CT, concerning the slice thickness, the use of tumour response. Oncological radiologists must con- contrast media, image filming, etc. Ultrasound should tinue to describe objective changes in tumour size, using not be used to measure tumour lesions or as a possible simple, standardized international guidelines but have to alternative to clinical measurements for superficial develop new tools that may provide additional indi- palpable lesions. RECIST response criteria are linked to cators not only reflecting changes in tumour volume, but the WHO criteria by the relationship between change in also demonstrating changes in tumour metabolism. diameter, product and volume. Partial response which was defined as a 50% decrease using WHO criteria (tumour area) becomes 30% with the new criteria (diam- eter) and the disease progression becomes a 20% increase Key points (tumour diameter) instead of 25% (tumour area). This (1) Guidelines for tumour response evaluation relationship was chosen partially to allow comparison unidimensional measurements. with response rates obtained using WHO criteria, (2) Methods of assessing tumour size. particularly in historical trials. For the moment, the RECIST guidelines are based on retrospective statistical evaluation of measurements obtained in clinical trials. References [1] WHO Handbook for Reporting Results of Cancer Treatment. Assessment of tumour response Geneva: World Health Organisation Offset Publication, 1979: Objective tumour shrinkage is widely used in everyday [2] Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting clinical practice to estimate the benefit of anti-cancer results of cancer treatment. Cancer 1981; 47: 207–14. treatments. According to the RECIST criteria, a per- [3] Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines centage change in tumour size of about 20% or 30% to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205–16. from baseline is necessary to determine a progression or [4] Thiesse Ph, Ollivier L, Di Stefano-Louineau D et al. for the a partial response while measurements on CT images Groupe Franc ¸ais d’Immunothe ´rapie of the Fe ´de ´ration with electronic calipers provide a precision of more than Nationale des Centres de Lutte Contre le Cancer. Response 1 mm. Ultrasound examinations should not be used in rate accuracy in oncology trials: reasons for interobserver clinical trials to measure tumour regression or pro- variability. J Clin Oncol 1997; 12: 3507–14. [5] Lassau N, Spatz A, Avril MA et al. Value of high-frequency gression of lesions that are not superficial and palpable. US for the pre-operative assessment of skin tumors. Radio- However, high frequency probes allow extremely Graphics 1997; 17: 1559–65. accurate measurements of cutaneous or sub-cutaneous [6] Mac Vicar D, Husband JE. Assessment of response following lesions closer to the histological than the clinical treatment for malignant disease. Br J Radiol 1997; 70: S41– [5] S49. measurements . Cross-sectional imaging permits 3- [7] Smith TA. FDG uptake, tumour characteristics and response dimensional measurements (3-D) and 3-D image display to therapy: a review. Nucl Med Commun 1998; 19: 97–105. and each technique provides information about tumour [8] Miles KA, Hayball MP, Dixon AK. Functional images of volume. While state-of-the-art imaging machines can hepatic perfusion obtained with dynamic CT. Radiology 1993; acquire such information these techniques are not yet 188: 405–11. widely available. Furthermore, standardization and [9] Padhani AR. Dynamic contrast-enhanced MRI studies in human tumours. Br J Radiol 1999; 72: 427–31. simplification of methodology are desirable and it is not [10] Padhani AR. Are current tumour response criteria relevant sure that increased precision of measurement of tumour for the 21st century? Br J Radiol 2000; 73: 1031–3. volume is an important goal in clinical trials. Decreasing tumour size is recognized as the major The digital object identifier for this article is: 10.1102/ indicator of tumour response, but other factors may 1470-7330.2001.017

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Cancer Imaging – Springer Journals

Published: May 5, 2015

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