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New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)

Published:December 22, 2008DOI:https://doi.org/10.1016/j.ejca.2008.10.026

      Abstract

      Background

      Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews.

      Highlights of revised RECIST 1.1

      Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of ⩾15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10 mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5 mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes ‘unequivocal progression’ of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions.

      Future work

      A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.

      Keywords

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      References

        • Paesmans M.
        • Sculier J.P.
        • Libert P.
        • et al.
        Response to chemotherapy has predictive value for further survival of patients with advanced non-small cell lung cancer: 10 years experience of the European Lung Cancer Working Party.
        Eur J Cancer. 1997; 33: 2326-2332
        • Buyse M.
        • Thirion P.
        • Carlson R.W.
        • et al.
        Relation between tumor response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis. Meta-analysis group in Cancer.
        Lancet. 2000; 356: 373-378
        • Goffin J.
        • Baral S.
        • Tu D.
        • et al.
        Objective responses in patients with malignant melanoma or renal cell cancer in early clinical studies do not predict regulatory approval.
        Clin Cancer Res. 2005; 15: 5928-5934
        • El-Maraghi R.H.
        • Eisenhauer E.A.
        Review of phase II trial designs used in studies of molecular targeted agents: outcomes and predictors of success in phase III.
        J Clin Oncol. 2008; 10: 1346-1354
        • Miller A.B.
        • Hoogstraten B.
        • Staquet M.
        • Winkler A.
        Reporting results of cancer treatment.
        Cancer. 1981; 47: 207-214
        • Tonkin K.
        • Tritchler D.
        • Tannock I.
        Criteria of tumor response used in clinical trials of chemotherapy.
        J Clin Oncol. 1985; 3: 870-875
        • Baar J.
        • Tannock I.
        Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials.
        J Clin Oncol. 1989; 7: 969-978
        • Therasse P.
        • Arbuck S.G.
        • Eisenhauer E.A.
        • et al.
        New guidelines to evaluate the response to treatment in solid tumors (RECIST Guidelines).
        J Natl Cancer Inst. 2000; 92: 205-216
        • Therasse P.
        • Eisenhauer E.A.
        • Verweij J.
        RECIST revisited: a review of validation studies on tumour assessment.
        Eur J Cancer. 2006; 42: 1031-1039
        • Bogaerts J.
        • Ford R.
        • Sargent D.
        • et al.
        Individual patient data analysis to assess modifications to the RECIST criteria.
        Eur J Cancer. 2009; 45: 248-260
        • Moskowitz C.S.
        • Jia X.
        • Schwartz L.H.
        • Gönen M.
        A simulation study to evaluate the impact of the number of lesions measured on response assessment.
        Eur J Cancer. 2009; 45: 300-310
        • Sargent D.
        • Rubinstein L.
        • Schwartz L.
        • et al.
        Validation of novel imaging methodologies for use as cancer clinical trials end-points.
        Eur J Cancer. 2009; 45: 290-299
        • Macdonald D.R.
        • Cascino T.L.
        • Schold Jr., S.C.
        • Cairncross J.G.
        Response criteria for phase II studies of supratentorial malignant glioma.
        J Clin Oncol. 1990; 8: 1277-1280
        • Cheson B.D.
        • Pfistner B.
        • Juweid M.E.
        • et al.
        Revised response criteria for malignant lymphoma.
        J Clin Oncol. 2007; 10: 579-586
        • Schwartz L.H.
        • Bogaerts J.
        • Ford R.
        • et al.
        Evaluation of lymph nodes with RECIST 1.1.
        Eur J Cancer. 2009; 45: 261-267
        • Rustin G.J.
        • Quinn M.
        • Thigpen T.
        • et al.
        Re: New guidelines to evaluate the response to treatment in solid tumors (ovarian cancer).
        J Natl Cancer Inst. 2004; 96: 487-488
        • Bubley G.J.
        • Carducci M.
        • Dahut W.
        • et al.
        Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group.
        J Clin Oncol. 1999; 17: 3461-3467
        • Scher H.
        • Halabi S.
        • Tannock I.
        • et al.
        Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.
        J Clin Oncol. 2008; 26: 1148-1159
        • Vergote I.
        • Rustin G.J.
        • Eisenhauer E.A.
        • et al.
        Re: new guidelines to evaluate the response to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.
        J Natl Cancer Inst. 2000; 92: 1534-1535
        • Van Glabbeke M.
        • Verweij J.
        • Judson I.
        • Nielsen O.S.
        EORTC Soft Tissue and Bone Sarcoma Group: Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas.
        Eur J Cancer. 2002; 38: 543-549
        • Dancey J.E.
        • Dodd L.E.
        • Ford R.
        • et al.
        Recommendations for the assessment of progression in randomised cancer treatment trials.
        Eur J Cancer. 2009; 45: 281-289
        • Ford R.
        • Schwartz L.
        • Dancey J.
        • et al.
        Lessons learned from independent central review.
        Eur J Cancer. 2009; 45: 268-274
        • Catalano C.
        • Francone M.
        • Ascarelli A.
        • Mangia M.
        • Iacucci I.
        • Passariello R.
        Optimizing radiation dose and image quality.
        Eur Radiol. 2007; 17: F26-F32
        • Low R.N.
        Abdominal MRI advances in the detection of liver tumours and characterization.
        Lancet Oncol. 2007; 8: 525-535
        • Barrett T.
        • Choyke P.L.
        • Kobayashi H.
        Imaging of the lymphatic system: new horizons.
        Contrast Media Mol Imaging. 2006; 1: 230-245
        • Shankar L.K.
        • Hoffman J.M.
        • Bacharach S.
        • et al.
        National Cancer Institute. Consensus recommendations for the use of 18F-FDG PET as an indicator of therapeutic response in patients in National Cancer Institute Trials.
        J Nucl Med. 2006; 47: 1059-1066