固形がんの治療効果判定のための 新ガイドライン RECISTガ …

1 ( RECIST ). version . JCOG New response evaluation criteria in solid tumours : revised RECIST guideline ( version ). Eisenhauer, P. Therasse, J. Bogaerts, Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij EUROPEAN JOURNAL OF CANCER 45 (2009) 228 247.. 20-15 .. 20 -6 .. JCOG . JCOG 2010 6 14 . No responsibility is assumed by Elsevier for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. Original English Edition 2008 Elsevier, Japanese Edition 2010 Elsevier Japan . RECIST . version New response evaluation criteria in solid tumours : revised RECIST guideline ( version ).. confirmation .. confirmation.

2 2000 RECIST PD . Response Evaluation Criteria in solid PD . Tumors PD . 20% 5mm .. RECIST . unequivocal . progression . 6,500 FDG-PET .. anatomical assessment .. 10 5 RECIST . 5 2 .. 1 3 PET MRI .. 15mm . 1 .. FDG- 10mm PET .. confirmation .. primary endpoint 2008 Elsevier Ltd. All rights reserved. Keyword Article history Response criteria solid tumours Received 17 October 2008. Accepted 29 October 2008. guidelines 3. EUROPEAN JOURNAL OF CANCER 45 (2009) 228 247 . New response evaluation criteria in solid tumours : revised RECIST guideline ( version ) . 20-15 . 20 -6 .. Japan Clinical Oncology Group JCOG .. Elsevier Ltd.. JCOG .. JCOG .. JCOG 2010 3 . JCOG / / .. / .. JCOG .. 20 -1 .. 20 -2 .. 20 -3 .. 20 -4 .. 20 -5 .. 20 -6 .. 4. EUROPEAN JOURNAL OF CANCER 45 (2009) 228-247. 1. 10 . 5 2 . RECIST 1 . primary endpoint .. objective response . progression-free RECIST . survival . II RECIST . RECIST 2000 2 . 3 1 .. III 9 . overall survival II 1 . time to event . 1-4 .. II .. II III 10.

3 III . primary endpoint . RECIST .. 1981 FDG-PET MRI . WHO primary endpoint .. WHO 2 confirmation . RECIST .. 5. WHO . RECIST . WHO . WHO. RECIST . 6 RECIST .. 7. RECIST . 1990 . International Working Party . RECIST . 8. 2000 .. 5. Jan Bogaerts Patrick Therasse . EORTC RECIST . 6,500 18,000 .. confirmation 2.. RECIST .. 10. Larry Schwartz . Robert Ford .. 11. primary endpoint . stable disease .. I .. 3 .. 1 3 . MRI CT . (18)F- ((18) . F-fluorodeoxyglucose) FDG- . PET .. RECIST 13 .. 14 .. FDG-PET . 12 .. Sargent .. / . 3.. II measurability .. 6. EUROPEAN JOURNAL OF CANCER 45 (2009) 228-247.. measurable non-measurable .. measurable . tumour lesions . cystic lesions .. 1 .. CT 10 mm CT 5 mm . II . caliper 10 mm .. X 20 mm . malignant lymph nodes .. CT 15 mm CT . 5 mm . 15. Schwartz .. specification .. non-measurable . 10 mm 10 . mm 15 mm . 4 .. bone lesions . clinical lesions .. FDG-PET X 10 mm .. CT MRI .. 7.. X . CT X .. CT X .. X CA-125 PSA . II 16-18 . Gynecologic Cancer CT MRI Intergroup.

4 CA- CT 125 19 . CT . 5 mm CT . II . CT 5 mm .. 2 .. MRI . CT MRI . II . CT PR partial CT MRI response CR complete response .. PR SD . PR SD PD . independent review .. 4 . II . overall tumour burden .. CT MRI . overall tumour burden .. primary endpoint .. measurable disease 1 . 3.. measurability . 8. EUROPEAN JOURNAL OF CANCER 45 (2009) 228-247. measurable disease 20 mm . measurable lesion 20 mm . 1 . II 4 .. 10 mm 15 mm . measurable disease' . measurable lesion' 10 mm . 1 . measurable disease' .. primary endpoint .. 2 . 5 . 2 1 .. 1 2 2. 4 . 5 . 10. Bogaerts .. Complete Response CR .. 10mm . whether target or non-target . II 3 .. CR .. CR . 3 . CR . pathological nodes CT 15 mm Partial Response PR .. 30% .. 2 Progressive Disease PD .. CT . MRI . 20% . 20 mm 30 mm 5 mm . 9. Note: the appearance of one or mm . more new lesions is also considered progression .. CT 5 mm .. CT .. PD .. Stable Disease SD .. PR . PD 5 mm .. II . 10 mm .. 10 mm .. 0 . CRF . CR . 10 mm . PR SD PD .. too small to measure.

5 Complete Response CR .. 2 mm .. CT 10mm . CR/ PD Non-CR/Non-PD .. 1 / . too small to measure . CRF Progressive Disease PD .. 0 mm Note: the appearance of one or more new lesions is also considered progression . 5 mm . : .. too small to . measure .. 5. SD PR . 10. EUROPEAN JOURNAL OF CANCER 45 (2009) 228-247.. CT .. II . 1 .. SD PR . CT MRI .. PD .. 1 . III .. FDG-PET .. CT FDG-PET . FDG-PET .. PD a. FDG-PET . FDG-PET . PD . 73% b. FDG-PET . 20% FDG-PET . FDG-PET CT . PD . FDG-PET CT . II . 5 6 CT . PD PD FDG-PET . CT . FDG-PET PD . substantial FDG-PET FDG . 2 FDG .. new lesions . Cooperative Group The Southwest Oncology Group . SWOG JCOG .. unequivocal .. best overall response .. 11. 3 50 mm . 2 80 mm . PD .. best overall response .. primary endpoint . PR CR . confirmation .. SD 2. PR PD . 1 PR SD .. 2 SD .. SD 2 PD SD . / PD . NE SD .. NE .. PD .. 4 . 1 . 3 .. CR CR CR. 2 . CR Non-CR/non-PD PR . CR PR . Non-PD or CR CR. PR PR.. Non-CR/non-PD Non-CR/non-PDa Non-PD or SD SD NE.

6 Or PD. Non-PD NE. PD. PD or PD CR PD NE . PD or PD a . SD . PD.. CR PR SD PD CR/ PD . NE . 12. EUROPEAN JOURNAL OF CANCER 45 (2009) 228-247.. 10 mm .. CR CRF CR . 0 FDG-PET . NE FDG-PET .. / FDG-PET . / CR . PR- . NE-PR .. symptomatic deterioration .. 1 .. 1 3 .. II . 6 8 . 3 CR PR .. CR CR CR. CR PR SD, PD or PRa CR SD SD SD PD. CR PD SD SD PD. CR NE SD SD NE. PR CR PR. PR PR PR. PR SD SD. PR PD SD SD PD. PR NE SD SD NE. NE NE NE. CR PR SD PD NE . a CR PR . PD CR SD . CR . CR PR . CR PR PR . 13. review' review . independent review' . central review' . independent review' .. organ sites .. duration of overall response . CR PR .. CR .. time to an event / duration of stable disease . SD .. 6 8 SD . 3 4 .. 2 .. CR PR . / confirmatory . measurement/duration of response SD . Confirmation SD . primary endpoint 2 .. PR CR .. Bogaerts 10 .. II III . SD primary endpoint .. / progression- free survival/proportion progression-free . II .. central review II . SD . 6 8 . 1 SD . central review'.

7 Central . 14. EUROPEAN JOURNAL OF CANCER 45 (2009) 228-247. PFS .. proportion progression-free .. unequivocal progression .. II .. ascertainment bias .. 20. van Glabbeke Dancey 21 . PFS .. rate .. independent review of response and response rate survival progression . rate proportion CR + PR primary endpoint . response rate .. response rate survival rate . response rate survival . proportion proportion surviving % surviving review .. III . III .. informative censoring .. Ford 22 . Ford .. PFS .. PFS .. PD .. III reporting 5 3 best response results . Bogaerts 10 II . 11. Moskowitz CR + PR primary endpoint .. 15.. 1. Complete response . 2. Partial response . 3. Stable disease . 4. Progression . 5. Inevaluable for response .. / . II .. 95% .. III . III .. III . primary endpoint .. II . 1 .. ITT intent to treat .. III RECIST . relaxed . 16. EUROPEAN JOURNAL OF CANCER 45 (2009) 228-247.. Reference in special issue Rationale (if applicable). RECIST RECIST .. C T CT 10 mm s l i c e CT 10 mm CT thickness 5 mm.

8 CT slice interval 5 mm . 20 mm .. 20 mm 10 mm .. CT Schwartz 15. 15 mm . 10 mm 15 mm .. 10 mm .. 10 1 5 1 2 Bogaerts 10. 5 10 5 .. 1 2 .. CR CR 10 mm Schwartz 15.. Schwartz 15. PD . 20% PD 20% 5 mm . PD 20% . PD . 5 mm .. PD . PD . 1 .. PD . 17. Reference in special issue Rationale (if applicable). RECIST RECIST .. 2 1 PFS Dancey 21. 1 . RECIST .. CR.. CR PR primary endpoint Bogaerts 10.. 4 primary endpoint .. II III PFS Dancey 21. PFS . PD . III PFS .. II II III II III . 9 5 .. 9 III .. III primary endpoint .. II III .. I II MRI PET/CT .. I . III . 18. EUROPEAN JOURNAL OF CANCER 45 (2009) 228-247. Daniel C. Sullivan, Duke University Medical Centre, USA;. Masakazu Toi, Kyoto University, Japan;.. Cindy Welsh, Centre for Drug Evaluation and Research, Food and Drug Administration, USA.. RECIST RECIST . 7 .. Amgen;. Richard Pazdur, Food and Drug Administration, USA;. AstraZeneca;. Francesco Pignatti, European Medicines Agency, London, UK. Breast Cancer International Research Group (BCIRG).

9 Bristol-Myers Squibb;. European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer Group and Gastrointestinal Group;. Erasmus University Medical Center, Rotterdam, The Netherlands;. Genentech;. Pfizer;. RadPharm;. Roche;. Sanofi Aventis.. Ohad Amit, Phil Murphy, Teri Crofts and Janet Begun, GlaxoSmithKline, USA;. Laurence H. Baker, Southwest Oncology Group, USA;. Karla Ballman, Mayo Clinic, USA;. Charles Baum, Darrel Cohen, and Mary Ashford Collier, Pfizer, USA;. Gary J. Becker, American Board of Radiology, Tucson, USA;. Jean-Yves Blay, University Claude Pertrand, Lyon France;. Renzo Canetta, Bristol-Myers Squibb, USA;. David Chang, Amgen Inc., USA;. Sandra Chica, Perceptive Informations Inc. (PAREXEL), USA;. Martin Edelman, University of Maryland Greenbaum Cancer Centre, USA;. Gwendolyn Fyfe, Genentech, USA;. Bruce Giantonio, Eastern Cooperative Oncology Group, USA;. Gary Gordon, Abbott Pharmaceuticals, USA;. Ronald Gottlieb, Roswell Park Cancer Institute, USA.

10 Simon Kao, University of Iowa College of Medicine, USA;. Wasaburo Koizumi, Kitasato University, Japan;. Alessandro Riva, Novartis Pharmaceuticals, USA;. Wayne Rackhoff, Ortho Biotech Oncology Research and Development, USA;. Nagahiro Saijo, President Japanese Society of Medical Oncology, Japan;. Mitchell Schnall American College of Radiology Imaging Network, USA;. Yoshiki Shimamura, PAREXEL International Inc., Japan;. Rajeshwari Sridhara, Centre for Drug Evaluation and Research, Food and Drug Administration, USA;. Andrew Stone, Alan Barge, AstraZeneca, United Kingdom;. Orhan Suleiman, Centre for Drug Evaluation and Research, Food and Drug Administration, USA;. 19.. CT MRI 5 mm . RECIST . 10 mm .. CT.. too small to measure . 5 mm . 3 RECIST CT .. RECIST 1 a. anatomic coverage .. CT . CT .. ALARA As Low . As Reasonably Achievable ALARA .. Speci c Notes b. IV contrast administration .. 1 X . X .. X CT 1 . CT 1 . MRI 3 CT .. MRI X . CT . 3 CT . 2 CT 3 CT . CT .. 2 CT . 10 mm CT . 20.