11. 効果判定とエンドポイントの定義（RECISTv1.1対応）

1 JCOG 0 XXX 11 _20090917 1/1211. New response evaluation criteria in solid tumours Revised RECIST guideline (version ) RECIST RECIST Eisenhauer et al., New response evaluation criteria in solid tumours: Revised RECIST guideline (version ). European Journal of Cancer 45 (2009) 228-247 Revised RECIST guideline(version ) X RECIST CR/PR/SD/PD JCOG progression PD Progressive Disease PD PD PD unequivocal progression PD unequivocal progression PD JCOG Progression-free survival PFS PD CT 5 mm

2 CT 5 mm CT 5 mm CT 3 28 3 CT MRI CT 3 MRI measurable lesion 1) 5 mm CT MRI MRI 10 mm 5 mm CT MRI MRI 2 2) 5 mm CT 15 mm JCOG 0 XXX 11 _20090917 2/12 10 mm 15 mm 10 mm 3) X 20 mm 4) 10 mm 1 - non-measurable lesion / 5 1 2 Target lesion reproducible repeated measurement - 1 5 1 2 2

3 Target lesion 3 reproducible repeated measurement 4 1 4 2 4 1 3 non-target lesion - 1 - JCOG 0 XXX 11 _20090917 3/12 CR Complete Response 10 mm 0 mm CR CR PET CT FDG-PET CR FDG-PET CR PR Partial Response 30% PD Progression 20% 5 mm SD Stable Disease PR PD NE Not Evaluable CR,PR,PD.

4 SD 100% 100% 5 mm too small tomeasure CT 0 mm 5 mm PR PD PD 1 CR Complete Response 10 mm CR PET CT FDG-PET CR FDG-PET CR Non-CR/non-PD CR/ PD 1 1 10 mm PD Progression JCOG 0 XXX 11 _20090917 4/12 SD PR Non-CR/non-PD 20% 2 44% 73% NE Not Evaluable CR, Non-CR/non-PD.

5 PD 1 CR PD PD PD Non-CR/non-PD 2 FDG-PET FDG-PET FDG 2 FDG 3 FDG-PET FDG-PET FDG-PET FDG-PET CT MRI 4 1 CT MRI CT MRI 2 PD JCOG PD 3 FDG-PET 4 FDG-PET 3 Overall Response Overall response 2 JCOG 0 XXX 11 _20090917 5/12 CR CR CR CR Non-CR/non-PD PR CR NE PR PR PD or NE PR SD PD or NE SD NE PD NE PD PD PD PD PD CR CR Non-CR/non-PD Non-CR/non-PD NE NE PD

6 PD PD Best Overall Response confirmation II II confirmation overall response CR PR SD PD NE Best Overall Response CR PR SD PD NE CR Complete Response 4 28 2 CR 2 CR CR CR PR Partial Response 4 28 2 PR CR PR 2 PR PR PR SD Stable Disease CR PR 2 PD 1 SD 6 8 1 2 3 SD SD PD SD NE SD PD SD SD NE PD PD NE NE PD PD SD PR CR , PD - PD PR CR , NE PD PD PD Progressive Disease CR PR SD PD NE Not Evaluable NE Best Overall Response confirmation confirmation JCOG 0 XXX 11 _20090917 6/12 III CR PR confirmation CR PR SD PD NE SD 2 SD 1 SD 2 PD PD 1 PD 1 NE 6 8 1 Best overall response SD 6 8 overall response SD 1 3 4 1 3 2 SD SD 2

7 WHO CR PR 4 duration of response confirmation RECIST criteria II phase III phase II