Table 2. Three-tier system of response assessment developed for the OPRA trial.
Complete response | Near-complete response | Incomplete response | |
---|---|---|---|
Endoscopy | • Flat, white scar • Telangiectasia • No ulcer • No nodularity |
• Irregular mucosa • Small mucosal nodules or minor mucosal abnormality • Superficial ulceration • Mild persisting erythema of the scar |
• Visible tumor |
Digital rectal examination | • Normal | • Smooth induration or minor mucosal abnormalities | • Palpable tumor nodules |
T2W-MRI | • Normal appearing bowel wall without any fibrosis in the tumor bed • Only dark T2 signal, no intermediate T2 signal • No visible lymph nodes or very few, small (<5 mm) nodes |
• Mostly dark T2 signal, some remaining intermediate signal and / or • Partial regression of lymph nodes |
• More intermediate than dark T2 signal, no T2 scar and / or • No regression of lymph nodes |
DW-MRI | • No visible signal on B800–B1000 and / or • Uniform, linear signal in the wall above the tumor is acceptable |
• Significant regression of signal on B800–B1000 | • Insignificant regression of signal on B800–B1000 |
Abbreviations: DW-MRI, diffusion-weighted magnetic resonance imaging; OPRA, organ preservation in rectal adenocarcinoma; T2W-MRI, T2-weighted magnetic resonance imaging.