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Table 1 Composite overall response in laBCC determined by ERIVANCE-like vs mRECIST criteria

From: Assessment of various efficacy outcomes using ERIVANCE-like criteria in patients with locally advanced basal cell carcinoma receiving sonidegib: results from a preplanned sensitivity analysis

MRIa Photographb Histologyc Composite overall response
mRECISTd,e ERIVANCE-like criteria
CR CR Negative CRc CR
PR (scar/fibrosis only) or SD (scar/fibrosis only) Negative
NA Negative
NA CR Negative CRc CR
PR (scar/fibrosis only) or SD (scar/fibrosis only) Negative
PR CR Negative PR CR
PR (scar/fibrosis only) or SD (scar/fibrosis only) Negative
SD CR Negative PR CR
PR (scar/fibrosis only) or SD (scar/fibrosis only) Negative
CR PR Negative PR CR
PR
SD
NA
CR SD Negative SD CR
PR
PR NA Negative PR CR
CR SD Positive or unknown SD PR
SD (scarring/fibrosis only)
PR SD Positive or unknown SD PR
SD (scarring/fibrosis only)
  1. aMeasurability per central review per RECIST v1.1 [23]
  2. bPR ≥50% reduction in the sum of perpendicular products; PD ≥25% increase in the sum of products per WHO criteria [25]
  3. cConfirmed CRs required multiple punch biopsy samples per lesion
  4. dAn independent review committee reevaluated all assessments for the laBCC cohort to determine a composite response
  5. eSince posttreatment ulceration, cyst formation, and scarring/fibrosis may be considered treatment effects and are not necessarily indicative of disease progression in laBCC, “scarring/fibrosis only” was allowed per mRECIST criteria, given that the other measures such as histology and MRI also showed no signs of disease progression
  6. CR complete response, laBCC locally advanced basal cell carcinoma, mRECIST modified RECIST, MRI magnetic resonance imaging, NA not available, PD progressive disease, PR partial response, RECIST Response Evaluation Criteria in Solid Tumors, SD stable disease, WHO World Health Organization