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

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

MRI^a	Photograph^b	Histology^c	Composite overall response
MRI^a	Photograph^b	Histology^c	mRECIST^d,e	ERIVANCE-like criteria
CR	CR	Negative	CR^c	CR
	PR (scar/fibrosis only) or SD (scar/fibrosis only)	Negative
	NA	Negative
NA	CR	Negative	CR^c	CR
NA	PR (scar/fibrosis only) or SD (scar/fibrosis only)	Negative	CR^c	CR
PR	CR	Negative	PR	CR
PR	PR (scar/fibrosis only) or SD (scar/fibrosis only)	Negative	PR	CR
SD	CR	Negative	PR	CR
SD	PR (scar/fibrosis only) or SD (scar/fibrosis only)	Negative	PR	CR
CR	PR	Negative	PR	CR
PR
SD
NA
CR	SD	Negative	SD	CR
PR	SD	Negative	SD	CR
PR	NA	Negative	PR	CR
CR	SD	Positive or unknown	SD	PR
CR	SD (scarring/fibrosis only)	Positive or unknown	SD	PR
PR	SD	Positive or unknown	SD	PR
PR	SD (scarring/fibrosis only)	Positive or unknown	SD	PR

^aMeasurability per central review per RECIST v1.1 [23]
^bPR ≥50% reduction in the sum of perpendicular products; PD ≥25% increase in the sum of products per WHO criteria [25]
^cConfirmed CRs required multiple punch biopsy samples per lesion
^dAn independent review committee reevaluated all assessments for the laBCC cohort to determine a composite response
^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
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

ISSN: 1471-2407