Spotlight on vismodegib in the treatment of basal cell carcinoma: an evidence-based review of its place in therapy

Figures & data

Table 1 ORRs and median DOR in the primary analysis and the 12-month, the 18-month, the 24-month, and the 30-month follow-up of ERIVANCE BCC study¹⁴ as they are assessed by an IRF and an investigator review

N=104	IRF-assessed ORR		Investigator-assessed ORR		Median DOR (IRF) (months)		Median DOR (investigator) (months)
	mBCC	laBCC	mBCC	laBCC	mBCC	laBCC	mBCC	laBCC
Primary analysis	30%	43%	45%	60%	7.6	7.6	12.9	7.6
• SOT: 51
12-month update	33.3%	47.6%	48.5%	60.3%	7.6	9.5	14.7	NE-SR
• SOT: 29
• NM
18-month update	—	—	48.5%	60.3%	—	—	14.7	20.3
• SOT: 21
• ISFU: 56
24-month update	—	—	48.5%	60.3%	—	—	14.8	26.2
• SOT: 14
• ISFU: 63
30-month update	—	—	48.5%	60.3%	—	—	14.8	26.2
• SOT: 9
• ISFU: 69

Abbreviations: BCC, basal cell carcinoma; DOR, duration of response; IRF, independent review facility; ISFU, in survival follow-up; laBCC, locally advanced basal cell carcinoma; mBCC, metastatic basal cell carcinoma; NE-SR, not estimable-still responding; NM, not mentioned; ORR, objective response rates; SOT, still on treatment.

Table 2 ORRs and median DOR of the three major clinical trials about vismodegib

Investigator-assessed ORR			Investigator-assessed median DOR (months)
Study	mBCC	laBCC	mBCC	laBCC
ERIVANCE^Citation14	48.5%	60.3%	14.8	26.2
EAS^Citation15	30.8%	46.4%	Not estimable short median duration of treatment
STEVIE^Citation18	37.9%	66.7%	10	22.7

Abbreviations: DOR, duration of response; laBCC, locally advanced basal cell carcinoma; mBCC, metastatic basal cell carcinoma; ORR, objective response rates.

Table 3 Etiopathogenesis and recommended management of the main treatment-related AEs from vismodegib

AE	Etiopathogenesis	Management
Alopecia	↓ Dermal papillae function/hair growth	Minoxidil 5% b.i.d.
Ageusia/dysgeusia	↓ Bitter/sweet responsivity Taste buds	Nutrition consult
Muscle spasms	↓ Myogenic factors Injury recovery	Amlodipine 10 mg/day
Weight loss	↓ Glucose uptake in muscle/brown adipocytes	Nutrition consult

Abbreviations: AEs, adverse events; b.i.d., twice a day.

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