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Giving the hedgehog pill first to shrink a large facial basal cell carcinoma made the operation smaller or less disfiguring in four out of five people. Over three years, though, more than a third of those who benefited had the cancer back.
The argument for a drug in basal cell carcinoma is usually about inoperable disease. VISMONEO asked a different and more common question: can the drug make an operable but disfiguring operation into a smaller one? Fifty-five patients with a facial basal cell carcinoma, median age 73 and mean target lesion size 47.3 mm, were given vismodegib 150 mg daily for four to ten months and then operated on once the best response had been reached. Four were inoperable at entry, fifteen operable with a major functional risk and 36 operable with a minor functional risk or a major risk to appearance.
Forty-four patients (80 per cent, 95 per cent confidence interval 67 to 90) were downstaged on the six-stage surgical classification, which was the primary endpoint. Of those 44, 27 had a complete response, 25 of them proved on biopsy. The objective response rate by the standard tumour response criteria was 71 per cent (59 to 88) and the mean treatment duration was 6.0 months.
The three-year follow-up is the part that is usually left out of the summary and should not be: 16 of the 44 downstaged patients had a known recurrence, 36 per cent (22 to 51). A neoadjuvant hedgehog inhibitor changes the operation. It does not remove the need for one, and it does not make the disease go away.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
55 enrolled.
44 of 55 patients; 95 per cent confidence interval 67 to 90
Source95 per cent confidence interval 59 to 88
Source16 of 44 patients; 95 per cent confidence interval 22 to 51
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Surgical downstaging after neoadjuvant vismodegibprimary | Vismodegib 150 mg daily before surgery | 55 | 80% | - | - | link |
| Objective response rate | Vismodegib 150 mg daily before surgery | 55 | 71% | - | - | link |
| Recurrence at 3 years among downstaged patients | Vismodegib 150 mg daily before surgery | 44 | 36% | - | - | link |
Shares STEVIE (vismodegib in ordinary practice), Hedgehog pathway inhibitors, ERIVANCE BCC, Why people stop taking hedgehog inhibitors.
Shares STEVIE (vismodegib in ordinary practice), Cemiplimab in basal cell carcinoma after a hedgehog inhibitor, Hedgehog pathway inhibitors, ERIVANCE BCC.
Shares Hedgehog pathway inhibitors, Smoothened (hedgehog pathway), Vismodegib, Hedgehog signalling.
Shares Hedgehog pathway inhibitors, Vismodegib, Locally advanced and metastatic basal cell carcinoma, Basal cell carcinoma.
Shares STEVIE (vismodegib in ordinary practice), Why people stop taking hedgehog inhibitors, Locally advanced and metastatic basal cell carcinoma, Basal cell carcinoma.
Shares Hedgehog pathway inhibitors, Why people stop taking hedgehog inhibitors, Smoothened (hedgehog pathway), Locally advanced and metastatic basal cell carcinoma.
Shares ERIVANCE BCC, Smoothened (hedgehog pathway), Vismodegib, Hedgehog signalling.
Shares Why people stop taking hedgehog inhibitors, Smoothened (hedgehog pathway), Vismodegib, Locally advanced and metastatic basal cell carcinoma.