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The largest trial of a cream against an operation for the commonest cancer found the cream is worse, and stayed worse at five years. About one person in six treated with the cream still needed something else done, against one in fifty after surgery. It is still a reasonable choice for some people, but it is not equivalent.
SINS randomised 501 people at twelve United Kingdom centres between 2003 and 2007 to imiquimod 5 per cent cream or to surgical excision with a 4 mm margin, for primary nodular or superficial basal cell carcinoma at low-risk sites. It was designed as a non-inferiority trial with a pre-specified margin of a relative risk of 0.87, and it was pragmatic: the question was whether a cream a person applies at home can replace an operation.
At three years, 178 of 213 participants in the imiquimod group (84 per cent) were treated successfully against 185 of 188 (98 per cent) after surgery, a relative risk of 0.84 with a 98 per cent confidence interval of 0.78 to 0.91 and p<0.0001. That confidence interval lies below the non-inferiority margin, so imiquimod was shown to be inferior rather than merely not shown to be non-inferior. At five years the figures were 170 of 206 (82.5 per cent) against 173 of 177 (97.7 per cent), a relative risk of 0.84 (0.77 to 0.91, p<0.001).
Two findings soften the verdict. Patient-assessed cosmetic outcome did not clearly differ between the groups, and most imiquimod failures happened in the first year, so a lesion that has responded early is likely to stay away. The commonest adverse events were itching (211 against 129 participants) and weeping (160 against 81), and twelve people (5 per cent) withdrew from imiquimod because of side effects against four (2 per cent) from surgery.
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.
501 randomised.
178 of 213 participants · 185 of 188 participants
Source170 of 206 participants · 173 of 177 participants
Source12 participants · 4 participants
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Clinical success at 3 yearsprimary | Imiquimod 5 per cent cream | 213 | 83.6% | - | <0.0001 | link |
| Surgical excision, 4 mm margin | 188 | 98.4% | ||||
| Clinical success at 5 years | Imiquimod 5 per cent cream | 206 | 82.5% | - | <0.001 | link |
| Surgical excision, 4 mm margin | 177 | 97.7% | ||||
| Withdrawal because of adverse events | Imiquimod 5 per cent cream | 249 | 5% | - | - | link |
| Surgical excision, 4 mm margin | 229 | 2% |
Shares SCIN (curettage then imiquimod against excision for nodular basal cell carcinoma), The margin in skin cancer surgery, Creams, light and cold for basal cell carcinoma, Basal cell carcinoma.
Shares Photodynamic therapy against imiquimod against fluorouracil for superficial basal cell carcinoma, Creams, light and cold for basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).
Shares The margin in skin cancer surgery, Creams, light and cold for basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).
Shares Mohs surgery against ordinary excision for facial basal cell carcinoma (Nijmegen trial), The margin in skin cancer surgery, Basal cell carcinoma, Skin cancer (all types).
Shares Photodynamic therapy against imiquimod against fluorouracil for superficial basal cell carcinoma, Creams, light and cold for basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).
Shares Mohs surgery against ordinary excision for facial basal cell carcinoma (Nijmegen trial), The margin in skin cancer surgery, Basal cell carcinoma, Skin cancer (all types).
Shares Imiquimod, Basal cell carcinoma.
Shares Photodynamic therapy against imiquimod against fluorouracil for superficial basal cell carcinoma, Creams, light and cold for basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).