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This trial compared the three non-surgical treatments people are actually offered for a thin basal cell carcinoma. Photodynamic therapy, the one that was assumed to be best, came last. The imiquimod cream was the best of the three at one year and still the best at five, though by then a fifth of those treated with it had the tumour back.
Seven Dutch hospitals randomised 601 patients with a histologically proven superficial basal cell carcinoma to methyl aminolevulinate photodynamic therapy, imiquimod cream or fluorouracil cream between 2008 and 2010, with a single blinded observer. Photodynamic therapy was the assumed best treatment and was made the comparator; the trial tested whether the two creams were non-inferior to it within 10 per cent.
At twelve months the proportion free of tumour at both three and twelve months was 72.8 per cent for photodynamic therapy (95 per cent confidence interval 66.8 to 79.4), 83.4 per cent for imiquimod (78.2 to 88.9) and 80.1 per cent for fluorouracil (74.7 to 85.9). Fluorouracil was non-inferior and imiquimod was superior: the difference against photodynamic therapy was 10.6 percentage points for imiquimod (1.5 to 19.5, p=0.021) and 7.3 points for fluorouracil (-1.9 to 16.5, p=0.120).
The five-year report is the one to quote, because it separates the two creams from each other. Tumour-free survival at five years was 62.7 per cent after photodynamic therapy (55.3 to 69.2), 80.5 per cent after imiquimod (74.0 to 85.6) and 70.0 per cent after fluorouracil (62.9 to 76.0). Against photodynamic therapy the hazard ratio for treatment failure was 0.48 for imiquimod (0.32 to 0.71, p<0.001) and 0.74 for fluorouracil (0.53 to 1.05, p=0.09); imiquimod also beat fluorouracil, hazard ratio 0.65 (0.43 to 0.98, p=0.04).
The side effects differ in kind rather than in amount. Moderate to severe pain and burning were reported during the photodynamic therapy session itself; the creams caused swelling, erosion, crusting and itching over weeks. In a separate analysis alongside the trial, twelve-month costs were 680 euros for photodynamic therapy, 526 for imiquimod and 388 for fluorouracil, so the most expensive treatment was also the least effective.
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.
601 randomised.
95 per cent confidence interval 74.0 to 85.6 · 95 per cent confidence interval 62.9 to 76.0 · 95 per cent confidence interval 55.3 to 69.2
Source95 per cent confidence interval 78.2 to 88.9 · 95 per cent confidence interval 74.7 to 85.9 · 95 per cent confidence interval 66.8 to 79.4
Source95 per cent confidence interval 0.32 to 0.71, p<0.001 · 95 per cent confidence interval 0.53 to 1.05, p=0.09
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Tumour-free survival at 5 yearsprimary | Imiquimod 5 per cent cream | - | 80.5% | - | - | link |
| Fluorouracil 5 per cent cream | - | 70% | ||||
| Methyl aminolevulinate photodynamic therapy | - | 62.7% | ||||
| Free of tumour at both 3 and 12 monthsprimary | Imiquimod 5 per cent cream | 189 | 83.4% | - | - | link |
| Fluorouracil 5 per cent cream | 198 | 80.1% | ||||
| Methyl aminolevulinate photodynamic therapy | 196 | 72.8% | ||||
| Hazard ratio for treatment failure at 5 years against photodynamic therapy | Imiquimod 5 per cent cream | - | 0.48 hazard ratio | - | - | link |
| Fluorouracil 5 per cent cream | - | 0.74 hazard ratio |
Shares SCIN (curettage then imiquimod against excision for nodular basal cell carcinoma), Creams, light and cold for basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).
Shares SINS (surgical excision against imiquimod cream for basal cell carcinoma), Basal cell carcinoma, Skin cancer (all types).
Shares Photodynamic therapy against cryotherapy for superficial basal cell carcinoma, Creams, light and cold for basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).
Shares SINS (surgical excision against imiquimod cream for basal cell carcinoma), Creams, light and cold for basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).
Shares SINS (surgical excision against imiquimod cream for basal cell carcinoma), Basal cell carcinoma, Skin cancer (all types).
Shares Creams, light and cold for basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).
Shares Photodynamic therapy lasers and light sources, Basal cell carcinoma, Skin cancer (all types).
Shares Imiquimod, Basal cell carcinoma.