Efficacy

One study of 35 patients evaluated the safety and efficacy of imiquimod 5% cream in the treatment of superficial and nodular BCC.49,50

Study

Method

Participants

Interventions

Outcomes

Beutner et al. 199943

Single centre

Age range 37-81 years

Imiquimod 5% cream: T1: twice/day;

FU: 6 weeks after treatment tumour

(USA)

Randomisation to give 2:1 ratio of

BP BCCs: T1 : 7; T2: 4; T3: 4; T5: 5; T6:

T2: once/day; T3: three times/week;

site excised and examined

Imiquimod cream to vehicle cream

11 patients

T4: twice/week;

histologically

Method of randomisation not

Size: 0-5-2 cm2

T5: once/week; T6: vehicle

known

Mainly upper body

ITT

Histological type: T1: 1 N, 2 S;

T2: 1 N, 3 S; T3: 4 S; T4: 2 N, 3 S;

T5: 2 N, 2 S; T6: 1 N, 10 S

Marks et al. 200151

Multicentre

72 male, 27 female

% imiquimod: T1: twice/day,

FU: 1, 2, 4, 6 weeks

(Australia and

Method of randomisation not

HP S BCC; surface area 0^5-2 cm2

T2: once/day, T3: twice/day for

Excision at week 6

New Zealand)

known

Location: 32% upper limbs,

3 days/week, T4: once/day for

Lost to FU: T2: 2 (pruritus) T3: 1

ITT

28% trunk, 40% head and neck

2 days/week

(cerebrovascular accident); T4: 1

(excision of nearby tumour)

Geisse et al. 200152

Multicentre, randomised, blinded,

Single, primary BP S BCC

Imiquimod for 12 weeks: T1: twice

FU: surgical excision 6 weeks after

(USA)

vehicle-controlled dose-response

(0'5-2-0 cm2)

dally ; T2: once dally;

treatment

Method of randomisation not

T3: Mon-Fri; T4: Mon,

known

Wed, Fri

ITT

Sterry et al. 200153

Multicentre, randomised open

93 patients, single, primary BP S BCC

T1/T2: Imiquimod 3 times/week for

FU: surgical excision 6 weeks after

(USA)

label, dose-response

(0'5-2 cm2)

6 weeks with (T1) and without

treatment

Method of randomisation not

(T2) occlusion; T3/T4: twice/week for 6

known

weeks, with (T3) and without (T4)

ITT

occlusion

(Continued)

Table 26.7

(Continued)

Study

Method

Participants

Interventions

Outcomes

Shumack et al. 200155 Multicentre, randomised, open

99 patients, single, primary, BP N BCC

Imlqulmod for 6 weeks: T1: twice dally;

FU: surgical excision 6 weeks after

(USA)

label, dose-response

(0-5-2 cm2)

T2: once dally; T3: twice

treatment

Method of randomisation not

dally 3 days/week for 6 weeks; T4:

known ITT

3/week for 6 weeks

Robinson et al.

Multicentre, randomised, blinded,

92 patients, single, primary BP N BCC

Imlqulmod for 12 weeks: T1 twice

FU: surgical excision 6 weeks after

200154 (USA)

vehicle-controlled dose-response

(0-5-2 cm2)

dally; T2: once dally; T3: Mon-Frl; T4:

treatment

Method of randomisation not

Mon, Wed, Frl

known ITT

See Table 26.1 for abbreviations.

This small trial suggested success rates similar to those of excision surgery, with the added advantage of no scarring.

In a phase II dose-response trial of imiquimod 5% cream applied for 6 weeks in 99 Australian patients with primary superficial BCC,51 histological clearance (defined as patients with no histological evidence of BCC when the site of the treated lesion was excised 6 weeks after imiquimod treatment) rates were 100% (3/3), 88% (29/33), 73% (22/30) and 70% (23/33) for twice-daily, once-daily, six-times-weekly and three-times-weekly regimens, respectively.

Another similar multicentre RCT of 128 patients with superficial BCC compared imiquimod twice daily, once daily, 5 days/week and 3 days/week versus vehicle using the same endpoints.52 Intention-to-treat analysis showed clearance rates of 100% (10/10), 87% (27/31), 81% (21/26) and 52% for the twice-daily, once-daily, 5 days/week and 3 days/week groups, respectively. Interestingly, there was a small vehicle response rate - 19% (6/32).

Another study53 of 93 patients with superficial BCC found that occlusion increased the success rate for three-times-weekly application of imiquimod from 76% (19/25) to 87% (20/23).

Two further industry-sponsored trials54,55 conducted in Australia and the US have evaluated imiquimod 5% cream for the treatment of nodular BCC. One55 reported histological clearance rates of 71% (25/35) for once-daily treatment for 6 weeks. Another vehicle-controlled RCT54 of 92 patients with nodular BCC who underwent treatment for 12 weeks using twice daily, once daily, 5 days/week or 3 days/week reported intention-to-treat histological clearance rates of 75% (3/4), 76% (16/21), 70% (16/23) and 60% (12/20), respectively, with a vehicle response rate of 13% (3/24).

This study suggested that longer treatment times (i.e. 12 weeks as opposed to 6 weeks) are needed to treat nodular tumours. This is what one might anticipate from a treatment that relies on percutaneous penetration - tumour depth may be an important predictor of treatment response.

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