PMID- 20666194
OWN - NLM
STAT- MEDLINE
DCOM- 20100818
LR  - 20201212
IS  - 0011-4162 (Print)
IS  - 0011-4162 (Linking)
VI  - 85
IP  - 6
DP  - 2010 Jun
TI  - Sustained clearance of superficial basal cell carcinomas treated with imiquimod 
      cream 5%: results of a prospective 5-year study.
PG  - 318-24
AB  - We conducted a prospective, multicenter, phase 3, open-label study to assess 
      long-term sustained clearance of superficial basal cell carcinomas (sBCCs) 
      treated with imiquimod cream 5%. A biopsy-confirmed tumor (area > or = 0.5 cm2 
      and diameter < or = 2.0 cm) was treated once daily 7 times per week for 6 weeks. 
      Participants with initial clinical clearance at 12 weeks posttreatment were 
      followed for 60 months. Tumor recurrence, serious adverse events (AEs), local 
      skin reactions (LSRs), and skin quality assessments (SQAs) were measured. The 
      initial clearance rate was 94.1% (159/169). Estimated sustained clearance 
      (proportion of participants who achieved initial clearance at the 12-week 
      posttreatment visit and remained clinically clear at each time point during the 
      long-term follow-up period; N=157) was 85.4% at 60 months (life-table method: 95% 
      confidence interval [CI], 79.3%-91.6%). The overall estimate of treatment success 
      was 80.4% at 60 months (N=169; 95% CI, 74.4%-86.4%). Of 20 recurrent tumors, 74 
      (70%) occurred within the first 24 months of follow-up. Local skin reactions and 
      application site reactions, the AEs reported by the most participants, occurred 
      predominantly during the treatment period and resolved posttreatment. Compared to 
      baseline, investigator-assessed SQA scores for the target tumor site improved for 
      skin surface abnormalities and hyperpigmentation, and worsened for 
      hypopigmentation. For low-risk sBCCs, daily application of imiquimod for 6 weeks 
      had high initial and 5-year sustained clearance rates.
FAU - Quirk, Christopher
AU  - Quirk C
AD  - Dermatology Specialist Group, Ardross, Western Australia, Australia.
FAU - Gebauer, Kurt
AU  - Gebauer K
FAU - De'Ambrosis, Brian
AU  - De'Ambrosis B
FAU - Slade, Herbert B
AU  - Slade HB
FAU - Meng, Tze-Chiang
AU  - Meng TC
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Aminoquinolines)
RN  - 0 (Antineoplastic Agents)
RN  - P1QW714R7M (Imiquimod)
SB  - IM
MH  - Administration, Cutaneous
MH  - Aminoquinolines/administration & dosage/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Carcinoma, Basal Cell/*drug therapy/pathology
MH  - Follow-Up Studies
MH  - Humans
MH  - Imiquimod
MH  - Neoplasm Recurrence, Local
MH  - Prospective Studies
MH  - Skin Neoplasms/*drug therapy/pathology
MH  - Treatment Outcome
EDAT- 2010/07/30 06:00
MHDA- 2010/08/19 06:00
CRDT- 2010/07/30 06:00
PHST- 2010/07/30 06:00 [entrez]
PHST- 2010/07/30 06:00 [pubmed]
PHST- 2010/08/19 06:00 [medline]
PST - ppublish
SO  - Cutis. 2010 Jun;85(6):318-24.