Are there sufficient numbers of low-risk basal cell carcinomas to justify general practitioners (family physicians) carrying out basal cell carcinoma surgery?
Abstract:Low-risk BCCs suitable for excision by GP surgeons are of low prevalence and it would be difficult for GPs to maintain competencies in BCC surgery. Dermatologists should continue to provide the lead in skin cancer diagnosis, treatment and management.
“…Trends in ageing populations means that supply of appropriate treatment such as excisional surgery may be stretched in State healthcare systems such as the UK National Health Service, and it has been estimated that the number of cases presenting to dermatologists will increase by 50% by 2030 (Madan et al, 2010). Such a trend has resulted in guidance for more family practitioners to provide treatment for low risk lesions in the community (Fremlin et al, 2016). Although excisional surgery remains the gold standard for most common types of BCC, a range of non-surgical approaches are available including photodynamic therapy (Wang et al, 2015), topical imiquimod cream, topical 5-fluorouracil, and topical ingenol (Clark et al, 2014).…”
Abbreviations BCC = basal cell carcinoma; nBCC = nodular basal cell carcinoma sBCC = superficial basal cell carcinoma; PDT = photodynamic therapy RCT = randomised controlled trial Abstract -200 words Main text -2600 words Tables -1 Figures -1 References -23 2 ABSTRACT Background: We previously reported modest clinical 3-year benefit for topical imiquimod compared with surgery for superficial or nodular basal cell carcinoma (sBCC, nBCC) at low risk sites in our non-inferiority randomised controlled SINS trial. Here we report 5-year data.Methods: Participants were randomised to imiquimod 5% cream once daily (sBCC, 6 weeks; nBCC, 12 weeks) or excisional surgery (4 mm margin). Primary outcome was clinical absence of initial failure or signs of recurrence at 3 year dermatology review. Five year success was defined as 3 year success plus absence of recurrences identified through hospital, histopathology and general practitioner records.
Results:Of 501 participants randomised, 401 contributed to the modified intention-to-treat analyses at year 3 (primary outcome), 383 (96%) of whom had data at year 5. Five year success rates for imiquimod were 82·5% (170/206) compared to 97·7% (173/177) for surgery (relative risk of imiquimod success 0·84, 95% CI 0·77 to 0·91, p<0.001). These were comparable to year 3 success rates of 83·6% (178/213) and 98.4% (185/188), for imiquimod and surgery, respectively. Most imiquimod treatment failures occurred in year one.
Interpretation:Although surgery is clearly superior to imiquimod, this study shows sustained benefit for lesions that respond early to topical imiquimod.
“…Trends in ageing populations means that supply of appropriate treatment such as excisional surgery may be stretched in State healthcare systems such as the UK National Health Service, and it has been estimated that the number of cases presenting to dermatologists will increase by 50% by 2030 (Madan et al, 2010). Such a trend has resulted in guidance for more family practitioners to provide treatment for low risk lesions in the community (Fremlin et al, 2016). Although excisional surgery remains the gold standard for most common types of BCC, a range of non-surgical approaches are available including photodynamic therapy (Wang et al, 2015), topical imiquimod cream, topical 5-fluorouracil, and topical ingenol (Clark et al, 2014).…”
Abbreviations BCC = basal cell carcinoma; nBCC = nodular basal cell carcinoma sBCC = superficial basal cell carcinoma; PDT = photodynamic therapy RCT = randomised controlled trial Abstract -200 words Main text -2600 words Tables -1 Figures -1 References -23 2 ABSTRACT Background: We previously reported modest clinical 3-year benefit for topical imiquimod compared with surgery for superficial or nodular basal cell carcinoma (sBCC, nBCC) at low risk sites in our non-inferiority randomised controlled SINS trial. Here we report 5-year data.Methods: Participants were randomised to imiquimod 5% cream once daily (sBCC, 6 weeks; nBCC, 12 weeks) or excisional surgery (4 mm margin). Primary outcome was clinical absence of initial failure or signs of recurrence at 3 year dermatology review. Five year success was defined as 3 year success plus absence of recurrences identified through hospital, histopathology and general practitioner records.
Results:Of 501 participants randomised, 401 contributed to the modified intention-to-treat analyses at year 3 (primary outcome), 383 (96%) of whom had data at year 5. Five year success rates for imiquimod were 82·5% (170/206) compared to 97·7% (173/177) for surgery (relative risk of imiquimod success 0·84, 95% CI 0·77 to 0·91, p<0.001). These were comparable to year 3 success rates of 83·6% (178/213) and 98.4% (185/188), for imiquimod and surgery, respectively. Most imiquimod treatment failures occurred in year one.
Interpretation:Although surgery is clearly superior to imiquimod, this study shows sustained benefit for lesions that respond early to topical imiquimod.
“…Despite high and rising incidence rates of BCCs reported in the literature, 27 41 we found that only a small proportion of BCCs can be considered ‘low-risk’ when taking into account body site, diameter and histological subtype, 41–43 which was recently confirmed by Fremlin et al . 42 Aside from the low volume, the number of excisions performed by GPs in the intervention group was even lower. According to the GPs this may have been partly related to the training being insufficient to change GPs’ practices.…”
ObjectivesIn 2016, the SKINCATCH Trial, a clustered multi-centre randomised trial, was initiated to assess whether low-risk basal cell carcinomas (BCCs) can be treated by general practitioners (GPs) without loss of quality of care. The trial intervention consisted of a tailored 2-day educational course on skin cancer management. The aim of this process evaluation was to investigate GPs’ exposure to the intervention, implementation of the intervention and experiences with the intervention and trial.Research design and methodsData on exposure to the intervention, implementation and experiences were obtained at several points during the trial. Complementary quantitative components (ie, surveys, database analysis, medical record analysis) and qualitative components (ie, interviews and focus groups) were used. Quantitative data were analysed using descriptive statistics; qualitative data were summarised (barrier interviews) or audiorecorded, transcribed verbatim and thematically analysed using Atlas.Ti (focus groups).ResultsFollowing a 100% intervention exposure, results concerning the implementation of the trial showed that aside from the low inclusion rate of patients with low-risk BCCs (n=54), even less excisions of low-risk BCCs were performed (n=40). Although the intervention was experienced as highly positive, several barriers were mentioned regarding the trial including administrative challenges, lack of time and high workload of GPs, low volume of BCC patients and patients declining to participate or requesting a referral to a dermatologist.ConclusionsAlthough GPs’ participation in the highly valued training was optimal, several barriers may have contributed to the low inclusion and excision rate of low-risk BCCs. While some of the issues were trial-related, other barriers such as low patient-volume and patients requesting referrals are applicable outside the trial setting as well. This may question the feasibility of substitution of surgical excisions of low-risks BCCs from secondary to primary care in the current Dutch setting.Trial registration numberTrial NL5631 (NTR5746).
“…Only 37% of model 2 GPs took written consent. In a review of 1743 BCCs excised over a 32-month period by GPs, 6 only 3% were considered to be ‘low risk’ according to NICE 2010 criteria. The authors concluded that low-risk BCCs are of low prevalence, which therefore leads to difficulties for GPs to maintain competencies.…”
ObjectivesTo assess compliance with 2010 National Institute for Health and Care Excellence (NICE) guidance on cancer services relating to the management of basal cell carcinomas (BCC) in the community, where except in specific circumstances it is recommended that only low-risk BCCs should be excised routinely.Design and settingA retrospective observational study of the histopathology reports of BCC excisions received from primary care in two district general hospitals in the South of England. One hundred consecutive BCC excisions were analysed from each hospital.Outcome measuresThe numbers of high-risk BCCs excised in primary care according to histological subtype, anatomical site and age and if these excisions were compliant with NICE 2010 guidance. Completeness of excision and mention of BCC on histology request were secondary outcomes.ResultsHistologically high-risk subtypes were present in 32% (64/200) of BCCs excised in the community. Only 17/64 were excised by general practitioners (GPs) who were accredited to do so. Non-compliance regarding anatomical site occurred in 16% of samples; only one was non-compliant regarding patient age. There was a high overall rate of complete excision (94.5%) with variation in presence of the term BCC on histology request forms.ConclusionsNICE 2010 guidance relating to BCC excision in primary care was not followed in a considerable number of cases. Compliance with NICE 2010 guidance depends on the ability to recognise high-risk BCCs clinically and manage appropriately. It also shows that despite close supervision by secondary care, there are still failures of compliance.GP training in identification of subtypes of BCC might be improved, as well as an increase in numbers of GPs accredited to carry out high-risk BCC excisions. Difficulty in diagnosing high-risk histological subtypes of BCC preoperatively should be considered in any future revision of NICE guidance.
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