ARTICLE
The fight against cutaneous melanoma is based mainly on improvement of
early diagnosis because maximum disease control
and survival are associated with excision of invasive melanoma lesions
less than 1.00 mm in thickness. On the other hand, to date there
is no certainty of efficacious treatment in cases of advanced disease,
including immunotherapy for AJCC stages with high risk of progression
[1]. Therefore, it is common opinion that the recently noted promising
levelling tendency of mortality trends in some countries should be attributed
to the improvement in the last few decades of early diagnosis of melanoma
[2].
Education campaigns aimed at encouraging skin self-examination coupled
with rapid access to specialized dermatological clinics represent the
key strategy to achieve early detection. NHS regulations in many European
countries, including the United Kingdom [3] and Italy [4], recommend referral
to specialists by general practitioners. Thus, GPs play a gate-keeper
role in limiting access to PLC consultation.
Alternatively, open access to skin cancer clinics can be offered to
the general population. This approach has been followed in countries with
high melanoma incidence, such as the USA and Australia [5], but also in
the Netherlands [6-8]. Although open skin cancer screening is theoretically
of value, its efficacy has not been established because few studies have
involved the systematic follow up of individuals with a positive screen
through to the results of histological diagnosis. Questions regarding
the cost-effectiveness of skin cancer screening efforts are still debated
[8, 9].
We report follow up data focussed on melanoma and NMSC detection rates
in more than 1,000 subjects examined at 1-day, open access clinics
on the occasion of an Italian nation-wide "Skin Cancer Day"
campaign promoted by the Federation of the Italian Dermatological Societies.
Materials and methods
We report the diagnostic outcome and pattern of referral of a series
of 1,042 subjects (404 males, mean age 35 years, 95 %
CI 32.3 — 38.5, and 638 females, mean age 34 years,
95 % CI 31 — 35.2) examined consecutively by specialized
dermatologic staff in 4 Italian open access clinics on "Skin
Cancer Day" (May 5, 2001), promoted by nation-wide media coverage
started 2 to 4 weeks before. A previous similar campaign had
been launched in the same period one year earlier. The dermatologic centers
participating in this study participated in a research project financed
by the Italian Ministry of University (Cofin MIUR 2001-2002).
According to organization criteria, only dermatologists with expertise
in the field of dermato-oncology, particularly regarding pigmented skin
lesions, were recruited for consultations, on a volunteer basis.
All the participating clinics were located in central Italy and were
part of a University Hospital. The number of individuals examined at each
PLC ranged from 130 to 528. The examination was free of charge and
no referral prescription from the family doctor was required. Therefore,
we assume that the individuals examined had not been preliminarly examined
by a GP.
As established in the study plan, dermatologists filled in a questionnaire
focussed on anamnestic and phenotypic information concerning family history
of melanoma, reason for presentation (a specific lesion to be examined
or not), phototype, eye color. The total number of nevi and atypical nevi
was counted, excluding the genitalia, examined only upon specific request
by the individual. The criteria for identifying atypical nevi were established
before the study according to a previously reported protocol [4].
Three possible diagnostic outcomes were allowed: (i) suspicious lesion
to be excised; (ii) no suspicious lesion, but presence of one or more
risk factors for melanoma and NMSC (in such cases, subjects were advised
to couple periodic self-skin examination with a dermatological visit every
6-12 months); (iii) no suspicious lesion nor well established risk
factors found (in such cases, subjects were advised to perform self-skin
examination only).
In order to obtain exhaustive follow up information on subjects referred
for surgery, such individuals were offered the possibility of having the
lesion excised by the same dermatologic staff of the University Hospital
who had performed the examination. All the subjects accepted this proposal.
Results
The frequency of constitutional risk factors for melanoma in subjects
referred to skin cancer clinics is reported in Table
I.
Two hundred and nineteen subjects examined at PLCs (21 %) had noticed
themselves that they had a specific cutaneous lesion that they considered
suspicious or equivocal and, thus, that should be examined by a specialist.
The main reasons for suspicion were the recent manifestation of the lesion
(23/219), the observation of morphologic changes (176/219), or the onset
of subjective symptoms (26/219). The remaining subjects reported wanting
dermatologic examination for reassurance about their moles.
As visit outcome (total body skin examination was performed in all subjects),
surgical excision of a lesion was recommended in 41 of 1,042 subjects
(3.9 %) (Table II).
Histologic diagnosis, data available for 39 of 41 lesions, demonstrated
3 superficial spreading melanomas (1 in situ, one "thin"
lesion, i.e. 0.30 mm in thickness, and one "thick" (4.53 mm)
lesion) and 6 NMSC (5 BCC and 1 SCC).
Therefore, the overall tumor detection rate including both melanoma
and NMSC was 0.8 % (9/1042), while the melanoma detection rate was
3/1042, 0.2 %. The positive predictive value, i.e. the probability
that a lesion clinically defined as suspicious by PLC dermatologists would
really be a tumor (melanoma or NMSC) was 23 % (9/39). The ratio of
numbers of tumors and benign lesions excised was 1:3.4, considering both
melanoma and NMSC, and 1:10.3 considering melanoma only.
Well established risk factors for melanoma were found in a small percentage
of subjects: a number of melanocytic
nevi larger than 50 was recorded in about 9 % of subjects, and
the presence of at least one atypical nevi in 11 %. Overall, only
85 subjects (85/1042, 8 %) were considered by the dermatologist
to be at high risk for melanoma; the great majority was considered at
intermediate or low risk. As a final suggestion, the examining physicians
considered it appropriate to recommend a dermatological consultation once
a year in 56.4 % of the cases; for about 40 % of the subjects,
they considered it sufficient to advise the individuals to carry out periodical
self-skin examination.
Overall, a striking majority of subjects (738/1042) declared having
decided on their own to present for consultation; only 88 of the
1,042 presented following a previous suggestion by the family doctor.
105 subjects (10 %) experienced strong anxiety about the possibility
of having a melanoma.
Concerning information about the existence of open access clinics during
the Skin Cancer Day, 596 (57 %) of the presenting subjects had been
informed by mass media (TV, radio, newspapers), 127 (12.1 %) by their
family doctor or pharmacist, and the rest by other sources (friends, others).
Only 44 subjects reported a family history of melanoma (at least
one first- or second-degree relative with melanoma) (44/1042 = 4 %);
11 subjects had had a melanoma previously and 53 (5 %) had had
other malignancies.
Discussion
From our data, the screening pick-up rate for melanoma in an intermediate
risk population presenting to open access skin cancer clinics was 1:347 (melanoma
and NMSC together = 1:116). This ratio is much lower than that
(1:64) recently found in the same population living in central Italy in
a series of subjects referred to specialized PLC by family doctors, i.e.
after a filtering process aimed at excluding subjects with only trivial
lesions [4].
In the present study, the instant prevalence of melanoma in this group
was therefore 0.2 %, compared to 1.6 % in the above-mentioned
GP-selected individuals.
A similar clear-cut difference in terms of prevalence of melanoma in
two different approaches to early diagnosis was recently found in the
British population: the screening pick-up rate of a 1-day melanoma screening
event offered by the Department of Dermatology of Swansea, UK (open access
clinics), was 1:277 [3]; this finding was largely comparable to that
registered for the national early detection campaign promoted in the USA
by the American Academy of Dermatology [10]. On the contrary, the approximate
pick-up rate of a local PLC working in the same geographical area of the
UK (filtering process of GPs) was of about 1:30. Thus, these data support
the view that a large proportion of individuals with benign skin lesions
might normally be appropriately diagnosed and reassured by their GPs.
This approach, in countries such as Italy and the UK with comprehensive
primary health coverage and overall low to intermediate melanoma incidence
rates (less than 10 x100,000 per year) may be more cost effective
than open access clinics. Primary care physicians, particularly if alerted
and trained for classification of pigmented skin lesions, can perform
an initial triage for melanoma and NMSC, followed by subsequent referral
to a dermatologist when necessary.
According to the evaluation made at the end of the examination by the
dermatologists, a number of nevi larger than 50 or the presence of
at least one atypical nevus (both well established risk factors for melanoma
in the Italian population) [11, 12] were found in 10 % of subjects
examined. The overall examination outcome was that only 8 % of examined
individuals were considered to be at high risk for melanoma.
Sixty-one per cent of the individuals examined were females: this finding
concords with the well known finding that women appear to respond more
favourably to health education messages, with an expected male-female
ratio of 1:1.6 [3]. Future campaigns should perhaps have some special
emphasis to reach men. Recent data showed that the occurrence of thick
(> 3.00 mm) melanomas is associated with male sex and old
age [13]. This population subset should be, therefore, more appropriately
targeted by educational messages and screening efforts.
This study dealt with a small series of subjects compared to the whole
series observed throughout Italy on the nation-wide "Skin Cancer
Day". Therefore, no inference will be attempted regarding early diagnosis
in our case series. We only mention that, incidentally, one out of the
three melanomas detected was not "early" (SSM 4.53 mm thick).
One may wonder why this subject (a 64-year-old man) waited so long, until
the 1-day melanoma screening, before seeking consultation. One possible
explanation is that he was appropriately "targeted" by media
coverage only on this occasion. At this point, even if the examination
had not been available, it is probable that informed subjects would have
referred elswhere to obtain a reassuring diagnosis. Therefore, we think
that the education of adults, with the encouragement to carry out self-skin
examination should be recommended in all populations. Conversely, given
the low frequency of tumors in the population sample examined, it is debatable
if open access clinics represent the optimal way to screen these subjects.
As has been said before, the involvement of GPs probably optimizes the
strategy of prevention by reducing the workload and increasing the specificity
of referral.
One crucial point remains, however, to be addressed: the risk of false
negative tumor diagnosis when subjects are filtered by GPs before referral
to PLC. Data obtained in formal diagnostic settings on clinical images
have demonstrated that family doctors are less skillful than dermatologists
in recognizing melanoma [14]. Unfortunately, in effect GPs are not asked
to classify melanomas, distinguishing them from non-melanomas, but merely
to individuate suspicious lesions to be referred to the specialist.
CONCLUSION
In conclusion, open access skin cancer screening proved feasible in a
Mediterranean population with intermediate melanoma incidence, yielding
an instant prevalence of skin cancer in the examined subjects similar
to that found in the northern European population. Additionally, it is
worthy of note that such campaigns increase awareness about skin cancers.
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