Annals of Oncology 19 (Supplement 2): ii86–ii88, 2008
Cutaneous malignant melanoma: ESMO Clinical
Recommendations for diagnosis, treatment and follow-
, A. Hauschild
& L. Jost
On behalf of the ESMO Guidelines Working Group*
Department of Dermatology, University of Kiel, Kiel, Germany;
Department of Dermatology, University of Kiel, Germany;
Department of Oncology, Kantonsspital,
The incidence of malignant melanoma varies from 3–5/100
000/year in Mediterranean countries to 12–20/100 000 in
Nordic countries. The mortality rate is 2/100 000 for females
and 3/100 000/year for males with a lesser variation with
geography. Melanoma mortality has doubled in males over the
last 25 years. Increased ultraviolet-B ray exposure of
a genetically predisposed population seems responsible for an
ongoing increase in incidence over recent decades.
Suspicious lesions are characterized by asymmetry, border
irregularities, color heterogeneity, dynamics (evolution of
color, elevation or size) (‘ABCDE rule’). Diagnosis should be
based on a full-thickness excisional biopsy with a small side
margin [B]. Processing by an experienced pathology institute is
mandatory. The histology report should follow the WHO
classiﬁcation and include maximum thickness in millimeters
(Breslow), level of invasion (Clark level I–V), presence of
ulceration, presence and extent of regression and clearance of
the surgical margins.
Physical examination with special attention to other suspicious
pigmented skin lesions including head and genitalia, tumor
satellites, in-transit metastases, regional lymph node and
systemic metastases is mandatory. Today, many primary
melanomas have a diameter of <5 mm. In low-risk melanomas
(tumor thickness <1 mm) no other investigations are necessary.
In higher stages imaging is recommended in order to exclude
regional or distant metastatic disease. The reﬁned version of the
ASCC staging and classiﬁcation system, which includes the
staging of microscopically positive lymph nodes, is the
classiﬁcation system of choice (Table 1).
treatment for localized disease
Wide excision of primary tumors with a normal skin margin of
0.5 cm for in situ melanomas, of 1 cm for tumors with
a Breslow thickness up to 2 mm and 2 cm for thicker tumors is
recommended [II, B]. Modiﬁcations may be needed for
preservation of function in melanomas of the ﬁngers and toes
or those of the face and the ear.
Routine elective lymphadenectomy or irradiation to the
regional lymph nodes is not recommended [II, B].
Sentinel lymph node biopsy in melanoma with a tumor
thickness of >1 mm is necessary for precise staging and is
followed by complete clearance of regional lymph nodes, if the
sentinel node was positive for micro-metastases [C]. This
procedure should be performed only by skilled teams in
There is no generally accepted adjuvant therapy to date for
patients with high-risk primary melanoma or completely
resected lymph node metastases (stage III). Adjuvant
immunotherapy with interferon-a (IFN-a) leads to
a signiﬁcant prolongation of disease-free survival in some but
not all randomized trials. Positive effects of high-dose IFN-a on
overall survival have been demonstrated in two out of three
randomized trials [C]. The optimal timing and dosing
schedules and the best type of interferon (pegylated versus
conventional) are not yet deﬁned. Therefore, adjuvant
interferon treatment is preferentially applied in the context of
randomized clinical trials in specialized centers.
Adjuvant chemotherapies, mistletoe extracts, viscum album
and hormone therapies are not beneﬁcial. Adjuvant
immunotherapy with other cytokines including interleukin-2,
tumor vaccination and immunochemotherapy are experimental
and not to be used outside of controlled clinical trials.
Radiotherapy for local tumor control should be considered
in case of inadequate resection margins of lentigo maligna
melanoma or R1 resections of melanoma metastases when
re-excision is not feasible [B].
*Correspondence to: ESMO Guidelines Working Group, ESMO Head Ofﬁce, Via L.
Taddei 4, CH-6962 Viganello-Lugano, Switzerland
Approved by the ESMO Guidelines Working Group: August 2002, last update
September 2007. This publication supercedes the previously published version—Ann
Oncol 2007; 18 (Suppl 2): ii71–ii73.
Conﬂict of interest: Dr Dummer has reported no conﬂicts of interest. Dr Hauschild has
reported that he is member of the advisory board for Schering-Plough, Synta, Pﬁzer,
BMS, Bayer and that he receives study grants from Bayer, Essex Pharma, Roche,
ª 2008 European Society for Medical Oncology