Standards of Service Provision for Patients with Melanoma in New Zealand

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Standards of

Service Provision for

Patients with Melanoma

in New Zealand



Dr
aft for sector feedback









This document was commissioned by the Ministry of Health

and developed by the
National Melanoma Tumour Standard Working Group. The documen
t is based on the
framework developed for the Standards of Service Provision for Lung Cancer
Patients in New Zealand. The document does not necessarily represent the views of
the Ministry of Health. The document is a draft version for sector feedback.


Draft for sector feedback


April 2013

2

Co
ntents

Introduction

................................
................................
................................
..........................

3

i. Background

................................
................................
................................
.....................

3

ii. Objective

................................
................................
................................
........................

3

iii. How the Melanoma service standards were developed

................................
.................

4

iv. Equity

................................
................................
................................
............................

4

v. Aligned

documents and policy

................................
.........

Error! Bookmark not defined.

vi. Standards Framework

................................
................................
................................
...

5

vii. Standards of service provision pathway for melanoma

................................
.................

5

1. Prevention and early identification

................................
................................
....................

6

2. Investigations, Staging and Diagnosis

................................
................................
..............

8

3. Timely Access to Services

................................
................................
..............................

13

4. Communication and Referral

................................
................................
..........................

15

5. Multidisciplinary Care

................................
................................
................................
.....

16

6. Care Coordination

................................
................................
................................
..........

18

7. Treatment

................................
................................
................................
.......................

19

8. Follow
-
up and surveillance

................................
................................
.............................

27

9. Clinical performance monitoring and research

................................
................................

29

Appendix 1: Patient Pathway

................................
................................
..............................

31

Append
ix 2: National Melanoma Working Group Membership

................................
............

32

Appendix 3: National Melanoma Working Group Advisors

................................
..................

33

Appendix 4: Reportin
g proforma for primary cutaneous malignant melanoma

....................

34

Appendix 7: Follow
-
up and surveillance

................................
................................
.............

38

Appendix 8: Abbreviations and a
cronyms used in this document

................................
.......

40

Appendix 9: Glossary of Terms

................................
................................
..........................

41

Appendix 10: Stakeholder Consultation

................................
................................
..............

43

Appendix 11: References

................................
................................
................................
...

44


Draft for sector feedback


April 2013

3

Introduction

i. Background

(a)
New Zealand has the highest incidence of melanoma in the world. The latest data available from
2009 shows that there wer
e 2212 new diagnoses of invasive melanoma, 2040 melanoma in situ and
326 deaths. In that year melanoma was the fourth most commonly registered invasive cancer and the
sixth most common cause of death from cancer.

(b)

Rates of melanoma incidence and mort
ality are consistently higher for males than females; in 2009
the death rate for males was more than twice that of females. The 2006 estimated health
-
care costs
of melanoma were $5.7 million.

(c)
The incidence of melanoma increases with age, with the m
edian age at diagnosis of 56 in men and
62 in women in 2008/2009. However, melanoma is one of the more common malignancies in younger
age groups with significant numbers diagnosed between 19 and 39 years of age.

(d)
Māori, Pacific and Asian peoples in New Zealand develop skin cancer, including melanoma, less
frequently than New Zealand Europeans. The cancer registry uses self identification for determining
ethnicity. Melanoma in Māori makes up less than 1% of all mela
noma diagnosed in New Zealand.
The incidence rate of melanoma is higher for Māori than for Pacific and Asian peoples.

(e)
Although Māori and Pacific peoples in New Zealand have a very low melanoma registration rate
compared to the New Zealand population
as a whole, they have a greater than expected number of
cases with thicker lesions and more extensive disease at diagnosis. There is evidence that the
resulting poorer prognosis can be accounted for in part by thicker melanomas and under recognition
which

occurs more commonly in minority ethnicities.

(f)
For melanoma, the thickness of the lesion at diagnosis is the strongest predictor of prognosis; in
general, the thinner the lesion, the better the outcome. According to an analysis of New Zealand data,
a
dvanced age, male sex, non
-
European ethnicity, nodular and acral types of melanoma are
associated with thick melanomas.

(g)
Melanoma is a major public health issue in New Zealand. It is imperative that standards are
developed to improve its prevention, e
arly diagnosis and treatment as well as decrease inequalities in
the delivery of services throughout the country.


References

1.

Liang JJC, Robinson E, Martin RCW.
Cutaneous Melanoma in New Zealand
,
2000
-
2004
.

ANZJS
2010; 80(5): 321
-
316.

2.

Martin RCW, Robinson
E.

Cutaneous Melanoma in Caucasian New Zealanders. ANZJS

2004
; 74:
233
-
7

3.

Ministry of Health. 2012
.
Cancer: New Registrations and Deaths 2009.
Wellington: Ministry of
Health
.

4.

O’Dea D.

The Costs of Skin Cancer to New Zealand: Wellington: Cancer Society of
New Zealand,
2009.

5.

Hore T
, Robinson E, Martin RC.

Malignant melanoma amongst M
ā
ori and New Zealand
Europeans, 2000
-
2004.

World J Surg 2010.

2010 Aug;34(8):1788
-
92.

6.

Sneyd MJ, Cox B. Clinical and histologic factors associated with melanoma thickness in New
Zealand Europeans, M
ā
ori, and Pacific peoples. Cancer 2011;117 (11): 2489
-
2498.

URL:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.25795/abstract
.


ii. Objective

(a)
To develop Standards of Service Provision for Melanoma in New Zealand in order to; improve
outcomes and reduce inequalities.

(b)
The scope includes: Diagnosis and Pre
vention, Investigation, Management, Supportive
C
are,
Research and Multidisciplinary meetings.

(c)

The Standards of Service Provision for Melanoma are intended to improve outcomes and ensure
consistency in services provided for all patients with melanoma in

New Zealand.

Draft for sector feedback


April 2013

4

iii. How the Melanoma service standards were developed

(a)
The Melanoma Service Standards were developed by a skilled Working Group representing key
specialities and interests across the melanoma pathway of care.

(b)
The group was chaired
by a lead clinician and had access to expert advisors in key content areas.

(c)
The development of these standards was driven by an intention to improve patient outcomes and
ensure national consistency of care. The need for evidence
-
based practice and effe
ctive utilisation of
health resources and expertise was recognised in the development of the standards.

(d)
Existing evidence
-
based standards, clinical guidelines and patient pathways were referred to when
developing the melanoma cancer standards. These in
cluded:



The Cancer Council Australia / Australian Cancer Network / Ministry of Health New Zealand,
Clinical Practice Guidelines for the Management of Melanoma in Australia and New Zealand

(NZGG 2008).



NHS Wales,
National Standards for Skin Cancer Services
2005

(NHS Wales 2005).



The Melanoma Taskforce UK.
Quality in Melanoma Care: A best practice pathway

(Melanoma
Taskforce 2012).



New Zealand Government,
Standards of Service Provision for Lung Cancer Patients in New
Zealand
, National Lung Cancer Working Grou
p (NZ lung Standards 2011).

(e)
Where no clear evidence was available, expert opinion has been obtained through the National
Melanoma Working Group and its advisors.

(f)
The
multidisciplinary

group assembled has been able to agree on the key principles of
high quality
melanoma management, but the path to consensus has not been straightforward. It is challenging
when experts come together with differing and at times conflicting points of view.
The project has
addressed contentious issues through rigorous and

respectful debate, focused on a need to reach a
consensus position
.



i
ii
. Equity

The differential health status between Māori and non Māori is an ongoing challenge for the health
sector. Cancer is an important contributor to these health inequalities.
This document contains clinical
and service standards that will improve melanoma care

for New Zealanders and
will
decrease

inequalit
y

of access and management in
this

country.


Draft for sector feedback


April 2013

5

vi. Standards Framework

(a)
The standards for the management of melanoma have been divided into
nine

clusters:



Prevention and early identification



Investigations,

staging and diagnosis



Timely access to services



Communication and referral



Multidisciplinary care



Care coordination



Treatment



Follow
-
up and surveillance



Clinical performance monitoring and research



vi
i
. Standards
of service provision pathway for melan
oma




Prevention and
early
identification

Investigation
s
,
Staging &
Diagnosis


Communication
and referral


Treatment


Follow Up

First specialist assessment


14 days

Decision to treat


31 days

Faster Cancer Treatment


62 days

Standard
1.1

Standard

1.2

Standard

1.3

Standard
2.1

Standard

2
.2

Standard

2
.3

Standard 2
.4


Standard 4.1

Standard
7
.1

Standard

7
.2

Standard 7.3

Standard 7.4


Standard 8
.1

Standard

8
.2

Car
e Coordination

Multidisciplinary Care

Standard
5.1

Standard 5.2

Clinical Performance Monitoring and Research

Standard 9
.1

Standard 9
.2

Standard 9.3

Standard 3
.1

Standard
3
.
2

Standard
3
.
3

Standard 3.4

Standard 2.
5

Standard 2.6

Standard 2.7

Standard 2
.8

Standard 7.5

Standard 7.6

Standard 7.7

Standard 7.8

Draft for sector feedback


April 2013

6

1
. Prevention and early identification

Standard 1.
1

Patients are offered evidence
-
based information on risk factors, prevention and early
detection of melanoma.

Standard
1.
2

All primary care
clinician
s are trained
to

recogni
se

skin lesions suspicious

for

melanoma.

Standard
1.
3

People at high risk of melanoma are identified and offered management appropriate to
their level of risk.


Standard 1
.1

Patients are offered evidence
-
based information on risk factors, prevention and
early detection of melanoma.

Rationale

(a)
There is consistent evidence that the best avenues for reducing the burden of
melanoma are prevention and early diagnosis.

Prevention

(b)
The causal association of cutaneous melanoma and non
-
melanoma skin
cancer and solar exposure is establ
ished
. Although t
here is no scientifically
valid
ated, safe threshold level of ultra violet

exposure that allows for maximal
vitamin D synthesis without increasing skin cancer risk
,
the brief exposures
required for vitamin D synthesis are
unlikely to incre
ase the risk.
1

There is str
ong
evidence that exposure to ultra violet

radiation in artificial tanning devices
(sunbeds/tanning units) causes DNA damage that can lead to the development of
both melanoma and non
-
melanoma skin cancer.
The risk increases wit
h greater
use and an earlier age at first use.

Early

Identification

(c)
T
he prognosis for

melanoma less than 1 mm thick

is very good, but
survival
decreases with increasing thickness
.


(d)

F
urther research is needed to better target early detection strate
gies to reduce
mortality from melanoma in New Zealand
.

Good practice
points

i.

Those at risk of melanoma in New Zealand should be informed that:



Sunburn should be avoided and ultra violet

protection (physical methods
complemented by sunscreen) adopted.



As br
ief sun exposures are needed to maintain vitamin D levels, total lack
of sun exposure is not advised without vitamin D supplementation
.




The use of artificial tanning devices (sunbeds/tanning units) should be
strongly discouraged. According to the Austral
ia/New Zealand Solaria
Standard, those under the age of 18 years and those with Skin Phototype
1 are prohibited from using sunbeds. Those 18 years and over should be
informed of the risks and lack of evidence for any health benefits.

ii.

All adults, particul
arly those 50 years of age and over, should be advised to:



Regularly examine their skin (including skin not normally exposed to the
sun) so that they can be aware of any changes
.



Get

someone else to check
areas
difficult to
see, such

as their back
.




Seek
advice from a doctor about suspicious lesions.

iii.

Information aimed at reducing melanoma deaths should focus on:



All adults, particularly males 50 years and over.



Raising awareness

of melanoma in M
ā
ori and other ethnic minorities
including the specific
featur
es of nodular and acral lentiginous melanoma.

Standard 1.2


All primary care
clinician
s are trained
to

recognis
e

skin lesions suspicious
for

melanoma.


Rationale

(a)
Primary care clinicians have an important role in the opportunistic discovery of
melano
ma as part of everyday practice. Therefore it is

essential that they have
the competence to
identify lesions su
spicious

of melanoma

and be alert for these.

(b)
The United Kingdom Melanoma Taskforce recommends that clear and




Draft for sector feedback


April 2013

7

targeted information also is pr
ovided to other professionals, e.g., physiotherapists,
who come into contact with people’s skin

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Good practice
points

i.

All primary care
clinician
s should be knowledgeable about the risks and types
of melanoma.

ii.

All clinicians should b
e alert for skin lesions with malignant features in the
context of physical examinations performed for other reasons.

iii.

All relevant
allied professionals who come into contact with people’s skin
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Monitoring
Criteria

a.

Royal New Zealand College of General Practitioner (RNZCGP) actions to
ensure members and trainees are trained approp
riately, including numbers of
skin lesion/dermoscopy courses for which the RNZCGP has granted
continuing medical education credit.

Standard
1.
3


People at high risk of melanoma are identified and offered management
appropriate to their level of risk.

Rat
ionale

(a)
While i
dentification of those at high risk for melanoma provides the potential to
focus early detection and prevention
, at present:



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Good practice
points

i.

I
ndividuals with two or more first
-
degree relatives with a history of melanoma
be
low the age of 40 years

should be examined carefully

and those found to
have melanoma and/or multiple atypical naevi:
.



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Draft for sector feedback


April 2013

8

2
. Investigations, Staging and Diagnosis


Clinical diagnosis

Standard 2.
1


Patients have access to a clinician who is trained in:

a.

Early detection and diagnosis of melan
oma, including the use of derm
oscopy

b.

Surgical skills to undertake str
aightforward excision of in
-
situ or thin melanoma

c.

The triage and referral of patients with lesions of uncertain potential, thicker
m
elanoma

and lesions on sites where surgery is difficult
.

Excision

biopsy

Standard
2.2

Melanocytic lesions suspected of being

melanoma
are

excised with a 2mm

margin,
including a cuff of subcutaneous fat
,

or referred to an expert for assessment. All tissue
specimens
are

sent for formalin
-
fixed paraffin
-
embedded histopathology
.

Histopathological reporting of cutaneous melanoma
(
Se
e Appendix 4)

Standard 2.3

Melanoma
is

reported histopathologically and staged histopathologically, clinically and
radiologically in accordance with the latest (currently the 7
th

edition) A
merican
J
oint
C
ommittee on
C
ancer

guidelines
.
The pathology report
for the diagnosis of primary
cutaneous melanoma and lymph node metastases
is

in
a synoptic / structured report
and

include
s

a minimum data set for
American Joint Committee
on Cancer
tumour
node metastasi
s (AJCC TNM) st
aging and other variables thought to a
ffect clinical
behaviour and survival
.


Standard 2.4

A diagnosis of malignant melanoma
is

reported in 5 workin
g days in 80% of cases and
all cases
are

reported in 10 working days.

Standard 2.5

The European Organisation for Research and Treatment of Cancer

protocol
is

used
for the processing and reporting of sentinel lymph node biopsies.


Appropriate investigations

Stage I or II

Standard 2.6

No patient
diagnosed with primary melanoma has

furt
her investigation (excluding
sentinel node biopsy
) unless symptoms
suspicious of metastasis are present.


Appropriate investigations

Stage III

Standard 2.7

Patients with low volume
microscopic
nodal
disease (N1a and N2a)
have no further
investigation unless symptoms suspicious of metastasis are present. Patients with
mac
roscopic nodal disease (N1b, N2b, N3) are

inv
estigated with whole body positron
emission tomography
-
computed tomography (PET
-
CT) and fine needle aspiration or
core biopsy.

Appropriate investigations Stage IV

Standard 2.8

Staging investigations are determin
ed by the planned treatment. In general
whole
body positron emission tomography
-
computed tomography

(
PET
-

CT
)

and
magnetic
resonance imaging (
MRI
)

brain are the preferred option
s

when invasive treatment is
envisaged.


Standard 2
.1

Clinical diagnosis

Patie
nts have

access to a
clinician

who
is

train
ed

in:

a.

Early detection and diagnosis of melanoma, including the use of dermoscopy

b.

Surgical skills to undertake straightforward excis
ion of in
-
situ or thin
melanoma

c.

The triage and referral of patients with lesions
of uncertain potential, thicker
melanomas and lesions on sites where surgery is difficult.

Rationale



Breslow thickness is reduced in
clinician
-
diagnosed melanoma, compared to
melanomas initially recognised by the patient or a family
/whānau

member.



Early d
etection of melanoma requires differentiating lesions with minor
atypical features and/or documented change from benign lesions



With training, dermoscopy may improve d
iagnostic accuracy for melanoma



Training in dermoscopy
and digital dermoscopy reduces

unn
ecessary
removal of benign lesions that do not have features suspicious of melanoma.

Good practice
points

i.

In larger primary care practice
s
,
at least one doctor

should be designated
a
nd trained in diagnosis and management of melanoma
.

ii.

Assessment should in
clude h
istory
of

change
, symptoms and their time
Draft for sector feedback


April 2013

9

course.

iii.

T
he whole skin surface
should be examined
under good lighting

to detect
melanoma
.

iv.

F
ormal training in dermoscopy improve
s

diagnostic accuracy.

v.

H
igh
-
quality digital macroscopic and dermoscopic images
of lesions
suspicious
for

melanoma

are useful to obtain
second opinion
s and

for
clinicopathological correlation.


vi.

S
equential digital dermoscopic imaging may be used to detect change in
suspicious flat melanocytic lesions lacking dermoscopic features of
mel
anoma when monitored short
-
term (3 months).

vii.

Clinicians should not rely on the use of automated instruments alone for the
diagnosis of primary melanoma.

Monitoring
Criteria

a.

Review Royal New Zealand College of General Practitioner actions
undertaken to ensu
re members comply with the Standard.

b.

Participation in skin cancer and dermoscopy training courses.

Standard 2.2


Excision
biopsy

Melanocytic lesions suspected of being melanoma are excised with a 2mm
mar
gin,

including a cuff of subcutaneous fat
,

or refe
rred to an expert for
assessment. All tissue specimens are sent for formalin
-
fixed paraffin
-
embedded
histopathology

Rationale



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pic慬敳i潮saiss
愠am慬l⁦潣畳 m敬慮潭愮



Froz敮⁳散瑩o湳
(including sections taken for Moh’s surgery)
慲攠畮sui瑡tl攠
f潲⁨os瑯t慴桯l潧ic慬 摩慧nosis m敬慮潭a


Good practice
points

i.

Non
-
experts should not perform incisional, shave or punch biop
sies of
lesions in which melanoma is a possible diagnosis.

ii.

Referral to an expert may include high quality digital clinical and
dermoscopic images of the lesion of concern.

iii.

The request form accompanying specimens submitted for biopsy should
include history
and written clinical / dermoscopic description of the lesion.
Where possible, especially in borderline lesions, include clinical and
dermoscopic images &/or an annotated diagram highlighting specific areas
of concern within the lesion.

iv.

Practitioners sh
ould monitor their benign: malignant and naevus:melanoma
ratios.

Monitoring
Criteria

a.

Clinical Audit
:




Initial Diagnostic Biopsy: Percentage

of
cases
with 2
mm
margin on a
histological measure

(>90%)
.



Individual practi
ti
oner audits of b
enign to malignan
t ratio

should be no
greater than 5:1.

Standard
2.3

Histopathological reporting of cutaneous melanoma

Melanoma
is

reported histopathologically and staged histopathologically,
clinically and radiologically in accordance with the latest (currently the 7
th

edition)
A
merican
J
oint
C
ommittee on
C
ancer

guidelines
.
The pathology report for the
diagnosis of primary cutaneous melanoma and lymph node metastases
is

in
a
synoptic / structured report and

include
s

a minimum data set for
American Joint
Committee tumour
node metastase
s (AJCC TNM) st
aging and other variables
thought to affect clinical behaviour and survival
. See Appendix 4.

Rationale

(a)
Formal staging of cancer is fundamental in providing clinicians and patients
with prognostic information, developing tr
eatment strategies, and directing and
analysing clinical trials. Staging of cutaneous melanoma continues to evolve
through identification and rigorous analysis of potential prognostic factors. The
latest multivariate analyses of prognostic factors for mela
noma were published in
the 7th edition
American Joint Committee on Cance
r (AJCC) Cancer Staging
Manual published in 2009. This reflects the outcome of work undertaken by
experts from North America, Europe, and Australia, who developed the AJCC

melanoma sta
ging database, a first
-
in
-
kind international integrated compilation of
Draft for sector feedback


April 2013

10

prospectively accumulated melanoma outcome data from several centres and
clinical trial cooperative groups. The latest edition represents the outcomes of
this collaboration from over 14

cancer centres and involving over 50,000
patients.
1,2

(b)
Pathologic assessment of a tissue biopsy is a critical aspect in the
multidisciplinary management of melanoma patients. Such assessment
establishes a definite diagnosis in most cases and provides i
nformation that, to a
major extent, influences patient prognosis and directs the next stages of
management.

(c)
Consistency and speed of reporting is improved by the use of discrete data
elements. The synoptic/structured report aims to improve the complete
ness and
usability of pathology reports for clinicians and improve decision support for
melanoma treatment.

It can be used for both in
-
situ and invasive melanoma.

(d)
This type of report also allows for easy retrieval of data elements for a variety
of uses

including audit and research. Synoptic reports may include a “comments”
or “microscopic” section which allows description of an unusual morphology and
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桡v攠e敥渠i湣l畤敤
K


攠ero

f潲ma

may 扥⁵ 敤⁦潲⁢osic micr潳c潰ic
摥scri灴p潮s⁩f
摥sir敤
K

Good practice
points

i.

The
American Joint Committee on Cancer (
AJCC
)

guidelines
should
be
adopted
.

ii.

Appropriate pathologic processi
ng and reporting
, clinical examination and

investigations

sho
uld be applied to reflect major changes in this latest
edition
.

iii.

The accurate diagnosis and reporting of primary cutaneous melanoma is
greatly enhanced by a full excision biopsy and this should be a standard.
This mainly applies to the diagnosis of small pi
gmented lesions which can be
completely excised relatively easily with 2mm margin of normal skin and a
cuff of subcutaneous fat by both primary care
clinician
s and specialists.
Partial biopsies for the diagnosis of large pigmented lesions especially on
the

face or acral sites may be appropriate but the patient should be under
the care of a melanoma specialist.

iv.

The clinical request form is an important starting point for the accurate
diagnosis of pigmented skin lesions. In addition to the mandatory
demograph
ic fields for any
International Accreditation New Zealand (
IANZ
)

accredited laboratory in New Zealand the specimen site and the type of
biopsy should be recorded accurately by the requesting clinician.
Recording
t
he clinical diagnosis or differential diagn
osis is also good practice. In
suspicious lesions which have been examined and detected by dermoscopy
a clinical photograph accompanying the specimen and annotated as to a
suspicious area or areas may ensure their representation on the slides.

v.

It is import
ant that the entire lesion is secti
oned and examined histologically
after formalin fixation and paraffin embedding.

vi.

For accurate assessment
of T1
a, T1b and T2 lesions at least four

tissue
sections should be examined. This ensures the most accurate Breslow
thickness in lesions in and around the 1mm mark which is critical for T1 to
T2 staging and is a reasonable number of sections for the detection of the
one mitosis required for T1a to T1b st
aging.

vii.

Pathologists reporting melanocytic lesions and melanoma sho
uld have had
adequate training, participate in regular continuing medical education in this
field and have ready access to a second opinion for difficult cases.

viii.

A field indicating the case has been reported to The New Zealand Cancer
Register should be incl
uded on the report so the clinician can be assured
that this has been done.

Monitoring
Criteria

a.

Multidisciplinary team

us
e of
American Joint Committee on Cancer (
AJCC
)

s
taging
.

b.

IANZ is the company which monitors the competence of all pathology
laboratorie
s in New Zealand. Laboratories have a review every year with a
comprehensive full audit every 3 years. This standard could be reviewed
Draft for sector feedback


April 2013

11

annually after its introduction to ensure compliance.

c.

Audit of correctly filled out histopathology request forms.

Standa
rd
2.4


A diagnosis of malignant melanoma
is

reported in 5 workin
g days in 80% of
cases and
all cases
are

reported in 10 working days.

Rationale

(a)
The diagnosis of melanoma is an important first step in management and like
all malignant diagnoses a time
ly report is highly desirable. A target of 5 working
days allows for adequate fixation of the specimen prior to sectioning as some
laboratories fix skin specimens for 24 hours prior to cutting. This also allows for
the possibility of referral to other coll
eagues in the department or in the same city
for confirmation/expert opinion of the lesion if necessary. If the case is being
referred overseas for an opinion an initial report should be issued in the interim
followed by a supplementary.

Good practice
poi
nts

i.

A final report or provisional report in the case of an expert opinion being
sought overseas will expedite clinical decision making in the majority of
cases
.

Monitoring
Criteria

a.

International Accreditation New Zealand (
IANZ
)

to monitor as per standard.

Standard 2.5


The European Organisation for Research and Treatment of Cancer

protocol
is

used for the processing and reporting of sentinel lymph node biopsies.

Rationale



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畳攠es⁳
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Am敲楣慮⁊潩n琠䍯tmi瑴t攠
潮⁃ 湣敲
AJ䍃C.




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r数潲琠o琠t桯ul搠慣桩敶攠ehe⁢ s琠t潳si扬攠ee瑥t瑩潮⁲慴e
.



䥮I瑨攠e慴as
琠AJ䍃

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整散瑥t

潮l 睩瑨t
imm畮潨is瑯t桥mic慬⁳瑵ti敳.



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-
4㔮5Th
敳攠
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-
2㔥⸠5o睥w敲Ⱐ瑨e⁅
畲潰u慮
Or条湩s慴io渠n潲⁒敳敡rc栠慮搠dr敡瑭敮琠tf⁃慮c敲

pr潴oc潬 桡s⁡ 摥t散瑩o渠
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散桮ical⁡湤
灡瑨潬o杩s琠tim攮



E湴n⁩湴n
E
畲up
敡渠佲条nis慴a潮⁦潲⁒敳敡rc栠hn搠dr敡瑭敮琠tf⁃慮c敲

clinic慬⁴ ials⁲敱uir敳⁡ 潰ti湧 瑨tir⁰牯 潣潬s.

Good practice
points

i.

E
uropean Organisation for Research and Treatment of Cancer

Protocol.

ii.

In this technique the node is bi
sected

along the longest ax
is and 6 pairs of
sections are cut and stai
ned for H
aemotoxylin and
E
osin (H&E)

and S100.
Most N
ew
Z
ealand

pathologists also use a melanoma specific marker such
as Melan A or HMB
-
45

so that triplet sections

would be advised. The interval
between the sectio
ns is 50 microns.


iii.

Metastatic melanoma must be distinguished from nodal naevi and
melanoph
ages. SOX 10 is a more recently developed nuclear stain for
melanocytes which in the future could replace both the S100 and melan
A/HMB 45 and

aid in differentiat
ing

melanocytes from melanophages.

iv.

Synoptic reporting of the sentinel node allows key elements to be easily
identified for multidisciplinary meeting review. In view of possible changes to
the definition of a positive lymph node based on tumour volume it is hig
hly
desirable that this is recorded in the report as <0.1mm, 0.1 to 1mm and
>1mm.

Monitoring
Criteria

a.

As most centres in New Zealand will not have
sufficiently
large numbers for
assessment of an acceptable positive rate it is important to review any false

negative cases. There may be other factors besides the histopathologic
assessment accounting f
or this and discussion at a multidisciplinary

meeting
would be the best mechanism for monitoring.

Standard 2.6

Appropriate investigations stage I or II

No patie
nt diagnosed with primary melanoma has

furt
her investigation (excluding
sentinel node biopsy
) unless symptoms suspicious of metastasis are present.

Draft for sector feedback


April 2013

12

Rationale

There is no evidence that radiological imaging in Stage I and II melanoma has
any impact on dete
cting metastases or changing patient prognosis and
management.

Good practice
points

i.

Imaging studies in patients with early stage melanoma are not indicated
.

ii.

Ultrasound examination of lymph node
s

is more accurate than palpation in
detecting lymph node meta
stases (more than 4.5mm in size) but should not
replace sentinel node biopsy
.

iii.

The yield of detecting occult regional or systemic disease in as
ymptomatic
patients with localis
ed stage I or II primary melanoma by extensive imaging
studies such as
magnetic re
sonance imaging (
MRI
)
,
computed tomography
(
CT
)
, or
whole body positron emission tomography and computed
tomography

(
PET
-
CT
)

is low and carries a high false positive rates
.

iv.

In one subset of patients, those with thick melanomas (T4a and T4b),
preoperative i
maging with whole body PET
-
CT should be considered. In one
study, the proposed treatment plan changed in 18% of cases.

Monitoring
Criteria

a.

No investigations in >90%

Standard 2.
7


Appropriate investigations
S
tage III

Patients with low volume
microsc
opic
nodal disease (N1a and N2a) have no
further investigation unless symptoms suspicious of metastasis are present.

Patients with macroscopic nodal disease
(N1b, N2b, N3)
are i
nvestigated with
whole body positron emission tomography
-
computed tomography (P
ET
-
CT) and
fine needle aspiration (FNA)

or core biopsy.

Standard 2.8


Appropriate investigations for S
tage IV

Staging investigations are determined by the planned treatment. In general
whole body
positron emission tomography
-
computed tomography

(
PET
-
CT
)

a
nd
magnetic resonance imaging (
MRI
)

brain are the preferred option
s

when invasive
treatment is envisaged.

Rationale

(a)

Patients with clinical
(N1b, N2b, N3),
locoregional melanoma (including

recurrences or clinically apparent nodal disease at presentation) r
equire
further imaging to detect clinically occult metastatic disease, with a view
to

improving survival, changing management, or providing more
accurate prognostic information
.

(b)

The detection of additional, unsuspected lesions in metastatic melanoma
may re
sult in a change of management.

Good practice
points

i.

Whole body
positron emission tomography
-
computed tomography

(
PET
-
CT
)

is preferred where the presence of any systemic disease will alter the
management decision e.g. whether or not to offer adjuvant radi
otherapy.

ii.

Macroscopic nodal, intransit or subcutaneous melanoma should be
confirmed by
fine needle aspiration

or core biopsy. Excision biopsy is
reserved for non
-
diagnostic investigations.

iii.

Whole body
positron emission tomography
-
computed tomography

(PET
-
CT
)
is more sensitive than conventional imaging in detecting distant metastases
4mm or greater at all sites except for brain where MRI is more sensitive.

iv.

Once the diagnosis of metastatic melanoma is established, no further
investigations are required unless
surgery is planned and the detection of
additional sites of distant disease would result in a change of management.

v.

In stage IV patients who are being considered for surgical resection, whole
body
positron emission tomography
-
computed tomography

(
PET
-
CT
)

c
an
complement conventional imaging studies prior to surgery to exclude other
sites of metastases.

Monitoring
Criteria

a.

Stage IIIa no investigations in >90%

b.

Stage IIIb/c, whole body
positron emission tomography
-
computed
tomography

(
PET
-
CT
)

scan in >95% of c
ases

c.

Stage IV audit of appropriate investigations


Draft for sector feedback


April 2013

1
3

3
. Timely Access to Services

Standard 3.1

Patients referred urgently
with a
biopsy confirmed or
high suspicion of melanoma
(including locally recurrent and metastatic melanoma and excluding melanoma in si
tu),
have

their first
specialist assessment within 14 days of the referral being received.

Standard 3.2

Urgent excision biopsy for suspicious lesions occurs within two weeks of specialist
assessment or image based triage. Image
-
guided core or fine needle a
spiration
biopsy for diagnosis occurs within two weeks of the request being received.

Standard 3.3

Patients

with a confirmed diagnosis of melanoma (including locally recurrent or
metastatic melanoma and excluding melanoma in situ) receive their recommended

cancer treatment (surgery, radiotherapy, systemic therapy or palliative care) within 31
days of decision
-
to
-
treat.

Standard 3.4

The time from receipt of first referral to the commencement of cancer treatment should
not exceed 62 days.


Standard 3.1


Patie
nts referred urgently with a
biopsy confirmed or
high suspicion of melanoma
(including locally recurrent and metastatic melanoma and excluding melanoma in
situ) have

their first
specialist assessment within 14 days of the referral being
received.

Standard

3.
2


Urgent excision biopsy for suspicious lesions occurs within two weeks of
specialist assessment or image based triage. Image
-
guided core or fine needle
aspiration biopsy for diagnosis occurs within two weeks of the request being
received.

Standard 3
.
3


Patients with a confirmed
diagnosis of melanoma (including locally recurrent or
metastatic melanoma and excluding melanoma in situ) receive their
recommended cancer treatment (surgery, radiotherapy, systemic therapy or
palliative care) within 31 days of

decision
-
to
-
treat.

Standard
3.
4


The time from receipt
of first referral to the commencement of cancer treatment
should not exceed 62 days.

Rationale

(a)
Timely access to quality cancer management is important to support good
health outcomes for New Zea
landers. Key components of successful cancer
management include early recognition and reporting of symptoms, expertise in
identifying patients requiring prompt referral and rapid access to investigations
and treatment.

(b)
A suspicion of melanoma or melan
oma diagnosis is very stressful for
patients, family and whānau. It is important that patients and family/whānau have
a clear expectation giving certainty about how quickly patients can receive
treatment.

(c)
Long waiting times may affect local control an
d survival for some patients with
melanoma and can result in delayed symptom management for palliative
patients.

(d)
Timed patient pathways have been put in place to ensure:

1.

Patients receive quality clinical care

2.

Patients are managed through the pathway a
nd experience well co
-
ordinated
service delivery

3.

Delays are avoided as far as possible.

(e)
The faster cancer treatment indicators adopt a timed patient pathway
approach across surgical and non
-
surgical cancer treatment and include
inpatients, outpatient a
nd day
-
patients. Shorter waits for cancer treatments is a
government health target. This health target includes all radiation treatment
patients and chemotherapy outpatients.

Good practice
points

i.

Excludes melanoma in situ.

ii.

Referral should ideally be elec
tronic with attached images of the lesion (high
quality macroscopic and
/or

dermoscopic image) including a ruler. Suspicious
lesions can then be triaged directly to have excision biopsy.



Draft for sector feedback


April 2013

14

iii.

Teledermoscopy
reports should be rec
eived by the referrer within 5

wo
rking
day
s

of the examination being performed
.

i.

Electronic report distribution is desirable
.

ii.

High suspicion of melanoma refers to skin lesions likely to be invasive
tumours, usually >6mm in diameter

and

irregular in structure and colour.
There is often a r
eliable history of change over several months of
observation, or change is observed by digital dermoscopic surveillance.

Monitoring
Criteria

a.

DHB reporting of faster cancer treatment indicators from April 2013.


Draft for sector feedback


April 2013

15

4
. Communication and Referral

Standard
4.
1

The formal referral pathway and required information should be agreed between
primary, secondary and tertiary care givers. Communications between health care
providers should include the patient’s name, date of birth and National Health Index
(NHI) number,

and ideally should be electroni
c. The referral should state either
“suspected melanoma” or “confirmed melanoma”.



Standard
4.
1

The formal referral pathway and required information should be agreed between
primary, secondary and tertiary care givers. Comm
unications between health care
providers should include the patient’s name, date of birth and National Health
Index (NHI) number, and ideally should be electronic.
The referral should state
either “suspected melanoma” or “confirmed melanoma”.

Rationale

(a
)
The purpose of the referral pathway is to ensure that all patients with
suspected melanoma are referred to the most appropriate
melanoma

service, and
that appropriate standardised information is available in the referral. (NZ Lung)

(b)
Appropriate inform
ation, whether provided in written form or via face
-
to
-
face
communication, is required to support patients and their carers throughout the
cancer journey. All healthcare professionals need to be sensitive to potential
problems with communication with infor
mation being tailored to the needs of
individual patients. Patients need appropriate information to make informed
choices about their treatment. Special training can improve communication skills
in general and will provide for effective communication of th
e diagnosis, treatment
options and treatment care plan. (Welsh Standards)

Good practice
points

i.

When the referral contains the words
‘suspected melanoma’,

to help with
prioritisation
,

ideally a macroscopic and dermoscopic image
are provided
with
an accurat
e measurement of the lesion using a marker scale or ruler.

ii.

A referral for

confirmed melanoma


after
excision biopsy should include the
synoptic pathological report to
aid

prioritisation
.

iii.

Electronic proforma
-
based referral is desirable.

iv.

T
hree
-
way communi
cation between primary, secondary and tertiary care
should be encouraged during the patient’s management and care.

v.

Referrals

should include relevant medical history, medications and allergies
.

Monitoring
Criteria

a.

DHB
s to grade and document melanoma re
ferrals at time of referral
.




Draft for sector feedback


April 2013

16

5
. Multidisciplinary Care

Standard
5.
1

P
atients with
the following are discussed at a multidisciplinary meeting:



stage III and IV cutaneous melanoma



desmoplastic melanoma



those

diagnosed with melanoma under 18 years of age



non
-
cutaneous melanoma

and the
outcome

communicated to the treating
clinician
, general practitioner and
patient within one week.

Standard
5.
2

Patients with melanoma
have access to a Skin Cancer Clinical Nurse Specialist (SK
-
CNS) or other health profession
al who

is a member of the melanoma multidisciplinary
meeting

to help coordinate all aspects of care.


Standard
5.
1

P
atients with
the following are discussed at a multidisciplinary meeting:



stage

III and IV cutaneous melanoma



desmoplastic melanoma



those

dia
gnosed with me
lanoma under 18 years of age




non
-
cutaneous melanoma
.

and the
outcome

communicated to the treating
clinician
, general practitioner and
patient within one week.

Rationale

(a)
International evidence shows that multidisciplinary care is a key p
art of
providing best practice treatment and care for patients with cancer.
Multidisciplinary team
s support clinicians, clinical audit, education, inclusion of
patients into clinical trials and reduction in unnecessary or duplicate
investigations.

(b)
Pat
ients with advanced melanoma can be complex to manage due to several
factors, including variation in presentation, potential involvement of any organ and
unpredictable course. Recent advances and controversies in melanoma reinforce
a need for carefully con
sidered treatment pathways to optimise care.

Good practice
points

i.

The minimum core membership of a melanoma multidisciplinary meeting
include
s:

a General Surgeon and/or Plastic Surgeon, Radiation Oncologist,
Medical Oncologist, Radiologist

and a Skin Ca
ncer Clinical Nurse Specialist
.
Pathologists,

Dermatologists, General Practitioners with Special Interest s
kin
cancer (GpwSI
-

skin cancer) and

Palliative Care

may

also
be
involved
.

ii.

The melanoma multidisciplinary meeting process within each hospital and
region is documented, including: multidisciplinary meeting members, referral
pathways, meeting frequency and videoconferencing links between regional
and provincial hospitals where appropriate.

iii.

Details of patients discussed at the multidisciplinary meeting

are recorded on
a standardised multidisciplinary meeting template.

iv.

Smaller provincial
multidisciplinary team
s or treating clinicians will aim to
present patients to their regional
multidisciplinary meeting

in person or via
teleconferencing
.

v.

Patients with
stage 1b melanoma and above will be recorded and discussed if
required.

vi.

The
multidisciplinary meeting

will record information in a database that can be
collated and analysed locally, regionally and nationally
.

vii.

The treating clinician will record the reason
for not following the treatment plan
recommended by the multidisciplinary
meeting
.

viii.

The recommendations from the
multidisciplinary meeting

discussion will be
available as an electronic record and accessible to other members of the
health care team.

Monitor
ing
Criteria

a.

Greater than 95% of appropriate cases are discussed at a melanoma
multidisciplinary meeting
.

b.

The multidisciplinary meeting outcome is communicated to the treating
clinician, general practitioner and patient within one week in >90% of cases.


Draft for sector feedback


April 2013

17

S
tandard
5.
2


1.

Melanoma patients
have access to a Skin Cancer Clinical Nurse Specialist (SK
-
CNS) or other health professional who is a member of the mel
anoma
multidisciplinary meeting

to help coordinate all aspects of care

Rationale

(a)
The collection and p
resentation of accurate patient information at a
multidisciplinary meeting

and feedback to the patient is fundamental to high
quality care.

Good practice
points

i.

Having a dedicated Skin Cancer Clinical Nurse Specialist

or other health
professional co
-
ord
inating written and v
erbal communication (including
use of
a dedicated melanoma
multidisciplinary meeting

referral proforma) improves
discussion efficiency and communication.

ii.

Adequate support staff and resources should be available to run an efficient
mela
noma
meeting.

Monitoring
Criteria

a.

The name and contact details of the designated patient
-
contact person (Skin
Cance
r Clinical Nurse Specialist

or another member of the melanoma
multidisciplinary meeting
)
is

accessible to patients

and their family/whānau
K


Draft for sector feedback


April 2013

18

6
. Care Coordination

Standard
6.
1

P
atients managed by a melan
oma multidisciplinary team
have a nominated single
point of contact,
preferably

a
Skin Cancer Clinical Nurse Specialist (SK
-
CNS)
or allied
health professional
with

in
-
depth/specialist knowledge of melanoma, to support them
to access psychosocial support, information and
coordinate

their cancer journey.

Standard 6.2


Each
treatment centre
has

a

melanoma clinical lead

to provide necessary leadership,
guidance and provisi
on of melanoma care.



Standard
6.
1

P
atients
managed by a melanoma multidisciplinary team

have a nominated single
point of contact,
preferably

a
Skin Cancer Clinical
Nurse

Specialist

(SK
-
CNS)
or
allied health professional
with

in
-
depth

/

specialist knowled
ge of melanoma, to
support them to access psychosocial support, information and
coordinate

their
cancer journey.

Standard 6.2

Each
treatment centre
has

a

melanoma clinical lead

to provide necessary
leadership, guidance and provision of melanoma care.

Rat
ionale

(a)
The cancer journey is complex and it is not uncommon for a patient to be seen
by many specialists within and ac
ross multiple District Health Board
s and across
the public and private sectors.
To work effectively both care coordination and
clinical

leadership is required.

(b)
For the patient, bringing together all aspects of the care pathway through
a
care coordinator is associated with improved patient quality of life

and

fewer days
in hospital.

Good practice
points

i.

Melanoma services
should have
a dedicated
Skin Cancer Clinical

Nurse
Specialist

(SK
-
CNS)
.

ii.

Patients should have their supportive care and psychosocial needs assessed
utilising validated tools and documented at each stage of their cancer journey
and given access to services appropriate t
o their needs.

iii.

Those affected by cancer should have access to mental health services
appropriate to their needs. Those experiencing significant distress or
disturbance should be referred to health practitioners with the requisite
specialist skills

iv.

The info
rmation, treatment and care patients are given should be culturally
appropri
ate for Māori, Pacific people and other ethnicities
.

v.

Māori patients, their whānau and those affected by cancer from other cultural
groups should be linked into culturally appropriate cancer support services.

vi.

All people affected by cancer, their family and

whānau should have access to
appropriate supportive care
and spiritual
services.

vii.

W
ritten information in a plain language format and individually tailored to the
patient should be offered to each new patient

with melanoma
. This should
cover:



General backgr
ound information about the specific cancer.



Detail of treatment options, specific local arrangements inc
luding
information about the multidisciplinary meeting

and support services and
whom the patient should contact if necessary.



Details of local self
-
help
/support groups and other appropriate
organisations.

viii.

Health professionals ensure that those affected by cancer understand the
information provided, or refer them on to suitably qualified service
providers/advisors who can interpret the information for them

where
necessary.

ix.

Patients are provided with their care coordinator’s name and contact details,
and the initial contact is made with the patient within seven days of diagnosis.

Monitoring
Criteria

a.

An audit of database records and clinical notes of contact

points between the
care coordinator and patient. Consider using a
validated
tool which can be
utilised with each contact.


Draft for sector feedback


April 2013

19

7
. Treatment


Treatment of primary melanoma including melanoma in situ

Standard
7.
1

H
istologic
ally confirmed melanomas require re
-
excis
ion

with margins determined by
Breslow thickness.



In
-
situ melanoma
s



5mm margins



Melanoma
s

<1mm


10mm margins



Melanoma
s

1
-
2mm


10
-
20mm margins



Melanoma
s

2
-
4mm


20mm margins



Melanoma
s

>4mm


20mm or greater margins


Lesions meeting histological st
aging
American Joi
nt Committee on Cancer (AJCC)
T1b o
r higher will be referred to a specialist for sentinel node biopsy at the time of the
re excisi
on.


Treatment of desmoplastic melanoma

Standard 7.2

The role of radiation treatment to improve local contro
l should be discussed in patients
with desmoplastic melanoma
.

Management of regional lymph nodes

Standard 7.3

Management of regional lymph nodes


sentinel node biopsy



Sentinel node biopsy is
offered to

patients with T1b or thicker melanoma who
have the ca
pacity to benefit from the procedure and is performed by surgeons
trained and experienced in the technique.




Sentinel node biopsy in melanoma requires triple locali
s
ation with preoperative
l
ymphoscint
i
graphy, intra
-
operative
localis
ation with blue dye and
a gamma

probe.

Standard 7.4

Management of regional lymph nodes


lymphadenectomy

An oncological therapeutic node dissection is offered to all patients with evidence of
metastatic nodal disease after appropriate staging and discussion at a
multidisciplinar
y meeting.
Lymphadenectomy nodal harvest results meet accepted
criteria.

Management of advanced melanoma

Standard 7.5

Patients
with loco
-
regional recurrent, locally advanc
ed and stage IV melanoma are
seen or discussed by

melanoma specialists experienced in

the care of melanoma
patients and part of a multidisciplinary meeting
, including:



Surgical oncology



Radiation oncology



Medical oncology


Non Cutaneous melanoma

Standard
7.6


P
atients wit
h non
-
cutaneous melanoma are discussed in a melanoma multidiscipli
nary
meeting

as well as the relevant site specific
multidisciplinary meeting
, with the treating
clinician

represented.



Psychosocial issues

Standard
7.7

Patients diagnosed with melanoma are assessed by appropriately qualified personnel
to identify support
ive care needs, including psychological distress, at key points of
their cancer journey, ideally using a validated tool and a clear referral process.

.

Palliative care

Standard 7.
8

Patients are offered early access to palliative care services when there a
re complex
symptom control issues

and

when curative treatment cannot be offered or when it is
declined
.







Draft for sector feedback


April 2013

20

Standard
7.
1

Treatment of primary melanoma including melanoma in situ (MIS)

H
istologically

confirmed melanomas require re
-
excision with margins

det
ermined by
Breslow thickness.



In
-
situ melanoma
s



㕭m m慲杩湳⸠



Melanoma
s

<1mm


㄰m洠m慲杩湳



Melanoma
s

1
-
2mm



J
㈰mm m慲杩湳



Melanoma
s

2
-
4mm


㈰mm m慲杩湳



Melanoma
s

>4mm


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Am敲楣慮⁊oi
湴nCo
mmi瑴t攠e渠䍡湣敲
Ag䍃F
qㅢ
r⁨ g桥r 睩ll⁢ ⁲敦敲e敤⁴ 愠a灥ci慬is琠t潲⁳敮瑩n敬 d攠ei潰sy⁡ 瑨t 瑩m攠ef
瑨t⁲攠數cisi
潮K

Rationale

(a)
Evidence based margins decrease local recurrence.


(b)
Sentinel Node Biopsy

is the best staging and prognostic t
est for melanoma and
may provide a survival benefit if metastatic melanoma is detected.

Good practice
points

i.

All doctors who undertake re
-
excision of melanoma require the appropriate
training and experience.

ii.

Re excision of melanoma
-
in
-
situ to 5mm margins
and
American Joi
nt
Committee on Cancer

(
AJCC
)

T1a

cases of
melanoma to 10mm margins can
be performed as a local anaesthetic procedure by either a primary care doctor
or specialist doctor with appropriate training and experience.

iii.

Patient information regardi
ng melanoma and increased risks for further new
melanoma be provided. Include advice for regular full body skin checks.

iv.

All melanoma that meet the criteria for a sentinel node biopsy,
(
AJCC T1b

and
above)
require re
-
exci
sion at the same time as the sentine
l node biopsy
. These
patients must be referred to a

melanoma service or surgeon with special
interest in melanoma, who is trained and experienced to provide this procedure
.

v.

Excisions should

have vertical edges and extend to

but not include

the deep
fascia
,

as
clinically
appropriate.

vi.

Precise measurement of margins are clinically mapped out from the scar with a
ruler before the definitive excision.

vii.

Patient
s should be provided with information about

surgical excision risks:
wound infection, haematoma, failure

of skin graft and flap, numbness
, scarring

and the possibility
that further surgery will be required
.

viii.

Appropriate data collection systems should be put in place to collate, publish
and audit post
-
surgery complications.

Breslow

Margin

Sentinel node stud
y

Melanoma in situ (Tis)

Melanomas <1.0 mm (T1)

5 mm

1 cm

No

Yes


if⁁g䍃⁔ㅢ

慢ov攠

䵥l慮潭慳‱


㈠Om
q㈩

䵥l慮潭慳′


㐠Qm
q㌩




O⁣m

㉣m

v敳

v敳

䵥l慮潭a
s

>‴ mm

Eq㐩

㈠Om

m潳sible


Monitoring
criteria

a.

Audit of r
eferral and re
-
exc
ision

rates.


b.

Audit of post
-
surgery morbidity and complication rates.

Standard
7.
2

Treatment of desmoplastic melanoma

The role of radiation treatment to improve local control should be discussed in
patients with desmoplastic melanoma.

Rationale

(a)
Desm
oplastic melanoma

most commonly occur on the head and neck and have
an increased risk of neurotropism (36
-
52%). Those lesions with neurotropism have
an increased risk of local recurrence.

Good practice
points

i.

Radiation treatment should be offered
to

patie
nts where the melanoma is
unresectable, where the margins are <1 cm or
where the melanoma has

marked neurotropism.

Monitoring
Criteria

Audit of the cases of desmoplastic melanoma treated by the institution to assess:

a.

Documentation of multidisciplinary me
eting discussion

b.

Margin status


Draft for sector feedback


April 2013

21

c.

Percentage receiving radiation treatment

d.

Recurrence rates

Standard
7.
3

Management of regional lymph nodes


sentinel node biopsy



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is 潦fer敤⁴

灡ti敮瑳 睩t栠
Tㅢ爠 桩ck敲e
m敬慮潭愠
wh漠
桡v攠eh攠e慰慣it
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瑲慩湥搠d湤 數灥ri敮c敤 i渠瑨t⁴散桮i煵e.




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lm灨潳ci湴i杲慰h,⁩湴牡
-
o灥r慴ave潣慬is慴a潮 睩瑨t扬略⁤攠慮d⁡ g慭ma

灲潢攮

Rationale



S瑵ti敳⁨慶攠e桯睮⁴桡琠th攠e敮ti湥l潤攠扩潰s
SNB)

瑥t桮iq略 is⁵ 敦畬⁦潲o
i摥湴nfi湧⁳m慬l lm灨 d攠e整es瑡t敳⁩渠n慴a敮瑳 睩瑨ti湴nrm敤i慴a 瑨tck湥ss
m敬慮潭愠⠱
-
4mm)⸠.乂⁤整ec瑳整es瑡t敳⁩渠nh攠ee湴nn敬 湯d攠e渠n㠠8漠


灥rc
敮琠tf⁴ 敳攠e慴a敮瑳⸠S乂⁡llows⁦潲⁡oc畲慴攠u瑡ti湧,⁰牯 湯s瑩c
i湦潲o慴a潮Ⱐ,m灲潶敤⁲敧io湡l⁣o湴牯l⁡ 搠d潳si扬攠e畲vival⁢敮敦it



T桩渠n敬慮潭慳
<1mm)⁡r攠e桥潳琠tomm潮⁦潲mf m敬慮潭愬a慮搠d慮
畳畡ll 扥⁣畲敤⁴桲潵h栠h畲杩cal⁲敭潶慬 潦⁴ 攠eri
m慲⁴ m潲⸠W桩l攠e乂 is
湯琠t散敳s慲 i渠n潳琠t慳敳Ⱐ,琠ta 扥⁣o湳id敲敤ei渠n敬散琠灡ti敮瑳 睩瑨⁴ i渠
m敬慮潭慳⁷桯⁨慶攠
p潯r⁰牯杮潳瑩c

f慣瑯牳Ⱐ,畣栠hs⁵ c敲慴ion



d敲e慬
mi瑯t敳
.



T桩c
k m敬慮潭慳
>4mm)

慲攠a潮si摥r敤潲攠oik敬
t漠on摥r杯
桡敭慴a来
n潵s整es瑡tis
⸠W桩l攠eh敲攠慲e⁦敷⁳t畤ies⁦潣畳i湧 ⁴桥 畳攠ef
S乂⁩n⁰ tie湴n wit栠hhick m敬慮潭慳Ⱐ瑨攠es攠ef⁓NB
f潲⁰慴i敮瑳 睩瑨⁴ ick
m敬慮潭慳

m慹⁢
co湳id敲敤⁩渠nel散琠t慳敳⁢ 琠th潵l搠de⁳畢j散琠瑯
m畬瑩摩sciplin慲敥瑩n朠gisc畳si潮
.



䍯Cp
l整e⁲敭潶慬 潦⁴ 攠牥m慩湩湧 lm灨 湯摥s
c潭灬整io渠
lm灨慤e湥c瑯t) 桡s⁢ 敮⁳桯睮⁴w⁰牥v敮琠trimi琠t畲瑨敲⁣慮c敲⁳灲敡搠i渠
som攠e慴a敮瑳⁡湤⁦慣ili瑡瑥⁢ 瑴敲⁲敧i潮al⁣潮瑲潬.⁉琠is 琠整ek湯wn w桥瑨tr
瑨ts⁡灰r潡ch⁩m灲潶敳⁳畲vival.

Good prac
tice
points

i.

Sentinel node biopsy (SNB)

is recommended for all patients with melanomas of
intermediate thickness (between 1 and 4 mm). Evidence is insufficient to
recommend routine SNB for patients with thin melanoma (less than 1 mm)
unless certain criteria

are met. SNB for patients with thick melanomas (greater
than 4 mm) may be used for staging or to facilitate regional control.

ii.

In order to make an informed choice about having a SNB or not, patients should
be provided with information about the likelihood

of the SNB being positive
based on the histological features of their melanoma. The use of validated
online nomograms such as the Memorial Sloan Kettering Cancer Cent
er.
Melanoma Nomogram provides this information as a percentage.
Informed
choice

also re
quires explanation of the role of SNB, the technique,
its
limitations, potential complications and alternative management if declined.

iii.

Preoperative lymphoscintigraphy is essential to identify which draining lymph
node fields contain the sentinel node(s). T
echnetium99 antimony sulphur colloid
is injected intradermally around the scar, and dynamic and static
lymphoscintograms obtained
.

iv.

Lymphoscintograms will be reported by radiologists and nuclear medicine
specialists trained and experienced in the technique.

v.

SNB is to be performed by surgeons trained and experienced in the technique.
The accepted learning curve is 30 cases
.

vi.

SNB is to be performed within 18 hours of lymphoscintigraphy.

vii.

Incisions are marked out with consideration given to therapeutic node disse
ction
access should nodes be positive.

viii.

In the Multicenter Selective Lymphadenectomy Trial (MSLT
-
I), the false
negative rate was 18% for SNB procedures at all body sites; this rate also
included early experiences with SNB at the multiple participating cent
res around
the world. It should be noted that some papers on SNB report the “failure rate”,
睨wc栠is t⁴ e⁴牵攠 慬se敧慴iv攠牡瑥ⰠI湤⁴桩s⁣慮 b攠eisl敡摩湧⸠K渠np䱔
J

瑨t⁦慩l畲攠u慴攠w慳 ㌮P┮

ix.

Completion lymph node dissection is recommended for
all

patients with a
positive SNB

at this time
.



Draft for sector feedback


April 2013

22

x.

Appropriate data collection systems should be put in place to collate,
report
and
audit post
-
surgery complications.

Monitoring
Criteria

a.

All T1b melanoma and above are recorded by the regional multidisciplinary
meeting and reasons for omission of SNB recorded.

b.

Uptake of sentinel node biopsy is greater than 90% in most patients (after due
consideration).

c.

Identification of ALL sentinel nodes in greater than 90% of cases

d.

False negative rate (not failure rate) <10%
.

Standard
7.
4

Management of regional lymph nodes


Lymphadenectomy

An oncological therapeutic node dissection
is

offered to all patients with evidence of
metastatic nodal disease after appropriate
staging and discussion at a
multidisciplinary meeting
.

Lymphadenectomy nodal harvest results meet accepted
criteria.

Rationale

(a)
Effective management of Stage III melanoma results in better regional control,
potential survival benefits and recruitment into clinical trials. Surgeons and units
experienced in

lymphadenectomy improve outcomes for patients.

Good practice
points

i.

All Stage IIIb patients should have imaging with

whole body

p
ositron emission
tomography
-
computed tomography

(
PET
-
CT
)

prior to surgery
.

ii.

Lymphadenectomy should be performed by surgeons tr
ained and experienced
in the procedure
s
.

iii.

Operation notes should fully describe the anatomical boundaries of the
lymphadenectomy and lymph node levels removed.

iv.

A therapeutic axillary lymph node dissection includes levels I
-
III
.

v.

A therapeutic neck dissectio
n needs to be tailored to the individual patient


m整es瑡tic⁤ s敡s攠慮day i湣lu摥⁲a摩calⰠI潤ifi敤⁲慤ical爠 el散瑩ve ck
摩ss散瑩o湳⁰ 畳⽭i湵s⁡ 灡r潴o摥ct潭y
K

vi.

A therapeutic inguinal dissection should involve skeletonisation of the femoral
vessel
s; removal of pudendal nodes, nodes anterior to the external oblique and
“Cloquet’s” nodes in the femoral canal
K

vii.

Patients with palpable inguinal node metastases or greater than 3 positive
nodes below the inguinal ligament

will

be considered for clearance o
f the iliac
and obturator nodes in the pelvis
.

viii.

Patients with staging evidence of pathological intrapelvic nodes
will
undergo an
iliac and obturator dissection plus/minus an

inguinal dissection
.

ix.

A
ll Stage III melanoma
will

be discussed at a
multidisciplinar
y team

and be
considered for adjuvant radiotherapy or enrolment in clinical trials
.

x.

Patients should have access to a lymphoedema specialist (physiotherapist), to
fit
compression garments and
provide
education
about
post
-
operative
lymphoedema management.

xi.

Ap
propriate data collection systems should be put in place to collate,
report and
audit post
-
surgery complications.

Monitoring
Criteria

a.

N
odal harvest number (Pathology and Surgical)

Lymph node count, greater
than 90% of time

Axilla:

>
18

Inguinal:

>
8

Ilio
-
inguinal:

>
15

Neck:

>
20 (> 4 levels dissected)


>10 (if

3 levels dissected)

b.

Audit of post
-
surgery morbidity and complication rates.


Standard
7.
5

Management of advanced melanoma

Patients with

loco
-
regional recurrent, locally advanc
ed and stage IV melan
oma are
seen or discussed by

melanoma specialists experienced in the care of
melanoma
patients and part of a multidisciplinary meeting, including:



Surgical oncolog
ists



Radiation oncolog
ists




Medical oncolog
ists


Rationale

(a)
Surgery has been show
n

to be
effective in palliating symptoms and in carefully

Draft for sector feedback


April 2013

23

selected patients may improve overall survival.

(b)
Radiation treatment has been shown to be effective in palliating symptoms and
decreasing recurrence of melanoma after surgery.

(c)
Systemic therapy has be
en shown to be effective in palliating symptoms and
improving survival.

Good practice
points

Surgery

i.

Clinical recurrence in a previously resected nodal basin should be resected
after appropriate staging investigations
.

ii.

Where there is a local recurrence w
ith no clinical nodal involvement a
sentinel
node biopsy

should be considered
.

iii.

Where there are multiple dermal recurrences
,

surgical excision should be
considered
and/
or BRAF testing and treatment
,

or if on the limbs
,

referral for
consideration of Isolated

Limb Infusion
.

iv.

Isolated limb infusion should be provided by clinicians and centres trained and
experienced with the technique. A national Isolated Limb Infusion Centre is
preferred.

v.

For patie
nts with limited brain metastasi
s and no or minimal extracranial

disease resection of the brain metastasis should be considered.

vi.

For patients with single level spinal cord compression and minimal or no other
metastatic disease surgical
treatment
should be considered
.


vii.

For patients with
symptomatic or
limited visceral d
isease
,
surgical

resection
should be considered
.

Radiation oncology

i.

Radiation treatment should be considered after surgical resection of locally
recurrent melanoma:



Palpable (macroscopic) metastatic nodal involvement of




ㄠN慲潴i搠湯d攬e潲




㈠O散k爠慸ill慲y 湯d敳Ⱐ潲




㌠Pr潩渠n潤敳



OR Extranodal spread (of tumour)



OR Maximum metastatic node diameter:

㌠Pm⁩渠neckⰠIr




㐠Qm⁩渠nxill愠ar⁧牯i渠⡔剏d⁣ri瑥物愩

ii.

Radiation treatment should be considered after the resect
ion of nodal
recurrence if it has not been previously given.

iii.

For patients with limited brain metastases (1
-
3) and no or
controlled

extracranial
disease stereotactic radiation treatment of the brain metastasis should be
considered.

iv.

Whole brain radiation tre
atment
could

be considered after a surgical resection
or stereotactic radiation treatment of a brain metastasis to improve progression
free survival.

v.

Patients with localised symptoms from melanoma metastases should be
referred for consideration of radiatio
n treatment to these sites.

Medical oncology

i.

P
atients with advanced melanoma should have their tumour assessed for the
presence of the
BRAF V600

mutation.

ii.

BRAF mutation inhibitor therapy
is available f
or BRAF mutation positive patients
(expected to be 50%
)
.

iii.

For BRAF wild
-
type patients there should be the availability of anti
-
CTLA
-
4

therapy. Likewise for BRAF

mutation positive patients who have progressed or
are not appropriate for BRAF

inhibitor therapy.

iv.

Palliative chemotherapy with single agent dacarbazi
ne or temozolamide should
be considered for patients who are not candidates for treatment with BRAF
-
inhibitor therapy or anti
-
CTLA
-
4 therapy and those who have progressed after
optimal treatment with other options.

Monitoring
Criteria

a.

Details of patients
discussed at the multidisciplin
ary meeting will be recorded.
(>
95%)
.

b.

The referrals and allocation of a first specialist appointment should be audited.


Draft for sector feedback


April 2013

24

c.

Availability of stereotactic radiation for the treatment of brain metastasis and
other metastatic disease

should be audited.

Standard
7.6

Non Cutaneous melanoma

All patients wit
h non
-
cutaneous melanoma are discussed in a melanoma
multidisciplinary meeting

as well a
s the relevant site
-
specific multidisciplinary
meeting
, with the treating
clinician

represente
d.

Rationale

(a)
Non cutaneous melanoma
s
are rare entities often presenting late with advanced
disease. To date there are no well
-
established protocols for staging and treatment
of these types of melanoma. Patients should all be referred to a tertiary
mul
tidisciplinary team

with experience in the specific region as well as a melanoma
multidisciplinary team

to allow for potential trial enrolment and melanoma specific
adjuvant therapy. International advice may be sought in more complex cases.

(b)
Ocular mel
anoma is a very complex disease with special anatomical
considerations. Further information can be found in the comprehensive document
accompanying the Clinical Practice Guidelines for the Management of Melanoma in
Australia and New Zealand.

(c)
No surviv
al benefit has been shown with aggressive surgery (abdomino perineal
resection, complete vulvectomy and hysterectomy) compared to wide local excision
in anorectal or vulvovaginal melanoma. There is a lack of publication of surgical
margins in the literatur
e but there is evidence in melanoma of the vulva
that
American Joint Committee on Cancer (AJCC)
staging prognostic indicators in
cutaneous melanoma (Breslow depth, ulceration and mitosis) are relevant.

(d)
There is a lack of evidence for sentinel node bio
psy in non cutaneous
melanoma. Disease progression via haemotological rather than lymphatic spread
may negate any prognostic benefit but in melanoma of the anus or vulva
, where
sentinel node biopsy

can be performed relatively easily
,

it may play a role in