Download Clinical Practice Guidelines in Australia and New Zealand for the Management of Melanoma: Evidence-based best practice guidelines PDF

TitleClinical Practice Guidelines in Australia and New Zealand for the Management of Melanoma: Evidence-based best practice guidelines
Author
LanguageEnglish
File Size2.2 MB
Total Pages268
Table of Contents
                            Contents
Foreword
New Zealand foreword
Preface
Executive summary
Introduction
Summary of clinical practice recommendations
1 	Prevention
2 	Population-based whole-body skin screening for melanoma
	2.1	Proportion of population undergoing whole-body skin examination
	2.2	Accuracy of whole-body skin examination by health professionals
	2.3	Thickness of melanoma detected through skin screening by health professionals
	2.4	Cost-effectiveness of population-based skin screening by health professionals
	2.5	Effectiveness of whole-body skin examination by health professionals in reducing melanoma mortality
3 	Identification and management of high-risk individuals
	3.1	Strongest predictors of future cutaneous melanoma
	3.2	Baseline risks due to age and sex
	3.3	Previous melanoma or other skin cancer
	3.4	Melanocytic naevi
	3.5	Skin and hair colour, skin phototype and freckling
	3.6	Sun exposure and its surrogates
	3.7	Family history of melanoma
	3.8	Management of high-risk individuals
	3.9	Good practice point
	3.10	Genetic risk factors and testing
4 	Classification and staging of melanoma
	4.1 Extract from AJCC Cancer Staging Manual, 6th edition, 2002
5  Clinical diagnosis
	5.1	How patients detect melanoma
	5.2	How doctors detect melanoma
	5.3	Clinical melanoma subtypes
	5.4	Good practice points
	5.5	Identification of the high-risk patient for prospective surveillance for melanoma
	5.6	Evidence-based assessment of aids to the clinical diagnosis of melanoma
	5.7	Total body photography (TBP) for early melanoma diagnosis in high-risk subjects
6 	Biopsy
	6.1	Complete excisional biopsies
	6.2	Partial biopsies
	6.3	Alternative approaches
	6.4	Good practice point
7 	Histopathological reporting of cutaneous melanoma
	7.1	Comments on the histopathological reporting of melanoma
	7.2	Pathology request form
	7.3	Recommended terminology and synonyms for cutaneous melanoma
	7.4	Format of the report
	7.5	Pathology report on sentinel and non-sentinel lymph nodes
	7.6 Pathology report on lymph node dissection specimens
8 	Appropriate investigations
	8.1	Investigations following the diagnosis of primary melanoma
	8.2	Investigations following the diagnosis of locoregional disease
	8.3	Investigations following the diagnosis of metastatic melanoma
9 	Congenital melanocytic naevi
	9.1	Risk of melanoma in patients with congenital melanocytic naevi
	9.2	Approach to management of patients with congenital melanocytic naevi
	9.3	Good practice points
10 	Lentigo maligna
11 	Treatment of primary melanoma
	11.1	Review of the evidence
	11.2	Good practice points
12 	Management of regional lymph nodes in melanoma
	12.1	Sentinel lymph node biopsy
	12.2	Therapeutic lymph node dissection
	12.3	Good practice points
13 	Management of locoregionally recurrent melanoma
	13.1	Persistent melanoma
	13.2	Local metastasis, in transit metastasis and satellitosis
	13.3	Regional lymph nodes
14 	Adjuvant systemic therapy of melanoma
15 	Treatment of disseminated melanoma
	15.1	Brain metastases
	15.2	Surgery
16 	Psychosocial issues in melanoma
	16.1	Effect of psychosocial interventions in patients with melanoma
	16.2	Communication strategies to reduce psychosocial morbidity and 	unmet needs in patients with melanoma
	16.3	Influence of patients’ psychosocial characteristics on prognosis
	16.4	Influence of psychosocial interventions on prognosis
17 	Palliative care in melanoma
	17.1	Timing of referral for palliative care
	17.2	Patients and families who benefit from referral to specialist palliative care
18 Multidisciplinary care of melanoma
	18.1	Review of the evidence
19 	Follow-up
	19.1	Introduction
	19.2	Undertaking follow-up
	19.3	Follow-up intervals and tests
	19.4	Value of follow-up
20 	Clinical trials
	20.1	Good practice point
21 	Treatment of desmoplastic melanoma
22 	Mucosal melanoma
	22.1	Melanoma of the anorectal region
	22.2	Mucosal melanoma of the head and neck
	22.3	Melanoma of the oesophagus
	22.4 Melanoma of the male genito-urinary tract
	22.5	Vulval melanoma
	22.6	Vaginal melanoma
	22.7	Good practice points
23 	Occult melanoma
24 	Ocular melanoma
25 	Melanoma in children
	25.1	Diagnosis
	25.2	Treatment and survival
26 	Pregnancy and melanoma (including hormone replacement therapy and oral contraceptives)
	26.1	Naevi and pregnancy
	26.2	Melanoma and pregnancy
	26.3	Pregnancy after the diagnosis of melanoma
	26.4	Treatment of melanoma during pregnancy
	26.5	Melanoma and hormone replacement therapy and the oral contraceptive pill
27 	Prognostic factors and survival outcomes in cutaneous melanoma
	27.1	Prognostic Factors
	27.2	Survival outcomes
28 	Complementary and alternative medicine
	28.1	CAM—what patients find worthwhile
	28.2	Comparing CAM and conventional therapies for melanoma
	28.3	Value for money and CAM therapies
29 	Melanoma in specific populations in Australia
	29.1	Melanoma in non-Caucasians
	29.2	Good practice point
30  Melanoma in Maori and melanoma in Pacific peoples in New Zealand
	30.1 Melanoma in Maori
	30.2	Good practice points
	30.3	Melanoma in Pacific peoples in New Zealand
	30.4	Good practice points
Appendices
	Appendix 1:	Medico-legal considerations
	Appendix 2:	Guideline development process
	Appendix 3: Working party membership and contributors to guidelines and public consultation submissions received
	Appendix 4: Dermoscopy versus naked eye examination for the diagnosis of melanoma
	Appendix 5: Recommended terminology and synonyms for cutaneous melanoma
	Appendix 6: New Zealand palliative care definition
Abbreviations and glossary
Index
Table 1: Trends in five-year relative survival from melanoma diagnosed in New South Wales, Australia, from 1980 to 1998
Table 2: Designations of levels of evidence according to type of research question
Table 3: Melanoma TNM classification
Table 4: Stage groupings for cutaneous melanoma
Table 5: The histological features of persistent primary melanoma versus
Table 6: Studies comparing Abdomino-pelvic resection and sphincter preserving wide local excision for patients with localised anal melanoma (more than 30 patients and published since 1990)
Table 7: Prognostic factors in melanoma
Table 8: Survival rates for melanoma TNM and staging categories
Table A1: Claims – National Medical Defence Organisation (1990–2005)
Table A2: Designations of levels of evidence according to type of research question
Figure 1: Trends in the age-standardised incidence rates (ASR) of melanoma in Australia and New Zealand
Figure 2: Trends in the age-standardised mortality rates (ASR) of melanoma in Australia and New Zealand
Figure 3: Distribution of lymph node metastases for melanomas 1.2–3.5mm thick
                        
Document Text Contents
Page 1

Clinical Practice Guidelines

in Australia and New Zealand

for the
Management of Melanoma

Evidence-based

Approved by

Best Practice
Guideline

www.moh.govt.nzwww.nzgg.co.nz

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Clinical Practice Guidelines for the Management of Melanoma in Australia and New Zealand94

Chapter 14: Adjuvant systemic therapy of melanoma

1. Observation is acceptable management for patients with resected
stage I–III melanoma

2. These patients be considered for enrolment in clinical trials of adjuvant
therapy. Sentinel lymph node biopsy is mandatory staging for the
stratification of patients on adjuvant therapy trials. Trials of adjuvant
therapy include an observation-only control arm

3. Patients with high-risk disease be considered for adjuvant therapy
with high-dose interferon-alpha

4. Because the toxicity associated with high-dose interferon is considerable,
the risks and benefits of therapy in individual patients be carefully
reviewed before proceeding

5. Patients be treated in an experienced medical oncology facility,
monitored closely for toxicity related to treatment with interferon,
and dose adjusted based on the degree of toxicity

1 Kirkwood JM, Manola J, Ibrahim J, Sondak V, Ernstoff MS, Rao U. A pooled analysis of eastern
cooperative oncology group and intergroup trials of adjuvant high-dose interferon for melanoma.
Clin Cancer Res 2004; 10(5):1670–1677.

2 Wheatley K, Ives N, Eggermont AM, Kirkwood JM, Cascinelli N, Markovic S et al. International
Malignant Melanoma Collaborative Group Interferon-{alpha} as adjuvant therapy for melanoma:
an individual patient data meta-analysis of randomised trials. J Clin Oncol (meeting abstracts)
2007; (25).

3 Eggermont AM, Suciu S, Santinami M, Kruit W, Testori A, Marsden J et al. EORTC Melanoma
Group EORTC 18991: Long-term adjuvant pegylated interferon-alpha2b (PEG-IFN) compared to
observation in resected stage III melanoma, final results of a randomised phase III trial. J Clin Oncol
(meeting abstracts) 2007; (25).

4 Kirkwood JM, Bender C, Agarwala S, Tarhini A, Shipe-Spotloe J, Smelko B et al. Mechanisms and
management of toxicities associated with high-dose interferon alfa-2b therapy. J Clin Oncol 2002;
20(17):3703–3718.

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Clinical Practice Guidelines for the Management of Melanoma in Australia and New Zealand 95

The outcome for patients with stage IV melanomas is poor. The median survival is only
six to nine months, with an estimated five-year survival of 5–10% depending on the
prognostic factors, the site of metastasis, the number of metastatic sites, and elevated
serum LDH levels.1,2

The standard chemotherapy has been single agent dacarbazine (DTIC) that has response
rates reported at 5–20%, but only 5% are complete responses and of short duration.3,4
Recently fotemustine was shown to produce higher overall response rate compared with
dacarbazine, but with only a trend towards overall survival. Unlike DTIC and temozolomide,
fotemustine is associated with higher risk of myelosuppression5.

The oral alkylating agent temozolomide has equivalent efficacy to dacarbazine (median
survival 7.7 months versus 6.4 respectively).6 Temozolomide resulted in better health-related
quality-of-life outcomes than dacarbazine, both in functional improvements and decreased
symptoms.7

Combination chemotherapy does not improve survival over single agents and may not
improve palliation of more toxic than single agents.8 For example, the Dartmouth regimen
(cisplatin, carmustine, DTIC and tamoxifen) has a slightly increased response rate but there
is no improvement in survival when compared to dacarbazine alone.4 The combination of
cisplatin and temozolomide did not improve the outcome compared to temozolomide alone.9

The addition of tamoxifen to chemotherapy is ineffective.10 The biological agent interferon-
alpha achieved single agent response rates around 15%, while IL2 phase II trials ranged
between 3% and 50%.11,12 Randomised trials of the combination showed no advantage over
single agents.13 Combining interferon-alpha with chemotherapy did not improve survival.
IL2 was combined with dacarbazine only in phase II trials.14 Similarly, adding interferon-
alpha to temozolomide improved the response rate but did not translate into a survival
advantage. Randomised studies of adding either or both interferon and interleukin to
combination chemotherapy has not resulted in improved survival of patients with metastatic
melanoma.15,16 To date no other biological treatment, either vaccines or targeted therapies
such as Bcl-2 antisense therapies, have been effective alone or demonstrated survival
advantages in randomised trials which add them to chemotherapy.17

Radiotherapy can improve symptoms from the effect of local tumours. The sites commonly
requiring treatment in melanoma are bone, brain, subcutaneous lesions, bulky lymph nodes,
liver and adrenal metastases. Whilst many of these can be treated with short fractionation
regimens such as 8 Gy in one fraction (bone metastases)18 or 20 Gy in five fractions
(brain metastases),19 larger and bulky tumours such as those involving lymph nodes or
widespread cutaneous deposits may require more lengthy schedules, such as 40 Gy in
fifteen fractions or 45 Gy in twenty fractions.

Treatment of disseminated melanoma15

Page 268

Clinical Practice Guidelines

in Australia and New Zealand

for the
Management of Melanoma

Evidence-based

Approved by

Best Practice
Guideline

www.moh.govt.nzwww.nzgg.org.nz

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