From the Guidelines
Assessment for advancing malignant melanoma involves a comprehensive approach using the ABCD criteria, staging, and various diagnostic tests, with the most recent guidelines recommending the use of the "ABCD rule" which includes Asymmetry, Border irregularities, Color heterogeneity, and Dynamics (or evolution in colors, elevation or size) 1. The diagnostic criteria for assessing progression of malignant melanoma include:
- The "ABCD rule" which evaluates suspicious lesions for Asymmetry, Border irregularities, Color heterogeneity, and Dynamics (or evolution in colors, elevation or size) 1
- The "ugly duckling" concept, which helps to identify melanomas by recognizing that nevi in the same individual tend to resemble one another, while melanomas often do not fit the individual's naevus pattern 1
- Dermoscopy by an experienced physician, which enhances the diagnostic accuracy 1
- Full-thickness excisional biopsy with a small side margin, which is mandatory for diagnosis 1
- Histology report following the American Joint Committee on Cancer (AJCC) classification, including information on maximum thickness, mitotic rate, presence of ulceration, and clearance of surgical margins 1 The staging of melanoma follows the TNM system, evaluating the primary Tumor thickness (Breslow depth), presence of Nodal involvement, and distant Metastasis. Further assessment includes:
- Sentinel lymph node biopsy for lesions >1mm thick 1
- Complete blood count, liver function tests, lactate dehydrogenase (LDH) levels, and imaging studies such as CT, MRI, PET scans, or ultrasound depending on the stage 1
- Genetic testing for BRAF mutations, which is important for guiding treatment options for advanced disease 1 Regular follow-up examinations are essential, with frequency based on staging—every 3-6 months for higher stages and 6-12 months for lower stages. It is also important to note that mutation testing for treatable mutations is mandatory in patients with advanced disease, and should be carried out in accredited institutes with careful quality controls 1.
From the FDA Drug Label
The major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS; as assessed by blinded independent central review [BICR] using Response Evaluation Criteria in Solid Tumors [RECIST v1. 1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ]).
The diagnostic criteria for assessing progression of malignant melanoma (skin cancer) are based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which includes:
- Assessment of tumor status at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter
- Evaluation of a maximum of 10 target lesions and a maximum of 5 target lesions per organ
- Blinded independent central review (BICR) to assess progression-free survival (PFS) 2
From the Research
Diagnostic Criteria for Malignant Melanoma
The diagnostic criteria for assessing the progression of malignant melanoma involve several techniques and considerations, including:
- Clinical assessment of pigmented lesions by healthcare professionals 3
- Architectural features such as asymmetry, confluence of growth, marked cellularity, and poor circumscription 3
- Cytological features including an irregular and thick nuclear membrane and prominent nucleoli 3
- Use of the ABCD method, total-body photography, skin surface microscopy, and machine vision for skin examinations 4
Staging and Prognosis
Staging and prognosis of malignant melanoma are crucial for determining the appropriate treatment and outcome, with factors such as:
- Early detection being critical for successful treatment and better survival rates 5, 6
- Metastatic melanoma having a poor prognosis with a median survival time of less than 1 year 6
- Surgery being the standard treatment for localized melanoma, while there is no standard therapy for advanced-stage melanoma 6
Treatment Options
Treatment options for malignant melanoma depend on the stage and primary lesion, and may include: