Critical appraisal:Maurichi A, Miceli R, Camerini T, Contiero P, Patuzzo R, Tragni G, et al 2010

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Critical Appraisal

Article being appraised

Maurichi A, Miceli R, Camerini T, Contiero P, Patuzzo R, Tragni G, et al. Pure desmoplastic melanoma: a melanoma with distinctive clinical behavior. Ann Surg 2010 Dec;252(6):1052-7 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21107116.


Applicable clinical question

Key Facts

Study Design

cohort study

Study aims:

To evaluate the excision margin necessary for desmoplastic melanoma (DM).

Number of Patients:

242

276 patients with DM identified among 8543 consecutive melanoma cases diagnosed & treated at Instituto Nazionale dei Tumori (INT) in Milan from January 1977 to December 2002.

Exclusion criteria: primary DM, mucosal DM, history of other cancers except basal cell carcinoma, narrow excisions (<1cm), and unavailability of pathological specimens.

Overall studied 242 patients, broken up into:
- Pure DM (PDM): 118

- Mixed DM (MDM): 124
Reported outcome(s):

- Clinical and Pathologic Characteristics of Patients with PDM and MDM
- Treatment of Primary Lesion
- Disease Recurrence
- Overall Survival and Melanoma-Specific Mortality

Results of outcome(s):

DISEASE RECURRENCE

Local Recurrence:
- Local Recurrence was more common in PDM (28 patients) than the MDM group (18 patients)
- Local Recurrence 5 year CCI for PDM:(CCI: 40% for ≤2 mm/1 cm, 18.5% for ≤2 mm/ 2 cm, and 18.1% for >2 mm/2 cm)
- Local Recurrence difference between 5-year CCI curves of local recurrence for the 2 groups was significant only for the subgroup with thin lesions (≤2 mm thick) excised with a 1 cm margin (CCI: 40% for PDM and about 18% for MDM patients, P = 0.034).
Distant Recurrence:
- 91.7% of distant metastases in PDM developed follwoing 1 or more local recurrences.
- 79.6% of distant metastases occurred as first event in MDM
- For thick lesions (>2 mm) excised with a 2 cm margin, where 5-year CCI of distant spread for MDM: 40%; PDM: 3% (P < 0.001).
- In the multivariable analysis, the 5-year cumulative incidence of distant metastasis was significantly higher for MDM than PDM patients (P < 0.001)


OVERALL 5 YEAR SURVIVAL:

- 27 deaths in the PDM group and 53 in the MDM group; 24 and 49 of these deaths, respectively,were melanoma related.
OS: 79.5% (95% CI, 71.0%–85.8%) for PDM; 61.3% (95% CI: 52.1%–69.2%) for MDM patients (P = 0.001).

Overall Mortality Trends relating to lesion-thickness-plus-excision-width differed fore PDM (p=0.014) but not MDM (p=0.185)

PDM:
- PDM patients with primary tumours who recieved 2cm excision: 85.2% (95% CI: 65.2%–94.2%).
- In the above, PDM patients with primary turmours <2mm 86.6% (95% CI: 75.0%–93.1%); PDM patients with primary lesions <2 mm with 2 cm excision: 60.0% (95% CI: 40.1%–75.0%) (p=0.014)
MDM
- MDM patients with primary tumours who recieved 2cm excision for primary tumours <2mm 68.8% (95% CI: 49.7%–81.8%); PDM patients with primary lesions <2 mm with 2 cm excision: 51.7% (95% CI: 38.2%–63.6%).
- MDM patients with primary tumours who recieved 1cm excision for primary tumours <2mm, 5 year OS was urvival was 70.6% (95% CI: 52.2%–83.0%).

COMPARISON:
- Melanoma mortality was higher for MDM than PDM in bothsubgroups with 2 cm margins, but this was reversed in the subgroup of thin lesions (≤2 mm) with 1 cm margins, where mortality was higher for PDM
Overall Mortality Trends relating to lesion-thickness-plus-excision-width differed fore PDM (p=0.014) but not MDM (p=0.185)

For 5 year CCI:
- In PDM: CCI of local recurrence was also greater in PDM excised with 1 cm margins (CCI: 40% for ≤2 mm/1 cm, 14.8% for ≤2 mm/ 2 cm, and 13.4% for >2 mm/2 cm)
- In MDM: mortality increased with stage but was independent of excision width (CCI: 29.4% for ≤2 mm/2 cm, 31.3% for ≤2 mm/ 1 cm, and 48.3% for >2 mm/2 cm).

Overall Mortality Trends relating to lesion-thickness-plus-excision-width differed fore PDM (p=0.014) but not MDM (p=0.185)

Includes an economic evaluation

no

Evidence ratings

Level of evidence

III-2

Risk of bias
High risk of bias Comments: Please replace this text and include any additional comments in regards to your risk of bias rating

Risk of bias assessment: cohort study

Subject selection
"New technology" group
Highly selected or not described
Comparison group
Highly selected or not described
Comparability of groups on demographic characteristics and clinical features
Comparable
Measurement of outcomes
Outcome measures blind to technology used
No, but objective measures used
Same method of measurement used across comparison groups
Yes
Completeness of follow-up
Was follow-up complete and were all patients included in the analysis?
Yes (follow-up >95%) or survival analysis using all patients
Result of appraisal

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Completed by

Meghna Kakani


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Article
Maurichi A, Miceli R, Camerini T, Contiero P, Patuzzo R, Tragni G, et al. Pure desmoplastic melanoma: a melanoma with distinctive clinical behavior. Ann Surg 2010 Dec;252(6):1052-7 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21107116.
Assigned to
User:Meghna.kakani
Topic area
Guidelines:Melanoma
Clinical question
Form
Form:Critical appraisal


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