Summary Background Complete lymph node dissection is recommended in patients with positive sentinel lymph node biopsy results. To date, the effect of complete lymph node dissection on prognosis is ...controversial. In the DeCOG-SLT trial, we assessed whether complete lymph node dissection resulted in increased survival compared with observation. Methods In this multicentre, randomised, phase 3 trial, we enrolled patients with cutaneous melanoma of the torso, arms, or legs from 41 German skin cancer centres. Patients with positive sentinel lymph node biopsy results were eligible. Patients were randomly assigned (1:1) to undergo complete lymph node dissection or observation with permuted blocks of variable size and stratified by primary tumour thickness, ulceration of primary tumour, and intended adjuvant interferon therapy. Treatment assignment was not masked. The primary endpoint was distant metastasis-free survival and analysed by intention to treat. All patients in the intention-to-treat population of the complete lymph node dissection group were included in the safety analysis. This trial is registered with ClinicalTrials.gov , number NCT02434107 . Follow-up is ongoing, but the trial no longer recruiting patients. Findings Between Jan 1, 2006, and Dec 1, 2014, 5547 patients were screened with sentinel lymph node biopsy and 1269 (23%) patients were positive for micrometastasis. Of these, 483 (39%) agreed to randomisation into the clinical trial; due to difficulties enrolling and a low event rate the trial closed early on Dec 1, 2014. 241 patients were randomly assigned to the observation group and 242 to the complete lymph node dissection group. Ten patients did not meet the inclusion criteria, so 233 patients were analysed in the observation group and 240 patients were analysed in the complete lymph node dissection group, as the intention-to-treat population. 311 (66%) patients (158 in the observation group and 153 in the dissection group) had sentinel lymph node metastases of 1 mm or less. Median follow-up was 35 months (IQR 20–54). Distant metastasis-free survival at 3 years was 77·0% (90% CI 71·9–82·1; 55 events) in the observation group and 74·9% (69·5–80·3; 54 events) in the complete lymph node dissection group. In the complete lymph node dissection group, grade 3 and 4 events occurred in 15 patients (6%) and 19 patients (8%) patients, respectively. Adverse events included lymph oedema (grade 3 in seven patients, grade 4 in 13 patients), lymph fistula (grade 3 in one patient, grade 4 in two patients), seroma (grade 3 in three patients, no grade 4), infection (grade 3 in three patients, no grade 4), and delayed wound healing (grade 3 in one patient, grade 4 in four patients); no serious adverse events were reported. Interpretation Although we did not achieve the required number of events, leading to the trial being underpowered, our results showed no difference in survival in patients treated with complete lymph node dissection compared with observation only. Consequently, complete lymph node dissection should not be recommended in patients with melanoma with lymph node micrometastases of at least a diameter of 1 mm or smaller. Funding German Cancer Aid.
Computerized clinical image analysis is shown to improve diagnostic accuracy for cutaneous melanoma but its effectiveness in preoperative assessment of melanoma thickness has not been studied. The ...aim of this study, is to explore how melanoma thickness correlates with computer-assisted objectively obtained color and geometric variables. All patients diagnosed with cutaneous melanoma with available clinical images prior to tumor excision were included in the study. All images underwent digital processing with an automated non-commercial software. The software provided measurements for geometrical variables, i.e., overall lesion surface, maximum diameter, perimeter, circularity, eccentricity, mean radius, as well as for color variables, i.e., range, standard deviation, coefficient of variation and skewness in the red, green, and blue color space. One hundred fifty-six lesions were included in the final analysis. The mean tumor thickness was 1.84 mm (range 0.2-25). Melanoma thickness was strongly correlated with overall surface area, maximum diameter, perimeter and mean lesion radius. Thickness was moderately correlated with eccentricity, green color and blue color. We conclude that geometrical and color parameters, as objectively extracted by computer-aided clinical image processing, may correlate with tumor thickness in patients with cutaneous melanoma. However, these correlations are not strong enough to reliably predict tumor thickness.
Sun exposed skin disease Lehmann, Percy, MD
Clinics in dermatology,
03/2011, Letnik:
29, Številka:
2
Journal Article
Recenzirano
Abstract A wide variety of dermatoses may arise in exposed areas and are at the same time induced or exacerbated by irradiation from the sun. The spectrum may range from acute sunburn to chronic ...effects of sun damage, including elastosis and ultraviolet-induced skin cancer. Inflammatory ultraviolet-induced dermatoses have a confusing nomenclature and classification that often leads to difficulties in the differential diagnosis. Modern nosology differentiates primary from secondary photodermatoses. Primary photodermatoses are believed to be mainly irradiation-induced and immunologically mediated. If the pathophysiology is not clearly defined, they are also called idiopathic. In cases of a known photosensitizer, local and systemic phototoxic or photoallergic reactions can be differentiated. Secondary photodermatoses have an established pathophysiology; for example, an enzyme defect such as occurs in the porphyrias or xeroderma pigmentosum, which leads to the abnormal sun sensitivity. Finally, preexisting dermatoses may be exacerbated by irradiation from the sun, as in systemic lupus erythematosus or Darier disease.
Abstract Lupus erythematosus (LE) represents an autoimmune disease with great clinical variability in which photosensitivity is a common feature for all forms and subsets. The nature and ...characteristics of clinical photosensitivity in LE have been elucidated through standardized phototesting procedures. The development of skin lesions after UV-injury is typically delayed starting from a few days up to three weeks after the irradiation, and may persist for months. Therefore, patients may not be aware of the detrimental effects of sunlight for their disease. The most photosensitive subset of LE is LE tumidus, followed by subacute cutaneous LE. Phototesting has also been crucial for studying the pathophysiology of LE-photosensitivity. Abnormalities of generation and clearance of UV-triggered apoptotic cells in LE are an important source of autoantigens. Recent data demonstrate the linkage of innate with adoptive immune pathways in UV-induced autoimmune response. Plasmocytoid dendritic cells (PDC) and their secreted IFN-α play a central role in the LE-pathogenesis. The recruitment of relevant leukocyte subsets is dependant on certain chemokines, which have been characterized in recent studies. An amplification cycle has been postulated, in which UV induces apoptosis and necrosis resulting in the production and release of chemokines. Subsequently, effector memory T cells as well as PDCs are recruited and activated perpetuating an amplification process that leads to UV-induced cutaneous LE lesion.
Objective We sought to assess if the exclusive use of a broad-spectrum sunscreen can prevent skin lesions in patients with different subtypes of cutaneous lupus erythematosus (CLE) induced by ...ultraviolet (UV) irradiation under standardized conditions. Methods A total of 25 patients with a medical history of photosensitive CLE were included in this monocentric, randomized, vehicle-controlled, double-blind, intraindividual study. The test product and its vehicle were applied 15 minutes before UVA and UVB irradiation of uninvolved skin areas on the upper aspect of the back in a random order, and standardized phototesting was performed daily for 3 consecutive days. Results Characteristic skin lesions were induced by UVA and UVB irradiation in 16 patients with CLE in the untreated area, and 14 patients showed a positive test result in the vehicle-treated area. In contrast, no eruptions compatible with CLE were observed in the sunscreen-treated area in any of the 25 patients. This resulted in significant differences ( P < .001) between UV-irradiated sunscreen-treated versus vehicle-treated areas, and between UV-irradiated sunscreen-treated versus untreated areas. Furthermore, a significant difference ( P < .05) was observed concerning the age of disease onset and the patient history of photosensitivity. Patients who were younger than 40 years at onset of CLE reported photosensitivity significantly more often than patients with a higher age of disease onset. None of the patients showed any adverse events from application of the test product or the vehicle. Limitations Data resulting from standardized experimental phototesting might not be transferable to a clinical setting. Conclusion These results indicate clearly that the use of a highly protective broad-spectrum sunscreen can prevent skin lesions in photosensitive patients with different subtypes of CLE.
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