Unmet information needs of patients with melanoma in Germany.

There is a scarcity of available data on unmet information needs (UINs) of melanoma patients (MPs) from Germany and of MPs with clinical stage IV. In a multicenter cross-sectional survey, we explored the UINs of 529 MPs by applying a standardized questionnaire. Subgroup differences in scope and contents of UINs were determined by univariate analyses. Predictors of the presence of UINs were identified by binary logistic regression. Overall, 55% of MPs reported UINs. Most MPs felt poorly or not informed about psychosocial support (24-31%). In MPs currently receiving medical treatment [odds ratio (OR): 1.9; P=0.017], MPs aging of at least 55 years (OR: 1.7; P=0.029), and in MPs who generally had a high need for information on their condition (OR: 2.4; P=0.001), the presence of UINs was significantly more likely than in post-treatment MPs, MPs more than 55 years of age, and those whose general information need was low. Most UINs concerned treatment-related information and were reported by MPs with tumor progression. Presence and scope of UINs did not differ significantly between metastatic and nonmetastatic MPs (57 vs. 53%; P=0.436). We highlighted differences in the presence, scope, and contents of UINs between MP subgroups, which should be considered when educating them in medical consultations and providing information via media. In particular, MPs felt insufficiently informed about psychosocial support and desired more treatment information.

Quality, Readability, and Understandability of German Booklets Addressing Melanoma Patients.

Booklets are the preferably used form among patient education materials and are often handed out during medical consultations in dermatological oncology settings. However, little is known about how beneficial they are and whether they correspond to essential quality characteristics. To assess the quality, readability, and understandability of currently freely available booklets written in German addressing melanoma patients (MP). Melanoma booklets in accordance with predefined criteria were searched and analyzed. Three reviewers independently assessed their quality and understandability by applying the DISCERN tool and PEMAT-P. The Flesch Reading Ease Score (FRES) was calculated to determine readability. Nine booklets addressing MP were analyzed. The overall median DISCERN score was 3.6 (interquartile range (IQR) 2.9-4.1), median PEMAT-P score was 91% (IQR 83-94.5), and median FRES was 43 (IQR 33.5-47.5), indicating a medium quality, a high application of understandability elements, but low readability in at least half of the booklets. Incomplete reporting on treatments and insufficient meta-information caused the main quality deficits. There is a need of content and didactic revision of German booklets for MP to raise their quality and to make them beneficial and understandable for more patients. An adaption in accordance with evidence-based criteria and an even stronger involvement of MP in assessment and development of patient education material are considered to be the best approaches.

Information-seeking and use of information resources among melanoma patients of German skin cancer centers.

BACKGROUND: This study aimed to explore the information-seeking behavior (ISB) of melanoma patients (MPs) and MP subgroups, in order to provide data for needs-based adaptation of information provision. METHODS: In a cross-sectional survey in 27 German skin cancer centers, we explored characteristics of the ISB of MPs with the aid of a standardized questionnaire. Sub-group differences were determined with the chi-squared test and predictors of media preferences with logistic regression. RESULTS: 67 % of the 529 participating MPs had clinical stage III or IV melanoma. Most of the participants (81 %) reported medical consultations as their regularly or frequently used information resource (IR). 58 % wished to have more advice about IRs from their physician. Only 8 % of MPs used the services of self-help groups and 12 % of MPs took advantage of the services of cancer counseling centers. The internet (63 %) and booklets (58 %) were reported to be the preferred media. Age, educational level, general need for information and lack of awareness of their own condition proved to be predictors for media preferences. CONCLUSIONS: Most MPs expected their physician to advise them about IRs they could use in addition to medical consultations. Peer support services were quite underused by MPs. The various preferences of media by MPs should be considered when deve-loping and providing IRs.

Intermittent High-Dose Intravenous Interferon Alfa-2b for Adjuvant Treatment of Stage III Melanoma: Final Analysis of a Randomized Phase III Dermatologic Cooperative Oncology Group Trial.

PURPOSE: To evaluate the efficacy, safety, tolerability, and quality of life (QoL) in patients receiving intravenous, intermittent high-dose interferon alfa-2b (IFN-α-2b [iHDI]) compared with standard high-dose IFN-α-2b (HDI). PATIENT AND METHODS: Patients with stage III resected lymph node or in-transit metastasis from cutaneous malignant melanoma were randomly assigned to receive either a standard HDI regimen or three courses of IFN-α-2b 20 MIU/m(2) administered intravenously 5 days a week for 4 weeks then repeated every 4 months. Distant metastasis-free survival was the primary end point for efficacy analysis. In addition, relapse-free survival, overall survival, safety as determined by Common Terminology Criteria for Adverse Events criteria, and QoL were secondary end points. RESULTS: Of 649 patients enrolled, 22 patients were excluded from the intent-to-treat analysis. The remaining 627 patients were well balanced between the arms according to sex, age, and stage. After a median follow-up of 55 months, a multivariable Cox model revealed no significant differences for distant metastasis-free survival (hazard ratio [HR], 1.21; P = .12) or overall survival (HR, 1.01; P = .85). In contrast, the difference for relapse-free survival was significant (HR, 1.27; P = .03), favoring standard HDI. Early termination of treatment because of adverse events or QoL occurred significantly more often with HDI than with iHDI (26.0% v 14.8%; P < .001). CONCLUSION: Although the safety and QoL profiles for the intermittent regimen were favorable, no significant difference was observed for survival while the HR for relapse with iHDI was increased. Therefore, an iHDI regimen, as tested here, cannot be recommended as adjuvant treatment for high-risk melanoma.

Association of genetic variants of the vitamin D receptor (VDR) with cutaneous squamous cell carcinomas (SCC) and basal cell carcinomas (BCC): a pilot study in a German population.

BACKGROUND: Vitamin D receptor (VDR) polymorphisms have important implications for vitamin D signalling and are associated with various malignancies. PATIENTS AND METHODS: In a German population, the frequency of several VDR polymorphisms (Apa1, Taq1, Bgl1) in basal cell carcinomas (BCCs, n=90) and cutaneous squamous cell carcinomas (SCCs, n=100) as compared to healthy controls (n=51) was analyzed. RESULTS: Impressive variations in the frequency of some VDR genotypes were found when comparing skin of cancer patients and controls. An association of the genotype AaTtBb with BCC risk was found (BCC: 45.7%, SCC: 39.8% and controls: 38.0%). The genotype aaTTBB was exclusively found in the control group (20%), which suggested that this genotype may be protective against skin carcinogenesis. Moreover, the aaTTbb genotype was associated with skin cancer risk, being found at a much higher frequency in BCCs (21%) and SCCs (17%) as compared to controls (8.0%). Comparison of the frequencies of the VDR genotypes in sunlight-exposed vs. not sunlight-exposed skin areas revealed BB 30.1% vs. 7.1% respectively in BCCs and BB 28.1% vs. 0.0% respectively in SCCs, indicating that vitamin D signalling may be of importance for photocarcinogenesis of the skin. Associations also indicated that the Apa1 and Taq1 genotypes may be of importance for photocarcinogenesis of BCCs, but not for SCCs. Comparison of the VDR genotype frequencies by age (younger than 60 years vs. 60 years or older) revealed no evidence of age-dependent variations in patients with BCCs or SCCs. CONCLUSION: VDR polymorphisms are of importance for the development of BCCs and cutaneous SCCs, but further explorations of these findings and their implications are required.

Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study).

OBJECTIVE: To compare the clinical efficacy and safety of endovenous laser treatment (EVLT) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) insufficiency. DESIGN: Two-center randomized controlled trial with 2-year follow-up. SETTING: Interventions were performed on ambulatory and hospitalized patients at 2 vein centers, a university dermatology department (EVLT-treated group), and a specialized vein clinic (HLS-treated group). PATIENTS: Random sample of 400 patients with GSV insufficiency. INTERVENTIONS: Patients were assigned (1:1) to EVLT or HLS of the GSV from September 2004 through March 2007; 185 and 161 patients (limbs), respectively, were treated per protocol. MAIN OUTCOME MEASURES: Clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), duplex-detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), hemodynamics (venous refilling time), quality of life (Chronic Venous Insufficiency Questionnaire 2), adverse effects, and visual analog scale-based evaluations of patients' satisfaction. RESULTS: Clinically recurrent varicose veins after surgery were similarly observed in both groups: 16.2% (EVLT-treated group) vs 23.1% (HLS-treated group); P = .15. Duplex-detected saphenofemoral refluxes occurred significantly more frequently after EVLT (17.8% vs 1.3%; P < .001). Both treatments equally improved medical condition (Homburg Varicose Vein Severity Score) and disease-related quality of life. Endovenous laser treatment caused more adverse effects (phlebitic reaction, tightness, dyspigmentation) but revealed advantages concerning hemodynamics, recovery, and cosmetic outcome. CONCLUSIONS: Both EVLT and HLS are comparably safe and effective procedures to treat GSV incompetence. The significantly higher rate and the course of duplex-detected saphenofemoral recurrences after EVLT remain a matter of further investigations. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN18322872.

Prospective evaluation of supportive care with or without CVD chemotherapy as a second-line treatment in advanced melanoma by patient's choice: a multicentre Dermatologic Cooperative Oncology Group trial.

This prospective, nonrandomized multicentre, phase III study compared best supportive care (BSC) alone with cisplatin, vindesine and dacabazine-based (CVD) chemotherapy and BSC in patients with advanced melanoma. A total of 117 pretreated patients with metastatic melanoma were evaluated, 34 patients in arm A (BSC) and 83 in arm B (BSC and CVD). Primary endpoint was overall survival and secondary endpoints were disease control rate and quality of life (European Organisation for Research and Treatment of Cancer QLQ-C30). Owing to sparse recruitment of patients for randomization, the protocol has been changed based on patients' choice. Baseline characteristics were imbalanced with respect to the Karnofsky Performance Index (P=0.001), the existence of brain metastases (P=0.035) and earlier application of chemoimmunotherapy (P=0.038). Disease control was observed in 8.8% of patients in arm A and in 28.9% of patients in arm B (P=0.028). Median overall survival time was 137 days in arm A and 229 days in arm B (P=0.014). Multivariate analyses could not ascribe this prognostic benefit to CVD treatment. No significant difference in the quality of life could be found. This study could not detect clear survival benefits for polychemotherapy with CVD compared with BSC alone in patients with advanced metastatic melanoma. Interestingly, having the choice of chemotherapy or BSC alone in a second-line situation, more than 70% of patients chose polychemotherapy.

Construction and evaluation of a multidimensional score to assess varicose vein severity - the Homburg Varicose Vein Severity Score (HVVSS).

To evaluate a novel score (HVVSS) for varicose vein patients combining subjective symptoms, clinical findings and functional data of venous insufficiency. 91 patients (118 legs) with primary varicose veins of the great, small or accessory anterior saphenous vein were treated with conventional surgery. HVVSS was assessed pre- and 3 months postoperatively. The data were compared with established clinical and disease-related life quality scores (VCSS, AVVQ, CIVIQ). Test responsiveness, validity and reliability were determined using correlations with CEAP stage and venous refilling time as hemodynamic parameter, and inter-observer variability was assessed. All scores were highly responsive to varicose vein surgery (p<0.001). HVVSS(0-100) decreased from 34.1 ± 13.0 to 9.6 ± 6.9 postoperatively. The relative score change of HVVSS was superior to VCSS (69.5% vs. 58.8%, p=0.005). HVVSS revealed highly significant correlations with the clinical CEAP stage and was exclusively able to differentiate mild from severe disease as defined by venous refilling time (p=0.009). Inter-observer reliability of HVVSS was confirmed by correlation coefficients of 0.977 and 0.950 pre- and postoperatively (p<0.001). HVVSS is a suitable and reliable tool to assess disease severity in varicose vein patients and to quantify therapeutic effects of varicose vein treatment.

Health-related quality of life before and during adjuvant interferon-α treatment for patients with malignant melanoma (DeCOG-trial).

Adjuvant treatment with interferon-α (IFN-α) for patients with malignant melanoma can improve relapse-free and overall survival, but IFN-associated side effects may reduce patient's quality of life. The aim of the study was to prospectively evaluate health-related quality of life (HRQoL) in patients with melanoma before and during Low-Dose IFN-α therapy. In a prospective multicenter trial conducted by the Dermatologic Cooperative Oncology Group, 850 patients with cutaneous stage II malignant melanoma received a standard Low-Dose of IFN-α-2a. We evaluated HRQoL using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 questionnaire at baseline and after 3, 6, and 12 months of IFN-α treatment in 282 patients. Nine of 15 subscales showed significant poorer results after 3 months of adjuvant IFN treatment. Symptoms included reduced physical functioning, reduced cognitive functioning, fatigue, nausea, pain, dyspnea, insomnia, diarrhea, and loss of appetite. We did not find a significant change over time for role, emotional, or social functioning. Only cognitive functioning and dyspnea continuously worsened through the twelfth month. At baseline women had significantly lower scores for physical and emotional functioning and for fatigue compared with men. During treatment, women scored significantly poorer on physical functioning, emotional functioning, fatigue, pain, and constipation subscales. Patients who reported having a bad or very bad QoL before treatment were 5.8 times more likely to discontinue treatment early because of psychiatric problems. We conclude that adjuvant low-dose IFN treatment is associated with significant deterioration of HRQoL. Specific psychosocial care should be offered especially for patients who report lower HRQoL and emotional problems before treatment to prevent early discontinuation.

Genetic variations in the genes encoding receptor activator nuclear factor κ B (RANK), receptor activator nuclear factor κ B ligand (RANKL) and osteoprotegerin (OPG) in patients with psoriasis and psoriatic arthritis: a case-control study.

Psoriasis (Ps) and psoriatic arthritis (PsA) are diseases of unknown origin. However, the receptor activator nuclear factor κ B ligand (RANKL) might play a key role in the pathomechanisms of the disease. Our aim was to study seven single nucleotide polymorphisms (SNP) in the genes encoding for receptor activator nuclear factor κ B (RANK, two SNP), osteoprotegerin (OPG, two SNP) and RANKL (three SNP in patients with Ps and PsA). A case-control study with 156 Ps patients (45 with PsA) and 516 healthy blood donors was conducted to evaluate an association of the SNP with Ps and PsA by genotyping of DNA by polymerase chain reaction. None of the seven SNP showed any differences in the allelic or genotype frequencies between Ps patients and controls. Our study showed no significant association between the SNP in the genes encoding for RANK, OPG and RANKL with susceptibility of disease in Ps and PsA patients.

Caterpillar dermatitis revisited: lepidopterism after contact with oak processionary caterpillar.

Caterpillar dermatitis (lepidopterism) is a disease that is caused by butterflies, moths and their caterpillars. Clinical signs and symptoms vary from itchy skin lesions to conjunctivitis, pharyngitis, malaise and anaphylactic reactions. We present the case of two brothers with typical skin lesions of leptidopterism. The older boy showed skin lesions after playing with caterpillars in the garden, whereas his younger brother was affected without direct contact to the caterpillars but only by playing with his brother. As the mother could show two caterpillars, lepidopterism could easily be diagnosed. Under a local therapy with a medium potent corticosteroid cream and a non-sedating orally administered antihistamine, all skin lesions as well as itching disappeared within 1 week.

Reciprocal responses of fibroblasts and melanocytes to α-MSH depending on MC1R polymorphisms.

The melanocortin 1-receptor (MC1R) exhibits several variants in form of single nucleotide polymorphisms (SNPs) that are known to differentially regulate melanocyte function. However, whether and how MC1R polymorphisms also affect fibroblast function has not been investigated so far.Therefore we measured intracellular cyclic adenosine monophosphate (cAMP) concentrations and cellular proliferation upon stimulation with alpha-melanocyte stimulating hormone (α-MSH) in eight different human fibroblast and melanocyte cell lines with wild type and different MC1R SNPs.We found that fibroblasts, as well as melanocytes, show differences in MC1R function depending on the MC1R genotype. MC1R stimulation with α-MSH in wild type (MC1R(wt)) melanocytes results in an increase of intracellular cAMP and cellular proliferation. In contrast, MC1R(wt) fibroblasts react with a decrease of intracellular cAMP and proliferation. In MC1R polymorphic fibroblasts (R163Q, R151C and V60L) both effects are significantly alleviated. Similar, but inverse effects could be found in MC1R polymorphic melanocytes (R142H and V92M) with a significantly lower cAMP increase and proliferation rate compared to MC1R(wt) melanocytes.Our results indicate that the MC1R displays reciprocal growth responses in melanocytes and fibroblasts, depending on the MC1R genotype. Thus, the MC1R seems to be not solely important for the skin pigmentary system, but also for the fibroblast function, and might influence different processes of the dermal compartment like wound healing, fibrosis and keloid formation.

Venoarterial flow index steadily improves after endovenous laser treatment of the great saphenous vein.

BACKGROUND: Endovenous laser treatment (EVLT) is a minimally invasive procedure to ablate varicose veins. The venous arterial flow index (VAFI) represents a quantitative duplex ultrasound parameter to characterize venous hemodynamics, which has not been investigated in EVLT so far. OBJECTIVE: To analyze the hemodynamic improvement of EVLT of the great saphenous vein (GSV) according to VAFI measurement. MATERIALS AND METHODS: One hundred thirty-three participants with complete GSV insufficiency were treated with 810-nm EVLT. VAFI as a ratio of venous and arterial flow volumes of the common femoral vessels and digital photoplethysmography (DPPG) were assessed before and 3 (n=129) and 12 months (n=71) after EVLT. RESULTS: EVLT was performed with an energy fluence of 22.5 J/cm², resulting in an occlusion rate of 98.4%. Duplex recurrence rates were 9.4% at 3-month and 15.5% at 12-month follow-up. VAFI significantly improved from 1.395 to 1.242 and 1.167 (p<.001) 3 and 12 months after EVLT. Venous refilling time (DPPG) accordingly increased from 20.0 to 36.9 seconds (p<.001) 3 months postoperatively. CONCLUSION: EVLT improves hemodynamic alterations in people with incompetent GSVs as demonstrated using VAFI and DPPG. VAFI might be a suitable diagnostic tool to quantify venous hemodynamics in people with varicose veins. The authors have indicated no significant interest with commercial supporters.