Observational study of a series of basal cell carcinomas: Evaluation of location as a risk factor for recurrence.

Basal cell carcinoma (BCC) is locally aggressive and its prognosis depends on the risk of recurrence. The initial location of the tumor is a key criterion for calculating the risk of recurrence. The aim of this study was to evaluate the sites that appear to be most at risk of recurrence of BCC. All cases of BCC analyzed at the anatomopathology laboratory of the University Hospital of Montpellier for 1 year were retrospectively included. In case of recurrence on the same site, only carcinomas that had previously been completely removed were analyzed. Among 803 BCC, 37 (4.6%) were confirmed as recurrent, including 34 (92%) on the head. The locations statistically at higher risk of recurrence were the temporal and frontal/temporal areas (32.4%), the medial canthus and lower eyelid area (18.9%), the ala and tip of the nose (16.2%), and the ears (8.1%). The frontal/temporal regions appear to be an area of major interest in this series. A high risk of recurrence was confirmed in the periorificial locations for the ear, the nose, and periorbital area, but not for the perioral area. In addition, the entire nose did not appear to be at risk, only the tip and the ala.

International multicentre observational study to assess the efficacy and safety of a 0·5 mg kg-1 per day starting dose of oral corticosteroids to treat bullous pemphigoid.

BACKGROUND: European guidelines propose a 0·5 mg kg-1 per day dose of oral prednisone as initial treatment for bullous pemphigoid (BP). We assessed the safety and efficacy of this regimen depending on BP extent and general condition of the patients. METHODS: In a prospective international study, we consecutively included all patients diagnosed with BP. Patients received a 0·5 mg kg-1 per day dose of prednisone, which was then gradually tapered 15 days after disease control, with the aim of stopping prednisone or maintaining minimal treatment (0·1 mg kg-1 per day) within 6 months after the start of treatment. The two coprimary endpoints were control of disease activity at day 21 and 1-year overall survival. Disease severity was assessed according to the Bullous Pemphigoid Disease Area Index (BPDAI) score. RESULTS: In total, 198 patients were included between 2015 and 2017. The final analysis comprised 190 patients with a mean age of 80·9 (SD 9·1) years. Control of disease activity was achieved at day 21 in 119 patients [62·6%, 95% confidence interval (CI) 55·3-69.5]; 18 of 24 patients (75%, 95% CI 53·3-90·2), 75 of 110 patients (68·8%, 95% CI 59·2-77·3) and 26 of 56 patients (46.4%, 95% CI 33·0-60·3) had mild, moderate and severe BP, respectively (P = 0·0218). A total of 30 patients died during the study. The overall Kaplan-Meier 1-year survival was 82·6% (95% CI 76·3-87·4) corresponding to 90·9%, 83·0% and 80·0% rates in patients with mild, moderate and severe BP, respectively (P = 0·5). Thresholds of 49 points for BPDAI score and 70 points for Karnofsky score yielded maximal Youden index values with respect to disease control at day 21 and 1-year survival, respectively. CONCLUSIONS: A 0·5 mg kg-1 per day dose of prednisone is a valuable therapeutic option in patients with mild or moderate BP whose general condition allows them to be autonomous.

[An original reconstruction technique for double upper white lip defect]. / Une technique originale de réparation d'une double perte de substance de l'hémilèvre supérieure blanche.

INTRODUCTION: Herein we report a case of a surgical repair of double substance loss along the nasolabial groove by means of a double superior advancement flap from the cheek to the upper lip that we have here called the "double jigsaw puzzle" flap. OBSERVATION: A 58-year-old man underwent surgery for 2 basal cell carcinomas located in the right white upper lip. The two lesions were first removed and the two defects were then carried over to the cheek symmetrically along the nasolabial groove. Two triangular "lugs" were excised on both sides to allow horizontal advancement of the cheek to the upper lip to fill the 2 gaps from the upper lip excisions like 2 pieces of a puzzle. The nasolabial groove was then recreated by deep anchoring stitches, with suturing comprising superficial stitches. DISCUSSION: This surgical flap can be created quickly and easily and yields good aesthetic results in the immediate postoperative period and in the longer term, and the scar is totally masked within the nasolabial fold. The only limitation to a good aesthetic outcome is the presence of a small area of hairless skin within what constitutes an area of hair growth in male subjects.

Daylight photodynamic therapy with methyl aminolevulinate cream is as effective as conventional photodynamic therapy with blue light in the treatment of actinic keratosis: a controlled randomized intra-individual study.

BACKGROUND: We know the efficacy of daylight phototherapy dynamic (DL-PDT) in the treatment of actinic keratosis (AK). But the almost studies have compared daylight with red light using methyl aminolevulinate cream and not with blue light. PDT with blue light is another conventional PDT that is effective in the treatment of AKs. OBJECTIVES: The aim of this study is to assess the efficacy and the safety of DL-PDT vs. PDT in blue light in the treatment of AKs. METHODS: This randomized, controlled, intra-individual efficacy and safety study enrolled 26 subjects. AKs on the face/scalp were treated once, with DL-PDT on one side and c-PDT on the contralateral side. Primary endpoints for DL-PDT at week 12 were efficacy with clearance of AKs and safety with assessment of pain. Lesions with complete response 12 weeks after one treatment session were followed until week 24. RESULTS: More than 1000 AK were studied. At week 12, the raw number of disappeared AK lesions at 3-month follow-up was 19.6 (±6.0) for DL-PDT and 20.0 (±6.9) for c-PDT with P = 0.8460 (90.5% vs. 94.2% of AK disappearance, respectively). The response was maintained at 6 months (90.0% and 94.6% of AK reduction, respectively). DL-PDT was nearly painless than c-PDT with light blue: 1.2 vs. 5.1, respectively (P < 0.0001). CONCLUSIONS: Daylight-PDT seems as effective as c-PDT with light blue and DL-PDT is less painful. The response of DL-PDT was sustainable until 6 months.

Rituximab is an effective treatment in patients with pemphigus vulgaris and demonstrates a steroid-sparing effect.

BACKGROUND: Corticosteroids (CS) with or without adjuvant immunosuppressant agents are standard treatment for pemphigus vulgaris (PV). The efficacy of adjuvant therapies in minimizing steroid-related adverse events (AEs) is unproven. OBJECTIVES: To utilize data collected in a French investigator-initiated, phase III, open-label, randomized controlled trial to demonstrate the efficacy and safety of rituximab and seek approval for its use in PV. METHODS: This was an independently conducted post hoc analysis of the moderate-to-severe PV subset enrolled in the Ritux 3 study. Patients were randomized to rituximab plus 0·5 or 1·0 mg kg-1 per day prednisone tapered over 3 or 6 months, or 1·0 or 1·5 mg kg-1 per day prednisone alone tapered over 12 or 18 months, respectively (according to disease severity). The primary end point was complete remission at month 24 without CS (CRoff) for ≥ 2 months, and 24-month efficacy and safety results were also reported. RESULTS: At month 24, 34 of 38 patients (90%) on rituximab plus prednisone achieved CRoff ≥ 2 months vs. 10 of 36 patients (28%) on prednisone alone. Median total cumulative prednisone dose was 5800 mg in the rituximab plus prednisone arm vs. 20 520 mg for prednisone alone. Eight of 36 patients (22%) who received prednisone alone withdrew from treatment owing to AEs; one rituximab-plus-prednisone patient withdrew due to pregnancy. Overall, 24 of 36 patients (67%) on prednisone alone experienced a grade 3/4 CS-related AE vs. 13 of 38 patients (34%) on rituximab plus prednisone. CONCLUSIONS: In patients with moderate-to-severe PV, rituximab plus short-term prednisone was more effective than prednisone alone. Patients treated with rituximab had less CS exposure and were less likely to experience severe or life-threatening CS-related AEs. What's already known about this topic? Pemphigus vulgaris (PV) is the most common type of pemphigus. Corticosteroids, a standard first-line treatment for PV, have significant side-effects. Although their effects are unproven, adjuvant corticosteroid-sparing agents are routinely used to minimize steroid exposure and corticosteroid-related side-effects. There is evidence that the anti-CD20 antibody rituximab is effective in the treatment of patients with severe recalcitrant pemphigus and in patients with newly diagnosed pemphigus. What does this study add? This study provides a more detailed analysis of patients with PV enrolled in an investigator-initiated trial. Rituximab plus prednisone had a steroid-sparing effect and more patients achieved complete remission off prednisone. Fewer patients experienced grade 3 or grade 4 steroid-related adverse events than those on prednisone alone. This collaboration between academia and industry, utilizing independent post hoc analyses, led to regulatory authority approvals of rituximab in moderate-to-severe PV.

Real-world treatment patterns and clinical outcomes in advanced cutaneous melanoma patients in France.

BACKGROUND: Since 2011, the management of advanced melanoma has radically changed with the availability of new therapies (immunotherapy and BRAF-targeted therapy) and with BRAF testing. OBJECTIVES: Following the introduction of these new therapies, the objectives of this AMEL study were to describe treatment patterns and evaluate overall survival (OS) among unresectable stage III/IV melanoma patients, in a real-life setting in France. METHODS: The AMEL study is a multicentre retrospective record review study. Thirty-three physicians working in 33 unique treatment centres participated in the study. Two hundred and sixty-four patients diagnosed between 1 January 2012 and 31 October 2012 with unresectable stage III/IV melanoma were included in the study. RESULTS: 94.7% of the patients received a first-line antitumour drug treatment, 62.5% a second-line treatment while 26.9% received a third-line treatment with no significant differences between patients with a BRAF mutation (50.4%) and BRAF wild type (47.0%). First-line treatment differs according to the BRAF status: 74.8% of patients with a BRAF mutation received a BRAF inhibitor while 79.3% of the BRAF wild-type patients were treated with conventional chemotherapy. In second line and over, the treatment patterns were more heterogeneous, depending on the BRAF mutation, the treatment received previously, the speed of progression of the disease and the availability of immunotherapy at the time the treatment was initiated. CONCLUSION: Regardless of the BRAF mutation status, the median OS of patients was 16 months (95% CI = 14-18). Compared to a similar study conducted in 2007 (MELODY), a gain of 4 months is observed. The gain seems to be higher for patients with a BRAF mutation (18 months) than for those without a BRAF mutation (14 months). The OS of patients who sequentially received both a BRAF inhibitor and ipilimumab (28 months) highlights the benefit of this treatment sequence.

[Locoregional treatments of brain metastases for patients with metastatic cutaneous melanoma: French national guidelines]. / Traitements locorégionaux de métastase(s) cérébrale(s) chez des patients atteints d'un mélanome cutané métastatique : recommandations nationales françaises.

INTRODUCTION: The management of metastatic cutaneous melanoma is changing, marked by innovative therapies. However, their respective use and place in the therapeutic strategy continue to be debated by healthcare professionals. OBJECTIVE: The French national cancer institute has led a national clinical practice guideline project since 2008. It has carried out a review of these modalities of treatment and established recommendations. METHODS: The clinical practice guidelines development process is based on systematic literature review and critical appraisal by experts. The recommendations are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines are reviewed by independent practitioners in cancer care delivery. RESULTS: This article presents the results of bibliographic search, the conclusions of the literature and the recommendations concerning locoregional treatments of brain metastases for patients with metastatic cutaneous melanoma.

[Management of patients with metastatic cutaneous melanoma: French national guidelines. French National Cancer Institute]. / Prise en charge thérapeutique des patients atteints d'un mélanome cutané métastatique : recommandations nationales françaises. L'Institut national du cancer.

BACKGROUND: Recent years have seen the emergence of new molecules for the treatment of patients with metastatic cutaneous melanoma, with significant benefits in terms of survival and the opening of new therapeutic perspectives. In addition, many techniques are currently being developed for locoregional treatment of metastatic sites. Management of metastatic melanoma is thus fast-changing and is marked by innovative therapeutic approaches. However, the availability of these new treatments has prompted debate among healthcare professionals concerning their use and their place in therapeutic strategy. AIMS: Since 2008, the French National Cancer Institute (INCa) has been leading a project to define and diffuse national clinical practice guidelines. It has performed a review of these treatment methods, which it aims to circulate, and it is seeking to develop recommendations in order to allow nationwide implementation of innovative approaches while promoting good use thereof. METHODS: The clinical practice guidelines development process is based on systematic literature review and critical appraisal by experts within a multidisciplinary working group, with feedback from specialists in cancer care delivery. The recommendations are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines are reviewed by independent practitioners in cancer care delivery. RESULTS: This article presents the national recommendations for first- and second-line systemic treatment and for locoregional treatment of metastatic sites in patients presenting metastatic cutaneous melanoma.

Treatment patterns and outcomes among patients diagnosed with unresectable stage III or IV melanoma in Europe: a retrospective, longitudinal survey (MELODY study).

BACKGROUND: MELanoma treatment patterns and Outcomes among patients with unresectable stage III or stage IV Disease: a retrospective longitudinal surveY (MELODY), the first multicountry, observational survey in patients with advanced melanoma, aimed to quantify the impact of existing treatment strategies by capturing information on treatment patterns and clinical outcomes. PATIENTS AND METHODS: Patients attending a participating site between 1st July 2005 and 30th June 2006 with ≥2 months follow-up were eligible. Data were retrieved retrospectively from advanced melanoma diagnosis until 1st May 2008. Treatment data were collected by line of therapy and response and progression-free survival data by line of systemic treatment. Overall survival (OS) was evaluated for all treated patients. RESULTS: Among all patients screened, 776 were eligible for this analysis. Median OS from the date of advanced disease diagnosis was 16.4 months. After excluding patients diagnosed prior to 1st July 2005 to account for any bias resulting from patient selection, the 12-month survival rate and median OS from the start date of second-line treatment was 28.8% and 6.8 months, respectively. Survival was lower in patients with brain metastases, elevated lactate dehydrogenase levels and more advanced disease. Rates of complete/partial tumour response were 15% and 7% in patients treated with first- and second-line systemic therapy, respectively. CONCLUSIONS: Despite receiving first- and second-line treatment, most patients with advanced melanoma have short survival times and poor prognoses, reinforcing the need for new treatments.

[Hypertensive leg ulcers: epidemiological characteristics and prognostic factors for healing in a prospective cohort]. / Angiodermites nécrotiques : caractéristiques épidémiologiques et facteurs pronostiques de cicatrisation dans une cohorte prospective.

BACKGROUND: The data concerning changes in the characteristics of hypertensive leg ulcers (HLU) were taken from open studies in a small patient cohort. The aim of this study was to describe the epidemiological characteristics and to identify prognostic factors for healing in a prospective cohort of 59 patients presenting HLU. PATIENTS AND METHODS: The cohort comprised patients included in a randomized, double-blind, controlled study published elsewhere; the patients were receiving becaplermin gel (Regranex(®)) or Duoderm Hydrogel™ once daily for eight weeks for the most recent wound. Total follow-up was 12 weeks. RESULTS: The epidemiological analysis was performed for 59 consecutive patients randomized in 17 dermatology departments. Mean patient age was 74.5 ± 9 years and 61% were female. Mean wound duration was 11.1 ± 9 weeks and median wound area was 16 cm(2) (q1; q3: 8; 25.5). Among, 94.9% of patients had hypertension and 39.7% were diabetic. A homolateral peripheral pulse was present in 91.5% of patients. At the end of follow-up, complete wound healing was obtained in 30.5% of the patients. In univariate analysis, neither the foregoing criteria nor the treatment group were significantly associated with healing during the study. CONCLUSION: This study confirms female predominance, old age, prevalence of diabetes and delay in the diagnosis of HLU. The prognosis for healing does not appear to be dependent on wound duration, wound area or the presence of moderate peripheral arterial disease, doubtless because this condition progresses by episodes of flare-up and under specific conditions.

Economic impact of healthcare resource utilisation patterns among patients diagnosed with advanced melanoma in the United Kingdom, Italy, and France: results from a retrospective, longitudinal survey (MELODY study).

OBJECTIVE: To describe patterns of healthcare resource utilisation and associated costs for patients with advanced melanoma in the United Kingdom (UK), Italy, and France. METHODS: For patients receiving systemic treatment, or supportive care, data describing hospitalisations, hospice care, and outpatient visits were retrieved retrospectively from advanced disease diagnosis as part of a multicountry observational study. Costs were estimated by multiplying utilisation level by unit cost. In an exploratory analysis, costs were compared between individuals who died within one year of initiating first-line treatment (short-term survivors) and those with ≥ 1 year follow-up (long-term survivors). RESULTS: Hospitalisation costs were highest in France (€6262 per-person compared with €3225 in the UK and €2486 in Italy), reflecting higher rates of hospitalisation. In contrast, outpatient costs were highest in the UK (€782 per-person, compared with €115 in France and €72 in Italy), reflecting the highest rate and frequency of outpatient visits and the highest cost per visit. Hospitalisation rates were consistently higher during supportive care compared with systemic therapy. Roughly one-third of patients entered clinical trials and were not included in the analysis. In exploratory analysis, total costs were generally higher for long-term survivors, but monthly per-patient costs were generally lower for long-term survivors, consistent with a hypothesis that resource utilisation and costs do not necessarily increase proportionally with extended survival. CONCLUSION: Total costs associated with resource utilisation for advanced melanoma patients varied across countries. Overall cost differences were due to differences in frequency and intensity of utilisation patterns and variation in unit costs of health resources.