Publications by authors named "Pietro Sollena"

17 Publications

  • Page 1 of 1

"Skin rashes" and immunotherapy in melanoma: distinct dermatologic adverse events and implications for therapeutic management.

Hum Vaccin Immunother 2021 Mar 24:1-8. Epub 2021 Mar 24.

Dermatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Immune checkpoint inhibitors have shown efficacy in the treatment of different cancers by stimulating the antitumoral activity of the patient's immune system, representing a major breakthrough in the field of cancer therapy. Monoclonal antibodies including anti-cytotoxic T-lymphocyte-associated protein 4, anti-programmed cell death protein 1 and its ligand inhibitors have been approved for advanced melanoma among other solid cancers. Although immunotherapy demonstrated a good safety profile, a new spectrum of multisystemic immune-related adverse events has been recently reported due to their use. Cutaneous reactions represent one of the leading adverse events, often reported in literature as "skin rash", and rarely further characterized in distinct dermatologic entities. Herein we describe the distinctive cutaneous rashes occurring during immunotherapies for advanced melanoma, discussing implications in the treatment management.
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http://dx.doi.org/10.1080/21645515.2021.1889449DOI Listing
March 2021

The Effects of Association of Topical Polydatin Improves the Preemptive Systemic Treatment on EGFR Inhibitors Cutaneous Adverse Reactions.

J Clin Med 2021 Jan 26;10(3). Epub 2021 Jan 26.

Dermatology Unit, Department of Systems Medicine, Tor Vergata University Hospital Foundation, 00133 Rome, Italy.

Epidermal Growth Factor Receptor inhibitors (EGFRi) are approved as therapeutic options in several solid tumors. Cutaneous papulopustular eruption is the most frequent cutaneous adverse-event (AE), usually treated with emollient or corticosteroids according to toxicity grade. Our study evaluated the efficacy and safety of a topical product containing polydatin, a glycosylated polyphenol, natural precursor of resveratrol showing anti-inflammatory and anti-oxidative activities, for the prevention and treatment of skin papulopustular rash in EGFRi-treated patients. Forty oncologic patients treated with EGFRi were enrolled in two groups: group-A, 20 patients with papulopustular AE, and group-B, 20 patients without cutaneous manifestations. The study consisted of twice-daily application of polydatin cream 1.5% (group-A) and 0.8% (group-B) for 6 months. In group-A patients, we observed at week 4 a remarkable improvement of skin manifestation and quality of life evaluated with National-Cancer-Institute-Common-Terminology-Criteria for Adverse-Events (NCI-CTCAE), Dermatology-Life-Quality-Index (DLQI) score and Visual-Analogue-Scale (VAS) pruritus, with a statistical significance of < 0.05. None of the patients of group-B developed skin AEs to EGFRi. No cutaneous AEs related to the polydatin product were reported in both groups. Polydatin can be a good topical aid for the prevention and management of papulopustular rash in cancer patients receiving EGFRi, also capable of improving cancer patients' quality of life.
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http://dx.doi.org/10.3390/jcm10030466DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7866016PMC
January 2021

Black Kids Matter initiative calls for greater inclusion of Black children in clinical trials.

Acta Paediatr 2021 06 11;110(6):1961-1962. Epub 2021 Jan 11.

Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

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http://dx.doi.org/10.1111/apa.15741DOI Listing
June 2021

Immune checkpoint-mediated psoriasis: A multicenter European study of 115 patients from the European Network for Cutaneous Adverse Event to Oncologic Drugs (ENCADO) group.

J Am Acad Dermatol 2021 May 3;84(5):1310-1320. Epub 2020 Dec 3.

Second Dermatology Department, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Background: Immune checkpoint inhibitor (ICI)-mediated psoriasis poses significant diagnostic and therapeutic challenges.

Objective: To report data on ICI-mediated psoriasis, emerging from the largest cohort to date, to our knowledge, and to propose a step-by-step management algorithm.

Methods: The medical records of all patients with ICI-mediated psoriasis were retrospectively reviewed across 9 institutions.

Results: We included a cohort of 115 individuals. Grade 1, 2, and 3 disease severity was reported in 60 of 105 (57.1%, 10 missing data), 34 of 105 (32.4%), and 11 of 105 (10.5%), respectively. The ratio between exacerbation and de novo cases was 1:4.3. The most common systemic therapy was acitretin (23 patients, 20.1%), followed by systemic steroids (8 patients, 7%), apremilast (7 patients, 6.1%), methotrexate (5 patients, 4.3%) and biologics (4 patients, 3.6%). Overall, 29 of 112 patients (25.9%) interrupted and 20 of 111 (18%) permanently discontinued ICIs because of psoriasis. Body surface area of greater than 10% at baseline had a 3.6 increased risk for ICI treatment modification (odds ratio, 3.64; 95% confidence interval, 1.27-10.45; P = .03) and a 6.4 increased risk for permanent discontinuation (odds ratio, 6.41; 95% confidence interval, 2.40-17.11; P < .001). Guttate psoriasis and grade 2 or 3 disease were significant positive predictors for antitumor response of ICI, whereas pruritus was a negative predictor.

Limitations: Retrospective design.

Conclusion: Acitretin, apremilast, and methotrexate are safe and effective modalities for ICI-mediated psoriasis. In most cases, ICI can be completed unhindered. A therapeutic algorithm is proposed.
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http://dx.doi.org/10.1016/j.jaad.2020.08.137DOI Listing
May 2021

COVID-19 hygiene measures: hand eczema and insights into ACE2 and integrins as key molecules for SARS-CoV-2 cutaneous transmission.

Int J Dermatol 2020 Nov 24;59(11):1409-1410. Epub 2020 Sep 24.

Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

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http://dx.doi.org/10.1111/ijd.15208DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537260PMC
November 2020

Vitiligo-like lesions in patients with advanced breast cancer treated with cycline-dependent kinases 4 and 6 inhibitors.

Breast Cancer Res Treat 2021 Jan 10;185(1):247-253. Epub 2020 Sep 10.

UOC Dermatologia, Fondazione Policlinico Universitario A. Gemelli-IRCCS, L.go Agostino Gemelli 8, 00168, Rome, Italy.

Purpose: Introduction of cyclin-dependent inhibitors was a milestone in therapeutics for patients with estrogen receptor+/HER2- metastatic breast cancer. Despite the wide use of such agents and remarkable improvement of survival rates, drug-related adverse events are not yet fully characterized. We describe vitiligo-like lesions as a new adverse event occurring in patients with advanced breast cancer treated with cyclin-dependent inhibitors.

Methods: We performed an international retrospective study including patients with advanced breast cancer who developed vitiligo-like lesions during treatment with cyclin-dependent kinases 4 and 6 inhibitors, in the period January 2018-December 2019. Patients > 18 years, both males and females, were recruited at six Dermatology Departments located in Italy (3), France (1) and Greece (2). We evaluated epidemiological and clinical characteristics, impact on quality of life and outcome of vitiligo-like lesions in patients treated with cyclin-dependent 4 and 6 inhibitors. The percentage of skin involved by vitiligo-like lesions was assessed using the Body Surface Area (BSA) score. Changes in patients' quality of life were investigated through the evaluation of the Dermatology Life Quality Index (DLQI) questionnaire.

Results: Sixteen women (median age: 62.5 years; range 40-79 years) treated with cyclin-dependent kinases 4 and 6 inhibitors for advanced breast cancer presented with vitiligo-like lesions during follow-up visits. Cutaneous lesions consisted of white, irregular macules and patches located mainly on sun-exposed areas in 11/16 patients or diffuse to the entire body surface in 5/16. Cutaneous lesions clearly impaired the quality of life of patients tested (DLQI ≥ 10).

Conclusions: We present for the first time, to our knowledge, a case series of vitiligo-like lesions developing in patients with advanced breast cancer treated with cyclin-dependent kinases 4 and 6 inhibitors. We showed that such lesions further impair the patients' quality of life and their treatment is challenging.
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http://dx.doi.org/10.1007/s10549-020-05914-wDOI Listing
January 2021

Italian expert consensus paper on the management of patients with actinic keratoses.

Dermatol Ther 2020 11 27;33(6):e13992. Epub 2020 Jul 27.

Dermatology Unit, University of Campania "L. Vanvitelli", Naples, Italy.

Two round tables involving experts were organized in order to reach a consensus on the management of patients with actinic keratosis (AK). In the first, seven clinical questions were selected and analyzed by a systematic literature review, using a Population, Intervention, Control, and Outcomes framework; in the second, the experts discussed relevant evidences and a consensus statement for each question was developed. Consensus was reached among experts on how to best treat AK patients with respect to different clinical scenarios and special populations. Lesion-directed treatments are preferred in patients with few AKs. Patients with multiple AKs are challenging, with more than one treatment usually needed to achieve complete lesion clearance or a high lesion response rate, therapy should be personalized, based on previous treatments, patient, and lesion characteristics. Methyl aminolevulinate-PDT, DL (day light) PDT, and imiquimod cream were demonstrated to have the lowest percentage of new AKs after post treatment follow-up. For IMQ 5% and 3.75%, a higher intensity of skin reactions is associated with higher efficacy. Photodynamic therapy (PDT) is the most studied treatment for AKs on the arms. Regular sunscreen use helps preventing new AKs. Oral nicotinamide 500 mg twice daily, systemic retinoids and regular sunscreen use were demonstrated to reduce the number of new squamous cell carcinomas in patients with AKs. Limited evidence is available for the treatment of AKs in organ transplant recipients. There is no evidence in favor or against the use of any of the available treatments in patients suffering from hematological cancer.
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http://dx.doi.org/10.1111/dth.13992DOI Listing
November 2020

Dermatologic surgery in the COVID-19 era: Observations and practical suggestions.

Dermatol Ther 2020 Nov 12;33(6):e13873. Epub 2020 Jul 12.

Department of Dermatology, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.

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http://dx.doi.org/10.1111/dth.13873DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323092PMC
November 2020

Social consequences of COVID-19 in a low resource setting in Sierra Leone, West Africa.

Int J Infect Dis 2020 Aug 1;97:23-26. Epub 2020 Jun 1.

Institute of Neurology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Economical and psychological consequences of the lockdown in low-resource setting in rural Africa are unknown. We drafted a survey in order to address the social impact of COVID-19 lockdown on a rural village in Sierra Leone. The survey developed by the study group and translated in the local language, distributed to the householders of the village on April 13th and responses collected on April 14th, when Sierra Leone was on day 11 of lockdown. The questions aimed to assess in the community the following items: age group, main activities before lockdown, change in income and ability to feed the family during lockdown, anxiety during lockdown. 78 householders (100% of Bureh Town) replied. All, expect one, declared a 51-80% (19.2%) to 81-100% (79.4%) reduction of weekly income compared with the pre-lockdown period, declaring difficulties in providing food for the family members (82%), and anxiety (60%). Our analyses showed that people lost their jobs and have difficulties in providing food for their families. Highlights: Our analyses in a low resource setting in rural Africa in Sierra Leone, West Africa, showed that people lost their jobs and have difficulties in providing food for their families, as a consequence of COVID-19 lockdown.
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http://dx.doi.org/10.1016/j.ijid.2020.05.104DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263219PMC
August 2020

Efficacy of topical beta-blockers in the management of EGFR-inhibitor induced paronychia and pyogenic granuloma-like lesions: case series and review of the literature.

Drugs Context 2019 6;8:212613. Epub 2019 Nov 6.

Istituto di Dermatologia, Università Cattolica del Sacro Cuore, Rome, Italy.

Nail toxicities, such as paronychia and pyogenic granuloma-like lesions, are well-recognized side effects of epidermal growth factor receptor inhibitor (EGFR-I) therapy that can significantly impair patient's quality of life and compliance to anticancer treatment. Numerous therapeutic options are available, with variable rates of success. Recently, topical β-blockers have emerged as a novel, non-invasive treatment strategy. We tested the effectiveness of topical timolol 0.5% gel, twice daily, under occlusion for 30 days, on paronychia and periungual pyogenic granuloma-like lesions in 9 patients being treated with EGFR-I. We also reviewed the available literature on this topic, which is the use of topical β-blockers in the management of EGFR-I-induced nail toxicities. We assessed 25 lesions consistent with the diagnosis of EGFR-I-induced pyogenic granuloma-like lesions and paronychia (21 diagnosed as pyogenic granuloma-like, and four as paronychia). Thirteen of the 25 lesions achieved complete resolution, 9/25 reached at least improvement, and only 3/25 did not respond to the intervention. As for the review, four papers met the scope of our research. The results confirmed at least partial benefit in the majority of treated patients. Among current strategies, high-potency topical corticosteroids are a well-known treatment option especially for paronychia, targeting the inflammatory component of such lesions; nevertheless, the management of pyogenic granuloma-like lesion is often more complex and the success rate is variable. Nail plate avulsion and phenol chemical matricectomy are not highly effective and display some degree of invasiveness. Topical β-blockers seem to be promising alternatives, especially in fragile cancer patients who may be unsuitable candidates for an invasive procedure.
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http://dx.doi.org/10.7573/dic.212613DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6860413PMC
November 2019

Efficacy and safety of Vismodegib treatment in patients with advanced basal cell carcinoma and multiple comorbidities.

Dermatol Ther 2019 11 30;32(6):e13108. Epub 2019 Oct 30.

Institute of Dermatology, Catholic University-Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.

Basal cell carcinoma (BCC) is the most common malignancy in Caucasians, and its incidence is increasing. Most BCCs are treated surgically, nevertheless surgery is not an effective treatment for locally advanced or metastatic BCC. Alterations in hedgehog signaling pathway, a key regulator of cell growth and differentiation during development, are implicated in the pathogenesis of basal-cell carcinoma. Vismodegib is a small-molecule inhibitor of smoothened (SMO), a key component of the hedgehog (Hh) signaling pathway, administered in BCC patients, especially when surgery and radiotherapy treatments have failed. We report a series of eight elderly patients treated with vismodegib for advanced BCC and affected by concomitant multiple comorbidities. The efficacy and tolerability of vismodegib in patients with single and/or multiple comorbidities has been poorly studied. In our observation an overall high safety and tolerability has been observed over the course of treatment, with side effects of grade I and II and no changes in vital parameters, electrocardiography and echocardiogram. Vismodegib has been shown to be a safe and well tolerated treatment option for elderly patients affected by multiple comorbidities and advanced BCC.
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http://dx.doi.org/10.1111/dth.13108DOI Listing
November 2019

Cosmetic assessment in brachytherapy (interventional radiotherapy) for breast cancer: A multidisciplinary review.

Brachytherapy 2019 Sep - Oct;18(5):635-644. Epub 2019 Jun 3.

Interdisciplinary Brachytherapy Unit, UKSH CL, Lübeck, Germany.

Purpose: This review was to focus on breast brachytherapy cosmetic assessment methods state of the art and to define the advantages and disadvantages related to.

Methods And Materials: We conducted a literature review of the major experience on breast brachytherapy cosmetic assessment methods in several databases (PubMed, Scopus, and Google Scholar databases). To identify the relevant works, a task force screened citations at title and abstract level to identify potentially relevant paper. An expert board reviewed and approved the text. The assessment systems were classified into three main groups: (1) the Oncological Toxicity Scales, (2) the Independent Patients Perspective Measures, (3) the Patient-Related Outcome Measures. Each cosmetic assessment method was evaluated following six parameters: (1) anatomical site, (2) advantages, (3) disadvantages, (4) subjective/objective, (5) quantitative/qualitative, (6) computers or pictures needs.

Results: Eleven assessment methods were selected. Three methods were classified as Oncological Toxicity Scale, six in the Independent Patients Perspective Measures classification, and two as Patient-Related Outcome Measures. Six methods are subjective, while eight are objective. Four systems are classified as quantitative, four as qualitative while three both. Five systems need informatics support. Moreover, each method was discussed individually reporting the main characteristics and peculiarities.

Conclusions: Cosmesis is one major end point for the patient who has a malignancy of low lethal potential. In modern personalized medicine, there is a need for standardized cosmetic outcome assessments to analyze and compare the results of treatments. No gold standard methods currently exist. The result of this review is to summarize the various cosmesis methods, defining the strengths and weaknesses of each one and giving a line in research and clinical practice.
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http://dx.doi.org/10.1016/j.brachy.2019.03.009DOI Listing
February 2020

Cutaneous squamous cell carcinoma. Italian Guidelines by SIDeMaST adapted to and updating EADO/EDF/EORTC guidelines.

G Ital Dermatol Venereol 2018 Dec 11;153(6):747-762. Epub 2018 Jun 11.

Department of Dermatology, Spedali Civili di Brescia, University of Brescia, Brescia, Italy.

Cutaneous squamous cell carcinoma (cSCC) is the second most common skin cancer, accounting for 20% of all cutaneous malignancies, and has an increasing incidence in the elderly as well as in the younger population. Although most cSCC is treated with simple therapeutic procedures, advanced cSCC can lead a significant risk for morbidity, negative impact on quality of life, and death. Proper management includes distinguishing between high-risk and low-risk lesions and determining treatment accordingly. A collaboration of multidisciplinary Italian experts has given birth to these recommendations on cSCC diagnosis and management, based on a critical review of the literature, existing European (EADO-EDF-EORTC) guidelines and the expert's experience. Topics covered include diagnostic path and histopathologic assessment, tumor staging, surgical and nonsurgical procedures, follow-up and management of localized and advanced disease.
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http://dx.doi.org/10.23736/S0392-0488.18.06093-5DOI Listing
December 2018

Skin Cancer Epidemics in the Elderly as An Emerging Issue in Geriatric Oncology.

Aging Dis 2017 Oct 1;8(5):643-661. Epub 2017 Oct 1.

1Institute of Dermatology, Policlinico A. Gemelli University Hospital, Catholic University of the Sacred Heart, Rome, Italy.

Skin cancer is a worldwide, emerging clinical need in the elderly white population, with a steady increase in incidence rates, morbidity and related medical costs. Skin cancer is a heterogeneous group of cancers comprising cutaneous melanoma and non-melanoma skin cancers (NMSC), which predominantly affect elderly patients, aged older than 65 years. Melanoma has distinct clinical presentations in the elderly patient and represents a challenging question in terms of clinical management. NMSC includes the basal cell carcinoma and cutaneous squamous cell carcinoma and presents a wide disease spectrum in the elderly population, ranging from low-risk to high-risk tumours, advanced and inoperable disease. Treatment decisions for NMSC are preferentially based on tumour characteristics, patient's chronological age and physician's preferences and operational settings. Several treatment options are available for NMSC, from surgery to non-invasive/medical therapies, but patient-based factors, such as geriatric comorbidities and patient's life expectancy, do not frequently modulate treatment goals. In melanoma, age-related variations in clinical management are significant and may frequently lead to under-treatment, limiting access to advanced surgical and medical treatments. Clinical decision-making in the care of elderly skin cancer patient should ideally implement a geriatric assessment, prioritizing patient-based factors and efficiently differentiating fit from frail cancer patients. Current clinical practice guidelines for NMSC and melanoma only partially address geriatric aspects of cancer care, such as frailty, limited life-expectancy, geriatric comorbidities and treatment compliance. We review the recent evidence on the scope and problem of skin cancer in the elderly population as well as age-related variations in its clinical management, highlighting the potential role of a geriatric approach in optimizing dermato-oncological care.
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http://dx.doi.org/10.14336/AD.2017.0503DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5614327PMC
October 2017

Lichen sclerosus of the glans simulating melanoma.

J Am Acad Dermatol 2017 Feb;76(2S1):S49-S51

Institute of Dermatology, Catholic University, Rome, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.jaad.2016.07.015DOI Listing
February 2017

Clinical predictors of nonresponse to anti-TNF-α agents in psoriatic patients: A retrospective study.

Dermatol Ther 2016 Sep 5;29(5):372-376. Epub 2016 May 5.

Dermatology Department, Catholic University of the Sacred Heart, Rome, Italy.

Although the heterogeneity of the therapeutic response to TNF-α blockers seems to be mainly due to genetic factors, several studies showed that a range of factors may influence it. The aim of our study was to investigate the impact of patients' demographic and clinical characteristics on primary response to an anti-TNF-α therapy in psoriatic patients. We retrospectively examined the relationship between various clinical and demographic features and response to treatment with etanercept, adalimumab, and infliximab, evaluated as PASI75 and average PASI improvement at weeks 12, 16, and 14, respectively. We analyzed data obtained from 199 patients. A better response to the treatment was significantly associated with male gender (OR = 2.59), coexistence of psoriatic arthritis (OR = 1.97), and PASI ≤15 at baseline (OR = 0.91). The present study supports that some clinical factors may be potential predictors of response to anti-TNF-α agents in psoriatic patients.
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http://dx.doi.org/10.1111/dth.12364DOI Listing
September 2016

Human leukocyte antigen-B*58:01 allele in a familial case of Stevens-Johnson syndrome induced by allopurinol.

J Dermatol 2015 Jul 20;42(7):753-4. Epub 2015 Apr 20.

Department of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.

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http://dx.doi.org/10.1111/1346-8138.12894DOI Listing
July 2015
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