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3. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial

Author

Stratigos, Alexander J, Sekulic, Aleksandar, Peris, Ketty, Bechter, Oliver, Prey, Sorilla, Kaatz, Martin, Lewis, Karl D, Basset-Seguin, Nicole, Chang, Anne Lynn S, Dalle, Stèphane, Orland, Almudena Fernandez, Licitra, Lisa, Robert, Caroline, Ulrich, Claas, Hauschild, Axel, Migden, Michael R, Dummer, Reinhard, Li, Siyu, Yoo, Suk-Young, Mohan, Kosalai, Coates, Ebony, Jankovic, Vladimir, Fiaschi, Nathalie, Okoye, Emmanuel, Bassukas, Ioannis D, Loquai, Carmen, De Giorgi, Vincenzo, Eroglu, Zeynep, Gutzmer, Ralf, Ulrich, Jens, Puig, Susana, Seebach, Frank, Thurston, Gavin, Weinreich, David M, Yancopoulos, George D, Lowy, Israel, Bowler, Timothy, and Fury, Matthew G

Published
2021
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5. Phase 2 open-label, multicenter, single-arm study of cemiplimab in patients with locally advanced basal cell carcinoma after hedgehog inhibitor therapy: Extended follow-up.

Author

Stratigos, Alexander J., Sekulic, Aleksandar, Peris, Ketty, Bechter, Oliver, Prey, Sorilla, Lewis, Karl D., Basset-Seguin, Nicole, Chang, Anne Lynn S., Dalle, Stéphane, Fernández Orland, Almudena, Licitra, Lisa, Robert, Caroline, Ulrich, Claas, Hauschild, Axel, Migden, Michael R., Dummer, Reinhard, Yoo, Suk-Young, Okoye, Emmanuel, Bassukas, Ioannis, and Loquai, Carmen

Published
2024
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10. Occurrence of type 1 and type 2 diabetes in patients treated with immunotherapy (anti-PD-1 and/or anti-CTLA-4) for metastatic melanoma: a retrospective study

Author

Gauci, Marie-Léa, Boudou, Philippe, Baroudjian, Barouyr, Vidal-Trecan, Tiphaine, Da Meda, Laetitia, Madelaine-Chambrin, Isabelle, Basset-Seguin, Nicole, Bagot, Martine, Pages, Cécile, Mourah, Samia, Resche-Rigon, Matthieu, Pinel, Sylvine, Sassier, Marion, Rouby, Franck, Eftekhari, Pirayeh, Lebbé, Céleste, and Gautier, Jean-François

Published
2018
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11. Correction to: Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study

Author

Sekulic, Aleksandar, Migden, Michael R., Basset-Seguin, Nicole, Garbe, Claus, Gesierich, Anja, Lao, Christopher D., Miller, Chris, Mortier, Laurent, Murrell, Dedee F., Hamid, Omid, Quevedo, Jorge F., Hou, Jeannie, McKenna, Edward, Dimier, Natalie, Williams, Sarah, Schadendorf, Dirk, Hauschild, Axel, and for the ERIVANCE BCC Investigators

Published
2019
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12. European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment - Update 2022

Author

Garbe, Claus, Amaral, Teresa, Peris, Ketty, Hauschild, Axel, Arenberger, Petr, Basset-Seguin, Nicole, Bastholt, Lars, Bataille, Veronique, Del Marmol, Veronique, Dréno, Brigitte, Fargnoli, Maria C, Forsea, Ana-Maria, Grob, Jean-Jacques, Hoeller, Christoph, Kaufmann, Roland, Kelleners-Smeets, Nicole, Lallas, Aimilios, Lebbé, Celeste, Lytvynenko, Bodhan, Malvehy, Josep, Moreno-Ramirez, David, Nathan, Paul, Pellacani, Giovanni, Saiag, Philippe, Stratigos, Alexander J, Van Akkooi, Alexander C J, Vieira, Ricardo, Zalaudek, Iris, Lorigan, Paul, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO), and the European Organization for Research and Treatment of Cancer (EORTC), Garbe, Clau, Amaral, Teresa, Peris, Ketty, Hauschild, Axel, Arenberger, Petr, Basset-Seguin, Nicole, Bastholt, Lar, Bataille, Veronique, Del Marmol, Veronique, Dréno, Brigitte, Fargnoli, Maria C, Forsea, Ana-Maria, Grob, Jean-Jacque, Hoeller, Christoph, Kaufmann, Roland, Kelleners-Smeets, Nicole, Lallas, Aimilio, Lebbé, Celeste, Lytvynenko, Bodhan, Malvehy, Josep, Moreno-Ramirez, David, Nathan, Paul, Pellacani, Giovanni, Saiag, Philippe, Stratigos, Alexander J, Van Akkooi, Alexander C J, Vieira, Ricardo, Zalaudek, Iri, and Lorigan, Paul

Subjects
Proto-Oncogene Proteins B-raf, Cancer Research, Consensus, Skin Neoplasms, Consensu, Systemic treatment, Oxime, HIGH-RISK MELANOMA, Antineoplastic Combined Chemotherapy Protocols, Oximes, Humans, Excisional margins, Melanoma, SENTINEL-NODE BIOPSY, Tumor thickne, Neoplasm Staging, POSTOPERATIVE STEREOTACTIC RADIOSURGERY, LENTIGO MALIGNA MELANOMA, Antineoplastic Combined Chemotherapy Protocol, Manchester Cancer Research Centre, ResearchInstitutes_Networks_Beacons/mcrc, MOHS MICROGRAPHIC SURGERY, Metastasectomy, Sentinel lymph node dissection, Interferon-alpha, RANDOMIZED PHASE-III, Adjuvant treatment, Tumor thickness, Cutaneous melanoma, Interferon-α, Mutation, Systematic Reviews as Topic, SURGICAL EXCISION MARGINS, Oncology, PRIMARY CUTANEOUS MELANOMA, STAGE IV MELANOMA, Excisional margin, Settore MED/35 - MALATTIE CUTANEE E VENEREE, DABRAFENIB PLUS TRAMETINIB, Human
Abstract

A unique collaboration of multidisciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO), and the European Organization of Research and Treatment of Cancer (EORTC) was formed to make recommendations on cutaneous melanoma diagnosis and treatment, based on the systematic literature reviews and the experts' experience. Cutaneous melanomas are excised with one to 2-cm safety margins. Sentinel lymph node dissection shall be performed as a staging procedure in patients with tumor thickness ≥1.0mm or ≥0.8mm with additional histological risk factors, although there is as yet no clear survival benefit for this approach. Therapeutic decisions in stage III/IV patients should be primarily made by an interdisciplinary oncology team ("tumor board"). Adjuvant therapies can be proposed in stage III/completely resected stage IV patients and are primarily anti-PD-1, independent of mutational status, or alternatively dabrafenib plus trametinib for BRAF mutant patients. In distant metastases (stage IV), either resected or not, systemic treatment is always indicated. For first-line treatment particularly in BRAF wild-type patients, immunotherapy with PD-1 antibodies alone or in combination with CTLA-4 antibodies shall be considered. In stage IV melanoma with a BRAF-V600E/K mutation, first-line therapy with BRAF/MEK inhibitors can be offered as an alternative to immunotherapy. In patients with primary resistance to immunotherapy and harboring a BRAF-V600E/K mutation, this therapy shall be offered as second-line therapy. Systemic therapy in stage III/IV melanoma is a rapidly changing landscape, and it is likely that these recommendations may change in the near future.

Published
2022

13. European consensus-based interdisciplinary guideline for melanoma. Part 1: Diagnostics: Update 2022

Author

Garbe, Claus, Amaral, Teresa, Peris, Ketty, Hauschild, Axel, Arenberger, Petr, Basset-Seguin, Nicole, Bastholt, Lars, Bataille, Veronique, Del Marmol, Veronique, Dréno, Brigitte, Fargnoli, Maria C, Forsea, Ana-Maria, Grob, Jean-Jacques, Höller, Christoph, Kaufmann, Roland, Kelleners-Smeets, Nicole, Lallas, Aimilios, Lebbé, Celeste, Lytvynenko, Bohdan, Malvehy, Josep, Moreno-Ramirez, David, Nathan, Paul, Pellacani, Giovanni, Saiag, Philippe, Stratigos, Alexander J, Van Akkooi, Alexander C J, Vieira, Ricardo, Zalaudek, Iris, Lorigan, Paul, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO), and the European Organization for Research and Treatment of Cancer (EORTC), Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), University Hospital Schleswig-Holstein [Kiel, Germany], Charles University [Prague] (CU), Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Odense University Hospital (OUH), King‘s College London, Université libre de Bruxelles (ULB), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), University of L'Aquila [Italy] (UNIVAQ), University of Medicine and Pharmacy 'Carol Davila' Bucharest (UMPCD), Aix Marseille Université (AMU), Medizinische Universität Wien = Medical University of Vienna, Frankfurt University Hospital, Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], Aristotle University of Thessaloniki, Shupyk National Medical Academy of Postgraduate Education [Kiev] (SNMAPE), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Clinic Barcelona Hospital Universitari, Hospital Universitario Virgen Macarena [Séville], Mount Vernon Cancer Centre [Northwood, UK] (MV2C), Mount Vernon Cancer Centre, University - Hospital of Modena and Reggio Emilia [Modena, Italy], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), University of Athens Medical School [Athens], The University of Sydney, Centro Hospitalar e Universitário [Coimbra], Università degli studi di Trieste = University of Trieste, University of Manchester [Manchester], European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO), and the European Organization for Research and Treatment of Cancer (EORTC), Pecqueret, Valérie, Garbe, Clau, Amaral, Teresa, Peris, Ketty, Hauschild, Axel, Arenberger, Petr, Basset-Seguin, Nicole, Bastholt, Lar, Bataille, Veronique, Del Marmol, Veronique, Dréno, Brigitte, Fargnoli, Maria C, Forsea, Ana-Maria, Grob, Jean-Jacque, Höller, Christoph, Kaufmann, Roland, Kelleners-Smeets, Nicole, Lallas, Aimilio, Lebbé, Celeste, Lytvynenko, Bohdan, Malvehy, Josep, Moreno-Ramirez, David, Nathan, Paul, Pellacani, Giovanni, Saiag, Philippe, Stratigos, Alexander J, Van Akkooi, Alexander C J, Vieira, Ricardo, Zalaudek, Iri, and Lorigan, Paul

Subjects
Cancer Research, Sequential digital, Consensus, Skin Neoplasms, Follow-up examinations, [SDV]Life Sciences [q-bio], Consensu, Mutation testing, NEEDLE-ASPIRATION-CYTOLOGY, Primary diagnosis, MALIGNANT-MELANOMA, AJCC classification, Positron Emission Tomography Computed Tomography, Dermatoscopy, Humans, MELANOCYTIC NEVI, Follow-up examination, Imaging diagnostic, Melanoma, SENTINEL-NODE BIOPSY, ComputingMilieux_MISCELLANEOUS, Primary diagnosi, AMERICAN JOINT COMMITTEE, Neoplasm Staging, Manchester Cancer Research Centre, ResearchInstitutes_Networks_Beacons/mcrc, Confocal reflectance microscopy, Cutaneous melanoma, Imaging diagnostics, Sequential digital dermatoscopy, Total body photography, Neoplasm Recurrence, Local, [SDV] Life Sciences [q-bio], ACRAL LENTIGINOUS MELANOMA, Neoplasm Recurrence, Oncology, Local, TOTAL-BODY PHOTOGRAPHY, REFLECTANCE CONFOCAL MICROSCOPY, Settore MED/35 - MALATTIE CUTANEE E VENEREE, FOLLOW-UP, Human
Abstract

International audience; Cutaneous melanoma (CM) is potentially the most dangerous form of skin tumor and causes 90% of skin cancer mortality. A unique collaboration of multi-disciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC) was formed to make recommendations on CM diagnosis and treatment, based on systematic literature reviews and the experts' experience. The diagnosis of melanoma can be made clinically and shall always be confirmed with dermatoscopy. If a melanoma is suspected, a histopathological examination is always required. Sequential digital dermatoscopy and full body photography can be used in high-risk patients to improve the detection of early melanoma. Where available, confocal reflectance microscopy can also improve clinical diagnosis in special cases. Melanoma shall be classified according to the 8th version of the American Joint Committee on Cancer classification. Thin melanomas up to 0.8 mm tumor thickness do not require further imaging diagnostics. From stage IB onwards, examinations with lymph node sonography are recommended, but no further imaging examinations. From stage IIC onwards whole-body examinations with computed tomography (CT) or positron emission tomography CT (PET-CT) in combination with brain magnetic resonance imaging are recommended. From stage III and higher, mutation testing is recommended, particularly for BRAF V600 mutation. It is important to provide a structured follow-up to detect relapses and secondary primary melanomas as early as possible. There is no evidence to define the frequency and extent of examinations. A stage-based follow-up scheme is proposed which, according to the experience of the guideline group, covers the optimal requirements, but further studies may be considered. This guideline is valid until the end of 2024.

Published
2022

15. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial

Author

Basset-Seguin, Nicole, Hauschild, Axel, Grob, Jean-Jacques, Kunstfeld, Rainer, Dréno, Brigitte, Mortier, Laurent, Ascierto, Paolo A, Licitra, Lisa, Dutriaux, Caroline, Thomas, Luc, Jouary, Thomas, Meyer, Nicolas, Guillot, Bernard, Dummer, Reinhard, Fife, Kate, Ernst, D Scott, Williams, Sarah, Fittipaldo, Alberto, Xynos, Ioannis, and Hansson, Johan

Published
2015
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18. Defining and recognising locally advanced basal cell carcinoma

Author

Amici, Jean Michel, Battistella, Maxime, Beylot-Barry, Marie, Chatellier, Anne, Dalac-Ra, Sophie, Dreno, Brigitte, Falandry, Claire, Froget, Nicolas, Giacchero, Damien, Grob, Jean Jacques, Guerreschir, Pierre, Leccia, Marie-Thérèse, Malard, Olivier, Mortier, Laurent, Routier, Emilie, Stefan, Andreea, Stefan, Dinu, Stoebner, Pierre-Emmanuel, and Basset-Seguin, Nicole

Published
2015
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19. PARKIN Inactivation Links Parkinson’s Disease to Melanoma

Author

Hu, Hui-Han, Kannengiesser, Caroline, Lesage, Suzanne, André, Jocelyne, Mourah, Samia, Michel, Laurence, Descamps, Vincent, Basset-Seguin, Nicole, Bagot, Martine, Bensussan, Armand, Lebbé, Céleste, Deschamps, Lydia, Saiag, Philippe, Leccia, Marie-Thérèse, Bressac-de-Paillerets, Brigitte, Tsalamlal, Amel, Kumar, Rajiv, Klebe, Stephan, Grandchamp, Bernard, Andrieu-Abadie, Nathalie, Thomas, Luc, Brice, Alexis, Dumaz, Nicolas, and Soufir, Nadem

Published
2016
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25. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study

Author

Sekulic, Aleksandar, Migden, Michael R., Basset-Seguin, Nicole, Garbe, Claus, Gesierich, Anja, Lao, Christopher D., Miller, Chris, Mortier, Laurent, Murrell, Dedee F., Hamid, Omid, Quevedo, Jorge F., Hou, Jeannie, McKenna, Edward, Dimier, Natalie, Williams, Sarah, Schadendorf, Dirk, Hauschild, Axel, and for the ERIVANCE BCC Investigators

Published
2017
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27. Expert Recommendations on Facilitating Personalized Approaches to Long-term Management of Actinic Keratosis: The Personalizing Actinic Keratosis Treatment (PAKT) Project.

Author

MORTON, Colin, BAHARLOU, Samira, BASSET-SEGUIN, Nicole, CALZAVARA-PINTON, Piergiacomo, DIRSCHKA, Thomas, GILABERTE, Yolanda, HAEDERSDAL, Merete, HOFBAUER, Günther, SAPRA, Sheetal, WAALBOER-SPUIJ, Rick, YIP, Leona, and SZEIMIES, Rolf-Markus

Subjects
ACTINIC keratosis, PATIENT compliance, MEDICAL personnel, KERATOSIS
Abstract

Actinic keratoses are pre-malignant skin lesions that require personalized care, a lack of which may result in poor treatment adherence and suboptimal outcomes. Current guidance on personalizing care is limited, notably in terms of tailoring treatment to individual patient priorities and goals and supporting shared decisionmaking between healthcare professionals and patients. The aim of the Personalizing Actinic Keratosis Treatment panel, comprised of 12 dermatologists, was to identify current unmet needs in care and, using a modified Delphi approach, develop recommendations to support personalized, long-term management of actinic keratoses lesions. Panellists generated recommendations by voting on consensus statements. Voting was blinded and consensus was defined as ≥75% voting ’agree’ or ’strongly agree’. Statements that reached consensus were used to develop a clinical tool, of which, the goal was to improve understanding of disease chronicity, and the need for long-term, repeated treatment cycles. The tool highlights key decision stages across the patient journey and captures the panellist’s ratings of treatment options for attributes prioritized by patients. The expert recommendations and the clinical tool can be used to facilitate patient-centric management of actinic keratoses in daily practice, encompassing patient priorities and goals to set realistic treatment expectations and improve care outcomes. [ABSTRACT FROM AUTHOR]

Published
2023
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31. Genes involved in the WNT and vesicular trafficking pathways are associated with melanoma predisposition

Author

Ibarrola-Villava, Maider, Kumar, Rajiv, Nagore, Eduardo, Benfodda, Meriem, Guedj, Mickael, Gazal, Steven, Hu, Hui-Han, Guan, Jian, Rachkonda, Sivaramakishna P., Descamps, Vincent, Basset-Seguin, Nicole, Bensussan, Armand, Bagot, Martine, Saiag, Philippe, Schadendorf, Dirk, Martin-Gonzalez, Manuel, Mayor, Matias, Grandchamp, Bernard, Ribas, Gloria, and Soufir, Nadem

Published
2015
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34. Genetic variation at KIT locus may predispose to melanoma

Author

Bourillon, Agnes, Hu, Hui-Han, Hetet, Gilles, Lacapere, Jean-Jacques, André, Jocelyne, Descamps, Vincent, Basset-Seguin, Nicole, Ogbah, Zighereda, Puig, Susana, Saiag, Philippe, Bagot, Martine, Bensussan, Armand, Grandchamp, Bernard, Dumaz, Nicolas, and Soufir, Nadem

Published
2013
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38. Eruptive squamous cell carcinomas following an acute skin inflammatory disease: A series of four cases.

Author

Moghadam, Parna, Herms, Florian, Baroudjian, Barouyr, Tetu, Pauline, Delyon, Julie, Jouenne, Fanélie, Boisson, Marie, Louveau, Baptiste, Mourah, Samia, Brunet‐Possenti, Florence, Duverger, Lucie, Gounant, Valérie, Lebbé, Céleste, and Basset‐Seguin, Nicole

Subjects
SQUAMOUS cell carcinoma, SKIN diseases, SKIN cancer, SOMATIC mutation
Abstract

The tumour-promoting role of long-lasting inflammation is well established in the skin where it promotes cutaneous squamous cell carcinoma (cSCC).[[1]] The implication of acute inflammation in cSCC is less described.[3] Generalized eruptive keratoacanthomas of Grzybowski (GEKA) is a rare variant of acquired eruptive keratoacanthomas (KA) displaying generalized eruption on photoexposed areas of hundreds of keratotic-centred follicular papules with severe pruritus. The largest skin lesions were surgically removed, and the patient was successfully treated with oral acitretin.[4] Other patients underwent surgical resection of tumours and received topical steroids on inflammatory lesions. Histopathological examination of skin tumours revealed invasive cSCC or KA, and biopsy specimens of eczematiform eruptions showed arguments for lichenoid or eczematiform lesions. [Extracted from the article]

Published
2023
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41. Highly Sensitive Multivariable Assay Detection of Melanocytic Differentiation Antigens and Angiogenesis Biomarkers in Sentinel Lymph Nodes With Melanoma Micrometastases

Author

Vitoux, Dominique, Mourah, Samia, Kerob, Delphine, Verola, Olivier, Basset-Seguin, Nicole, Baccard, Michel, Schartz, Noel, Ollivaud, Laurence, Archimbaud, Alain, Servant, Jean-Marie, Revol, Marc, Toubert, Marie-Elisabeth, Podgorniak, Marie-Pierre, Plassa, François, Porcher, Raphael, and Lebbé, Céleste

Published
2009
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42. Sonidegib in the Treatment of Locally Advanced Basal Cell Carcinoma: A Retrospective Study.

Author

HERMS, Florian, BAROUDJIAN, Barouyr, DELYON, Julie, LALY, Pauline, TETU, Pauline, LEBBE, Céleste, and BASSET-SEGUIN, Nicole

Subjects
BASAL cell carcinoma, HEDGEHOG signaling proteins, SPASMS, MOHS surgery
Abstract

Sonidegib, a hedgehog pathway inhibitor, is indicated for treatment of locally advanced basal cell carcinoma, based on the results of the BOLT study. However, to date, no real-world study of sonidegib has been reported. An observational, retrospective, single-centre study (PaSoS study) was conducted. The primary objective was to evaluate the efficacy of sonidegib for treatment of locally advanced basal cell carcinoma in a real-world setting. Secondary objectives included modalities of use, tolerability, tumour evolution, and management after discontinuation. A total of 21 patients treated with sonidegib were included from March 2018 to January 2021. The median follow-up was 18.7 months and median exposure 7.0 months. Objective response (OR) rate was 81.0% (n = 17) including 6 (29%) patients with a complete response (CR). Disease control rate was 100%. First tumour response was rapid, with a median time of 2.3 months. Nine (43%) patients underwent surgery after sonidegib discontinuation, and no relapse was observed. All the patients experienced at least 1 adverse event (AE). Muscle spasms were the most frequent AE (n = 14; 67%), followed by dysgeusia (n = 8; 38%) and alopecia (n = 12; 57%). The efficacy and safety profile of sonidegib in this first-to-date real-life trial are consistent with prior results. Overall, real-world evidence corroborated sonidegib efficacy and tolerability as a first-line treatment for locally advanced basal cell carcinoma. [ABSTRACT FROM AUTHOR]

Published
2022
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44. Assessment of quality of life using Skindex-16 in patients with advanced basal cell carcinoma treated with vismodegib in the STEVIE study

Author

Hansson, Johan, Bartley, Karen, Karagiannis, Thomas, Grob, Jean-Jacques, Kunstfeld, Rainer, Dreno, Brigitte, Mortier, Laurent, Ascierto, Paolo, Licitra, Lisa, Dutriaux, Caroline, Thomas, Luc, Meyer, Nicolas, Guillot, Bernard, Dummer, Reinhard, Fife, Kate, Ernst, D Scott, Yim, Yeun Mi, Dimier, Natalie, Fittipaldo, Alberto, Basset-Seguin, Nicole, Hauschild, Axel, Hôpital de la Timone [CHU - APHM] (TIMONE), Medizinische Universität Wien = Medical University of Vienna, Université de Nantes (UN), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Bordeaux [Bordeaux], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Pathogénèse et contrôle des infections chroniques (PCCI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), University hospital of Zurich [Zurich], Service de Dermatologie [AP-HP Hôpital Saint-Louis], Hopital Saint-Louis [AP-HP] (AP-HP), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
Adult, Male, Skin Neoplasms, Time Factors, Adolescent, Pyridines, Emotions, Antineoplastic Agents, Hedgehog pathway inhibitor, STEVIE, HRQoL, Young Adult, basal cell carcinoma, Surveys and Questionnaires, locally advanced, vismodegib, Humans, Anilides, skin and connective tissue diseases, Aged, Aged, 80 and over, integumentary system, Middle Aged, Carcinoma, Basal Cell, Quality of Life, Female, [SDV.MHEP.DERM]Life Sciences [q-bio]/Human health and pathology/Dermatology
Abstract

International audience; Health-related quality of life (HRQoL) data are limited in patients with advanced basal cell carcinoma. To report HRQoL outcomes based on STEVIE (NCT01367665), a phase 2 study of vismodegib safety in patients with metastatic BCC or locally advanced BCC that is unsuitable for surgery or radiotherapy. Skindex-16 and MD Anderson Symptom Inventory (MDASI) questionnaires were completed at baseline and at three subsequent visits. Clinically meaningful improvement was defined as a ≥10-point decrease from baseline (Skindex-16) or improvement of at least 3 points from baseline (MDASI). HRQoL-evaluable patients with locally advanced BCC (n = 730) had ≥10-point improvements in Skindex-16 emotion domain scores at all time points. Changes in symptom and function scores in these patients or in any domain scores at any time point in patients with metastatic BCC (n = 10) were not clinically meaningful. Of 10 patients with symptomatic metastatic BCC at baseline, six had ≥3-point improvements in MDASI symptom severity. Skindex-16 and MDASI showed improvement in HRQoL in vismodegib-treated patients with locally advanced or metastatic BCC or BCC.

Published
2018

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