8th european school of dermato-oncology update on ... · 11:30 –12:30 course g: surgical pearls...

Course DirectorsAna-Maria Forsea, Bucharest, Romania

Claus Garbe, Tuebingen, GermanyAxel Hauschild, Kiel, Germany

Judit Oláh, Szeged, Hungary

8th EUROPEAN SCHOOL OF DERMATO-ONCOLOGY UPDATE ON CUTANEOUS ONCOLOGY (ESDO)JANUARY 16th–18th, 2020ABBA HOTEL BERLIN, GERMANY

DIAMOND SPONSOR

FINAL PROGRAM

European Association of Dermato-Oncology (EADO) 2

Target Audience 2

Educational Objectives 2

Course Organization 3

Program Overview 4

Program 6

Thursday, January 16th, 2020 6

Friday, January 17th, 2020 7 Non-Melanoma Skin Cancer Day

Saturday, January 18th, 2020 10

Course Faculty 11

General Information 14

Sponsors 16

www.dermato-oncology2020.org

Content

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European Association of Dermato-Oncology (EADO)

The EADO is a non-profit organization funded in 1999 to promote, coordinate and improve clinical and laboratory research activities in the field of skin cancer including primary and sec-ondary prevention, early detection, clinical diagnosis and clinical and experimental research. EADO has organized many successful meetings and the upcoming ones are visible on the website (www.eado.org).The EADO initiates for the eighth time a course dedicated to fundamentals in skin cancer targeted to specialists and residents in the final phase of their resident program. They will benefit a comprehensive and updated course to improve their decision-making process for the management of all types and stages of skin cancer, from diagnosis, primary treatment and adjuvant treatment, to the management of locoregional disease and distant metastatic disease.

Target Audience

This 2,5-day educational course targets doctors who are actively involved in the treatment of skin cancer. Dermatologists or other specialists who have completed specialist training, or residents in the final year of their training program, are likely to gain the most from this course.

Educational Objectives

The principal aim of the course is to provide a comprehensive and detailed understanding of the decision-making process for the management of all types and stages of skin cancer. This will include diagnosis and primary treatment, management of locoregional disease and distant metastatic disease, and adjuvant treatment. This is particularly relevant given the rapid progress in our understanding of melanoma and non-melanoma skin cancer, and the development of new treatments. In particular delegates will acquire the following knowledge:

1. Strategies for diagnosis of melanoma, Merkel cell and non-melanoma skin cancer including dermoscopy and confocal laser microscopy.

2. The indications, risks and benefits and strategies for mole screening.

3. Diagnosis of skin cancer: how to break bad news.

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4. The indications and methods for genetic diagnosis and genetic counseling of skin cancer patients.

5. The present AJCC staging systems and how to stage melanoma, Merkel cell and cutaneous squamous cell carcinoma, and other non-melanoma skin cancers.

6. The value of imaging and biomarkers for the detection of metastases and disease staging.

7. Adjuvant treatment of skin cancer: radiotherapy, immunotherapy, chemotherapy.

8. New systemic treatments for stage IV melanoma: targeted agents and immuno-therapeutics.

9. New treatment options of advanced basal cell carcinoma.

10. New systemic treatments for advanced Merkel cell and squamous cell carcinoma.

11. The characteristics of mucosal and uveal melanomas and their treatment options.

12. Options for topical treatment of epithelial skin cancers.

13. The current classification of cutaneous lymphoma, staging and treatment options for different subtypes of cutaneous lymphoma.

14. Clinical trials in skin cancer: an update.

15. The indications and strategies for supportive treatments including best supportive care.

Course Organization

The course consists of plenary sessions and interactive outbreak sessions. Plenary sessions will comprise clear structured and up-to-date presentations followed by audience discussion. Voting devices will be used to respond to multiple choice questions. These questions may precede the presentation of the structured knowledge or may be presented at the end in order to test the level of knowledge the audience has gained. The main part of the course consists of 8 interactive sessions, each with no more than 30 at-tendants. Every participant takes part in each of these sessions which mainly comprise case-based discussion. These will be used to illustrate treatment pathways, how risk and benefit are assessed, and how management decisions are made.

We look forward to welcoming you in Berlin in January 2020!

Ana-Maria Forsea, MD Claus Garbe, MD Axel Hauschild, MD Judit Oláh, MDCourse Directors

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8:00 9:00 10:00 11:00 12:00

Group I

Group II

Group III

Group IV

Thursday January 16th, 2020

Group I

Group II

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Group IV

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Friday January 17th, 2020 Non-Melanoma Skin Cancer Day

COURSE E A. M. Forsea

COURSE F M. Weichenthal


COURSE G R. Kaufmann


COURSE H A. Hauschild



Group I

Group II

Group III

Group IV

Saturday January 18th, 2020

Lectures: Valencia Course A+E: Pamplona Course B+F: Santander Course C+G: Burgos Course D+H: Salamanca

All meeting rooms are located on the ground floor.

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Program OverviewA commercial exhibition will be held on

all days close to the meeting rooms.

COURSE C C. Garbe

COURSE D O. Michielin

COURSE A J. J. Grob

COURSE B C. Lebbé


COURSE A J. J. Grob

COURSE B C. Lebbé

COURSE C C. Garbe

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COURSE B C. Lebbé

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COURSE A J. J. Grob

Non-Melanoma Skin Cancer Day

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Thursday, January 16th, 2020

13:45 –14:00 Welcome and course introduction Claus Garbe, Tuebingen, Germany

PLENARY SESSION 1: What is new in diagnostics and treatment? Chairpersons: Iris Zalaudek and Joseph Malvehy

14:00 –14:15 LECTURE 1: Dermoscopy of difficult lesions – beyond ABCD Valencia Iris Zalaudek, Trieste, Italy

14:20 –14:35 LECTURE 2: Computer dermoscopy: a must? Valencia Aimilios Lallas, Thessaloniki, Greece

14:40 –14:55 LECTURE 3: Update on imaging tools in skin cancers Valencia Josep Malvehy, Barcelona, Spain

15:00 –15:15 LECTURE 4: The neoadjuvant approach in skin cancer Valencia Christoph Höller, Vienna, Austria

15:15 –15:30 Discussion

15:30 –16:00 Coffee Break

16:00 –17:00 COURSE A: Clinical trials fundamentals – understanding trial Group I Pamplona design, data analysis, result interpretation and ethical issues

Jean Jacques Grob, Marseille, France

16:00 –17:00 COURSE B: How to organize a skin cancer center? Group II Santander Celeste Lebbé, Paris, France

16:00 –17:00 COURSE C: Management of melanoma patients stages I–III Group III Burgos Claus Garbe, Tuebingen, Germany

16:00 –17:00 COURSE D: Targeted therapy of melanoma, SCC, BCC and DFSP Group IV Salamanca Olivier Michielin, Lausanne, Switzerland

Program

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17:30 –18:30 COURSE B: How to organize a skin cancer center? Group I Santander Celeste Lebbé, Paris, France

17:30 –18:30 COURSE C: Management of melanoma patients stages I–III Group II Burgos Claus Garbe, Tuebingen, Germany

17:30 –18:30 COURSE D: Targeted therapy of melanoma, SCC, BCC and DFSP Group III Salamanca Olivier Michielin, Lausanne, Switzerland

17:30 –18:30 COURSE A: Clinical trials fundamentals – understanding trial Group IV Pamplona design, data analysis, result interpretation and ethical issues Jean Jacques Grob, Marseille, France

Friday, January 17th, 2020 Non-Melanoma Skin Cancer Day

PLENARY SESSION 2: Controversies in Dermatooncology Chairpersons: Jean Jacques Grob and Alexander Stratigos

08:00 –08:15 LECTURE 5: Sunscreens prevent skin cancer: Yes Valencia Veronique del Marmol, Brussels, Belgium

08:15 –08:30 LECTURE 6: Sunscreens prevent skin cancer: No Valencia Claus Garbe, Tuebingen, Germany


08:45 –09:00 LECTURE 7: Skin cancer screening saves lifes: Yes Valencia Alexander Stratigos, Athens, Greece

09:00 –09:15 LECTURE 8: Skin cancer screening saves lifes: No Valencia Dirk Schadendorf, Essen, Germany



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10:00 –11:00 COURSE E: Principals of follow-up in skin cancer patients Group I Pamplona Ana-Maria Forsea, Bucharest, Romania

10:00 –11:00 COURSE F: Cutaneous lymphomas: diagnosis and management Group II Santander Michael Weichenthal, Kiel, Germany

10:00 –11:00 COURSE G: Surgical pearls in the treatment Group III Burgos of keratinocyte skin cancer Roland Kaufmann, Frankfurt, Germany

10:00 –11:00 COURSE H: Immune checkpoint inhibition for melanoma, Group IV Salamanca MCC, SCC and BCC Axel Hauschild, Kiel, Germany


11:30 –12:30 COURSE F: Cutaneous lymphomas: diagnosis and management Group I Santander Michael Weichenthal, Kiel, Germany

11:30 –12:30 COURSE G: Surgical pearls in the treatment Group II Burgos of keratinocyte skin cancer

Roland Kaufmann, Frankfurt, Germany

11:30 –12:30 COURSE H: Immune checkpoint inhibition for melanoma, Group III Salamanca MCC, SCC and BCC Axel Hauschild, Kiel, Germany

11:30 –12:30 COURSE E: Principals of follow-up in skin cancer patients Group IV Pamplona Ana-Maria Forsea, Bucharest, Romania

12:30 –13:00 Lunch

PLENARY SESSION 3: New challenges in skin cancer treatment Chairpersons: Holger Hänßle and Ketty Peris

13:00 –13:30 LECTURE 9: Artificial intelligence in skin cancer diagnosis Valencia Holger Hänßle, Heidelberg, Germany

13:30-14:00 LECTURE 10: What is new for actinic keratosis? Valencia Ketty Peris, Rome, Italy

14:00 –15:00 Non-Melanoma skin cancer cases – interactive presentation to Valencia the tumor board Ana-Maria Forsea, Petr Arenberger, David Moreno

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15:30 –16:30 COURSE G: Surgical pearls in the treatment Group I Burgos of keratinocyte skin cancer

Roland Kaufmann, Frankfurt, Germany

15:30 –16:30 COURSE H: Immune checkpoint inhibition for melanoma, Group II Salamanca MCC, SCC and BCC

Axel Hauschild, Kiel, Germany

15:30 –16:30 COURSE E: Principals of follow-up in skin cancer patients Group III Pamplona Ana-Maria Forsea, Bucharest, Romania

15:30 –16:30 COURSE F: Cutaneous lymphomas: diagnosis and management Group IV Santander Michael Weichenthal, Kiel, Germany


17:00 –18:00 COURSE H: Immune checkpoint inhibition for melanoma, Group I Salamanca MCC, SCC and BCC

Axel Hauschild, Kiel, Germany

17:00 –18:00 COURSE E: Principals of follow-up in skin cancer patients Group II Pamplona Ana-Maria Forsea, Bucharest, Romania

17:00 –18:00 COURSE F: Cutaneous lymphomas: diagnosis and management Group III Santander Michael Weichenthal, Kiel, Germany

17:00 –18:00 COURSE G: Surgical pearls in the treatment Group IV Burgos of keratinocyte skin cancer Roland Kaufmann, Frankfurt, Germany

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Saturday, January 18th, 2020

08:30 –09:30 COURSE C: Management of melanoma patients stages I–III Group I Burgos Claus Garbe, Tuebingen, Germany

08:30 –09:30 COURSE D: Targeted therapy of melanoma, SCC, BCC and DFSP Group II Salamanca Olivier Michielin, Lausanne, Switzerland

08:30 –09:30 COURSE A: Clinical trials fundamentals – understanding trial Group III Pamplona design, data analysis, result interpretation and ethical issues Jean Jacques Grob, Marseille, France

08:30 –09:30 COURSE B: How to organize a skin cancer center? Group IV Santander Celeste Lebbé, Paris, France


10:00 –11:00 COURSE D: Targeted therapy of melanoma, SCC, BCC and DFSP Group I Salamanca Olivier Michielin, Lausanne, Switzerland

10:00 –11:00 COURSE A: Clinical trials fundamentals – understanding trial Group II Pamplona design, data analysis, result interpretation and ethical issues

Jean Jacques Grob, Marseille, France

10:00 –11:00 COURSE B: How to organize a skin cancer center? Group III Santander Celeste Lebbé, Paris, France

10:00 –11:00 COURSE C: Management of melanoma patients stages I–III Group IV Burgos Claus Garbe, Tuebingen, Germany


PLENARY SESSION 4: Melanoma diagnostics and follow-up Chairpersons: Ketty Peris

11:30 –12:00 LECTURE 11: Targeted therapies: management of adverse events Valencia Lidija Kandolf Sekulovic, Belgrade, Serbia

12:00 –12:30 LECTURE 12: Immune checkpoint inhibition: Valencia management of adverse events Christoffer Gebhardt, Hamburg, Germany

12:30 –13:30 Melanoma cases – interactive presentation to the tumor board Valencia Judit Oláh, Lidija Kandolf, Ricardo Vieira

14:00 –16:00 European Examination Dermato-Oncology 2020 Salamanca

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A

Petr Arenberger, MDProfessor of Dermatology, Director Department of DermatologyCharles University3rd School of MedicineSrobarova 50CZ-100 34 Prague, Czech RepublicPhone: +420-26716-3000Email: [email protected]

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Veronique Del Marmol, MDDepartment of Clinical ChemistryErasme Hospital – ULBRoute de Lennik 8081070 Brussels, Belgium

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Ana-Maria Forsea, MDAssociate Professor for DermatologyDepartment of DermatologyCarol Davila University of Medicineand Pharmacy BucharestBulevardul Eroii Sanitari 8050474 Bucharest, RomaniaPhone: +40-21-3180462Email: [email protected]

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Claus Garbe, MDProfessor of DermatologyDepartment of DermatologyEberhard Karls University Liebermeister Str. 2572076 Tuebingen, GermanyPhone: +49-7071-2987110Email: [email protected]

Christoffer Gebhardt, MDSkin Cancer CenterUniversity Hospital Hamburg-EppendorfMartinistr. 5220246 Hamburg, GermanyPhone: +49-40-741057626Email: [email protected]

Jean Jacques Grob, MDProfessor of DermatologyService de Dermatology and Cancer ResearchHôpital de la Timone 264 Rue St. Pierre 13005 Marseille, FrancePhone: +33-491-388591Email: [email protected]

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Holger Hänßle, MDHeidelberg University HospitalIm Neuenheimer Feld 40069120 Heidelberg, Germany

Course Faculty

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Axel Hauschild, MDProfessor of Dermatology Department of Dermatology University of Kiel Rosalind-Franklin-Str. 724105 Kiel, GermanyPhone: +49-431-50021131Email: [email protected]

Christoph Höller, MDProfessor of DermatologyDepartment of Dermatology Medical University of Vienna Waehringer Guertel 18–201090 Vienna, AustriaPhone: +43-1-404004786Email: christoph.hoeller@meduniwien. ac.at

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Lidija Kandolf Sekulovic, MDProfessor of DermatologyDepartment of DermatologyMedical FacultyMilitary Medical AcademyCrnotravska 1711000 Belgrade, SerbiaPhone: +381-11-3608583Email: [email protected]

Roland Kaufmann, MDProfessor of Dermatology, Director Department of DermatologyClinical Center J. W. Goethe University Theodor-Stern-Kai 760590 Frankfurt/Main, GermanyPhone: +49-69-63015311Email: [email protected]

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Aimilios Lallas, MDAristotle University of ThessaloikiDepartment of Dermatology54124 Thessaloniki, Greece

Celeste Lebbé, MDProfessor of DermatologyDepartment of DermatologyHôpital Saint-Louis1, Avenue Claude-Vellefaux75010 Paris, FrancePhone: +33-142494679Email: [email protected]

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Josep Malvehy, MDDirector of the Melanoma Unit Department of Dermatology Hospital Clinic of Barcelona C/Villarroel 17008036 Barcelona, SpainPhone: +34-933638920Email: [email protected]

Olivier Michielin, MDHead of Melanoma ClinicDepartment of OncologySwiss Institute of BioinformaticsLudwig Institute1015 LausanneSwitzerlandPhone: +41-21-692-4053Email: [email protected]

David Moreno-Ramirez, MDUniversity Hospital Virgen MacarenaCalle Dr. Fedriani, 341009 Seville, Spain

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Judit Oláh, MD Department of DermatologyUniversity of SzegedKoranyi Fasor 63720 Szeged, HungaryPhone: +36-62-545984Email: [email protected]

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Ketty Peris, MDDepartment of DermatologyCatholic University of RomeLargo a Gemelli, 800168 Rome, ItalyPhone: +39-630154227Email: [email protected]

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Dirk Schadendorf, MDUniversity Hospital of EssenHufelandstr. 5545147 Essen, GermanyPhone: +49-201-7232430Email: [email protected]

Alexander Stratigos, MDDepartment of DermatologyUniversity of Athens School of Medicine Andreas Sygros Hospital5 Dragoumi StreetAthens 161 21, GreecePhone: +30-210-7231731Email: [email protected]

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Ricardo Vieira, MDFaculty of MedicineUniversity of CoimbraPólo I – Edífico CentralRua Larga3004-504 Coimbra, PortugalPhone: +35-1-3957-00Email: [email protected]

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Michael Weichenthal, MDProfessor of DermatologyDepartment of DermatologyUniversity of KielRosalind-Franklin-Str. 724105 Kiel, GermanyPhone: +49-431-500-21141Email:[email protected]

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Iris Zalaudek, MDHead of the Dermatology ClinicUniversity of TriesteHospital MaggiorePiazza dell' Ospedale 134125 Trieste, ItalyEmail: [email protected]

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Cancellation PolicyCancellations must be received in writing by December 19, 2019. No refunds will be granted after that date. A processing fee of 30 Euro will be deducted from each can-celled registration. Substitutions are possible. To substitute a registration, please send an email including the name of the original registrant and the name of the person substituting to [email protected].

The participant acknowledges that he/she has no right to lodge damage claims against the organizers should the holding of the meeting be hindered or prevented by unex-pected, political or economic events or generally by force, or should the non-appearance of speakers or other reasons need program changes. With registration, the participant accepts this proviso.

Course Organization

MedConcept Gesellschaft für medizinische Projekte mbH Friedenstraße 58 15366 Neuenhagen b. Berlin, Germany Phone: +49 (0)3342 42689-30 Fax: +49 (0)3342 42689-40 E-Mail: [email protected] www.medconcept.org

Course VenueABBA Hotel BerlinLietzenburger Str. 8910719 BerlinGermany

Phone: +49 (0)30 8871860 E-Mail: [email protected]

General Information

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Exhibition Opening HoursThursday, January 16: 13:00–18:30Friday, January 17: 07:30–18:00Saturday, January 18: 08:00–13:30

FeesRegistration Fee of 380 Euro (incl. VAT) covers

– Admission to scientific sessions – Welcome reception– Admission to exhibition – Coffee breaks and lunch – Bag with course documents – Certificate of attendance

Language and TranslationThe official language of the meeting will be English. Simultaneous translation will not be provided.

Registration / Information DeskThe registration desk is situated at the ground floor of the ABBA Hotel Berlin next to the reception.

Opening hoursThursday, January 16: 12:00 –19:00 Friday, January 17: 07:30 –18:00 Saturday, January 18: 08:00 –14:00

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GOLD SPONSOR

BRONZE SPONSORS

FURTHER SPONSORS

DIAMONDSPONSOR

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Notes

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At the Forefront of Immuno-Oncology Research

© 2018 Bristol-Myers Squibb Company. All rights reserved. IODE19SD03239 12/19

We’re in pursuit of

GROUNDBREAKING RESEARCH

Visit the Bristol-Myers Squibb booth to learn more

OPY-19-1033_Nachdruck_Anzeige_ESDO_12_2019_148x210mm_RZ.indd 1 19.12.19 14:40

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Notes

More than half of the patients treated in the adjuvant setting with Tafinlar® + Mekinist® remained recurrence-free after four years.3

The Art of Protecting Patients.

For stage-III melanoma with BRAF-V600 mutation.a

Tafinlar® 50 mg / - 75 mg Hartkapseln. Wirkstoff: Dabrafenib. Zusammensetzung: Eine 50 mg- bzw. 75 mg-Hartkapsel enthält 50 mg bzw. 75 mg Dabrafenib (als Dabrafenibmesilat). Sonstige Bestandteile: Kapsel-inhalt: Mikrokristalline Cellulose, Magnesiumstearat, hochdisperses Siliciumdioxid. Kapselhülle: Eisen(III)-oxid (E172), Titandioxid (E171), Hypromellose (E464). Drucktinte: Eisen(II,III)-oxid (E172), Schellack, Propylenglycol. Anwendungsgebiete: Melanom: Als Monotherapie oder in Kombination mit Trametinib zur Behandlung v. er-wachsenen Patienten mit nicht-resezierbarem od. metastasiertem Melanom mit einer BRAF-V600-Mutation. Adjuvante Melanom Behandlung: In Kombination mit Trametinib zur adjuvanten Behandlung v. erwachsenen Melanom-Patienten im Stadium III mit einer BRAF-V600-Mutation nach vollständiger Resektion. Nicht-klein-zelliges Lungenkarzinom (NSCLC): In Kombination mit Trametinib zur Behandlung v. erwachsenen Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkarzinom mit einer BRAF-V600-Mutation. Gegenanzeigen: Überempfindlichkeit gegen den Wirkstoff oder einen der sonstigen Bestandteile. Schwangerschaft. Stillzeit. Pat. m. Melanom oder NSCLC v. BRAF-Wildtyp (Wirksamkeit u. Sicherheit nicht erwiesen). Nebenwirkungen: Monotherapie: Sehr häufig: Papillom. Verminderter Appetit. Kopfschmerzen. Husten. Übelkeit, Erbrechen, Durchfall. Hyperkeratose, Haarausfall, Hautausschlag, palmar-plantares Erythrodysästhesie-Syndrom. Arthralgie, Myalgie, Schmerzen i. d. Extremitäten. Pyrexie, Fatigue, Schüttelfrost, Asthenie. Häufig: Platten-epithelkarzinom d. Haut, seborrhoische Keratose, Akrochordon (Saitenwarze), Basalzellkarzinom. Hypophos-phatämie, Hyperglykämie. Verstopfung. Trockene Haut, Pruritus, aktinische Keratose, Hautläsion, Erythem, Photosensitivität. Grippeartige Erkrankung. Gelegentlich: Neue primäre Melanome. Überempfindlichkeit. Uveitis. Pankreatitis. Pannikulitis. (Akutes) Nierenversagen, Nephritis. Häufigkeit nicht bekannt: Weitere neue maligne Erkrankungen (insb. bei Vorliegen e. RAS-Mutation). Kombinationstherapie: Sehr häufig: Na-sopharyngitis. Verminderter Appetit. Kopfschmerz, Schwindel. Bluthochdruck. Hämorrhagie. Husten. Bauch-schmerzen, Verstopfung, Durchfall, Übelkeit, Erbrechen. Trockene Haut, Juckreiz, Hautausschlag, Erythem. Arthralgie, Myalgie, Schmerzen i. d. Extremitäten, Muskelkrämpfe. Fatigue, Schüttelfrost, Asthenie, peripheres Ödem, Pyrexie, grippeartige Erkrankung. Anstieg d. ALT u. AST. Häufig: Harnwegsinfekt. Zellulitis, Follikulitis, Nagelbettentzündung, pustulärer Hautausschlag. Kutanes Plattenepithelkarzinom, Papillom, seborrhoische Keratose. Neutropenie, Anämie, Thrombozytopenie, Leukopenie. Dehydration, Hyponaträmie, Hypophos-phatämie, Hyperglykämie. Verschwommenes Sehen, Sehstörung, Uveitis. Verringerte Auswurffraktion. Niedriger Blutdruck, Lymphödem. Atemnot. Mundtrockenheit, Stomatitis. Akneiforme Dermatitis, aktinische Keratose, Nachtschweiß, Hyperkeratose, Haarausfall, palmar-plantares Erythrodysästhesie-Syndrom, Haut-läsion, Hyperhidrose, Pannikulitis, Hautfissuren, Photosensitivität. Schleimhautentzündung, Gesichtsödem. Anstieg d. AP und CPK im Blut, Anstieg d. GGT. Gelegentlich: Neues primäres Melanom, Akrochordon (Sai-tenwarze). Überempfindlichkeit. Chorioretinopathie, Netzhautablösung, periorbitales Ödem. Bradykardie. Pneumonitis. Pankreatitis, Kolitis. Nierenversagen, Nephritis. Selten: Gastrointestinale Perforation. Häufigkeit nicht bekannt: Weitere neue maligne Erkrankungen (insb. bei Vorliegen e. RAS-Mutation). Tiefe Venen-thrombose (TVT)/Lungenembolie (LE). Myokarditis. Stevens-Johnson-Syndrom, Arzneimittelexanthem mit Eosinophilie und systemischen Symptomen, Generalisierte exfoliative Dermatitis. Verschreibungspflichtig. Weitere Hinweise: S. Fachinformation. Stand: Mai 2019 (MS 07/19.14). Novartis Pharma GmbH, Roonstr. 25, 90429 Nürnberg. Tel.: (0911) 273-0, Fax: (0911) 273-12 653. www.novartis.de

Mekinist® 0,5 mg / - 2 mg Filmtabletten. Wirkstoff: Trametinib. Zusammensetzung: Eine 0,5 mg- bzw. 2 mg-Filmta-blette enthält 0,5 mg bzw. 2 mg Trametinib-Dimethylsulfoxid (1:1), entsprechend 0,5 mg bzw. 2 mg Trametinib. Sonstige Bestandteile: Tablettenkern: Mannitol (E421), mikrokristalline Cellulose (E460), Hypromellose (E464), Croscarmellose-Na-trium (E468), Magnesiumstearat (E470b), Natriumdodecylsulfat, hochdisperses Siliciumdioxid (E551). Tabletten-Film-überzug: Hypromellose (E464), Titandioxid (E171), Macrogol, zusätzl: Eisen(III)-hydroxid-oxid x H2O (E172) (für die 0,5 mg- Tabletten), Polysorbat 80 (E433) u. Eisen(III)-oxid (E172) (für die 2 mg-Tabletten). Anwendungsgebiete: Melanom: Als Monotherapie oder in Kombination mit Dabrafenib zur Behandlung v. erwachsenen Patienten mit nicht-resezierbarem od. metastasiertem Melanom mit einer BRAFV600- Mutation. Adjuvante Melanom Behandlung: In Kombination mit Da-brafenib zur adjuvanten Behandlung v. erwachsenen Melanom- Patienten im Stadium III mit einer BRAF-V600-Mutation nach vollständiger Resektion. Nicht-kleinzelliges Lungenkarzinom (NSCLC): In Kombination mit Dabrafenib zur Behandlung v. erwachsenen Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkarzinom mit einer BRAF-V600-Mutation. Gegenanzeigen: Überempfindlichkeit gegen den Wirkstoff oder einen der sonstigen Bestandteile. Schwangerschaft. Still-zeit. Bei Anwend. in Kombination mit Dabrafenib: Pat. m. Melanom oder NSCLC v. BRAF-Wildtyp (Wirksamkeit u. Sicherheit nicht erwiesen). Nebenwirkungen: Monotherapie: Sehr häufig: Bluthochdruck, Hämorrhagie. Husten, Atemnot. Durchfall, Übelkeit, Erbrechen, Verstopfung, Bauchschmerzen, Mundtrockenheit. Hautausschlag, akneiforme Dermatitis, trockene Haut, Juckreiz, Haarausfall. Fatigue, peripheres Ödem, Pyrexie. Anstieg der AST. Häufig: Follikulitis, Nagelbettentzündung, Zellulitis, pustulärer Hautausschlag. Anämie. Überempfindlichkeit. Dehydratation. Verschwommenes Sehen, periorbitales Ödem, Sehstörung. Linksventrikuläre Dysfunktion, verringerte Auswurffraktion, Bradykardie. Lymphödem. Pneumonitis. Stomatitis. Erythem, palmar-plantares Erythrodysästhesie-Syndrom, Hautfissuren, aufgesprungene Haut. Gesichtsödem, Schleimhautentzündung, Asthenie. Anstieg d. ALT, AP u. CPK im Blut. Gelegentlich: Chorioretinopathie, Papillenödem, Netz-hautablösung, Netzhautvenenverschluss. Herzinsuffizienz. Interstitielle Lungenerkrankung. Gastrointestinale Perforation, Kolitis. Rhabdomyolyse. Häufigkeit nicht bekannt: Tiefe Venenthrombose (TVT)/Lungenembolie (LE). Kombinationsthera-pie: Sehr häufig: Nasopharyngitis. Verminderter Appetit. Kopfschmerz, Schwindel. Bluthochdruck, Hämorrhagie. Husten. Bauchschmerzen, Verstopfung, Durchfall, Übelkeit, Erbrechen. Trockene Haut, Juckreiz, Hautausschlag, Erythem. Arthralgie, Myalgie, Schmerzen i. d. Extremitäten, Muskelkrämpfe. Fatigue, Schüttelfrost, Asthenie, peripheres Ödem, Pyrexie, grippe-artige Erkrankung. Anstieg der ALT u. AST. Häufig: Harnwegsinfekt, Zellulitis, Follikulitis, Nagelbettentzündung, pustulärer Hautausschlag. Kutanes Plattenepithelkarzinom, Papillom, seborrhoische Keratose. Neutropenie, Anämie, Thrombozytope-nie, Leukopenie. Dehydration, Hyponaträmie, Hypophosphatämie, Hyperglykämie. Verschwommenes Sehen, Sehstörung, Uveitis. Verringerte Auswurffraktion. Niedriger Blutdruck, Lymphödem. Atemnot, Mundtrockenheit, Stomatitis. Akneiforme Dermatitis, aktinische Keratose, Nachtschweiß, Hyperkeratose, Haarausfall, palmar-plantares Erythrodysästhesie- Syn-drom, Hautläsion, Hyperhidrose, Pannikulitis, Hautfissuren, Photosensitivität. Schleimhautentzündung, Gesichtsödem. Anstieg der AP und CPK im Blut, Anstieg der GGT. Gelegentlich: Neues primäres Melanom, Akrochordon (Saitenwarze). Überempfindlichkeit. Chorioretinopathie, Netzhautablösung, periorbitales Ödem. Bradykardie. Pneumonitis. Pankreatitis, Kolitis. Nierenversagen, Nephritis. Selten: Gastrointestinale Perforation. Häufigkeit nicht bekannt: Myokarditis. Stevens-Johnson-Syndrom, Arzneimittelexanthem mit Eosinophilie und systemischen Symptomen, Generalisierte exfoliative Der-matitis. Weitere neue maligne Erkrankungen (insb. bei Vorliegen einer RAS-Mutation). TVT/LE. Verschreibungspflichtig. Weitere Hinweise: Siehe Fachinformation. Stand: Mai 2019 (MS 07/19.12). Novartis Pharma GmbH, Roonstr. 25, 90429 Nürn-berg. Tel.: (0911) 273-0, Fax: (0911) 273-12 653. www.novartis.de

ALSO APPROVED FOR THE ADJUVANT TREATMENT OF MELANOMA a

a Tafinlar® in combination with Mekinist® is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. Tafinlar® as monotherapy or in combination with Mekinist® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.1, 2

+ 4-year follow-up of Tafinlar® + Mekinist® vs. Placebo: HR (95 %-C): 0.49 (0.40 – 0.59) 3; HR = hazard ratio; RFS = recurrence-free survival1. SmPC Tafinlar® 2. SmPC Mekinist® 3. Hauschild A et al. Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600–Mutant Stage III Melanoma. DOI: 10.1200/JCO.18.01219 Journal of Clinical Oncology – published online before print October 22, 2018.

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10th European Post-Chicago Melanoma/Skin Cancer Meeting

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