Clinicopathological characteristics, diagnosis and treatment of melanoma in Serbia--the Melanoma Focus Study.

Introduction: Treatment options for metastatic melanoma in Serbia are limited due to the unavailability of newly approved biologic agents and lack of clinical studies. Also, there is a paucity of data regarding the treatment approaches in different tertiary centers and efficacy of available chemotherapy protocols. The aim of this study was to obtain more detailed data about treatment protocols in Serbia based on structured survey in tertiary oncology centers.  Materials, subjects and methods: Data about the melanoma patients treated in year 2011, were analysed from hospital databases in 6 referent oncology centers in Serbia, based on the structured survey, with the focus on metastatic melanoma patients (unresectable stage IIIC and IV).  Results: A total of 986 (79-315 in different centers) patients were treated, with 320 (32.45 %) newly diagnosed patients. There were 317 patients in stage IIIC/IV, 77/317 (23%) aged 60 years). At initial diagnosis 12.5% of patients were in stage III and 4.5% in stage IV. The most common type was superficial spreading melanoma (50-66%), followed by nodular melanoma (23.5-50%). Apart from the regional and distant lymph node metastases, the most frequent organ involved in stage IV disease were distant skin and soft tissues (12-55%), lungs (19-55.5%), liver (10-60%), and bones (3-10%). The first line therapy in stage IV metastatic melanoma was dacarbazine in 60-90% of patients, while the second line varied between centers.  Disease control (CR+PR+SD) was achieved in 25.7% of patients treated with the first line chemotherapy (DTIC) and 23.1% of patients treated with the second line therapy, but the duration of response was short: in first-line therapy 6.66±3.36 months (median 6.75 months). More then 90% of patients were treated outside the clinical trials. Conclusion: Based on this survey, there is a large unmet need for the new treatment options for metastatic melanoma in Serbia. Development of national guidelines, and greater involvement in international clinical studies could lead to widening of treatment options for this chemotherapy resistant disease. Sažetak Uvod: Terapijske mogucnosti za metastatski melanom u Srbiji su ograniceni zbog nedostupnosti novoodobrenih bioloskih lekova i veoma malog broja multicentricnih internacionalnih klinickih studija. Takođe, postoji mali broj podataka o terapijskom pristupu metastatskom melanoma u razlicitim tercijarnim centrima i efikasnosti raspoloživih protokola hemioterapije. Cilj ove studije je bio da se dobiju detaljniji podacie o protokolima lecenja u Srbiji, na osnovu strukturisane ankete u tercijarnim onkoloskim centrima. Materijal i metodi: podaci o obolelilam od melanoma lecenih u 2011. godini u Srbiji dobijeni su i analizirani iz bolnickih baza 6 referentnih onkoloskih centara u Srbiji, na osnovu strukturisane ankete, sa fokusom na metastatski melanom (inoperabilni stadijum IIIC i IV) . Rezultati: Ukupno je leceno 986 (79-315 u razlicitim centrima) pacijenata, od cega je 320 (32,45 %) bilo novodijagnostikovanih. Bilo je 317 pacijenata u stadijumu inoperabilnog IIIC/IV, 77/317 (23%) starosti 60 godina). Kod 12,5% pacijenata dijagnoza je postavljena  stadijumu III, a 4,5 % u fazi IV. Najcesci klinicko-patoloski tip bio je povrsno sireci (50-66%) i  nodularni melanom (23.5-50%). Osim regionalnih i udaljenih metastaza limfnih žlezda, najcesce zahvaceni organi u IV stadijumu bolesti bili su udaljene kutane i subkutane metastaze (12-55 %), pluca (19-55.5 %), jetra (10-60 %) i kosti (3-10 %). Prva linija terapije u inoperabilnom III i stadijumu IV metastatskog melanoma je dakarbazin u 60-90 % bolesnika, dok je druga linija je varirala između centara. Kontrola bolesti (CR+PR+SD) ostvarena je u 25,7 % pacijenata lecenih prvom linijom hemoterapije (DTIC) i 23,1% pacijenata sa drugom linijom terapije. Trajanje odgovora bilo je kratko: u prvoj liniji terapije 6,66±3,36 meseci (medijana 6,75 meseci). Vise od 90 % bolesnika leceni su van klinickih studija. Zakljucak: Na osnovu ovog istraživanja, postoji velika potreba za novim terapijskim opcijama metastatskog melanoma u Srbiji. Razvoj nacionalnih smernica i vece ucesce u međunarodnim klinickim studijama može dovesti do prosirenja opcije za lecenje ove bolesti otporne na hemioterapiju.