Prognostički faktori za pojavu recidiva i metastaza kod osoba sa visokorizičnim melanomom kože i uticaj bolesti na kvalitet života

Abstract

obolelelih. Kvalitet ţivota osoba kod kojih je dijagnostikovan visokorizični melanom koţe (IIC i III stadijum) moţe se vremenom menjati, u zavisnosti od toka bolesti. Osobe sa melanomom koţe, nakon primarnog hirurškog lečenja, imaju povećan rizik za loko-regionalni recidiv bolesti i/ili udaljene metastaze i za smrtni ishod usled progresije bolesti. Najvaţniji prognostički faktori koji imaju ulogu u predviĎanju toka bolesti nakon primarnog hirurškog lečenja su histomorfološke karakteristike melanoma, karakteristike pacijenata i serološki parametri. CILJ: Ciljevi istraţivanja bili su: ispitati validnost i pouzdanost upitnika za merenje kvaliteta ţivota, prethodno lingvistički i kulturološki adaptiranog na srpski jezik; proceniti kvalitet ţivota osoba sa melanomom koţe nakon završenog primarnog hirurškog lečenja i u periodu 6–12 meseci od postavljanja dijagnoze (u slučaju pojave recidiva i ranije); ispitati prediktore promene kvaliteta ţivota osoba sa melanomom tokom godinu dana praćenja iispitati prediktore pojave recidiva i metastaza melanoma. METOD: Istraţivanje je sprovedeno od juna 2017. do decembra 2018. godine u Institutu za onkologiju i radiologiju Srbije. U cilju validacije Upitnika za funkcionalnu procenu terapije raka – melanoma (FACT-M) sprovedena je studija preseka. Za longitudinalno ispitivanje kvaliteta ţivota, kao i za procenu ishoda bolesti (recidivi i metastaze) primenjena je prospektivna kohortna studija. Ustudiju su uključeni ispitanici sa histopatološki dokazanim melanom koţe u kliničkom stadijumu IIC, IIIA, IIIB i IIIC, kod kojih klinički i radiografski nisu potvrĎeni znaci bolesti nakon primarnog hirurškog lečenja. Sociodemografski i klinički podaci prikupljeni su iz medicinske dokumentacije i uz pomoć opšteg upitnika. Za inicijalno i kontrolno merenje kvaliteta ţivota korišćeni su Opšti upitnik za merenje kvaliteta ţivota povezanog sa zdravljem (SF-36) i upitnik FACT-M. Kvalitet ţivota je procenjivan tokom dva merenja: nakon završenog primarnog hirurškog lečenja i potvrde dijagnoze visokorizičnog melanoma koţe i nakon 6 do 12 meseci, a u slučaju pojave recidiva i metastaza i ranije. Za procenu stepena depresivosti primenjena je Bekova skala depresivnosti (BDI). TakoĎe, praćene su vrednosti laktatdehidrogenaze (LDH), C-reaktivnog proteina (CRP) i vitamina D u krvi. REZULTATI: Srpska verzija upitnika FACT-M pokazala je dobru unutrašnja konzistentnost merenu Kronbahovim alfa koeficijentom (0,912) i MekDonaldovim omega koeficijentom (0,904). UtvrĎeno je da je Skala funkcionalne procene opšte terapije raka (FACT-G) u našoj populaciji imala sedam, umesto četiri domena.Melanomska skala (MS) i melanomska hirurška skala (MSS) nisu odgovarale originalnoj jednodimenzionalnoj strukturi. Inicijalni kvalitet ţivota povezan sa zdravljem je bio bolji, ako su ispitanici imali niţi BDI skor, tj. manje depresivnih simptoma, niţi Funkcionalni performans status pacijenata(ECOG PS) i viši nivo vitamina D u serumu. Kvalitet ţivota povezan sa zdravljem na kontroli bio je bolji, ako su ispitanici i dalje bili zaposleni tokom praćenja, ako su imali niţi BDI skor, tj. manje depresivnih simptoma, niţi Breslow skor, odsustvo metastaza i niţi nivo CRP u serumu na kontrolnom merenju. Osobe koje su imale veće pogoršanje kvaliteta ţivota povezanog sa zdravljem razvile su više depresivnih simptoma tokom praćenja (B = -2,50, 95% interval poverenja [IP] -3,05--1,94, p=0,001), imale su povećanje TNM-T stadijuma melanoma (B = -4,46, 95% IP -8,76--0,16, p=0,042) i prisustvo metastaza (B = -24,36, 95% IP -36,55--12,16, p=0,001)...

BACKGROUND: Melanoma is a malignant tumor thathas an impact on the quality of life of a patient due to the severity and potential complications. The quality of life of persons diagnosed with high-risk cutaneous melanoma (stages IIC and III) may change over time, depending on the course of the disease. People with high-risk cutaneous melanoma, have an increased risk of loco-regional relapse and/or developing distant metastases as well as a higher risk of dying due to the disease progressionafter primary surgical treatment. The most important prognostic factors that mayhave a role in disease prognosis after the primary (surgical) treatment are the histomorphological characteristics of melanoma, patient’s characteristics, but also some serological indicators. OBJECTIVES:The objectives of the study were: to examine the validity and reliability of the quality of life questionnaire, which was previously linguistically and culturally adapted in Serbian language; to assess the quality of life of persons with cutaneous melanoma after the primary surgical treatment and after 6-12 months of follow-up (in case of recurrence even earlier); to examine the predictors of change in the quality of life of people with melanoma over 1 year of follow-up; to examine the predictors of melanoma recurrence and metastases. METHODS: The study was conducted from June 2017 to December 2018 at the Institute of Oncology and Radiology of Serbia. To validate the Functional Assessment of Cancer Therapy – Melanoma (FACT-M), a cross-sectional study was conducted. A prospective cohort study was used for longitudinal examination of the quality of life as well as for the assessment of melanoma outcomes (recurrence and metastases). This study included subjects with histopathologically verified cutaneous melanoma in clinical stages IIC, IIIA, IIIB and IIIC, among whom no signs of disease were clinically and radiographically present after the primary surgical treatment. The sociodemographic and clinical data were collected from the medical records and using a general questionnaire. Short Form 36 Health Survey(SF-36) and FACT-M were used to quantify quality of life. The quality of life was assessed: after the primary surgical treatment and confirmation of the diagnosis of high-risk melanoma and after 6-12 months(in case of recurrence and/or metastases even earlier). The Beck Depression Inventory (BDI) was used to assess the degree of depressive symptoms. Also, lactate dehydrogenase (LDH), C-reactive protein (CRP) and vitamin D values were monitored. RESULTS: The Serbian version of the FACT-M questionnaire showed good internal consistency as measured by the Cronbach's alpha coefficient (0.912) and the McDonald's omega coefficient (0.904).It was found that the Functional Assessment of Cancer Therapy – General (FACT-G) in our populationhad 7 instead of 4 domains. The Melanoma scale (MS) and Melanoma surgery scale (MSS) did not fit the original one-dimensional structure.The baseline health-related quality of life was higher, i.e. better, if the participants had a lower BDI score, i.e. fewer depressive symptoms, lower ECOG Performance Status (ECOG PS), and higher serum vitamin D levels. The control health-related quality of life was higher, i.e. better, if the participants were still employed during follow-up, had a lower BDI score, i.e. fewer depressive symptoms, lower Breslow score, absence of metastases, and lower serum CRP levels on control measurement. Individuals who had a greater decline in the health-related quality of lifedeveloped more depressive symptoms over follow-up (B = -2.50, 95% confidence interval [CI] - 3.05--1.94, p = 0.001), had a progression of melanoma according to TNM-T classification (B = -4.46, 95% CI -8.76--0.16, p = 0.042) and the metastases (B = -24.36, 95% CI -36.55--12.16, p = 0.001)...