Real-world Observational Multi-center Study: Retrospective Analysis of Diagnostic and Treatment Patterns for Stage III–IV Melanoma in Ukraine from 2018 to 2020

Abstract

BACKGROUND: Despite open-access sources with information about cancer patients (National Cancer Registry of Ukraine), there are considerable gaps about actual diagnostic methods and specific treatment patterns or any details on how different regimens are applied for melanoma treatment in Ukraine.

OBJECTIVES: This non-interventional, multicenter, retrospective medical chart review study aims to describe real-world therapeutic strategies and characterize the profile of patients with melanoma Stage III–IV in real-life clinical practice in Ukraine.

METHODS: Anonymized data were collected from medical records of 747 patients in 9 oncology centers in Ukraine - four private and five public. The data variables were retrieved, captured in electronic case report forms, and analyzed with descriptive statistical methods.

INCLUSION CRITERIA: Subjects were not enrolled unless they met all the following criteria: (1) Age >18 years at the time of being diagnosed with III–IV stage melanoma. (2) Morphologically (including cytology) confirmed diagnosis of III–IV stage melanoma. Sufficient available medical records for data abstraction to meet the objectives of the study, that is, the patient has been under the medical care of the participating site for the entirety of the patient observation period or the patient’s detailed historical data on their disease course, and clinical management are otherwise available at the participating site consent has been granted by the Institutional Review Board/Ethical Committee of the study site.

EXCLUSION CRITERIA: Subjects were not enrolled if they met any of the following criteria: (1) The patient has received treatment with anticancer systemic therapy for reasons other than melanoma. (2) Primary cancer other than melanoma. (3) The patient is participating (or was participating) in any investigational program/clinical trial with interventions outside of routine clinical practice. All the statistical tests were two sided and performed at a 0.05 significance level. p-values were rounded to three decimal places. p < 0.001 were reported as <0.001 in tables.

RESULTS: Most melanoma cases (95.05%) were diagnosed histologically, although information about the primary tumor’s characteristics and treatment are heterogeneous. Most individuals (51.05%) diagnosed with Stage III undergo surgical treatment without additional therapy. Chemotherapy constitutes the primary form of systemic therapy for Stages III and IV, accounting for 33.3% and 45.65%, respectively.

CONCLUSION: It is crucial to tackle the problems associated with diagnosing and treating melanoma in Ukraine. This involves creating a unified registry for melanoma patients, establishing uniform methods for staging and re-staging, and standardizing medical records. Nevertheless, the most critical issue is the absence of access to modern therapy, which should be addressed at the state level.