Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy

Inclusion criteria

• The study can include all patients who are scheduled, at a physician's discretion, to receive the therapy with the drug Remaxol®, solution for infusions, or Ademethionine, lyophilizate for solution for intravenous and intramuscular injection, according to the approved instruction for the medical use of the drug and established clinical practice of a healthcare facility, and who meet all the following criteria:

• Males and females aged from 40 to 70 years inclusive.
• Verified diagnosis of neoplasm (morphologically proven).
• Receiving the course polychemotherapy (PCT).
• PCT regimens with pronounced hepatotoxic effects, which use drugs from the following pharmacologic classes:

• Competitive antagonists (5-Fluorouracil, Methotrexate etc.);
• Alkylating agents (Cyclophosphamide, Oxaliplatin etc.);
• Antitumor antibiotics (Doxorubicin, Bleomycin etc.);
• Drugs influencing tubulin (Trabectedin, Paclitaxel etc.);
• Topoisomerase inhibitors (Irinotecan, Etoposide etc.).

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• Contraindications for the continuation of PCT at the time of a visit to a physician for its continuation, because of developed hepatotoxicity.
• Stage of the treatment: supporting, hepatoprotective and detoxication therapy to correct hepatotoxicity developed during PCT, to remove it and continue the chemotherapeutic treatment.
• A patient is scheduled to receive one of the following infusion therapies with the following regimen, as part of the routine clinical practice:
• It is planned to administer the drug Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days.
• It is planned to administer the drug Ademethionine, lyophilisate for solution for intravenous and intramuscular injection, by intravenous drop infusion in the dose of 800 mg/day, on everyday basis for 14 days. ECOG performance status score: 1-2 inclusive (Karnofsky score: 50-80 %).
• Hepatotoxicity grade according to the classification of the US National Cancer Institute (NCCN, CTC) - 2 and 3.
• Scores by selected parameters of CTCAE (National Cancer Institute Common Toxicity Criteria for Adverse Events) scale - I and II.
• Patient's written consent for participation in the study according to the current legislation.

Exclusion criteria

• Pregnancy, breast-feeding.
• Mental disorders requiring psychiatric observation.
• Chronic alcohol abuse and/or substance abuse.
• HIV-infection, syphilis, virus hepatitis, autoimmune hepatitis, storage diseases, tuberculosis.
• Administration of monoclonal antibodies, (multi)kinase inhibitors during the PCT session immediately preceding this study.
• Administration of methionine-, Ademetionine-, malate- and/or succinate-containing medicines during the last month.
• Prescription of other malate-, succinate, or methionine-containing medicines (mexidol, cytoflavin, etc.).
• Decompensation of any severe/clinically apparent somatic diseases of the kidneys, liver, cardiovascular system, respiratory system, endocrine system, etc., as decided by the investigating physician.
• Contraindications mentioned in the approved instructions for use of medicines applied in the study (idiosyncrasy to the product components).
• Disease or use of medicines, which, in the doctor's opinion, can influence safety, tolerability and efficiency of the study medicines.