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:
• •1. Males and females aged from 40 to 70 years inclusive.
• •2. Verified diagnosis of neoplasm (morphologically proven).
• •3. Receiving the course polychemotherapy (PCT).
• •4. PCT regimens with pronounced hepatotoxic effects, which use drugs from the following pharmacologic classes:
• •1. Competitive antagonists (5-Fluorouracil, Methotrexate etc.);
• •2. Alkylating agents (Cyclophosphamide, Oxaliplatin etc.);
• •3. Antitumor antibiotics (Doxorubicin, Bleomycin etc.);
• •4. Drugs influencing tubulin (Trabectedin, Paclitaxel etc.);
• •5. Topoisomerase inhibitors (Irinotecan, Etoposide etc.).
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• •1. Contraindications for the continuation of PCT at the time of a visit to a physician for its continuation, because of developed hepatotoxicity.
• •2. Stage of the treatment: supporting, hepatoprotective and detoxication therapy to correct hepatotoxicity developed during PCT, to remove it and continue the chemotherapeutic treatment.
• •3. A patient is scheduled to receive one of the following infusion therapies with the following regimen, as part of the routine clinical practice:
• •4. 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.
• •5. 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 %).
• •6. Hepatotoxicity grade according to the classification of the US National Cancer Institute (NCCN, CTC) - 2 and 3.
• •7. Scores by selected parameters of CTCAE (National Cancer Institute Common Toxicity Criteria for Adverse Events) scale - I and II.
• •8. Patient's written consent for participation in the study according to the current legislation.