Corticosteroids for Doxorubicin Liposome-Induced Hand-Foot-Skin Reactions

Exclusion Criteria18

• Received chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first study dose (or within 5 half-lives, whichever is shorter). Exceptions: The washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy to avoid prolonged patient waiting).
• Previous treatment with liposomal doxorubicin or similar formulations.
• Allergy History: Known hypersensitivity to liposomal products or doxorubicin.
• Cardiovascular Diseases:
• Severe arrhythmias/conduction abnormalities (e.g., clinically significant ventricular arrhythmias, second- or third-degree AV block).
• History of myocardial infarction, coronary artery bypass grafting (CABG), or heart failure (NYHA Class ≥II).
• LVEF ≤50%or prolonged QTcF (\>450 ms in males; \>470 ms in females).
• Active Infections: Grade ≥2 （NCI CTCAE v5.0）
• Immunosuppression:
• Active autoimmune diseases, immunodeficiency (e.g., HIV-positive), or congenital/acquired immune disorders.
• History of organ transplantation or chronic corticosteroid use.
• HBsAg-positive with HBV-DNA ≥500 IU/mL. Exception: If HBV-DNA \<500 IU/mL and chronic hepatitis is deemed stable/inactive by the investigator, enrollment is permitted.
• Other Infections: Positive for HCV antibody or syphilis-specific antibody.
• Neurological/Psychiatric Disorders: History of epilepsy, dementia, or other uncontrolled conditions.
• CNS Metastases: Symptomatic brain or leptomeningeal metastases, or uncontrolled CNS lesions. Exception: Asymptomatic brain metastases or lesions stable for ≥28 days without steroids/antitumor therapy are allowed.
• Any other condition that, per investigator assessment, may compromise patient safety or study compliance.
• Pregnant or breastfeeding women.
• Patients deemed ineligible for the study by the investigator.