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Randomized Controlled Trial Comparative Study
Interferon-α versus interleukin-2 in Chinese patients with malignant melanoma: a randomized, controlled, trial.
- Shenglong Li, Xixi Wu, Peng Chen, Yi Pei, Ke Zheng, Wei Wang, Enduo Qiu, and Xiaojing Zhang.
- Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute.
- Anticancer Drugs. 2019 Apr 1; 30 (4): 402-409.
AbstractThe US Food and Drug Association has approved interferon-α (IFN-α) and interleukin-2 (IL-2) as adjuvant therapy in malignant melanoma. The objective of the study was to compare efficacy and safety of subcutaneous interferon-α with continuous intravenous IL-2 in Chinese patients with malignant melanoma. A total of 250 patients with unresectable malignant melanoma were subjected to randomized in 1 : 1 ratio. Patients received subcutaneous 9×10 IU/m IFN-α (IFN-α group, n=125) or continuous intravenous 9×10 IU/m IL-2 (IL-2 group, n=125) at every 21 days for 4 months. The response, progression-free survival, overall survival, adverse effects, and cost were evaluated by experts in the field. IL-2 and IFN-α were effective in improvement of malignant melanoma after 4 months of intervention. IL-2 was effective in improving brain metastasis. Patients of the IL-2 group had a higher overall survival (P<0.0001) and a higher progression-free survival (P=0.002) than those of IFN-α group. The IL-2 group reported hypotension, kidney dysfunction, liver dysfunctions, flu-like symptoms, and capillary leak syndrome as adverse effects. IFN-α group reported thrombocytopenia and neutropenia as adverse effects. Healthcare management and expert charges lead to increase in the cost of treatment for IL-2 group patients than IFN-α group (P<0.0001). Continuous intravenous IL-2 should be recommended in relapse-free Chinese patients with malignant melanoma. Level of Evidence: I.
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