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Published on: February 24, 2023
A pilot study of low-dose thalidomide and interferon alpha-2b in patients with metastatic melanoma who failed prior
Magdolna Solti1, David Berd, Michael J Mastrangelo
1Division of Medical Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA.
Abstract:
Melanoma is a hypervascular tumor and angiogenesis plays a critical role in the development/progression of metastases. As various pathways are involved in tumor angiogenesis, a combination of agents with different antiangiogenesis activities is a reasonable approach. To determine the efficacy and toxicity of combination treatment with low-dose thalidomide and low-dose interferon (IFN) in patients with stage IV melanoma who failed prior treatment(s), fifteen patients with metastatic melanoma (nine cutaneous, six uveal) received oral thalidomide (200 mg daily) with subcutaneous interferon (IFN)-alpha2b (3 MIU, 3x/week). Stabilization or regression of metastases (as evidenced by computed tomographic measurement) was the primary endpoint of the study. Patients were evaluated monthly for toxicity and every 2 months for clinical response. At a median follow-up of 22.8 months (range, 12-32 months), one patient with metastatic cutaneous melanoma achieved partial response, three patients achieved stable disease (one uveal, two cutaneous), nine patients progressed, and two were not evaluable. The time to progression was 6 months for the patient with partial response, and 2, 5.5+ and 11 months for three patients with stable disease. The estimated median overall survival was 4.7 months (confidence interval, 2.2-9.9 months; range, 0.9-31.5 months), and median progression-free survival was 1.8 months (confidence interval, 1.5-3.0 months; range, 0.5-14 months). Grade 3 toxicities related to treatment included neutropenia (n=5), elevation of transaminases (n=2), and neuropathy (n=1). No treatment-related deaths were experienced. Thalidomide+IFN is a safe and tolerable palliative treatment for previously treated stage IV melanoma.
Insights
This study found that combining low-dose thalidomide and interferon (IFN) is a safe palliative option for stage IV melanoma patients. While not curative, this combination offers tolerable treatment for advanced metastatic melanoma.
Area of Science:
- Oncology
- Medical Research
- Pharmacology
Background:
- Melanoma is a hypervascular tumor where angiogenesis significantly impacts metastasis.
- Targeting multiple angiogenesis pathways with combination therapy is a rational approach for advanced melanoma.
Purpose of the Study:
- To evaluate the efficacy and toxicity of combining low-dose thalidomide with low-dose interferon (IFN)-alpha2b.
- To assess this combination therapy in patients with stage IV melanoma who have not responded to prior treatments.
Main Methods:
- Fifteen patients with stage IV melanoma (cutaneous and uveal) received oral thalidomide (200 mg daily) and subcutaneous IFN-alpha2b (3 MIU, 3x/week).
- Primary endpoint was stabilization or regression of metastases, with monthly toxicity and bi-monthly response evaluations.
Main Results:
- One partial response and three stable disease cases were observed among evaluable patients.
- Median overall survival was 4.7 months, and median progression-free survival was 1.8 months.
- Grade 3 toxicities included neutropenia (n=5), elevated transaminases (n=2), and neuropathy (n=1); no treatment-related deaths occurred.
Conclusions:
- Combination therapy with thalidomide and IFN is a safe and tolerable palliative treatment for previously treated stage IV melanoma.
- This approach warrants consideration for patients with advanced metastatic melanoma who have exhausted other treatment options.
