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Modulation of human lymphoblastoid interferon activity by melatonin in metastatic renal cell carcinoma. A phase II
1Oncological Day Hospital, Institute of Internal Medicine, Florence, Italy.
Background:
Numerous attempts to identify active cytotoxic agents for the treatment of metastatic renal cell carcinoma (RCC) have proved disappointing. However, several recent developments in biologic therapy of neoplastic disease have substantially improved the prospects for the treatment of advanced RCC. Melatonin (MLT), a hormone regulated by the pineal gland, has been shown to act on the immune system by causing the release of cytokines from activated T-cell populations.
Methods:
A series of 22 patients with documented progressing RCC entered a trial in which the authors studied the effect of a long term regimen (12 months) with human lymphoblastoid interferon (IFN), 3 mega units (MU) intramuscularly 3 times per week, and MLT, 10 mg orally every day.
Results:
Twenty-one patients were evaluable for response and toxicity. There were seven remissions (33%): three complete, involving lung and soft tissue and four partial, with a median duration at the time of this writing of 16 months. Nine patients achieved stable disease, and five progressed. General toxicity was mild. Fever, chills, arthralgias, and myalgias occurred rarely. Leukopenia and hepatic enzyme elevation were modest and always reversible.
Conclusions:
Response rate and toxic effects observed during this study warrant additional randomized studies to define the role of MLT's concomitant administration in the clinical response to IFN in metastatic RCC.
Insights
This study explored the combination of melatonin (MLT) and interferon (IFN) for metastatic renal cell carcinoma (RCC). The treatment showed a 33% remission rate with mild toxicity, suggesting potential for advanced RCC therapy.
Area of Science:
- Oncology
- Immunology
- Endocrinology
Background:
- Metastatic renal cell carcinoma (RCC) treatment has historically faced challenges with cytotoxic agents.
- Biologic therapies offer improved prospects for advanced RCC.
- Melatonin (MLT), a pineal gland hormone, modulates the immune system by influencing cytokine release from T-cells.
Purpose of the Study:
- To evaluate the efficacy and toxicity of a combined 12-month regimen of human lymphoblastoid interferon (IFN) and melatonin (MLT) in patients with advanced metastatic RCC.
Main Methods:
- A trial involving 22 patients with documented progressing RCC.
- Treatment consisted of 3 mega units (MU) of IFN intramuscularly three times weekly and 10 mg of MLT orally daily for 12 months.
- Twenty-one patients were evaluable for response and toxicity.
Main Results:
- Seven out of 21 evaluable patients (33%) achieved remission (3 complete, 4 partial), with a median duration of 16 months.
- Nine patients had stable disease, and five experienced disease progression.
- General toxicity was mild, with rare occurrences of fever, chills, arthralgias, and myalgias. Leukopenia and elevated hepatic enzymes were modest and reversible.
Conclusions:
- The observed response rate and toxicity profile suggest that concomitant administration of MLT with IFN warrants further investigation.
- Additional randomized studies are needed to define the precise role of MLT in enhancing clinical response to IFN for metastatic RCC.