Levamisole in advanced human breast cancer

Area of Science:

• Immunology
• Oncology
• Clinical Pharmacology

Background:

• Primary inoperable breast cancer (stage III) presents a significant clinical challenge.
• Radiotherapy can render patients clinically disease-free, necessitating adjuvant treatment strategies.
• Modulation of the immune response is a potential therapeutic avenue for cancer treatment.

Purpose of the Study:

• To evaluate the efficacy of levamisole as an adjuvant therapy in women with primary inoperable breast cancer.
• To assess the impact of levamisole on disease-free interval and overall survival.
• To investigate levamisole's effects on immune parameters and its toxicity profile.

Main Methods:

• A randomized clinical trial involving 43 women with stage III breast cancer.
• Patients were rendered disease-free by radiotherapy and then allocated to either a control group or a levamisole-treated group.
• Levamisole was administered orally (150 mg three times a week on alternate weeks) with follow-up via physical examination and laboratory tests.

Main Results:

• The levamisole group showed a significantly prolonged median disease-free interval (25 vs. 9 months) compared to controls.
• Survival rates were substantially higher in the levamisole group (90% alive at 30 months vs. 35% in controls).
• Levamisole treatment increased delayed hypersensitivity skin reactions and absolute lymphocyte counts, with no significant observed toxicity.

Conclusions:

• Levamisole demonstrates significant efficacy in prolonging disease-free interval and improving survival in patients with advanced breast cancer.
• The observed enhancement of immune responses suggests levamisole's potential as an immunomodulatory agent in cancer therapy.
• Levamisole is a well-tolerated treatment option with a favorable safety profile in this patient population.