Vindesine. A clinical trial with special reference to neurological side effects

Area of Science:

• Oncology
• Pharmacology
• Clinical Medicine

Background:

• Vindesine (VDS) has demonstrated promising tumoricidal activity in preclinical and clinical studies, particularly in leukemias and lymphomas.
• Understanding the safety profile and dose-related toxicities of VDS is crucial for its clinical application in cancer chemotherapy.

Purpose of the Study:

• To evaluate the clinical, hematologic, and neurological side effects of vindesine (VDS) in patients with advanced malignant neoplasms.
• To investigate potential dose-response relationships for VDS-induced toxicities.

Main Methods:

• Twenty-two chemotherapy-naive patients with various malignant neoplasms received vindesine (VDS) intravenously at doses ranging from 0.5 to 3.0 mg/m2.
• Treatment was administered once or thrice weekly.
• Clinical observations, hematologic parameters, and neurological assessments including electroneurography were performed.

Main Results:

• Common clinical side effects included fatigue, paresthesias, and myalgias.
• Hematologically, a trend towards leukopenia was noted at higher VDS doses, with a significant increase in thrombocyte count.
• A dose-related diminution of proprioceptive reflexes, particularly in the lower extremities, was observed, with diminished or absent Achilles and patellar reflexes noted even at 2.0 mg/m2 VDS.

Conclusions:

• Vindesine (VDS) exhibits a manageable side effect profile, with neurological effects, specifically proprioceptive reflex impairment, being a notable dose-dependent toxicity.
• Further research is warranted to optimize VDS dosing strategies to maximize therapeutic efficacy while minimizing neurological side effects in cancer patients.